Active ingredient
- omeprazole
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 08553/0641.
Omeprazole 10 mg, 20 mg, 40 mg Gastro-Resistant Capsules, Hard
Package leaflet: Information for the user
Omeprazole 10 mg, 20 mg, 40 mg Gastro-Resistant Capsules, Hard
Omeprazole
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
What is in this leaflet
1. What Omeprazole is and what it is used for
2. What you need to know before you take Omeprazole
3. How to take Omeprazole
4. Possible side effects
5. How to store Omeprazole
6. Contents of the pack and other information
1. What Omeprazole is and what it is used for
Omeprazole contains the active substance omeprazole. It belongs to a group of medicines called ‘proton pump inhibitors’. They work by reducing the amount of acid that your stomach produces.
Omeprazole is used to treat the following conditions:
In adults:
In children:
Children over 1 year of age and ≥ 10 kg
Children and adolescents aged over 4 years
2. What you need to know before you take Omeprazole
Do not take Omeprazole:
Do not take Omeprazole if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Omeprazole.
Warnings and precautions
Talk to your doctor or pharmacist before taking Omeprazole.
Omeprazole may hide the symptoms of other diseases. Therefore, if any of the following happen to you before you start taking Omeprazole or while you are taking it, talk to your doctor straight away:
If you take Omeprazole on a long-term basis (longer than 1 year) your doctor will probably keep you under regular surveillance. You should report any new and exceptional symptoms and circumstances whenever you see your doctor.
Taking a proton pump inhibitor like Omeprazole, especially over a period of more than one year, may slightly increase your risk of fracture in the hip, wrist or spine. Tell your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).
If you get a rash on your skin, especially in areas exposed to the sun tell your doctor as soon as you can, as you may need to stop your treatment with Omeprazole. Remember to also mention any other ill-effects like pain in your joints.
Children
Some children with chronic illnesses may require long-term treatment although it is not recommended.
Do not give this medicine to children under 1 year of age or < 10 kg.
Other medicines and Omeprazole
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines that you buy without a prescription. This is because Omeprazole can affect the way some medicines work and some medicines can have an effect on Omeprazole.
Do not take Omeprazole if you are taking a medicine containing nelfinavir (used to treat HIV infection).
Tell your doctor or pharmacist if you are taking any of the following medicines:
If your doctor has prescribed the antibiotics amoxicillin and clarithromycin as well as Omeprazole to treat ulcers caused by Helicobacter pylori infection, it is very important that you tell your doctor about any other medicines you are taking.
Omeprazole with food and drink
See section 3.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Omeprazole is excreted in breast milk but is not likely to influence the child when therapeutic doses are used. Your doctor will decide whether you can take Omeprazole if you are breastfeeding.
Driving and using machines
Omeprazole is not likely to affect your ability to drive or use any tools or machines. Side effects such as dizziness and visual disturbances may occur (see section 4). If affected, you should not drive or operate machinery.
Omeprazole contains sucrose and sodium
Omeprazole contains sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium-free’.
3. How to take Omeprazole
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Your doctor will tell you how many capsules to take and how long to take them for. This will depend on your condition and how old you are.
The recommended dose is:
Use in adults
To treat symptoms of GORD such as heartburn and acid regurgitation:
To treat ulcers in the upper part of the intestine (duodenal ulcer):
To treat ulcers in the stomach (gastric ulcer):
To prevent the duodenal and stomach ulcers from coming back:
To treat duodenal and stomach ulcers caused by NSAIDs (Non-Steroidal Anti-Inflammatory Drugs):
To prevent duodenal and stomach ulcers if you are taking NSAIDs:
To treat ulcers caused by Helicobacter pylori infection and to stop them coming back:
To treat too much acid in the stomach caused by a growth in the pancreas (Zollinger-Ellison syndrome):
Use in children and adolescents
To treat symptoms of GORD such as heartburn and acid regurgitation:
To treat ulcers caused by Helicobacter pylori infection and to stop them coming back:
Taking this medicine
What to do if you or your child have trouble swallowing the capsules
If you take more Omeprazole than you should
If you take more Omeprazole than prescribed by your doctor, talk to your doctor or pharmacist straight away.
If you forget to take Omeprazole
If you forget to take a dose, take it as soon as you remember it. However, if it is almost time for your next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose.
If you stop taking Omeprazole
Do not stop taking Omeprazole without first talking to your doctor or pharmacist.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you notice any of the following rare but serious side effects, stop taking Omeprazole and contact a doctor immediately:
Other side effects include:
Common side effects (may affect up to 1 in 10 people)
Uncommon side effects (may affect up to 1 in 100 people)
Rare side effects (may affect up to 1 in 1,000 people)
Very rare side effects (may affect up to 1 in 10,000 people)
Not known (frequency cannot be estimated from available data)
Omeprazole may in very rare cases affect the white blood cells leading to immune deficiency. If you have an infection with symptoms such as fever with a severely reduced general condition or fever with symptoms of a local infection such as pain in the neck, throat or mouth or difficulties in urinating, you must consult your doctor as soon as possible so that a lack of white blood cells (agranulocytosis) can be ruled out by a blood test. It is important for you to give information about your medicine at this time.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme website www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Omeprazole
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the folding box, blister and carton after EXP. The expiry date refers to the last day of that month.
Al/Al blister: Store below 25°C. Store in the original package in order to protect from moisture.
PVC-PVDC/Al blister: Store below 25°C. Store in the original package in order to protect from moisture.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information
What Omeprazole Capsules contains
The active substance is omeprazole. Each gastro-resistant capsule, hard contain 10 mg, 20 mg or 40 mg of omeprazole.
The other ingredients are:
Content: hypromellose, maize starch, methacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30% (sodium lauryl sulphate, polysorbate 80, methacrylic acid-ethyl acrylate copolymer), disodium phosphate dihydrate, sucrose, talc, triethyl citrate, titanium dioxide (E-171).
Capsule: gelatine, titanium dioxide (E-171).
Printing ink: potassium hydroxide, strong ammonia solution, propylene glycol, shellac, black iron oxide (E-172).
What Omeprazole Capsules looks like and contents of the pack
Opaque white hard gelatine capsule printed “OM 10”, “OM 20” or “OM 40”. Capsule content: white to slightly pink/beige spherical pellets.
Omeprazole 10mg Capsules are available in packs of:
Al/Al blister: 15, 30, 60 and 100 gastro-resistant capsules, hard. PVC-PVDC/Al blister: 14, 28 gastro-resistant capsules, hard.
Omeprazole 20 mg Capsules are available in packs of:
Al/Al blister: 15, 30, 50, 60 and 100 gastro-resistant capsules, hard. PVC-PVDC/Al blister: 14, 28 gastro-resistant capsules, hard.
Omeprazole 40 mg Capsules are available in packs of:
Al/Al blister: 15, 30, 50, 60 and 100 gastro-resistant capsules, hard. PVC-PVDC/Al blister: 7, 14 and 28 gastro-resistant capsules, hard.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Manufacturer
This leaflet was last revised in 02/2019
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