• 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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

• are allergic to omeprazole or any of the other ingredients of this medicine (listed in section 6).
• are allergic to medicines containing other proton pump inhibitors (eg pantoprazole, lansoprazole, rabeprazole, esomeprazole).
• are taking a medicine containing nelfinavir (used for HIV infection).

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:

• You lose a lot of weight for no reason and have problems swallowing.
• You get stomach pain or indigestion.
• You begin to vomit food or blood.
• You pass black stools (blood-stained faeces).
• You experience severe or persistent diarrhoea, as omeprazole capsules have been associated with a small increase in infectious diarrhoea.
• You have severe liver problems.
• You have ever had a skin reaction after treatment with a medicine similar to omeprazole capsules that reduces stomach acid.
• You are due to have a specific blood test (Chromogranin A).

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:

• Extreme tiredness or lack of energy
• Pins and needles
• Sore or red tongue, mouth ulcers
• Muscle weakness
• Disturbed vision
• Problems with memory, confusion, depression

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:

• Ketoconazole, itraconazole, posaconazole or voriconazole (used to treat infections caused by a fungus)
• Digoxin (used to treat heart problems)
• Diazepam (used to treat anxiety, relax muscles or in epilepsy)
• Phenytoin (used in epilepsy). If you are taking phenytoin, your doctor will need to monitor you when you start or stop taking omeprazole
• Medicines that are used to thin your blood, such as warfarin or other vitamin K blockers.
  Your doctor may need to monitor you when you start or stop taking omeprazole
• Rifampicin (used to treat tuberculosis)
• Atazanavir (used to treat HIV infection)
• Tacrolimus (in cases of organ transplantation)
• St John’s wort (Hypericum perforatum) (used to treat mild depression)
• Cilostazol (used to treat intermittent claudication)
• Saquinavir (used to treat HIV infection)
• Clopidogrel (used to prevent blood clots (thrombi))
• Erlotinib (used to treat cancer)
• Methotrexate (a chemotherapy medicine used in high doses to treat cancer) – if you are taking a high dose of methotrexate, your doctor may temporarily stop your omeprazole capsules treatment

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’.

• It is recommended that you take your capsules in the morning.
• You can take your capsules with food or on an empty stomach.
• Swallow your capsules whole with half a glass of water. Do not chew or crush the capsules. This is because the capsules contain coated pellets which stop the medicine from being broken down by the acid in your stomach. It is important not to damage the pellets.

• If you or your child have trouble swallowing the capsules:
  • Open the capsules and swallow the contents directly with half a glass of water or put the contents into a glass of still (non-fizzy) water, any acidic fruit juice (e.g. apple, orange or pineapple) or apple sauce.
  • Always stir the mixture just before drinking it (the mixture will not be clear). Then drink the mixture straight away or within 30 minutes.
  • To make sure that you have drunk all of the medicine, rinse the glass very well with half a glass of water and drink it. The solid pieces contain the medicine - do not chew or crush them.

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 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.

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