OMEPRAZOLE 10mg, 20mg, 40mg GASTRO-RESISTANT TABLETS
(Referred to as Omeprazole Tablets throughout this leaflet)
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 further questions, please ask your doctor or your pharmacist.
- This medicine has been prescribed for you personally and you should 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 Omeprazole Tablets are and what are they used for
- 2. Before you take Omeprazole Tablets.
- 3. How to take Omeprazole Tablets.
- 4. Possible side effects.
- 5. How to store Omeprazole Tablets.
- 6. Further information
What Omeprazole Tablets Are And What Are They Used For
Omeprazole is a type of drug called a proton pump inhibitor (PPI). It reduces the production of acid in your stomach. Your doctor has prescribed this medicine for:
- acid from the stomach escaping into the food pipe causing pain, inflammation and heartburn (reflux oesophagitis and oesophageal reflux disease);
- acid indigestion which can cause stomach pain or discomfort (dyspepsia);
- ulcer in the upper part of the intestine (duodenal ulcer) or stomach (gastric ulcer);
- to protect your stomach or duodenum from ulcers if you are taking NSAIDs (non-steroidal anti-inflammatory drugs) (for Omeprazole 10 mg and 20 mg Gastro-Resistant Tablets only);
- excess acid in the stomach caused by a tumour in the pancreas (Zollinger-Ellison syndrome);
- prevention of damage to the lungs caused by breathing in stomach fluids (acid aspiration). For instance, before an operation.
Before You Take Omeprazole Tablets:
DO NOT TAKE OMEPRAZOLE TABLETS IF:
You are allergic to Omeprazole or any of the ingredients in Omeprazole Tablets (see Section 6: ‘Further information’).
TAKE SPECIAL CARE WITH OMEPRAZOLE TABLETS
Consult your doctor if:
- You are pregnant or might be or if you are breast-feeding
- You have any liver problems
Taking other medicines
You should tell your doctor about any other medicines which you are taking even if you have purchased them without a prescription, especially:
- diazepam (for your nerves);
- phenytoin (for epilepsy);
- warfarin (for thinning the blood);
- digoxin (for the heart);
- itraconazole or ketoconazole (for fungal infection).
Important information about some of the ingredients of Omeprazole Tablets:
This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
How To Take Omeprazole Tablets:
Omeprazole Tablets can be taken at any time of the day. Your doctor will tell you how many tablets to take and when to take them. The strength of tablet you take and the length of time you take them for will depend on what condition you are suffering from and how you respond to the medicine. The dosages below are those usually recommended.
You can take your tablets with food or on an empty stomach. The tablets should not be chewed or crushed, they should be swallowed whole, with a drink of water or fruit juice.
Always take Omeprazole Tablets exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure. If you have the impression that the effect of Omeprazole Tablets is too strong or too weak, talk to your doctor or pharmacist.
Treatment of children: Omeprazole Tablets are not suitable for children.
Treatment for heart burn (reflux oesophagitis and oesophageal reflux disease): for adults, the usual dose is Omeprazole 20 mg once a day for 4 weeks. Your doctor may tell you to continue taking the tablets or increase the dose depending on how you respond to treatment. To stop your symptoms returning, your doctor may tell you to continue taking your Omeprazole 20 mg Tablets or reduce the dose to 10 mg.
Relief of acid indigestion which causes stomach pain or discomfort (dyspepsia): the usual dose is Omeprazole 10 mg or 20 mg once daily for 2-4 weeks. Your doctor will tell you how long to take the tablets for. If you experience no improvement in the symptoms you are suffering from, you should return to your doctor.
Treatment for stomach ulcers (gastric ulcer) and ulcers in the upper part of the intestine (duodenal ulcer): the usual dose is Omeprazole 20 mg once a day. Your doctor will tell you how long to take the tablets for. This will usually be between 4-8 weeks. The dose may need to be increased depending on how you respond to treatment. To stop your ulcer coming back, the usual dose is Omeprazole 10 mg once a day unless your symptoms return. If your symptoms return, your doctor may increase the dose.
Treatment and prevention of stomach ulcers, duodenal ulcers and associated symptoms caused by NSAIDs: if you have had trouble with an ulcer in the past and need to continue taking a NSAID, the only recommended dose is Omeprazole 20 mg once a day. Your doctor will tell you how long to take your tablets for.
Before an operation which requires a general anaesthetic: the usual dose is Omeprazole 40 mg the evening before surgery and then another Omeprazole 40 mg two to six hours before surgery.
Treatment for excess acid in the stomach caused by a growth in the pancreas (Zollinger-Ellison Syndrome): the normal starting dose is Omeprazole 60 mg once a day. If the dose is more than 80 mg a day, half the dose should be taken in the morning and half at night. Your doctor will tell you how many tablets to take and when to take them.
If you take more Omeprazole Tablets than you should: If you take more than the recommended number of tablets, go to your nearest hospital casualty department or contact your doctor at once.
If you forget to take Omeprazole Tablets: If you do forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, do not take the missed dose, just take the next dose on time. Never take a double dose to make up for the missed one.
Possible Side Effects
Like all medicines, Omeprazole Tablets may sometimes cause side effects as well as the effects that are needed. These are usually mild and go away when you stop taking this medicine.
Allergic reactions
If any of the following happen, do not take more OMEPRAZOLE TABLETS. Tell your doctor immediately, or go to the casualty department at your nearest hospital:
- Severe skin blisters
- Swelling of the lips, tongue and throat
- Wheezing
- Fever
Common side effects are: headache; diarrhoea; constipation; stomach ache; feeling sick; vomiting; wind.
Uncommon side effects are: dizziness; pins and needles; light headed-ness; feeling faint; sleepiness; trouble sleeping; liver disease which may make your skin and eyes yellow; rash; itching; generally feeling unwell.
Rare side effects are: development of breasts in men; dry mouth; sore mouth; thrush in the mouth or gullet; blood disorders which may lead to frequent infections with symptoms of fever, severe chills, sore throat, mouth ulcers, bleeding or bruising more easily than normal or tiredness; liver failure leading to brain damage; painful swollen joints, aching muscles or muscle weakness; impotence; skin sensitivity to light; severe blisters and bleeding in the lips, eyes, mouth, nose and genitals; unusual hair loss or thinning; kidney disease; increased sweating; blurred vision; taste disturbance; low blood sodium.
If you are very unwell, you may feel confused, nervous, aggressive, depressed and see, feel or hear things that are not there.
If you suffer from any of these side effects, or if you get any other unusual or unexpected symptoms, talk to your doctor or pharmacist.
How To Store Omeprazole Tablets
Keep your medicine in a safe place where children cannot see or reach it.
On the label you will find the letters "exp" followed by some numbers. These numbers are the date when the medicine is no longer fit for use. Do not use this medicine after this date.
Keep your medicine in the original blister strip and do not store above 30°C.
Remember to return any unused tablets to your pharmacist.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required.
Further Information
What OMEPRAZOLE TABLETS contains
The name of your medicine is Omeprazole 10 mg, 20 mg or 40 mg Gastro-Resistant Tablets. Each tablet contains 10 mg, 20 mg or 40 mg of the active ingredient, Omeprazole.
In addition your tablets also contain the following inactive ingredients: lactose monohydrate, sodium starch glycollate, sodium stearyl fumarate, sodium stearate, hydroxypropyl methylcellulose (HPMC) acetate succinate, Sepisperse AP-3527 (which contains propylene glycol, titanium dioxide E-171, red iron oxide E-172, hypromellose and yellow iron oxide E-172), talc, triethyl citrate, monoethanolamine, sodium lauryl sulphate and traces of carnauba wax.
What OMEPRAZOLE TABLETS look like and contents of the pack
Omeprazole Gastro-Resistant Tablets are brownish-pink film coated capsule shaped tablets.
Omeprazole 10 mg and 20 mg Gastro-Resistant Tablets are available in packs of 28 tablets in foil blister strips.
Omeprazole 40 mg Gastro-Resistant Tablets are available in packs of 7 or 28 tablets in foil blister strips. Not all pack sizes may be marketed.
Product License Holder/Manufacturer of Omeprazole 10 mg, 20 mg and 40 mg Gastro-Resistant Tablets:
This leaflet was approved in: July 2009.
1256420112-E
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