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Omeprazole 10mg, 20mg & 40mg gastro-resistant Capsules
Omeprazole 10mg gastro-resistant capsules, hard
Omeprazole 20mg gastro-resistant capsules, hard
Omeprazole 40mg gastro-resistant capsules, hard
1. What omeprazole capsules are and what it is used for
2. What you need to know before you take omeprazole capsules
3. How to take omeprazole capsules
4. Possible side effects
5. How to store omeprazole capsules
6. Contents of the pack and other information
The name of your medicine is Omeprazole 10mg, 20mg and 40mg gastro-resistant capsules, hard (called omeprazole capsules throughout this leaflet). Omeprazole capsules contain 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 capsules are used to treat the following conditions:
In adults:
In children:
Children over 1 year of age and ≥ 10 kg
Children and adolescents over 4 years of age
Do not take omeprazole capsules if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking omeprazole capsules.
Talk to your doctor or pharmacist before taking omeprazole capsules.
Serious skin reactions including Stevens- Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS) and acute generalized exanthematous pustulosis (AGEP) have been reported in association with omeprazole treatment. Stop using omeprazole and seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.
Omeprazole capsules may hide the symptoms of other diseases. Therefore, if any of the following happen to you before you start taking omeprazole capsules or while you are taking them, talk to your doctor straight away:
When taking omeprazole, inflammation in your kidney may occur. Signs and symptoms may include decreased volume of urine or blood in your urine and/or hypersensitivity reactions such as fever, rash, and joint stiffness. You should report such signs to the treating physician.
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 capsules, 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 capsules.
Remember to also mention any other ill-effects like pain in your joints.
This medicine may affect the way that your body absorbs vitamin B12, particularly if you need to take it for a long time. Please contact your doctor if you notice any of the following symptoms, which could indicate low levels of Vitamin B12:
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.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because omeprazole capsules can affect the way some medicines work and some medicines can have an effect on omeprazole capsules.
Do not take omeprazole capsules 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.
You can take your capsules with food or on an empty stomach.
If you are pregnant or breast-feeding, 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 capsules if you are breast-feeding.
Omeprazole capsules are 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.
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’.
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 doses are given below.
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):
Children
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:
If you take more omeprazole capsules than prescribed by your doctor, talk to your doctor or pharmacist straight away.
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.
Do not stop taking omeprazole capsules 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.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you notice any of the following rare (may affect up to 1 in 1,000 people) or very rare (may affect up to 1 in 10,000 people) but serious side effects, stop taking omeprazole capsules and contact a doctor immediately:
Other side effects include:
Common (may affect up to 1 in 10 people)
Uncommon (may affect up to 1 in 100 people)
Rare (may affect up to 1 in 1,000 people)
Very rare (may affect up to 1 in 10,000 people)
Not known (frequency cannot be estimated from the available data)
Omeprazole capsules 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.
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 at: 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.
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 carton after EXP. The expiry date refers to the last day of that month.
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 protect the environment.
Each omeprazole capsule contains 10 mg, 20 mg or 40 mg of omeprazole (the active substance).
The excipients are:
Pellets: sugar spheres (contain sucrose and maize starch), lactose anhydrous, hypromellose, hydroxypropylcellulose, sodium lauryl sulfate, disodium phosphate dodecahydrate, methacrylic acid – ethylacrylate copolymer (1:1) dispersion 30 per cent, macrogol 6000, talc.
Empty hard gelatinous capsule contains:
Body: black iron oxide (E 172), red iron oxide (E 172), yellow iron oxide (E 172), titanium dioxide (E 171), gelatin.
Cap: indigo carmine (only omeprazole capsules 40 mg), red iron oxide (E 172), yellow iron oxide (E 172), titanium dioxide (E 171), gelatin.
Omeprazole 10mg gastro-resistant capsules, hard No.4 (length approximately 14.3 mm) with light brown body and orange cap. Capsule contains off white to slightly yellowish-brown spherical pellets.
Omeprazole 20mg gastro-resistant capsules, hard No.3 (length approximately 15.9 mm) with light brown body and red cap. Capsule contains off white to slightly yellowish-brown spherical pellets.
Omeprazole 40mg gastro-resistant capsules, hard No.2 (length approximately 18.0 mm) with light brown body and brown cap. Capsule contains off white to slightly yellowish-brown spherical pellets.
Type of container
Blisters made of oPA/Al/HDPE+PE+desiccant+HDPE - Aluminium or oPA/Al/PVC - Aluminium in a folding paper box.
Size of package: 7, 14, 28 or 56 capsules Not all pack sizes may be marketed.
The Marketing Authorisation Holder is
The Manufacturer is
This leaflet was last revised in April 2023
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