• 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 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

In adults:

• ‘gastro-oesophageal reflux disease’ (GORD). This is where acid from the stomach escapes into the gullet (the tube which connects your throat to your stomach) causing pain, inflammation and heartburn
• ulcers in the upper part of the intestine (duodenal ulcer) or stomach (gastric ulcer)
• ulcers which are infected with bacteria called ‘Helicobacter pylori’. If you have this condition, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal
• ulcers caused by medicines called NSAIDs (Non-Steroidal Anti-Inflammatory Drugs). Omeprazole can also be used to stop ulcers from forming if you are taking NSAIDs.
• too much acid in the stomach caused by a growth in the pancreas (Zollinger-Ellison syndrome).

In children:

Children over 1 year of age and ≥ 10 kg

• ‘gastro-esophageal reflux disease’ (GORD). This is where acid from the stomach escapes into the gullet (the tube which connects your throat to your stomach) causing pain, inflammation and heartburn. In children, the symptoms of the condition can include the return of stomach contents into the mouth (regurgitation), being sick (vomiting) and poor weight gain.

Children and adolescents over 4 years of age

• ulcers which are infected with bacteria called ‘Helicobacter pylori’. If your child has this condition, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.

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

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.

Talk to your doctor or pharmacist before taking Omeprazole.

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 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:

• 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 has 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 that reduces stomach acid
• you are due to have a specific blood test (Chromogranin A).

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).

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.

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

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.

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 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:

• 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 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.

See section 3.

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.

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. 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 c rush them.

If you take more Omeprazole 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 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 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.

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).

Opaque white hard gelatine capsule printed “OM 10”, “OM 20” or “OM 40”. Capsule content: white to slightly pink/beige spherical pellets.

Omeprazole 10 mg 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 and 30 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.

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