Omeprazole 20mg Gastro-Resistant Capsules
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OMEPRAZOLE 20 mg GASTRO-RESISTANT CAPSULES
(Omeprazole)
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 become 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 Gastro-resistant Capsules are and what they are used for
2. Before you take Omeprazole Gastro-resistant Capsules
3. How to take Omeprazole Gastro-resistant Capsules
4. Possible side effects
5. How to store Omeprazole Gastro-resistant Capsules
6. Further information
1. WHAT OMEPRAZOLE GASTRO-RESISTANT CAPSULES ARE AND WHAT THEY ARE USED
The active ingredient, omeprazole, belongs to a group of medicines called “proton pump inhibitors”. It works by reducing the production of acid in your stomach.
Omeprazole is used to treat the following condi-tions:
• Reflux oesophagitis and Oesophageal reflux disease, where acid from the stomach escapes into the food pipe causing pain, inflammation and heartburn.
• Acid indigestion (dyspepsia) which can cause stomach pain and/or discomfort.
• Ulcers in the upper part of the intestine (duodenal ulcer) or stomach (gastric ulcer). For patients who have had previous trouble with an ulcer and need to continue therapy with a non-steroidal anti-inflammatory drug (NSAID), omeprazole can heal ulcers or prevent an ulcer developing. In such patients, omeprazole protects the stomach or duodenum whilst they are taking NSAIDs.
• Ulcers which are infected with bacteria called Helicobacter pylori.
• Prevention of damage to the lungs caused by breathing in stomach fluids (acid aspiration), e.g. before an operation.
• Zollinger-Ellison syndrome, when excess stomach acids are produced due to a growth in the pancreas.
2. BEFORE YOU TAKE OMEPRAZOLE GASTRO-RESISTANT CAPSULES
If any of the following applies to you, speak to your doctor or pharmacist before you start taking Omeprazole Capsules as they may not be suitable for you.
Do not take Omeprazole Capsules:
• if you are hypersensitive (allergic) to omeprazole or any of the other ingredients of Omeprazole Capsules.
• if you are taking atazanavir (a medicine used to treat HIV)
• if your doctor suspects you have an ulcer, he may wish to run tests to exclude the possibility of serious illness before you take Omeprazole Capsules
Take special care with Omeprazole Capsules:
Tell your doctor if you suffer from any of the following:
• liver problems
• if you are going to have an operation and anaesthetic (including at the dentist) tell your doctor or dentist that you are taking Omeprazole Capsules
• if you have an intolerance to sucrose
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).
Omeprazole acts to reduce the acid in your stomach and this may lead to a slightly increased risk of infections of the stomach and intestine, such as Salmonella and Campylobacter.
Long term treatment with Omeprazole in children is not recommended. You should speak with your doctor or pharmacist if you are not sure.
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.
Check with your doctor or pharmacist, before starting treatment with Omeprazole Capsules, if you are taking any other medicines, especially the following,
• Diazepam (for your nerves)
• Phenytoin (for epilepsy)
• Warfarin and other medicines used for thinning the blood
• Digoxin (for the heart)
• Ketoconazole, itraconazole or variconazole
• Atazanavir (for treating HIV)
• Clarithromycin (an antibiotic)
• Tacrolimus (an immunosuppressant).
Taking Omeprazole Capsules with food and drink
You can take your capsules with food or on an empty stomach at any time of the day. The capsules should not be chewed or crushed. Please refer to section 3 - How to take Omeprazole.
Pregnancy and Breast-feeding:
Omeprazole Capsules can be used during pregnancy and if you are breast-feeding.
Driving and using machines:
Your medicine does not usually affect your ability to drive or operate machinery. However you should not drive or operate machinery if you experience any side effects such as dizziness and light headedness as your ability to drive or operate machines may be affected.
Important information about some of the ingredients of Omeprazole Capsules:
This medicine 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 GASTRO-RESISTANT CAPSULES
Always take Omeprazole exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Omeprazole Capsules should not be chewed or crushed. They should be swallowed whole with a drink of water. If you have trouble swallowing, the capsules can be opened and the contents taken in the following way:
• swallow directly with half a glass of water, or
• suspended in 10 ml of still water or fruit juice like apple, orange or pineapple, or
• gently mixed in yoghurt or apple sauce.
It is important that the contents of the capsules are not crushed or chewed and that you drink half a glass of water after you have taken the contents of the capsules.
ADULTS
Treatment for heartburn (Reflux oesophagitis and oesophageal reflux disease) - The usual dose is 20 mg omeprazole taken once a day for 4 weeks. Your doctor may ask you to continue taking the capsules or increase the dose depending on how you respond to treatment. To stop your symptoms returning your doctor may tell you to continue to take 20 mg omeprazole or reduce the dose to 10mg.
Relief of Acid Indigestion (Dyspepsia) - The usual dose is 10 mg or 20 mg once a day for a period of 2 - 4 weeks. Your doctor will tell you how long to take your capsules for. If you do not experience any improvement in your symptoms you should return to your doctor.
Treatment of ulcers in the upper part of the intestine (duodenal ulcer) and stomach (gastric ulcer) -The usual dose is 20 mg omeprazole once a day for a period of 4 - 8 weeks depending on your symptoms. Your doctor may increase the dose depending on how you respond to treatment. To stop your ulcer coming back, the usual dose is omeprazole 10 mg once daily unless your symptoms return. If your symptoms return, your doctor may increase the dose.
Treatment and prevention of stomach ulcers, duodenal ulcers and associated symptoms caused by NSAIDs
If you have previously had trouble with an ulcer and need to continue taking a NSAID the recommended dose is omeprazole 20 mg once daily. Your doctor will advise how long you need to take the capsules for.
Treatment of Ulcers caused by infection with the bacteria called Helicobacter Pylori The usual dose is omeprazole 40 mg once a day or 20 mg taken twice a day for a period of 1 - 2 weeks. Your doctor will also tell you to take one or two of the following antibiotics; amoxicillin, clarithromycin, metronidazole or tinidazole. Follow the directions for taking your medicine very carefully and if you are unsure about anything, ask your doctor or pharmacist.
Before a hospital operation when you are to be given a general anaesthetic - The usual dose is omeprazole 40 mg taken the evening before surgery, and another 40 mg dose two to six hours before surgery.
Zollinger - Ellison Syndrome - The usual starting dose is omeprazole 60 mg once a day. If the dose is more than 80 mg a day, half the dose should be taken in the morning and half at night. Your doctor will tell you how many capsules to take and when to take them.
CHILDREN
Reflux oesphagitis - The usual starting dose is dependent on age and weight. Your doctor will tell you what dose to take. Treatment should be given for 4-8 weeks. If symptoms persist after the end of the treatment consult your doctor.
Gastroesophageal reflux disease (heartburn and acid reflux) - The usual starting dose is dependent on age and weight. Your doctor will tell you what dose to take. Treatment should be given for 2-4 weeks. If symptoms persist after the end of the treatment consult your doctor.
Treatment of Ulcers caused by infection with the bacteria called Helicobacter Pylori - For children over the age of 4 years the dose of omeprazole and combined antibiotics will depend on their weight. Your doctor will tell you what dose to take. Treatment usually lasts 1 week but your doctor may increase this to two weeks if required.
If you take more Omeprazole Capsules than you should:
If you (or someone else) accidentally take too many Omeprazole 20 mg Capsules, contact your doctor or pharmacist immediately.
If you forget to take Omeprazole Capsules:
If you forget to take a dose, take it as soon as you remember. If it is nearly time for your next dose just take the next dose and forget about the one you missed. Do not take a double dose to make up for the forgotten dose.
If you stop taking Omeprazole:
Do not stop taking Omeprazole without talking to your doctor first. If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Omeprazole can cause side effects, although not everybody will experience them. These are usually mild and go away when you stop taking this medicine.
If the following happens, stop taking the capsules and tell your doctor immediately or go to the emergency department at your nearest hospital:
• An allergic reaction (angioedema): swelling of the face, lips, tongue or throat, or difficulty breathing or swallowing.
This is a very serious but rare side effect. You may need urgent medical attention or hospitalisation.
Common (occur in more than 1 in 100 patients, but less than 1 in 10 patients
• Headache
• Diarrhoea, constipation, stomach pain, sickness, feeling sick and flatulence (wind)
Uncommon (occur in more than 1 in 1000 patients but less than 1 in 100 patients)
• Dizziness or a feeling of spinning, pins and needles, light headedness, feeling faint, drowsiness and insomnia
• Increased liver enzymes
• Itchy skin, rash and hives
• Feeling of general discomfort
• Fracture of the hip, wrist or spine if omeprazole is used in high doses and over a long period of time.
Rare (occur in more than 1 in 10000 but less than 1 in 1000 patients)
• Feeling of confusion, agitation, aggression, depression and hallucination
• Dry mouth, swelling of the mouth and yeast infections in the stomach or intestine
• Liver problems, jaundice (yellowing of the skin or eyes), liver failure
• Sensitivity to light, blistering, unusual reddening of the skin, flu like symptoms and blistering or skin lesions (Stevens-Johnson syndrome), patches of dead skin and hair loss
• Larger breasts (males only)
• Leukopenia, thrombocytopenia and agranulocytosis (decrease in number of blood cells)
• Arthritic symptoms, muscle pain and muscular weakness
• Impotence
• Hypersensitivity reactions e.g. rapid swelling of the skin and tissues, fever, difficulty in breathing, interstitial nephritis (kidney disease) and anaphylactic shock (strong allergic reaction). Increased sweating, peripheral oedema (swelling of hands and feet), blurred vision, taste disturbance and low blood sodium.
Frequency not known
If you are on Omeprazole Capsules 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.
If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE OMEPRAZOLE GASTRO-RESISTANT CAPSULES
• Keep out of the reach and sight of children.
• Store below 30 °C.
• Do not use Omeprazole after the expiry date which is stated on the carton after ‘EXP'. The expiry date refers to the last day of that month
• 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. FURTHER INFORMATION
• The active substance is omeprazole and each capsule contains 20 mg of omeprazole as gastro resistant granules.
• The other ingredients are: sugar spheres, sodium starch glycolate, sodium laurilsulfate, povidone, potassium oleate, oleic acid, hypromellose, methacrylic acid - ethyl acrylate copolymer (1:1), triethyl citrate, titanium dioxide and talc. The capsule coating also contains carrageenan, titanium dioxide (E171), FDC blue 1, Red 40, Hypermellose, potassium chloride and yellow 6. The printing ink contains shellac, polyvinylpyrrolidone, propylene glycol, sodium hydroxide and titanium dioxide (E171).
What Omepraozle 20 mg Gastro-resistant Capsules look like and the contents of the pack
The capsules have an orange body and blue cap and are marked with O20. Omeprazole 20 mg Capsules are available in aluminium blisters of 28 capsules.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Zentiva, One Onslow Street,
Guildford, Surrey, GU1 4YS, UK
Manufacturer:
TEVA Pharma S.L.U.
Poligono Industrial Malpica calle C
50016- Zaragoza Spain
© 2012 Zentiva
This leaflet was last revised in May 2012
For information in large print or Braille please contact the Marketing Authorisation on 01483 554101
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