Children's Allergy Drug Facts

Dosage Form: liquid
Publix Super Markets, Inc. Children's Allergy Drug Facts

Active ingredient (in each 5 mL teaspoonful)

Cetirizine HCl 5 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

• runny nose


• sneezing


• itchy, watery eyes


• itching of the nose or throat

Warnings

Do not use

if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.

Ask a doctor before use if you have

liver or kidney disease. Your doctor should determine if you need a different dose.

Ask a doctor or pharmacist before use if you are

taking tranquilizers or sedatives.

When using this product

• drowsiness may occur avoid alcoholic drinks


• alcohol, sedatives, and tranquilizers may increase drowsiness


• be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

an allergic reaction to this product occurs. Seek medical help right away.

If pregnant or breast-feeding:

• if breast-feeding: not recommended


• if pregnant: ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

• use only with enclosed dosing cup

adults and children 6 years and over	1 teaspoonful (5 mL) or 2 teaspoonfuls (10 mL) once daily depending upon severity of symptoms; do not take more than 2 teaspoonfuls (10 mL) in 24 hours.
adults 65 years and over	1 teaspoonful (5 mL) once daily; do not take more than 1 teaspoonful (5 mL) in 24 hours.
children 2 to under 6 years of age	1/2 teaspoonful (2.5 mL) once daily. If needed, dose can be increased to a maximum of 1 teaspoonful (5 mL) once daily or 1/2 teaspoonful (2.5 mL) every 12 hours. Do not give more than 1 teaspoonful (5 mL) in 24 hours.
children under 2 years of age	ask a doctor
consumers with liver or kidney disease	ask a doctor

Other information

• do not use if carton is opened, or if printed neckband is broken or missing


• store between 20° to 25°C (68° to 77°F)

Inactive ingredients

acetic acid, artificial grape flavor, glycerin, methylparaben, natural banana flavor, propylene glycol, propylparaben, sodium acetate, sucrose, water

Principal Display Panel

Indoor & Outdoor Allergies

Children's Allergy

Cetirizine Hydrochloride Oral Solution, 1 mg/mL

Antihistamine

24 Hour Relief of:

Sneezing

Itchy, Watery Eyes

Runny Nose

Itchy Throat or Nose

Grape Flavored Syrup

2 yrs. and older

Dosing Cup Included

Original Prescription Strength

Compare to active ingredient in Children's Zyrtec®

Children's Allergy Carton

CHILDRENS ALLERGY  cetirizine hydrochloride  liquid

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 56062-974 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CETIRIZINE HYDROCHLORIDE (CETIRIZINE) CETIRIZINE HYDROCHLORIDE 5 mg  in 5 mL

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color YELLOW (Pale Yellow) Score      Shape Size Flavor GRAPE Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 56062-974-26 1 BOTTLE In 1 CARTON contains a BOTTLE 1 120 mL In 1 BOTTLE This package is contained within the CARTON (56062-974-26)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA090254	01/15/2009

Labeler - Publix Super Markets Inc (006922009)

Revised: 05/2009Publix Super Markets Inc

More Children's Allergy Drug Facts resources

• Children's Allergy Drug Facts Side Effects (in more detail)
• Children's Allergy Drug Facts Use in Pregnancy & Breastfeeding
• Drug Images
• Children's Allergy Drug Facts Drug Interactions
• Children's Allergy Drug Facts Support Group
• 73 Reviews for Children's Allergy Drug Facts - Add your own review/rating

Compare Children's Allergy Drug Facts with other medications

• Hay Fever
• Urticaria

Torsemide

Class: Loop Diuretics
VA Class: CV702
Chemical Name: N-[[(1-Methylethyl)amino]carbonyl]-4-[(3-methylphenyl) amino]-3-pyridinesulfonamide
Molecular Formula: C₁₆H₂₀N₄O₃S
CAS Number: 56211-40-6
Brands: Demadex

Introduction

A sulfonamide, loop-type diuretic and antihypertensive agent.^{1 a}

Uses for Torsemide

Edema

Management of edema associated with CHF^{1 4} or hepatic¹ or renal¹ disease (including chronic renal failure).^a

Hypertension

Management of hypertension (alone or in combination with other classes of antihypertensive agents).^{1 2 3}

One of several preferred initial therapies in hypertensive patients with CHF, acute pulmonary edema, or renal disease.^{2 3}

Can be used as monotherapy for initial management of uncomplicated hypertension;^{1 2 3 a} however, thiazide diuretics are preferred by JNC 7.¹¹

Torsemide Dosage and Administration

General

• 
  

  The manufacturer states that since oral and IV doses of torsemide are therapeutically equivalent, torsemide dosage is identical for oral or IV administration.¹

  
  

Edema

• 
  

  Most experts state that all patients with symptomatic CHF who have evidence for, or a prior history of, fluid retention generally should receive diuretic therapy in conjunction with moderate sodium restriction (≤3 g of sodium daily), an ACE inhibitor, and usually a β-blocker, with or without a cardiac glycoside.⁴

  
  


• 
  

  Hospitalization of the patient during initiation of therapy is advisable for patients with hepatic cirrhosis and ascites or chronic renal failure.^{1 a b}

  
  


• 
  

  Chronic use of any diuretic in hepatic disease has not been adequately studied.^{1 a}

  
  

Administration

Administer orally, by direct IV injection, or by continuous IV infusion.¹

Oral Administration

Administer orally without regard to meals.¹

IV Administration

For solution and drug compatibility information, see Compatibility under Stability.

IV administration may be used when a rapid onset of diuresis is desired or when oral therapy is not practical.¹

If torsemide is administered through an IV line, flush the IV line with 0.9% sodium chloride before and after administration.^a

Dilution

For IV infusion, dilute in 5% dextrose, 0.9% sodium chloride, or 0.45% sodium chloride injection.^a

Rate of Administration

For direct IV injection, administer slowly over a period of 2 minutes.¹

Dosage

Adults

Edema

CHF

Oral

Initially, 10–20 mg, given as a single dose.¹ Increase as necessary by approximately doubling daily dosage until desired diuresis is attained.¹ Single doses exceeding 200 mg not adequately studied.¹

IV

Initially, 10–20 mg, given as a single dose.¹ Increase as necessary by approximately doubling dosage until desired diuresis is attained.¹ Single doses exceeding 200 mg not adequately studied.¹

Hypertension

Oral

Initially, 5 mg once daily.¹ If adequate hypotensive response not attained in 4–6 weeks, may increase dosage to 10 mg once daily.¹ If adequate response not observed with 10 mg once daily, an additional antihypertensive agent should be added to antihypertensive therapy.¹

IV

Initially, 5 mg once daily.¹ If adequate hypotensive response not attained in 4–6 weeks, may increase dosage to 10 mg once daily.¹ If adequate response not observed with 10 mg once daily, an additional antihypertensive agent should be added to antihypertensive therapy.¹

Prescribing Limits

Adults

Edema

CHF

Oral

Maximum of 200 mg as a single dose (daily).¹

IV

Maximum of 200 mg as a single dose (daily).¹

Hypertension

Oral

Maximum of 10 mg once daily.¹

IV

Maximum of 10 mg once daily.¹

Special Populations

Renal Impairment

Edema

Edema Associated with Chronic Renal Failure

Oral or IV

In adults, initially, 20 mg once daily.¹ Increase as necessary by approximately doubling dosage until desired diuresis is attained.¹ Single doses exceeding 200 mg not adequately studied.^{1 a}

Hepatic Impairment

Chronic use in hepatic disease not adequately studied.¹

Edema

Edema Associated with Hepatic Cirrhosis

Oral or IV

In adults, initially, 5–10 mg once daily, given concomitantly with an aldosterone antagonist or a potassium-sparing diuretic.^a Increase as necessary by approximately doubling dosage until desired diuresis is attained.^a Single doses exceeding 40 mg not adequately studied.¹

Cautions for Torsemide

Contraindications

• 
  

  Anuria.¹

  
  


• 
  

  Known hypersensitivity to torsemide or to sulfonylureas.¹

  
  

Warnings/Precautions

Warnings

Hepatic Effects

Sudden alterations of electrolyte balance in patients with cirrhosis may precipitate hepatic coma; use with caution in patients with hepatic cirrhosis and ascites.¹

Therapy in such patients is best initiated in the hospital.¹ Use an aldosterone antagonist or potassium-sparing agent concomitantly with torsemide to prevent hypokalemia and metabolic alkalosis in such patients.¹

Ototoxicity

Tinnitus and hearing loss, usually reversible, have been observed following rapid IV injection of other loop diuretics and following oral torsemide administration.¹ Administer IV slowly (over 2 minutes); do not exceed 200 mg as a single dose.¹

Fluid, Electrolyte, and Cardiovascular Effects

Observe carefully for manifestations of fluid and electrolyte depletion (e.g., dryness of mouth, thirst, weakness, lethargy, drowsiness, restlessness, muscle pains or cramps, muscular fatigue, hypotension, oliguria, tachycardia, nausea, vomiting).^{1 a}

Excessive diuresis may cause dehydration and blood volume reduction with circulatory collapse and possibly vascular thrombosis and embolism, particularly in geriatric patients.^{1 a}

Laboratory changes may include altered serum concentrations of sodium, chloride, and potassium; acid-base abnormalities; and increased BUN.^{1 a} If electrolyte imbalance, hypovolemia, or prerenal azotemia develops, torsemide should be discontinued until the abnormality is corrected; treatment then may be restarted at a reduced dosage.^{1 a}

Risk of hypokalemia, especially with brisk diuresis, with inadequate oral electrolyte intake, in those with cirrhosis, or during concomitant use of corticosteroids or ACTH.^{1 a} Risk of arrhythmias secondary to hypokalemia in patients with cardiovascular disease, especially those receiving concomitant therapy with a cardiac glycoside.^{1 a}

Periodically monitor serum potassium and other electrolyte concentrations.^{1 a}

General Precautions

Endocrine Effects

Possible increased blood glucose concentrations; hyperglycemia occurred rarely. ^{1 a}

Renal and Electrolyte Effects

Small, dose-related, reversible increases in BUN, serum creatinine, and uric acid concentrations reported.^{1 a} Symptomatic gout reported at an incidence similar to placebo.¹

Slight alterations in calcium and magnesium concentrations.^{1 a}

Other Effects

Increases in total plasma cholesterol concentrations may occur; usually subside during chronic therapy.^{1 a}

Increases in plasma triglyceride concentrations reported.^{1 a}

In long-term studies, no clinically important differences in lipid profiles compared to baseline.^{1 a}

No clinically important effects on hemoglobin; hematocrit; WBC, erythrocyte, or platelet counts; or serum alkaline phosphatase concentrations.^{1 a}

Specific Populations

Pregnancy

Category B.¹

Lactation

Not known whether torsemide is distributed into milk.¹ Caution if used in nursing women.¹

Pediatric Use

Safety and efficacy not established.¹

Renal calcifications reported in severely premature infants with edema secondary to patent ductus arteriosus and hyaline membrane disease receiving another loop diuretic.^{1 a} Increased risk of persistent patent ductus arteriosus in premature neonates with hyaline membrane disease receiving another loop diuretic also has been reported.^{1 a}

Geriatric Use

No substantial differences in safety and efficacy relative to younger adults.^{1 a}

Renal Impairment

Seizures reported in patients with acute renal failure receiving higher than recommended dosages of torsemide.^{1 a}

Common Adverse Effects

Headache, excessive urination, dizziness, rhinitis, asthenia, diarrhea, ECG abnormality, increased cough.^{1 a}

Interactions for Torsemide

Specific Drugs

Drug	Interaction	Comments
Cholestyramine	Decreased absorption of torsemide in animals1 a	Avoid simultaneous administration when used concomitantly1 a
Digoxin	Increased torsemide AUC1 a	Torsemide dosage adjustment not necessary1 a
Lithium	Reduced renal clearance of lithium and increased risk of lithium toxicity reported with other diuretics 1 a	Avoid concomitant use or use great caution1 a
Ototoxic drugs (e.g., aminoglycoside antibiotics, ethacrynic acid)	Possible additive ototoxic effect when ototoxic drugs used concomitantly with other diuretics, especially in those with impaired renal function1 a
Probenecid	Reduced secretion of torsemide into proximal tubule and decreased diuretic activity1 a
Salicylates (e.g., aspirin, NSAIAs)	Concomitant use of NSAIAs with another loop diuretic (furosemide) occasionally associated with renal dysfunction.1 a Indomethacin may partially inhibit natriuretic effect of torsemide in those with dietary sodium restriction (50 mEq daily) 1 a Concomitant use with high dosages of salicylates may result in salicylate toxicity1 a
Spironolactone	Reduced renal clearance of spironolactone1 a	Adjustment of spironolactone or torsemide dosage not necessary1 a

Torsemide Pharmacokinetics

Absorption

Bioavailability

Bioavailability is approximately 80%.¹

Onset

Following oral administration, onset of diuresis occurs within 1 hour; maximal effect during the first or second hour.^{1 a}

Following IV administration, onset of diuresis occurs within 10 minutes; maximal effect within 1 hour.^{1 a}

Duration

Diuretic effect persists 6–8 hours following oral or IV administration.^{1 a}

Food

Food delays the time to peak plasma concentration following oral dosing but does not affect extent of absorption or diuretic activity.^{1 a}

Plasma Concentrations

Following oral administration, peak plasma concentrations achieved within 1 hour.¹

Distribution

Extent

Not known whether torsemide is distributed into milk.^{1 a}

Plasma Protein Binding

>99%.^{1 a}

Elimination

Metabolism

Hepatic metabolism accounts for approximately 80% of total clearance.^{1 a} Carboxylic acid derivative, the major metabolite, is inactive.^{1 a}

Elimination Route

Urinary excretion accounts for approximately 20% of total clearance in patients with normal renal function.^{1 a} Most renal clearance occurs via active secretion of the drug by the proximal tubules into tubular urine.^{1 a}

Half-life

Approximately 3.5 hours.^{1 a}

Special Populations

In patients with decompensated CHF, hepatic and renal clearance are reduced, resulting in delivery of less drug to the intraluminal site of action and decreased natriuretic effect.^{1 a} Total clearance is about half of that of healthy individuals; half-life and AUC increased.^{1 a}

In patients with renal failure, renal clearance (but not total clearance) is reduced, resulting in delivery of less drug to the intraluminal site of action and decreased natriuretic effect.^{1 a}

In patients with hepatic cirrhosis, renal clearance (but not total clearance) and half-life are increased.¹

In geriatric patients, decreased renal clearance.^{1 a}

Stability

Storage

Oral

Tablets

15–30°C.¹ Do not freeze.^{1 a}

Parenteral

Injection

15–30°C.^{1 a} Do not freeze.^{1 a}

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Parenteral

Solution Compatibility^HID

Compatible
Dextrose 5% in water
Sodium chloride 0.45 or 0.9%

Y-Site CompatibilityHID

Compatible
Milrinone lactate

ActionsActions

• 
  

  Acts from within the lumen of the thick ascending portion of the loop of Henle, where it inhibits the sodium/potassium/chloride carrier system.¹

  
  


• 
  

  Increases urinary excretion of sodium, chloride, and water without having an important effect on glomerular filtration rate, renal plasma flow, or acid-base balance.¹

  
  

Advice to Patients

• 
  

  Risks associated with excessive fluid loss or electrolyte imbalance.^{1 a}

  
  


• 
  

  Potential for postural hypotension; importance of rising slowly from a seated position.¹

  
  


• 
  

  Importance of informing patients with diabetes mellitus that blood glucose concentrations may increase.¹

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.¹

  
  


• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.¹

  
  


• 
  

  Importance of informing patients of other important precautionary information.¹ (See Cautions.)

  
  

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Torsemide

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Tablets	5 mg*	Demadex (with povidone; scored)	Roche
			Torsemide Tablets	Apotex, Par, Pliva, Roxane, Teva
		10 mg*	Demadex (with povidone; scored)	Roche
			Torsemide Tablets	Apotex, Par, Pliva, Roxane, Teva, UDL,
		20 mg*	Demadex (with povidone; scored)	Roche
			Torsemide Tablets	Apotex, Par, Pliva, Roxane, Teva, UDL
		100 mg*	Demadex (with povidone; scored)	Roche
			Torsemide Tablets	Apotex, Par, Pliva, Teva
Parenteral	Injection, for IV use	10 mg/mL	Demadex	Roche

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Demadex 10MG Tablets (MEDA PHARMACEUTICALS): 30/$43.69 or 90/$110.37

Demadex 100MG Tablets (MEDA PHARMACEUTICALS): 30/$160.99 or 90/$455.97

Demadex 20MG Tablets (MEDA PHARMACEUTICALS): 30/$55.99 or 90/$139.97

Torsemide 10MG Tablets (TEVA PHARMACEUTICALS USA): 30/$29.99 or 90/$79.97

Torsemide 100MG Tablets (TEVA PHARMACEUTICALS USA): 30/$89.99 or 90/$249.96

Torsemide 20MG Tablets (TEVA PHARMACEUTICALS USA): 30/$22.99 or 90/$59.98

Torsemide 5MG Tablets (CAMBER PHARMACEUTICALS): 30/$18.99 or 90/$56.97

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions August 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

1. Boehringer Mannheim. Demadex (torsemide) tablets and injection prescribing information. Rockville, MD: 1993 Oct.

2. National Heart, Lung, and Blood Institute National High Blood Pressure Education Program. The sixth report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC VI). Bethesda, MD: National Institutes of Health. (NIH publication No. 98-4080.)

3. Kaplan NM. Choice of initial therapy for hypertension. JAMA. 1996; 275:1577-80. [IDIS 365188] [PubMed 8622249]

4. Anon. Consensus recommendations for the management of chronic heart failure. On behalf of the membership of the advisory council to improve outcomes nationwide in heart failure. Part II. Management of heart failure: approaches to the prevention of heart failure. Am J Cardiol. 1999; 83:9-38A.

5. Izzo JL, Levy D, Black HR. Importance of systolic blood pressure in older Americans. Hypertension. 2000; 35:1021-4. [PubMed 10818056]

6. Frohlich ED. Recognition of systolic hypertension for hypertension. Hypertension. 2000; 35:1019-20. [PubMed 10818055]

7. Bakris GL, Williams M, Dworkin L et al. Preserving renal function in adults with hypertension and diabetes: a consensus approach. Am J Kidney Dis. 2000; 36:646-61. [IDIS 452007] [PubMed 10977801]

8. Associated Press (American Diabetes Association). Diabetics urged: drop blood pressure. Chicago, IL; 2000 Aug 29. Press Release from web site.

9. Appel LJ. The verdict from ALLHAT—thiazide diuretics are the preferred initial therapy for hypertension. JAMA. 2002; 288:3039-42. [IDIS 490723] [PubMed 12479770]

10. The ALLHAT Officers and Coordinators for the ALLHAT Collaborative Research Group. Major outcomes in high-risk hypertensive patients randomized to angiotensin-converting enzyme inhibitor or calcium channel blocker vs diuretic: the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). JAMA. 2002; 288:2981-97. [IDIS 490721] [PubMed 12479763]

11. National Heart, Lung, and Blood Institute National High Blood Pressure Education Program. The seventh report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 7) Express. Bethesda, MD: May 14 2003. From NIH website. (http://www.nhlbi.nih.gov/guidelines/hypertension/jncintro.htm). (Also published in JAMA. 2003; 289:2560-72.

a. Roche Pharmaceuticals. Demadex (torsemide) tablets and injection prescribing information. Nutley, NJ: 2003 Apr.

b. AHFS Drug Information 2007. McEvoy GK, ed. Furosemide. American Society of Health-System Pharmacists; 2007: 2690-4.

HID. Trissel LA. Handbook on injectable drugs. 14th ed. Bethesda, MD: American Society of Health-System Pharmacists; 2007:1581.

More Torsemide resources

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

• Torsemide MedFacts Consumer Leaflet (Wolters Kluwer)


• Torsemide Prescribing Information (FDA)


• Torsemide Professional Patient Advice (Wolters Kluwer)


• torsemide Concise Consumer Information (Cerner Multum)


• torsemide Advanced Consumer (Micromedex) - Includes Dosage Information


• Demadex Prescribing Information (FDA)

Compare Torsemide with other medications

• Ascites
• Edema
• Heart Failure
• High Blood Pressure
• Nonobstructive Oliguria
• Renal Failure

Mesasal Rectal

Generic Name: mesalamine (Rectal route)

me-SAL-a-meen

Commonly used brand name(s)

In the U.S.

• Canasa


• Rowasa


• sfRowasa

In Canada

• Mesasal


• Pentasa


• Salofalk

Available Dosage Forms:

• Suppository


• Enema

Therapeutic Class: Gastrointestinal Agent

Chemical Class: Salicylate, Non-Aspirin

Uses For Mesasal

Mesalamine is used to treat inflammatory bowel disease, such as ulcerative colitis. This medicine works inside the bowel by helping to reduce inflammation and other symptoms.

Mesalamine 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, mesalamine is used in certain patients with the following medical condition:

• Ulcerative colitis, history of—prevent it from occurring again

Before Using Mesasal

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

Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of mesalamine in children with use in other age groups.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of mesalamine in the elderly with use in other age groups.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

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.

• Varicella Virus Vaccine

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.

• Ardeparin


• Certoparin


• Dalteparin


• Danaparoid


• Enoxaparin


• Nadroparin


• Parnaparin


• Reviparin


• Tamarind


• Tinzaparin


• Warfarin

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.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Kidney disease—The use of mesalamine may make this condition worse.

Proper Use of mesalamine

This section provides information on the proper use of a number of products that contain mesalamine. It may not be specific to Mesasal. Please read with care.

For best results, empty your bowel just before using the rectal enema or suppository.

Keep using this medicine for the full time of treatment even if you begin to feel better after a few days. Do not miss any doses.

For patients using the enema form of this medicine:

• This medicine usually comes with patient directions. Read them carefully before using this medicine.


• Remove the bottles from the protective foil pouch, being careful not to squeeze or puncture them. The enema is an off-white to tan color. Contents of the enemas removed from the foil pouch may darken with time. Slight darkening will not affect the potency of the contents. However, enemas with dark brown contents should be discarded.


• Shake the bottle well to make sure that the medication is thoroughly mixed. Remove the protective cover from the applicator tip. Hold bottle at the neck so that no medicine spills out.


• Lie on your left side with your left leg straight and your right knee bent in front of you for balance. You can also lie in the knee-chest position, on your knees with your chest touching the bed.


• Gently insert the rectal tip of the enema applicator pointed slightly toward your naval to prevent damage to the rectal wall. Tilt the nozzle slightly toward the back and squeeze slowly to cause the enema to flow into your rectum. Steady pressure will discharge most of the medicine. After administering, withdraw and discard the bottle.


• Remain in position for at least 30 minutes to allow the medicine to distribute thoroughly. Retain the medicine all night if possible.

For patients using the suppository form of this medicine:

• This medicine usually comes with patient directions. Read them carefully before using this medicine.


• Detach one suppository from strip of suppositories. Hold suppository upright and carefully remove the foil wrapper.


• Avoid excessive handling of the suppository, which is designed to melt at body temperature.


• Insert suppository (pointed end first) completely into rectum with gentle pressure. Retain the suppository for 3 hours or longer, if possible, to achieve the best result.

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 inflammatory bowel disease:
  
  • For enema dosage form:
    
    • Adults and teenagers—4 grams (1 unit), used as directed, every night for three to six weeks.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For suppository dosage form:
    
    • Adults and teenagers—500 milligrams (mg), inserted into your rectum, two or three times a day for three to six weeks or 1000 mg, inserted into your rectum, one time a day at bedtime for three to six weeks.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

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 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 Mesasal

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

Contact your doctor if you develop cramping, acute abdominal pain, bloody diarrhea, fever, headache or rash. These may be symptoms of a serious condition.

Tell your doctor right away if you experience chest pain or shortness of breath.

Check with your doctor if you notice rectal bleeding, blistering, pain, burning, itching, or other sign of irritation not present before you started using this medicine.

Mesalamine rectal enema may stain clothing, fabrics, painted surfaces, marble, granite, vinyl, or other surfaces it touches.

Mesasal 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 as soon as possible if any of the following side effects occur:

Less common or rare

• Abdominal or stomach cramps or pain (severe)


• anxiety


• back pain (severe)


• bloody, black, or tarry stools


• blue or pale skin


• bright red blood in the stool


• chest pain, possibly moving to the left arm, neck, or shoulder


• chills


• diarrhea (severe)


• fast heartbeat


• fever


• headache (severe)


• nausea or vomiting


• shortness of breath


• skin rash


• stomach cramps, tenderness, pain


• swelling of the stomach


• unusual tiredness or weakness


• watery or bloody diarrhea


• yellow eyes or skin

Incidence not known

• Blood in urine


• change in frequency of urination or amount of urine


• cough


• difficulty in breathing


• drowsiness


• high fever


• increased thirst


• loss of appetite


• lower back or side pain


• painful or difficult urination


• pale skin


• sore throat


• sores, ulcers, or white spots on lips or in mouth


• swelling of feet or lower legs


• swollen glands


• troubled breathing


• unexplained or unusual bleeding or bruising


• weakness

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

• Abdominal or stomach cramps or pain (mild)


• gas or flatulence


• headache (mild)


• nausea

Less common or rare

• Acne


• diarrhea


• dizziness


• leg or joint pain


• loss of hair


• rectal pain or irritation

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: Mesasal Rectal 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 Mesasal Rectal resources

• Mesasal Rectal Side Effects (in more detail)
• Mesasal Rectal Use in Pregnancy & Breastfeeding
• Mesasal Rectal Drug Interactions
• Mesasal Rectal Support Group
• 0 Reviews for Mesasal Rectal - Add your own review/rating

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• Ulcerative Proctitis

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

UK

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

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.

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

Copyright © 2012 Wolters Kluwer Health, Inc.

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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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.

© 2008 GlaxoSmithKline group of companies

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