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Wednesday, August 8, 2012

Dilzem XL

DILZEM XL 120 mg, 180 mg, 240 mg

Prolonged-release

Hard Capsules

(Diltiazem hydrochloride)

Read all of this leaflet carefully before you start taking this medicine.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1. What DILZEM XL is and what it is used for.

2. Before you take DILZEM XL.

3. How to take DILZEM XL.

4. Possible side effects.

5. How to store DILZEM XL.

6. Further information.

What Dilzem Xl Is And What It Is Used For

DILZEM XL contains the active ingredient, diltiazem hydrochloride.

Diltiazem belongs to a group of medicines called calcium channel blockers. These medicines work to lower blood pressure and ease anginal chest pain by preventing the narrowing of blood vessels.

DILZEM XL is designed to release the active ingredient, diltiazem, in a controlled manner throughout the whole day so that blood pressure and angina are treated for a full 24 hour period.

DILZEM XL is used to treat and control mild to moderately high blood pressure and to prevent and treat chest pain due to the narrowing of blood vessels in the heart.

Before You Take Dilzem Xl

Do not take DILZEM XL if you:

Are allergic to diltiazem hydrochloride or any of the other ingredients of DILZEM XL.

Are a woman able to have children and not using contraception.

Are pregnant or think you may be pregnant or are breast-feeding.

Are currently in shock (reduced blood flow to vital organs).

Suffer from any serious heart problems such as heart failure with shortness of breath and abnormal heart rhythm which may result in palpitation.

Have a very low pulse rate or low blood pressure.

Are currently receiving an infusion of a muscle relaxant called dantrolene (this is only given in hospitals).

Take special care with DILZEM XL if you have:

Diabetes.

Any liver or kidney problems.

Any heart problems such as heart failure with shortness of breath, low pulse rate and abnormal heart rhythm which may result in palpitation.

A rare disease of the blood pigment called ‘porphyria’, or anyone in your family has it.

If any of the above apply to you, please tell your doctor before taking DILZEM XL.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This is especially important if you are taking any of the following medicines:

Digoxin, beta-blockers (such as propanolol), ACE inhibitors (such as enalapril), warfarin, amiodarone or any other medicines used to treat heart problems.

Methyldopa, nifedipine, diuretics (such as bendrofluazide), alpha blockers such as hytrin and doxazosin.

Simvastatin or atorvastatin (used to treat high cholesterol).

Phenobarbital or carbamazepine (used to treat epilepsy).

Rifampicin to treat tuberculosis.

Theophylline used to treat asthma.

Ciclosporin (a corticosteroid).

Lithium (used to treat mental problems).

If you are due to have surgery, or visit your dentist, tell the doctor or dentist that you are taking DILZEM XL as it may interact with anaesthetics.

Pregnancy and breast-feeding

Do not take DILZEM XL if you are pregnant, think you may be pregnant, or if you are breast-feeding.

Driving and using machines

DILZEM XL should not affect your ability to drive or use machines. However, if you feel faint or dizzy, do not drive or operate any machines.

Important information about some of the ingredients of DILZEM XL

DILZEM XL contains sucrose. If you have been told that you have an intolerance to some sugars, contact your doctor before taking DILZEM XL.

How To Take Dilzem Xl

Always take DILZEM XL exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The usual dose for adults is one 180 mg capsule a day.

Always swallow the capsules whole with water.

Do not suck or chew the capsule or remove the contents as this will affect the special release properties of the product.

Your doctor may increase the dose of DILZEM XL, depending on your response to the drug.

Elderly patients and those with kidney or liver problems may be started on a lower dose of 120 mg a day.

DILZEM XL is not recommended for children.

If you take more DILZEM XL than you should

If you accidentally take too many DILZEM XL capsules, tell your doctor immediately or go to the nearest hospital accident and emergency department. Take along any capsules that are left, the container and the label so that the hospital staff can easily tell what medicine you have taken.

If you forget to take DILZEM XL

If you forget to take a dose, take it as soon as you remember. If it is almost time for your next dose (up to eight hours before), do not take the missed dose but take your next dose at your normal time. Do not take a double dose to make up for the forgotten one.

Dilzem XL Side Effects

Like all medicines, DILZEM XL can cause side effects, although not everybody gets them.

If you notice any of the following, stop taking DILZEM XL and contact your doctor immediately:

Swelling of the face, lips, tongue or glands.

Skin rash, blistering affecting the skin, mouth, eyes, genitals or anus.

Sore throat and fever.

As these may be signs of an allergic reaction.

If you notice any of the following, stop taking DILZEM XL and contact your doctor immediately:

Darkening of your urine.

Pale stools.

Yellowing of your skin or eyes.

As these may be signs of liver problems.

The most common side effects of DILZEM XL (affecting between 1 in 10 and 1 in 100 people) are:

Headache, dizziness, weakness.

Slow or irregular heart rate, changes in the hearts electrical impulses.

Flushing, feeling sick.

Other side effects of DILZEM XL include:

Chest pain, heart failure, low blood pressure, palpitations, fainting, numbness.

Memory loss, depression, nervousness, change in personality.

Problems sleeping, tiredness, hallucinations, shaking, ringing in ears, staggering.

Rash, itching, increased skin sensitivity to sunlight.

Loss of appetite, constipation, diarrhoea, indigestion, being sick, weight gain, inflammation or overgrowth of the gums.

Eye irritation, lazy eye, blocked nose, nose bleed, shortness of breath.

Pain in muscles, bones or joints.

Increased need to pass urine or an increased volume of urine, especially at night.

Swelling of breast tissue in men, loss of ability to have, or loss of interest in sex.

Reduction in blood platelets which increases the risk of bruising or bleeding, increased blood sugar levels.

If any of these side effects become serious or you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist

How To Store Dilzem Xl

Do not store above 25°C. Store in the original package.

Keep out of the reach and sight of children.

Do not use DILZEM XL after the last day of the month shown in the expiry date printed on the carton and on the blister strips.

If your doctor tells you to stop your treatment, return any left over capsules to the pharmacist.

Further Information

What DILZEM XL contains

Each DILZEM XL capsule contains 120 mg, 180 mg or 240 mg of the active ingredient diltiazem hydrochloride. The other ingredients are: fumaric acid, talc, povidone, sugar spheres (containing sucrose and maize starch), ammonio methacrylate copolymer Type A, ammonio methacrylate copolymer Type B. The capsule shell contains gelatin, titanium dioxide (E171), black iron oxide (E172), shellac and propylene glycol (E1520).

What DILZEM XL looks like and contents of the pack

DILZEM XL capsules are white coloured capsules printed with e120, e180 or e240. They are supplied in blister packs of 28 capsules.

Marketing Authorisation Holder

Cephalon Limited

1 Albany Place

Hyde Way

Welwyn Garden City

Hertfordshire

AL7 3BT

Manufacturer

Elan Pharma International Ltd.

Athlone

Co. Westmeath

Ireland

This leaflet was last approved in September 2009

For more information in the UK please call free on 0800 783 4869 or e-mail: UKMedInfo@cephalon.com

6001280/8

0024/12

Monday, August 6, 2012

Metrotop (Molnlycke Health Care )

1. Name Of The Medicinal Product

Metrotop.

2. Qualitative And Quantitative Composition

Metronidazole BP 0.8% w/v.

3. Pharmaceutical Form

A colourless aqueous gel.

4. Clinical Particulars

4.1 Therapeutic Indications

For the treatment of malodorous fungating tumours, gravitational ulcers and decubitus ulcers (pressure sores).

4.2 Posology And Method Of Administration

For external use only. Adults: All wounds should be cleaned thoroughly. Flat wounds require a liberal application of the gel over the complete area. Cavities should be loosely packed with paraffin gauze which has been smeared in the gel. All wounds should be covered with a non-adherent dressing and a pad of lint or gauze. Sticking may occur if the appropriate dressing is not used. Use once or twice daily as necessary. Elderly: No specific instructions. Children: Where necessary, instructions apply as for adults.

4.3 Contraindications

Known hypersensitivity to metronidazole.

4.4 Special Warnings And Precautions For Use

The following statements take into account the possibility that metronidazole may be absorbed after topical application. However, there is no evidence of any significant systemic concentrations of metronidazole following topical applications. Peripheral neuropathy has been reported in association with prolonged use of metronidazole. The elimination half-life of metronidazole remains unchanged in the presence of renal failure. Such patients, however, retain the metabolite of metronidazole. The clinical significance of this is not known at present. However, in patients undergoing dialysis, metronidazole and metabolites are efficiently removed.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Some potentiation of anticoagulant therapy has been reported when metronidazole has been used with the warfarin type oral anticoagulants. Patients receiving phenobarbitone metabolise metronidazole at a much faster rate than normal, reducing the half-life to approximately 3 hours. Patients are advised not to take alcohol during systemic metronidazole therapy because of the possibility of a disulfiram-like reaction.

4.6 Pregnancy And Lactation

There is inadequate evidence of the use of metronidazole in pregnancy. Metronidazole gel cannot therefore be recommended during pregnancy or lactation where significant systemic absorption may occur unless the physician considers it essential.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

No adverse effects have been reported. Systemic metronidazole therapy may occasionally cause an unpleasant taste in the mouth, furred tongue, nausea, vomiting, gastrointestinal disturbance, urticaria, angioedema and anaphylaxis. Drowsiness, dizziness, headache, ataxia, skin rash, pruritus, and darkening of the urine have been reported, but rarely.

4.9 Overdose

There is no specific treatment for gross overdosage of metronidazole. Gastric lavage is recommended in cases of accidental ingestion. Uneventful recovery has followed overdosage of up to 12g taken orally. Metronidazole is readily removed from the plasma by dialysis.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Metronidazole is a potent agent against the anaerobic bacteria which are believed to produce odorous metabolites as a result of localised tissue colonisation. The aim of the product is to provide a high concentration of metronidazole at and around the site of colonisation in a water-miscible base. This form allows surface spread and penetration within the wound accompanied by ease of aseptic application and up to 24 hours duration of action.

5.2 Pharmacokinetic Properties

There is presently no evidence of any systemic concentrations of metronidazole following topical application.

5.3 Preclinical Safety Data

No further data given.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Hypromellose (4500); benzalkonium chloride solution; purified water.

6.2 Incompatibilities

None known.

6.3 Shelf Life

The shelf life shall not exceed 24 months from the date of manufacture.

6.4 Special Precautions For Storage

Do not store above 25°C. Once opened the contents should be used within 28 days of opening.

6.5 Nature And Contents Of Container

Polypropylene tubes each fitted with a plastic screw cap and tamper-evident seal and enclosed within a printed cardboard carton. Single tubes may sometimes be supplied without a carton. Pack sizes: The 15g, 30g and 60g tubes are available singly or in boxes of 12.

6.6 Special Precautions For Disposal And Other Handling

None given.

7. Marketing Authorisation Holder

Medlock Medical Limited, Tubiton House, Medlock Street, Oldham, OL1 3HS.

8. Marketing Authorisation Number(S)

PL 21248/0040.

9. Date Of First Authorisation/Renewal Of The Authorisation

16^th September 2005.

10. Date Of Revision Of The Text

September 2005.

Friday, August 3, 2012

Ibuprofen Chewable Tablets

Pronunciation: EYE-bue-PROE-fen
Generic Name: Ibuprofen
Brand Name: Examples include Children's Motrin and Motrin Junior Strength

Ibuprofen Chewable Tablets are a nonsteroidal anti-inflammatory drug (NSAID). It may cause an increased risk of serious and sometimes fatal heart and blood vessel problems (eg, heart attack, stroke). The risk may be greater if you already have heart problems or if you take Ibuprofen Chewable Tablets for a long time. Do not use Ibuprofen Chewable Tablets right before or after bypass heart surgery.

Ibuprofen Chewable Tablets may cause an increased risk of serious and sometimes fatal stomach ulcers and bleeding. Elderly patients may be at greater risk. This may occur without warning signs.

Ibuprofen Chewable Tablets are used for:

Treating minor aches and pains caused by the common cold, flu, sore throat, headaches, or toothaches. It may be used to reduce fever. It may also be used for other conditions as determined by your doctor.

Ibuprofen Chewable Tablets are an NSAID. Exactly how it works is not known. It may block certain substances in the body that are linked to inflammation. NSAIDs treat the symptoms of pain and inflammation. They do not treat the disease that causes those symptoms.

Do NOT use Ibuprofen Chewable Tablets if:

you are allergic to any ingredient in Ibuprofen Chewable Tablets

you have had a severe allergic reaction (eg, severe rash, hives, trouble breathing, growths in the nose, dizziness) to aspirin or an NSAID (eg, ibuprofen, celecoxib)

you have recently had or will be having bypass heart surgery

you are in the last 3 months of pregnancy

Contact your doctor or health care provider right away if any of these apply to you.

Before using Ibuprofen Chewable Tablets:

Some medical conditions may interact with Ibuprofen Chewable Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding

if you are taking any prescription or nonprescription medicine, herbal product, or dietary supplement

if you have allergies to medicines, foods, or other substances

if you have a history of kidney or liver disease, diabetes, or stomach or bowel problems (eg, bleeding, perforation, ulcers, persistent or returning stomach pain or heartburn)

if you have a history of swelling or fluid buildup, lupus, phenylketonuria, asthma, growths in the nose (nasal polyps), or mouth inflammation

if you have high blood pressure, blood disorders, bleeding or clotting problems, heart problems (eg, heart failure), or blood vessel disease, or if you are at risk for any of these diseases

if you are dehydrated or have low fluid volume (eg, caused by diarrhea, vomiting, not drinking fluids)

if you have poor health or low blood sodium levels, you drink alcohol, or you have a history of alcohol abuse

Some MEDICINES MAY INTERACT with Ibuprofen Chewable Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

Anticoagulants (eg, warfarin), aspirin, corticosteroids (eg, prednisone), heparin, or selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine) because the risk of stomach bleeding may be increased

Probenecid because it may increase the risk of Ibuprofen Chewable Tablets's side effects

Cyclosporine, lithium, methotrexate, or quinolones (eg, ciprofloxacin) because the risk of their side effects may be increased by Ibuprofen Chewable Tablets

Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril) or diuretics (eg, furosemide, hydrochlorothiazide) because their effectiveness may be decreased by Ibuprofen Chewable Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Ibuprofen Chewable Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Ibuprofen Chewable Tablets:

Use Ibuprofen Chewable Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Ibuprofen Chewable Tablets comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Ibuprofen Chewable Tablets refilled.

Take Ibuprofen Chewable Tablets by mouth with or without food. It may be taken with food if it upsets your stomach. Taking it with food may not lower the risk of stomach or bowel problems (eg, bleeding, ulcers). Talk with your doctor or pharmacist if you have persistent stomach upset.

Chew well before swallowing.

If you miss a dose of Ibuprofen Chewable Tablets and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose. Go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about the proper use of Ibuprofen Chewable Tablets.

Important safety information:

Ibuprofen Chewable Tablets may cause dizziness or drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use Ibuprofen Chewable Tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

Serious stomach ulcers or bleeding can occur with the use of Ibuprofen Chewable Tablets. Taking it in high doses or for a long time, smoking, or drinking alcohol increases the risk of these side effects. Taking Ibuprofen Chewable Tablets with food will NOT reduce the risk of these effects. Contact your doctor or emergency room at once if you develop severe stomach or back pain; black, tarry stools; vomit that looks like blood or coffee grounds; or unusual weight gain or swelling.

Do NOT take more than the recommended dose or use for longer than 10 days for pain or 2 days for sore throat without checking with your doctor.

If stomach pain or upset gets worse or does not get better, check with your doctor. If pain or fever gets worse or lasts for more than 3 days, check with your doctor.

If a child using Ibuprofen Chewable Tablets does not get any relief within 24 hours, contact the child's doctor.

Check with your doctor if you have a severe or persistent sore throat. Check with your doctor if you have a sore throat with fever, headache, nausea, and vomiting.

Ibuprofen Chewable Tablets has ibuprofen in it. Before you start any new medicine, check the label to see if it has ibuprofen in it too. If it does or if you are not sure, check with your doctor or pharmacist.

Some of these products contain phenylalanine. If you must have a diet that is low in phenylalanine, ask your pharmacist if it is in your product.

Do not take aspirin while you are using Ibuprofen Chewable Tablets unless your doctor tells you to.

Use Ibuprofen Chewable Tablets with caution in the ELDERLY; they may be more sensitive to its effects, including stomach bleeding and kidney problems.

Different brands of Ibuprofen Chewable Tablets may have different dosing instructions for CHILDREN. Follow the dosing instructions on the package labeling. If your doctor has given you instructions, follow those. If you are unsure of the dose to give a child, check with your doctor or pharmacist.

PREGNANCY and BREAST-FEEDING: Ibuprofen Chewable Tablets may cause harm to the fetus. Do not take it during the last 3 months of pregnancy. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Ibuprofen Chewable Tablets while you are pregnant. It is not known if Ibuprofen Chewable Tablets are found in breast milk. Do not breast-feed while taking Ibuprofen Chewable Tablets.

Possible side effects of Ibuprofen Chewable Tablets:

All medicines can cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; dizziness; gas; headache; heartburn; nausea; stomach pain or upset.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; trouble breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody or black, tarry stools; change in the amount of urine produced; chest pain; confusion; dark urine; depression; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; mental or mood changes; numbness of an arm or leg; one-sided weakness; red, swollen, blistered, or peeling skin; ringing in the ears; seizures; severe headache or dizziness; severe or persistent stomach pain or nausea; severe vomiting; shortness of breath; stiff neck; sudden or unexplained weight gain; swelling of hands, legs, or feet; unusual bruising or bleeding; unusual joint or muscle pain; unusual tiredness or weakness; vision or speech changes; vomit that looks like coffee grounds; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Ibuprofen side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include decreased urination; loss of consciousness; seizures; severe dizziness or drowsiness; severe nausea or stomach pain; slow or troubled breathing; unusual bleeding or bruising; vomit that looks like coffee grounds.

Proper storage of Ibuprofen Chewable Tablets:

Store Ibuprofen Chewable Tablets at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Ibuprofen Chewable Tablets out of the reach of children and away from pets.

General information:

If you have any questions about Ibuprofen Chewable Tablets, please talk with your doctor, pharmacist, or other health care provider.

Ibuprofen Chewable Tablets are to be used only by the patient for whom it is prescribed. Do not share it with other people.

If your symptoms do not improve or if they become worse, check with your doctor.

Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Ibuprofen Chewable Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

More Ibuprofen resources

Ibuprofen Side Effects (in more detail)
Ibuprofen Dosage
Ibuprofen Use in Pregnancy & Breastfeeding
Drug Images
Ibuprofen Drug Interactions
Ibuprofen Support Group
51 Reviews for Ibuprofen - Add your own review/rating

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Thursday, August 2, 2012

Beconase Aqueous Nasal Spray

Beconase

Aqueous Nasal Spray

beclometasone dipropionate

50 micrograms

Read all of this leaflet carefully before you start using this medicine.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if
their symptoms are the same as yours.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1 What Beconase is and what it is used for

2 Before you use Beconase

3 How to use Beconase

4 Possible side effects

5 How to store Beconase

6 Further information

What Beconase Aqueous Nasal Spray is and what it is used for

Beconase Aqueous Nasal Spray (called ‘Beconase’ in this leaflet) contains a medicine called beclometasone
dipropionate. This belongs to a group of medicines called steroids (also called ‘cortico-steroids’).

Steroids work by reducing inflammation

they reduce swelling and irritation in your nose

this helps to relieve itching, sneezing and your blocked or runny nose.

Beconase is used to prevent and treat:

Inflammation in the lining of your nose (rhinitis) due to seasonal allergies, such as Hayfever.

Inflammation in the lining of your nose (rhinitis) due to year round (perennial) allergies, such as animal allergies.

Before you use Beconase Aqueous Nasal Spray

Do not use Beconase if:

you are allergic (hypersensitive) to beclometasone dipropionate or any of the other ingredients of
Beconase Aqueous Nasal Spray (listed in section 6).

Taking other medicines

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This includes herbal medicines.

Check with your doctor or pharmacist before using your medicine if:

you have had steroids for a long time, either as an injection or by your mouth.

you have ever had an operation on your nose

you have an infection in your nose

If you are unsure if the above apply to you, talk to your doctor or pharmacist before using Beconase.

Taking Beconase with food and drink

You can use Beconase at any time of day, with or without food.

Pregnancy and breast-feeding

Talk to your doctor before using this medicine if you are pregnant, might become pregnant, or are breast-feeding.

Driving and using machines

Beconase is not likely to affect you being able to drive or use any tools or machines.

Important information about some of the ingredients of Beconase

Beconase contains Benzalkonium chloride which may cause problems with your breathing (bronchospasm).

How to use Beconase Aqueous Nasal Spray

Always use Beconase exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Do not use in children under 6 years old.

It takes a few days for this medicine to work. So keep using it, even though you may not feel better
straight away.

You should use the spray every day.

How much to use - adults and children (aged 6 and over)

The usual starting dose is 2 sprays into each nostril twice a day.

The most you would use in over 24 hours is normally 8 sprays (4 sprays per nostril).

As you become better, your doctor may ask you to use a lower dose - one spray into each nostril twice a day.

If your symptoms then get worse, your dose may be increased back to the starting dose.

Do not use a larger dose or use your nasal spray more often than your doctor tells you.

If you use high doses of Beconase

There are times when your doctor may need to adjust the dose of the steroid you are given or the way in
which you take it. These times are:

times of extreme stress

during admission to hospital after a serious accident, injury or illness

before and after a surgical operation.

If you think that any of these apply to you whilst using Beconase, speak to your doctor or pharmacist.

Preparing your spray

Each spray has a dust cap which protects the nozzle and keeps it clean. Remember to take this off before using the spray.

A new spray (or one that has not been used for a few days), may not work first time. You need to ‘prime’ the spray by pumping the spray a few times until a fine mist is produced.

1 Hold the bottle as shown and make sure it is pointed away from you.

2 Put your forefinger and middle finger on the collar either side of the nozzle and put your
thumb underneath the bottle.

3 Keep your thumb still, and press down with your fingers to pump the spray.

If the spray does not work and you think it may be blocked, you will need to clean it. Please see
the section over the page, Cleaning your spray.

Never try to unblock or enlarge the tiny spray hole with a pin or other sharp object. This will damage the way the spray works.

Using your spray

1 Shake the bottle and take off the dust cap.

2 Blow your nose gently.

3 Close one nostril with your finger as shown, and put the nozzle in the other nostril. Tilt
your head forward slightly and keep the bottle upright. Hold the bottle as shown.

4 Start to breathe in slowly through your nose. While you are breathing in press down firmly on the collar with your fingers. A spray of fine mist will go into your nostril.

5 Breathe out through your mouth.

6 Repeat step 4 to use a second spray in the same nostril.

7 Remove the nozzle from this nostril and breathe out through your mouth.

8 Repeat steps 3 to 6 for your other nostril.

9 After using your spray, wipe the nozzle carefully with a clean tissue or handkerchief, and replace the dust cap.

Cleaning your spray

Clean your spray at least once a week, or more often if it gets blocked.

1 Take the dust cap off.

2 Pull upwards on the white collar to remove the nozzle.

3 Soak the nozzle and dust cap in warm water for a few minutes.

4 Then rinse under a running tap.

5 Shake off the excess water and let them dry in a warm place.

6 Put the nozzle back on the spray.

7 ‘Prime’ the bottle as described in the section over the page, Preparing your spray.

If you forget to use Beconase

If you miss a dose, just use the next dose when it is due.

If you use more Beconase than you should

Tell your doctor if you use more than you were told to.

If you stop using Beconase

Do not stop treatment even if you feel better, unless your doctor tells you to stop. If you do stop, the
symptoms may come back.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Possible side effects

Like all medicines, Beconase can cause side effects, although not everybody gets them. The following side
effects may happen with this medicine:

Immediately after you use your spray

You may sneeze a little, but this soon stops.

Very occasionally you may find you get an unpleasant taste or smell.

Tell your doctor as soon as possible if you notice any of the following side effects:

Common (affects less than 1 in 10 people)

A dry or painful nose or throat.

Bad nose bleeds.

Mild allergic reactions including skin rashes or redness, itching or weals like nettle rash or hives.

Very rare (affects less than 1 in 10,000 people)

Problems with your eyes such as pain or blurred vision.

Damage to your nose

Severe allergic reactions - the signs may include swelling of your face or throat, shortness of breath
or wheezing. If this happens, tell your doctor straight away - you may need urgent medical treatment.

Very rarely, the normal production of steroids in your body may be affected. This is more likely to happen if
you use high doses for a long time. Your doctor will help stop this happening by making sure you use the lowest dose of steroid which controls your symptoms.

In children this side effect can rarely cause them to grow more slowly than others. Children who receive
this treatment for a long period of time will have their height checked regularly by their doctor.

If you notice any side effects not listed in this leaflet tell your doctor as soon as possible.

How to store Beconase Aqueous Nasal Spray

Keep out of the reach and sight of children.

Protect from frost and light.

Do not store above 30°C (86°F).

Do not put in a refrigerator.

Do not use Beconase after the expiry date which is stated on the label and carton after ‘EXP’. The expiry
date refers to the last day of that month.

Stop using this bottle three months after you first opened it.

If you are told to stop using this medicine return any unused spray to your pharmacist to be destroyed.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to protect the environment.

Further Information

What Beconase Aqueous Nasal Spray contains

The active substance is beclometasone dipropionate.

The other ingredients are microcrystalline cellulose, sodium carboxymethylcellulose, dextrose, polysorbate 80, purified water and the preservatives benzalkonium chloride and phenylethylalcohol. These other
ingredients are needed to make a stable suspension which will not go off.

What Beconase Aqueous Nasal Spray looks like and contents of the pack

Each bottle delivers 200 sprays. Each spray contains 50 micrograms of beclometasone dipropionate.

Marketing Authorisation Holder

Glaxo Wellcome UK Ltd

Trading as Allen and Hanburys

Stockley Park West

Uxbridge

Middlesex

UB11 1BT

Manufacturer

Glaxo Wellcome SA

Aranda de Duero

Burgos

Spain

Other formats:

To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:

0800 198 5000 (UK Only)

Please be ready to give the following information:

Product name Beconase Aqueous Nasal Spray

Reference number 10949/0104

This is a service provided by the Royal National Institute of the Blind.

Leaflet date: September 2008

Beconase is a trademark of the GlaxoSmithKline group of companies.

10000000046898

Tuesday, July 31, 2012

Symbicort 200 Turbuhaler

Generic Name: budesonide and formoterol (Inhalation route)

bue-DES-oh-nide, for-MOE-ter-ol FUE-ma-rate

Commonly used brand name(s)

In the U.S.

Symbicort

In Canada

Symbicort 100 Turbuhaler

Symbicort 200 Turbuhaler

Available Dosage Forms:

Aerosol Liquid

Powder

Therapeutic Class: Antiasthma, Anti-Inflammatory/Bronchodilator Combination

Pharmacologic Class: Adrenal Glucocorticoid

Uses For Symbicort 200 Turbuhaler

Budesonide and formoterol is a combination of two medicines that are used to help control the symptoms of asthma and improve lung function. It is used when a patient's asthma has not been controlled sufficiently on other asthma medicines, or when a patient's condition is so severe that more than one medicine is needed every day. This medicine will not relieve an asthma attack that has already started.

This medicine is also used to treat air flow blockage and reduce the worsening of chronic obstructive pulmonary disease (COPD). This includes chronic bronchitis and emphysema.

Inhaled budesonide belongs to the family of medicines known as corticosteroids (cortisone-like medicines). It works by preventing inflammation (swelling) in the lungs that causes an asthma attack.

Inhaled formoterol belongs to the family of medicines known as bronchodilators. It works by helping the muscles around the airways in your lungs stay relaxed to prevent asthma symptoms, such as wheezing and shortness of breath.

This medicine is available only with your doctor's prescription.

Before Using Symbicort 200 Turbuhaler

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of budesonide and formoterol combination in children. However, safety and efficacy have not been established in children younger than 12 years of age. .

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of budesonide and formoterol combination in the elderly. However, elderly patients with heart problems may require special caution when receiving budesonide and formoterol combination.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acebutolol

Alprenolol

Arotinolol

Atenolol

Befunolol

Betaxolol

Bevantolol

Bisoprolol

Boceprevir

Bopindolol

Brofaromine

Bucindolol

Bupranolol

Bupropion

Carteolol

Carvedilol

Celiprolol

Clorgyline

Dilevalol

Esmolol

Furazolidone

Iproniazid

Isocarboxazid

Labetalol

Landiolol

Lazabemide

Levobetaxolol

Levobunolol

Linezolid

Mepindolol

Metipranolol

Metoprolol

Moclobemide

Nadolol

Nebivolol

Nialamide

Nipradilol

Oxprenolol

Pargyline

Penbutolol

Phenelzine

Pindolol

Procarbazine

Propranolol

Rasagiline

Selegiline

Sotalol

Talinolol

Telaprevir

Tertatolol

Timolol

Toloxatone

Tranylcypromine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Erythromycin

Itraconazole

Ketoconazole

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of budesonide and formoterol

This section provides information on the proper use of a number of products that contain budesonide and formoterol. It may not be specific to Symbicort 200 Turbuhaler. Please read with care.

This medicine is used with a special inhaler and usually comes with patient directions or a Medication Guide. Read the directions carefully before using this medicine. If you do not understand the directions or you are not sure how to use the inhaler, ask your doctor or pharmacist to show you what to do.

Use this medicine only as directed. Do not use more of it and do not use it more often than your doctor ordered. Also, do not stop taking this medicine without telling your doctor. To do so may increase the chance of side effects.

When you use the inhaler for the first time, or if you have not used it for 7 days or longer, or if the inhaler has been dropped, it may not deliver the right amount of medicine with the first puff. Therefore, before using the inhaler, prime it by spraying the medicine two times into the air away from the face, and shaking it well for 5 seconds before each spray.

How to use this medicine:

Take the inhaler out of the moisture-protective foil pouch before you use it for the first time.

Do not use the inhaler for this medicine with any other medicine.

Prime the inhaler before use by shaking the inhaler well for 5 seconds and then releasing a test spray. Once again, shake the inhaler and release a second test spray.

Breathe out to the end of a normal breath (exhale). Do not breathe into the inhaler.

Holding the inhaler level, put the mouthpiece fully into your mouth and close your lips around it. Do not block the mouthpiece with your teeth or tongue.

While pressing down firmly and fully on the grey top of the inhaler, breathe in through your mouth as deeply as you can until you have taken a full deep breath.

Hold your breath and remove the mouthpiece from your mouth. Continue holding your breath as long as you can up to 10 seconds before breathing out slowly. This gives the medicine time to settle in your airways and lungs.

Release your finger from the grey top and then turn your head away from the inhaler. Breathe out slowly to the end of a normal breath. Do not breathe into the inhaler.

Shake the inhaler again for 5 seconds and take the second puff following exactly the same steps you used for the first puff.

Replace the mouthpiece cover after using the medicine.

Gargle and rinse your mouth with water after each dose; this will help prevent hoarseness, throat irritation, and infection in the mouth. Do not swallow the water after rinsing.

Each inhaler comes with a dose tracker card to track the number of puffs you have used. Mark off or punch through each of your morning and evening doses. You must discard the inhaler after you have used the number of inhalations on the product label and box, or within 3 months of opening the foil pouch.

Clean the inhaler every 7 days by wiping the mouthpiece with dry cloth. However, you must use a new inhaler with each refill of your medicine.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For inhalation dosage form (aerosol):
- For preventing an asthma attack:
  - Adults and children 12 years of age and older—Two puffs in the morning and another 2 puffs in the evening. Each puff contains 80 or 160 micrograms (mcg) of budesonide and 4.5 mcg of formoterol.
  - Children younger than 12 years of age—Use and dose must be determined by your child's doctor.
- For treatment of COPD:
  - Adults—Two puffs in the morning and another 2 puffs in the evening. Each puff contains 160 micrograms (mcg) of budesonide and 4.5 mcg of formoterol.
  - Children 12 years of age and older—Not used for COPD in this age group.
  - Children younger than 12 years of age—Not used for COPD in this age group.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the canister at room temperature, away from heat and direct light. Do not freeze. Do not keep this medicine inside a car where it could be exposed to extreme heat or cold. Do not poke holes in the canister or throw it into a fire, even if the canister is empty.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

When you store the inhaler, make sure to always place the mouthpiece down.

Precautions While Using Symbicort 200 Turbuhaler

It is very important that your doctor check the progress of you or your child at regular visits, to make sure that this medicine is working properly and to check for any unwanted effects that may be caused by this medicine. You may need to have your eyes checked at regular visits. Be sure to keep all appointments.

Although this medicine decreases the number of asthma episodes, it may increase the chances of a severe asthma episode when they do occur. Talk to your doctor about any questions or concerns that you have.

This should not be the first and only medicine you use for asthma or COPD. This medicine will not stop an asthma attack that has already started. Your doctor may prescribe another medicine for you to use in case of an acute asthma attack or an acute COPD flare-up. If the other medicine does not work as well, tell your doctor right away.

Take all of your COPD medicines as your doctor ordered. If you use any type of corticosteroid medicine to control your breathing, keep using it as ordered by your doctor. Do not change your doses or stop using your medicines without asking your doctor.

You or your child should not use this medicine if your asthma attack has already started or if you already have a severe asthma attack. Your doctor may prescribe another medicine (e.g., a short-acting inhaler) for you to use in case of an acute asthma attack. Call your doctor immediately for instructions.

Do not use any other asthma medicine or medicine for breathing problems without talking to your doctor. This medicine should not be used with salmeterol (Serevent®), formoterol (Perforomist™), or arformoterol (Brovana®) inhalers.

Talk to your doctor or get medical care right away if:

Your or your child's symptoms do not improve after using this medicine for 1 week or if they become worse.

Your short-acting inhaler does not seem to be working as well as usual and you need to use it more often (e.g.; you use 1 whole canister of your short-acting inhaler in 8 weeks time, or you need to use 4 or more inhalations of your short-acting inhaler for 2 or more days in a row).

You or your child have a significant decrease in your peak flow when measured as directed by your doctor.

You may get infections more easily while using this medicine. Tell your doctor right away if you or your child have been exposed to someone with chickenpox or measles.

This medicine may cause fungus infection of the mouth or throat (thrush). Tell your doctor right away if you have white patches in the mouth or throat; or pain when eating or swallowing.

Patients with COPD may be more likely to have pneumonia when taking this medicine. Check with your doctor if you start having increased sputum (spit) production, change in sputum color, fever, chills, increased cough, or an increase in breathing problems.

Using too much of this medicine or using it for a long time may increase your risk of having adrenal gland problems. Talk to your doctor if you or your child have more than one of these symptoms while you are using this medicine: darkening of the skin; diarrhea; dizziness; fainting; loss of appetite; mental depression; nausea; skin rash; unusual tiredness or weakness; or vomiting.

This medicine may cause paradoxical bronchospasm, which may be life-threatening. Check with your doctor right away if you are having a cough, difficulty with breathing, shortness of breath, or wheezing.

If you or your child develop a skin rash, hives, or any allergic reaction to this medicine, stop taking the medicine and check with your doctor as soon as possible.

This medicine may decrease bone mineral density when used for a long time. A low bone mineral density can cause weak bones or osteoporosis. If you have any questions about this, ask your doctor.

This medicine may cause children to grow more slowly than usual. Talk to your child's doctor if you have any concerns.

This medicine may affect blood sugar and potassium levels. If you notice a change in the results of your blood or urine sugar or potassium tests or if you have any questions, check with your doctor.

Your doctor may want you to carry a medical identification card stating that you or your child are using this medicine and that you may need additional medicine during times of emergency, a severe asthma attack or other illness, or unusual stress.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Symbicort 200 Turbuhaler Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Body aches or pain

chills

cough, fever, sneezing, or sore throat

difficulty with breathing

ear congestion

fever

headache

loss of voice

muscle aches

pain or tenderness around the eyes and cheekbones

shortness of breath or troubled breathing

stuffy or runny nose

tightness of the chest or wheezing

unusual tiredness or weakness

Less common

Abdominal or stomach pain

bladder pain

bloody or cloudy urine

congestion

cough producing mucus

diarrhea

difficult, burning, or painful urination

dryness of the throat

fast, irregular, pounding, or racing heartbeat or pulse

frequent urge to urinate

general feeling of discomfort or illness

hoarseness

joint pain

loss of appetite

lower back or side pain

nausea

noisy breathing

shakiness in the legs, arms, hands, or feet

shivering

sore mouth or tongue

sweating

tender, swollen glands in the neck

trembling or shaking of the hands or feet

trouble with swallowing

trouble with sleeping

voice changes

vomiting

white patches in the mouth or on the tongue

Rare

Blurred vision

confusion

decreased urine

dizziness or lightheadedness when getting up from a lying or sitting position suddenly

dry mouth

enlarged pupils

fainting

flushed, dry skin

fruit-like breath odor

increased hunger

increased sensitivity of the eyes to light

increased sweating, possibly with fever or cold, clammy skin

increased thirst

increased urination

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

mood changes

muscle cramps

nervousness

numbness or tingling in the hands, feet, or lips

pounding in the ears

seizures

severe chest pain

severe headache

slow, fast, pounding, or irregular heartbeat or pulse

stiff or sore neck

unexplained weight loss

Incidence not known

Blindness

decreased vision

eye pain

puffiness or swelling of the eyelids or around the eyes, face, lips or tongue

tearing

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Arm, back, or jaw pain

chest pain or discomfort

darkening of the skin

drowsiness

mental depression

rapid, deep breathing

restlessness

skin rash

sleeplessness

stomach cramps

unable to sleep

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Stomach discomfort

Less common

Acid or sour stomach

belching

difficulty with moving

heartburn

indigestion

muscle spasms or stiffness

pain in the arms or legs

stomach upset

swollen joints

Rare

Bad, unusual, or unpleasant (after) taste

change in taste

deep or fast breathing with dizziness, numbness to feet, hands, and around the mouth

fear

hives or welts

irritability

itching skin

large, flat, blue, or purplish patches in the skin

redness of the skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Symbicort 200 Turbuhaler side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Symbicort 200 Turbuhaler resources

Symbicort 200 Turbuhaler Side Effects (in more detail)
Symbicort 200 Turbuhaler Use in Pregnancy & Breastfeeding
Symbicort 200 Turbuhaler Drug Interactions
Symbicort 200 Turbuhaler Support Group
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Asthma, Maintenance
COPD
COPD, Maintenance

Monday, July 30, 2012

Epivir A/F

Generic Name: lamivudine (Oral route)

la-MIV-ue-deen

Oral route(Tablet;Solution)

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported. Severe acute exacerbations of hepatitis B have been reported in patients who have hepatitis B infection or are co-infected with hepatitis B virus (HBV) and HIV-1 and have discontinued lamivudine; monitor hepatic function upon discontinuation of therapy. EPIVIR(R) tablets and oral solution (used to treat HIV-1 infection) contain a higher dose of the active ingredient (lamivudine) than EPIVIR-HBV(R) tablets and oral solution (used to treat chronic hepatitis B). Patients with HIV infection should receive only dosage forms appropriate for treatment of HIV-1. EPIVIR-HBV(R) tablets and oral solution contain a lower dose of the same active ingredient (lamivudine) as EPIVIR(R) tablets and oral solution used to treat HIV infection. If treatment with EPIVIR-HBV(R) is prescribed for chronic hepatitis B for a patient with unrecognized or untreated HIV infection, rapid emergence of HIV resistance is likely because of subtherapeutic dose and inappropriate monotherapy .

Commonly used brand name(s)

In the U.S.

Epivir

Epivir A/F

Epivir HBV

In Canada

Heptovir

Available Dosage Forms:

Solution

Tablet

Therapeutic Class: Antiretroviral Agent

Pharmacologic Class: Nucleoside Reverse Transcriptase Inhibitor

Uses For Epivir A/F

Lamivudine is used in the treatment of the infection caused by the human immunodeficiency virus (HIV) or hepatitis B virus. HIV is the virus that causes acquired immune deficiency syndrome (AIDS). Lamivudine is taken together with zidovudine (AZT) or other medications used to treat HIV.

Lamivudine will not cure or prevent HIV infection or AIDS; however, it helps keep HIV from reproducing and appears to slow down the destruction of the immune system. This may help delay the development of problems usually related to AIDS or HIV disease. Lamivudine will not keep you from spreading HIV to other people. People who receive this medicine may continue to have other problems usually related to AIDS or HIV disease. Lamivudine is not a cure for the hepatitis B virus; the long-term effects of the drug on the infection and the liver are unknown at this time.

Lamivudine is available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in product labeling, lamivudine is used in certain patients with the following medical condition:

Human immunodeficiency virus (HIV) infection due to occupational exposure (possible prevention of)

Before Using Epivir A/F

Allergies

Pediatric

Lamivudine can cause serious side effects. In one study, children with advanced AIDS were more likely than children who were less ill to develop pancreatitis (inflammation of the pancreas) and peripheral neuropathy (a problem involving the nerves). Therefore, it is especially important that you discuss with your child's doctor the good that this medicine may do as well as the risks of using it. Your child must be seen frequently and your child's progress carefully followed by the doctor while the child is taking lamivudine.

Geriatric

Lamivudine has not been studied specifically in older people. Therefore, it is not known whether it causes different side effects or problems in the elderly than it does in younger adults. Talk to your doctor first if you have liver, kidney, heart problems or other diseases. Your doctor may need to adjust your dose.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

Interactions with Medicines

Interferon Alfa

Ribavirin

Zalcitabine

Interactions with Food/Tobacco/Alcohol

Proper Use of lamivudine

This section provides information on the proper use of a number of products that contain lamivudine. It may not be specific to Epivir A/F. Please read with care.

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Also, do not stop taking lamivudine or zidovudine without checking with your doctor first.

Keep taking lamivudine for the full time of treatment , even if you begin to feel better.

This medicine works best when there is a constant amount in the blood. To help keep the amount constant, do not miss any doses . If you need help in planning the best times to take your medicine, check with your health care professional.

If you are using lamivudine oral suspension, use a specially marked measuring spoon or other device to measure each dose accurately. The average household teaspoon may not hold the right amount of liquid. The lamivudine oral suspension contains sucrose. Tell your doctor if you are diabetic before you start taking this medicine.

Only take medicine that your doctor has prescribed specifically for you. Do not share your medicine with others.

Dosing

For oral dosage forms (oral solution and tablets):
- For treatment of hepatitis B infection:
  - Adults —100 milligrams (mg) once a day.
  - Children younger than 16 years of age—Use and dose must be determined by your doctor.
- For treatment of HIV infection or AIDS:
  - Adults weighing 50 kilograms (kg) (110 pounds) or more—150 milligrams (mg) twice a day together with other HIV medications.
  - Adults weighing less than 50 kg (110 pounds)—2 mg per kg of body weight twice a day together with other HIV medications.
  - Children 3 months to 16 years of age—4 mg per kg of body weight, up to 150 mg per dose, twice a day together with other HIV medications.
  - Children younger than 3 months of age—Use and dose must be determined by your doctor.

Note: Patients that require treatment for both hepatitis B and either AIDS or HIV should follow the dosing schedule for HIV or AIDS

Missed Dose

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Epivir A/F

It is very important that your doctor check your progress at regular visits.

Do not take any other medicines without checking with your doctor first. To do so may increase the chance of side effects from lamivudine.

If you have both HIV and hepatitis B virus (HBV) infections, deterioration of liver disease has occurred when lamivudine treatment is stopped. Discuss any changes in your treatment and medicines with your doctor.

HIV may be acquired from or spread to other people through infected body fluids, including blood, vaginal fluid, or semen. If you are infected, it is best to avoid any sexual activity involving an exchange of body fluids with other people. If you do have sex, always wear (or have your partner wear) a condom (“rubber”). Only use condoms made of latex, and use them every time you have vaginal, anal, or oral sex. The use of a spermicide (such as nonoxynol-9) may also help prevent transmission of HIV if it is not irritating to the vagina, rectum, or mouth. Spermicides have been shown to kill HIV in lab tests. Do not use oil-based jelly, cold cream, baby oil, or shortening as a lubricant—these products can cause the condom to break. Lubricants without oil, such as K-Y Jelly, are recommended. Women may wish to carry their own condoms. Birth control pills and diaphragms will help protect against pregnancy, but they will not prevent someone from giving or getting the AIDS virus. If you inject drugs, get help to stop. Do not share needles or equipment with anyone. In some cities, more than half of the drug users are infected, and sharing even 1 needle or syringe can spread the virus. If you have any questions about this, check with your health care professional.

Epivir A/F Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common—especially in children

Abdominal or stomach pain (severe)

feeling of fullness

nausea

sensation or pins and needles

skin rash

stabbing pain

tingling, burning, numbness, or pain in the hands, arms, feet, or legs

unsteadiness or awkwardness

vomiting

Rare

Abdominal discomfort

decreased appetite

diarrhea

fast, shallow breathing

feeling of fullness

fever, chills, or sore throat

general feeling of discomfort

muscle pain or cramping

nausea

shortness of breath

sleepiness

unusual tiredness or weakness

Incidence not determined

Cough

dark urine

difficulty swallowing

dizziness

fast heartbeat

fever

hives or welts

itching

light-colored stools

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

redness of skin

tightness in chest

upper right abdominal pain

wheezing

yellow eyes and skin

More common

Canker sores

difficulty in moving

discouragement

ear discharge

ear swelling

feeling sad or empty

general feeling of discomfort or illness

irritability

loss of appetite

loss of interest or pleasure

nasal discharge or congestion

pain in joints

sores, ulcers, or white spots on lips or tongue or inside the mouth

stomach pain or cramps

swollen and painful spots on neck, armpit, or groin

swollen joints

trouble concentrating

trouble sleeping

unusually warm skin

weight loss

Less common

Acid or sour stomach

belching

cough

heartburn

indigestion

stomach discomfort or upset

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Epivir A/F side effects (in more detail)

Incidence not determined

Body fat redistribution or accumulation

blurred vision

dry mouth

flushed, dry skin

fruit-like breath odor

hair loss

increased hunger or thirst

increased urination

sweating

thinning of hair

More Epivir A/F resources

Epivir A/F Side Effects (in more detail)
Epivir A/F Use in Pregnancy & Breastfeeding
Drug Images
Epivir A/F Drug Interactions
Epivir A/F Support Group
1 Review for Epivir A/F - Add your own review/rating

Compare Epivir A/F with other medications

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Sunday, July 29, 2012

Acetasol HC otic

Generic Name: acetic acid and hydrocortisone (otic) (as SEET ik AS sid and hy dro KOR ti zone)

Brand Names: Acetasol HC

What is Acetasol HC (acetic acid and hydrocortisone (otic))?

Acetic acid fights bacteria.

Hydrocortisone is a steroid. It reduces the actions of chemicals in the body that cause inflammation, redness, and swelling.

The combination of acetic acid and hydrocortisone otic is used to treat conditions inside the ear, such as redness, itching, or swelling.

Acetic acid and hydrocortisone otic may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Acetasol HC (acetic acid and hydrocortisone (otic))?

Before using this medication, tell your doctor if you have a ruptured ear drum. Tell your doctor if you have had any other ear infections or conditions before getting the condition for which you are now being treated. Hydrocortisone can make a pre-existing infection worse.

Do not use acetic acid and hydrocortisone otic on a child younger than 3 years old without a doctor's advice.

Use this medication exactly as it was prescribed for you. Do not use it in larger amounts or for longer than recommended by your doctor.

There may be other drugs that can affect acetic acid and hydrocortisone otic. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Stop using this medication and get emergency medical help if you think you have used too much medicine, or if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Less serious side effects are more likely, and you may have none at all. Talk to your doctor about any side effect that seems unusual or is especially bothersome.

Call your doctor if your symptoms do not improve or if they get worse during the first 5 to 7 days of treatment with acetic acid and hydrocortisone otic.

What should I discuss with my health care provider before using Acetasol HC (acetic acid and hydrocortisone (otic))?

This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. This medication can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not use acetic acid and hydrocortisone otic on a child younger than 3 years old without a doctor's advice.

How should I use Acetasol HC (acetic acid and hydrocortisone (otic))?

Use this medication exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor. Use this medicine only in the affected ear. You may not need to use it in both ears.

Use 3 to 5 drops of this medication in each affected ear every 4 to 6 hours, unless your doctor has told you otherwise.

To use the ear drops, first remove the cap from the dropper bottle. Lie down or tilt your head with your ear facing upward. Pull back on your ear gently to open up the ear canal. Hold the dropper upside down over your ear canal and drop the correct number of ear drops into the ear.

Do not place the dropper tip into your ear, or allow the tip to touch any surface. It may become contaminated.

After using the ear drops, stay lying down or with your head tilted for at least 5 minutes. You may use a small piece of cotton ball to plug the ear and keep the medicine from draining out. Follow your doctor's instructions about the use of cotton.

Wipe the tip of the medicine bottle with a clean tissue. Do not wash the dropper tip.

Call your doctor if your symptoms do not improve or if they get worse during the first 5 to 7 days of treatment with acetic acid and hydrocortisone otic.

Store this medication at room temperature away from moisture and heat. Do not allow the medicine to freeze.

What happens if I miss a dose?

Use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and use the medicine at the next regularly scheduled time. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

An overdose of acetic acid and hydrocortisone otic applied to the ears is not expected to produce life-threatening symptoms.

What should I avoid while using Acetasol HC (acetic acid and hydrocortisone (otic))?

This medicine is for use only in the ear. Avoid getting the medication in your eyes, mouth, and nose, or on your lips. If it does get into any of these areas, wash with water.

Do not use other ear drops unless your doctor has prescribed them.

Do not give the medicine to another person, even if you think they have the same skin condition you have. Do not use this medication for any ear condition that has not been checked by your doctor.

Acetasol HC (acetic acid and hydrocortisone (otic)) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Other less serious side effects are more likely to occur, such as:

mild stinging, itching, burning, or irritation in the ear;

loss of appetite;

weight loss (especially in a child); or

weakness.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Acetasol HC (acetic acid and hydrocortisone (otic))?

More Acetasol HC resources

Acetasol HC Side Effects (in more detail)
Acetasol HC Dosage
Acetasol HC Use in Pregnancy & Breastfeeding
Acetasol HC Support Group
0 Reviews for Acetasol HC - Add your own review/rating

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Otitis Externa

Where can I get more information?

Your pharmacist can provide more information about acetic acid and hydrocortisone otic.

See also: Acetasol HC side effects (in more detail)