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Omeprazole 10mg Gastro-Resistant Hard Capsules

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Document: leaflet MAH GENERIC_PL 21562-0014 change

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PATIENT INFORMATION LEAFLET

OMEPRAZOLE 10MG, 20MG & 40MG GASTRO-RESISTANT HARD

CAPSULES

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 any further questions, ask your doctor or pharmacist.

•    This medicine has been prescribed for you. Do 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 gets 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 is and what it is used for

2.    Before you take Omeprazole

3.    How to take Omeprazole

4.    Possible side effects

5.    How to store Omeprazole

6.    Further information

1. WHAT OMEPRAZOLE IS AND WHAT IT IS USED FOR

These capsules contain the active substance Omeprazole. Omeprazole 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:

•    Gastro-esophageal reflux disease (GERD). 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’ (GERD). GERD is described above. 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.

2. BEFORE YOU TAKE OMEPRAZOLE Do not take Omeprazole

•    If you are allergic(hypersensitive) to Omeprazole or any of the other ingredients in these capsules

•    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).

If you are not sure, talk to your doctor or pharmacist before taking these capsules.

Take special care with Omeprazole

Omeprazole may hide the symptoms of other diseases. Therefore, if any of the following happen to you before you start taking these 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 has been associated with a small increase in infectious diarrhoea.

•    You have severe liver problems.

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 other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained 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 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 (Hypericumperforatum) (used to treat mild depression)

•    Cilostazol (used to treat intermittent claudication)

•    Saquinavir (used to treat HIV infection)

•    Clopidogrel (used to prevent blood clots (thrombi))

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.

Taking Omeprazole with food and drink

You can take your capsules with food or on an empty stomach.

Pregnancy and breast-feeding

Before taking these capsules tell your doctor if you are pregnant or trying to get pregnant. Your doctor will decide whether you can take Omeprazole during this time.

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.

Important information about some of the ingredients of these capsules

These capsules contain 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.

3. HOW TO TAKE OMEPRAZOLE

Always take these capsules exactly as your doctor has told you. You should 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 usual doses are given below.

Adults:

To treat symptoms of GERD such as heartburn and acid regurgitation:

•    If your doctor has found that your gullet has been slightly damaged, the usual dose is 20mg once a day for 4-8 weeks. Your doctor may tell you to take a dose of 40mg for a further 8 weeks if your gullet has not yet healed.

•    The usual dose once the gullet has healed is 10mg once a day.

•    If your gullet has not been damaged, the usual dose is 10mg once a day.

To treat ulcers in the upper part of the intestine (duodenal ulcer):

•    The usual dose is 20mg once a day for 2 weeks. Your doctor may tell you to take the same dose for a further 2 weeks if your ulcer has not yet healed.

•    If the ulcer has not fully healed, the dose can be increased to 40 mg once a day for 4 weeks.

To treat ulcers in the stomach (gastric ulcer):

•    The usual dose is 20mg once a day for 4 weeks. Your doctor may tell you to take the same dose for a further 4 weeks if your ulcer has not yet healed.

If the ulcer has not fully healed, the dose can be increased to 40 mg once a day for 8 weeks.

To prevent the duodenal and stomach ulcers from coming back:

•    The usual dose is 10mg or 20mg once a day. Your doctor may increase the dose to 40mg once a day.

To treat duodenal and stomach ulcers caused by NSAIDs (Non-Steroidal AntiInflammatory Drugs):

•    The usual dose is 20mg once a day for 4-8 weeks.

To prevent duodenal and stomach ulcers if you are taking NSAIDs:

•    The usual dose is 20mg once a day.

To treat ulcers caused by Helicobacter pylori infection and to stop them coming back:

•    The usual dose is 20 mg twice a day for one week.

•    Your doctor will also tell you to take two antibiotics from either amoxicillin, clarithromycin or metronidazole.

To treat too much acid in the stomach caused by a growth in the pancreas (Zollinger-Ellison syndrome):

•    The usual dose is 60mg daily.

•    Your doctor will adjust the dose depending on your needs and will also decide for how long you need to take the medicine.

Children:

To treat symptoms of GERD such as heartburn and acid regurgitation:

•    Children over 1 year of age and with a body weight of more than 10 kg may take Omeprazole. The dose for children is based on the child’s weight and the doctor will decide the correct dose.

To treat ulcers caused by Helicobacter pylori infection and to stop them coming back:

•    Children aged over 4 years may take Omeprazole. The dose for children is based on the child’s weight and the doctor will decide the correct dose.

•    Your doctor will also prescribe two antibiotics called amoxicillin and clarithromycin for your child.

Taking this medicine

•    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.

What to do if you or your child have trouble swallowing the capsules

•    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 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 your 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.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Omeprazole can cause side effects, although not everybody gets them.

If you notice any of the following rare but serious side effects, stop taking these capsules and contact a doctor immediately:

•    Sudden wheezing, swelling of your lips, tongue and throat or body, rash, fainting or difficulties in swallowing (severe allergic reaction).

•    Reddening of the skin with blisters or peeling. There may also be severe blisters and bleeding in the lips, eyes, mouth, nose and genitals. This could be Stevens-Johnson syndrome or toxic epidermal necrolysis.

•    Yellow skin, dark urine and tiredness which can be symptoms of liver problems.

Side effects may occur with certain frequencies, which are defined as follows:

Very common:

Affects more than 1 user in 10

Common:

Affects 1 to 10 users in 100

Uncommon:

Affects 1 to 10 users in 1,000

Rare:

Affects 1 to 10 users in 10,000

Very rare:

Affects less than 1 user in 10,000

Not known:

Frequency cannot be estimated from the available data

Other side effects include:

Common side effects

•    Headache.

•    Effects on your stomach or gut: diarrhoea, stomach pain, constipation, wind (flatulence).

•    Feeling sick (nausea) or being sick (vomiting).

Uncommon side effects

•    Swelling of the feet and ankles.

•    Disturbed sleep (insomnia).

•    Dizziness, tingling feelings such as “pins and needles”, feeling sleepy.

•    Spinning feeling (vertigo).

•    Changes in blood tests that check how the liver is working.

•    Skin rash, lumpy rash (hives) and itchy skin.

•    Generally feeling unwell and lacking energy.

Rare side effects

•    Blood problems such as a reduced number of white cells or platelets. This can cause weakness, bruising or make infections more likely.

•    Allergic reactions, sometimes very severe, including swelling of the lips, tongue and throat, fever, wheezing.

•    Low levels of sodium in the blood. This may cause weakness, being sick (vomiting) and cramps.

•    Feeling agitated, confused or depressed.

•    Taste changes.

•    Eyesight problems such as blurred vision.

•    Suddenly feeling wheezy or short of breath (bronchospasm).

•    Dry mouth.

•    An inflammation of the inside of the mouth.

•    An infection called thrush which can affect the gut and is caused by a fungus.

•    Liver problems, including jaundice which can cause yellow skin, dark urine, and tiredness.

•    Hair loss (alopecia).

•    Skin rash on exposure to sunshine.

•    Joint pains (arthralgia) or muscle pains (myalgia).

•    Severe kidney problems (interstitial nephritis).

•    Increased sweating.

Very rare side effects

•    Changes in blood count including agranulocytosis (lack of white blood cells).

•    Aggression.

•    Seeing, feeling or hearing things that are not there (hallucinations).

•    Severe liver problems leading to liver failure and inflammation of the brain.

•    Sudden onset of a severe rash or blistering or peeling skin. This may be associated with a high fever and joint pains (Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).

•    Muscle weakness.

•    Enlarged breasts in men.

Frequency not known

If you are on Omeprazole for more than three months it is possible that the levels of magnesium in your blood may fall. Low levels of magnesium can be seen as fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate. If you get any of these symptoms, please tell your doctor promptly. Low levels of magnesium can also lead to a reduction in potassium or calcium levels in the blood. Your doctor may decide to perform regular blood tests to monitor your levels of magnesium.

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).

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.

Do not be concerned by this list of possible side effects. You may not get any of them. 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.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. 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.

By reporting side effects you can help provide more information on the safety of this medicine.

5.    HOW TO STORE OMEPRAZOLE

•    Keep out of the reach and sight of children.

•    Do not use these capsules after the expiry date which is stated on the pack after EXP. The expiry date refers to the last day of that month.

•    Do not store above 30°C.

•    Keep the bottle tightly closed in order to protect from moisture. Do not use after 28 days after first opening.

•    Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6.    ADDITIONAL INFORMATION Composition of Omeprazole capsules

-    The active substance is Omeprazole. Each capsule contains 10mg, 20mg or 40mg of Omeprazole.

-    The other ingredients are: hypromellose, talc, titanium dioxide, metacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30% (also sodium laurilsulfate and polysorbate 80), triethylcitrate, ethylcellulose, oleic acid, colloidal anhydrous silica, sugar spheres (sucrose and maize starch), gelatin and black ink (shellac and black iron oxide).

What the product looks like and contents of the pack

The capsules are opaque, white coloured and printed with OM 10, OM 20 and OM 40 for the 10mg capsules, 20mg capsules and 40mg capsules, respectively.

All strengths come in bottle packs of 14 and 28 capsules. The 40mg strength also comes in a bottle pack of 7 capsules. Not all packs may be marketed.

Marketing Authorisation Holder

DISTRIQUIMICA, S.A., Av. Mare de Deu de Montserrat, 221 - Bajos, 08041 Barcelona, Spain

Manufacturer

Laboratorios Dr. Esteve, S.A. Sant Marti, s/n, Poligono Industrial La Roca, 08170, Martorelles, Barcelona, Spain.

This package leaflet was last updated in October 2014.

For information in large print or braille contact the Marketing Authorisation Holder above, telephone 0034.93.446.00.00 or e-mail mcastella@esteve.es.