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Omeprazole 20 Mg Gastro-Resistant Capsules

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Document: leaflet ALMUS PHARMACEUTICALS_PL 21690-0011 change

PACKAGE LEAFLET: INFORMATION FOR THE USER

Omeprazole 20mg gastro-resistant capsules

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

-    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.

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:

•    '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).

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.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE OMEPRAZOLE

Do not take Omeprazole

•    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).

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:

•    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.

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 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.

Omeprazole may interfere with some test (chromogranin A). To avoid this interference the omeprazole should be temporarily stopped five days before testing.

Other medicines and Omeprazole

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

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)

•    Erlotinib (used to treat cancer)

•    Methotrexate (used to treat rheumatoid arthritis and some cancers)

•    St John’s wort (Hypericum perforatum) (used to treat mild depression)

•    Cilostazol (used to treat cramp-like pain in your legs when you walk and is caused by insufficient blood supply in your legs)

•    Saquinavir (used to treat HIV infection)

•    Clopidogrel (used to prevent blood clots )

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

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

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby ask your doctor for advice before taking this medicine. 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.

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.

3. HOW TO TAKE OMEPRAZOLE

Always take Omeprazole exactly as your doctor 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 GERD such as heartburn and

acid regurgitation:

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

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

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

To treat ulcers in the upper part of the intestine

(duodenal ulcer):

•    The usual dose is 20 mg 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 does not fully heal, 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 20 mg 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 does not fully heal, 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 10 mg or 20 mg once a day. Your doctor may increase the dose to 40 mg once a day.

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

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

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

•    The usual dose is 20 mg once a day.

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

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

•    Your doctor will also tell you to take two antibiotics among amoxicillin, clarithromycin and metronidazole.

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

•    The usual dose is 60 mg daily.

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

Use in 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 mix the contents with a small amount of yoghurt, 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 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, 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:

•    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.

Other side effects include:

Common side effects (may affect up to 1 in 10 people)

•    Headache.

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

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

Uncommon side elects (may affect up to 1 in 100 people)

•    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.

•    Fracture of the hip, wrist or spine.

Rare side effects (may affect up to 1 in 1,000 people)

•    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. Th i s 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 (may affect up to 1 in 10,000 people)

•    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.

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.

Not known (frequency cannot be estimated from the available data)

•    Inflamation in the gut (leading to diarrhoea).

•    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.

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

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 Yellow Card Scheme: 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 this medicine out of the sight and reach of children.

•    Do not use this medicine after the expiry date which is stated on the pack after “EXP:”. The expiry date refers to the last day of that month. HDPE bottle: Use within 3 months of opening.

•    Store below 25°C.

•    Store this blister in the original package or keep the bottle tightly closed in order to protect from moisture. Replace cap firmly after use.

•    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 20mg gastro-resistant capsules contains:

-    The active substance    is omeprazole.

Omeprazole 20mg capsules contain 20 mg of omeprazole.

-    The other ingredients are:

•    Capsule content:sugar spheres (consisting of corn starch and sucrose), sodium laurilsulfate, Disodium phosphate, anhydrous, mannitol, hypromellose 6 cP, macrogol 6000, talc, polysorbate 80, titanium dioxide (E 171), and methacrylic acid-ethylacrylate copolymer (1:1) .

•    Capsule s/e/l'gelatine, the colouring agents quinoline yellow (E 104) and titanium dioxide (E 171).

What Omeprazole 20mg gastro-resistant capsules

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looks lke and consults of the pack

Opaque yellow capsule containing off-white to cream-white spherical microgranules

Pack sizes:

Blisters of 7, 14, 15, 28, 30, 50, 56, 60, 90, 98, 100, 140 or 280 capsules; hospital pack of 500 capsules.

HDPE bottles of 5, 7, 14, 15, 28, 30, 50, 56, 60, 90, 100, 105 or 250 capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

CHEMO IBERICA, S.A.

Gran Via Carlos III, 98, 7th,

08028 Barcelona SPAIN

LABORATORIOS LICONSA, S.A.

Av. Miralcampo, N° 7, Poligono Industrial Miralcampo

19200 Azuqueca de Henares (Guadalajara)

SPAIN

This leaflet was last revised in 07/2015