Omeprazole 10 Mg Gastro-Resistant Capsules
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Omeprazole 10 mg gastro-resistant capsules, hard
Omeprazole
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information or advice.
- 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.
- You must talk to a doctor if you do not feel better or if you feel worse after 14 days.
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 gastro-resistant capsules 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 in adults for the short-term treatment of reflux symptoms (for example, heartburn, acid regurgitation).
Reflux is the backflow of acid from the stomach into the gullet “foodpipe”, which may become inflamed and painful. This may cause you symptoms such as a painful burning sensation in the chest rising up to the throat (heartburn) and a sour taste in the mouth (acid regurgitation).
It might be necessary to take the capsules for 2-3 consecutive days to achieve improvement of symptoms.
You must talk to a doctor if you do not feel better or if you feel worse after 14 days.
2. What you need to know before you take Omeprazole Do not take Omeprazole
• if you are allergic (hypersensitive) 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 (for HIV infection).
Warnings and precautions
Do not take Omeprazole for more than 14 days without consulting a doctor. If you do not experience relief, or if you experience a worsening of symptoms, consult your doctor.
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 had previous gastric ulcer or gastrointestinal surgery.
• You continuously suffer from or are on continuous symptomatic treatment of indigestion or heartburn for 4 or more weeks.
• Y ou have j aundice or severe liver disease.
• You are aged over 55 years with new or recently changed symptoms.
Patients should not take omeprazole as a preventative medication.
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).
You should specifically tell your doctor or pharmacist if you are taking clopidogrel (used to prevent blood clots (thrombi)).
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)
• Methotrexate (used to treat cancer)
• St John’s wort (Hypericum perforatum) (used to treat mild depression)
• Cilostazol (used to treat intermittent claudication)
• Saquinavir (used to treat HIV infection)
Omeprazole with food and drink
You can take your capsules with food or on an empty stomach.
Pregnancy and breast-feeding
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. 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
Omeprazole gastro-resistant 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 this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The usual dose is one 20 mg capsule or two 10 mg capsules once a day for 14 days. Contact your doctor if you are not free from symptoms after this period.
It might be necessary to take the capsules for 2-3 consecutive days to achieve improvement of symptoms.
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 have trouble swallowing the capsules
• If you 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 recommended, 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 effects (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.
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. 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.
• An inflammation of the colon called “microscopic colitis”; this inflammation may be observed as watery diarrhoea.
• 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.
• Hypomagnesaemia
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.
Reporting of side effects
If you get any side effects, talk to your doctor. 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 this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the outer and inner pack after EXP. The expiry date refers to the last day of that month.
• Store below 25°C.
• Store in the original package in order to protect from moisture.
• HDPE bottle: Use within 3 months of opening. 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 protect the environment.
6. Contents of the pack and other information
What Omeprazole contains
- The active substance is omeprazole: Each capsule contains 10 mg 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) . See section 2 "Omeprazole contains sucrose”
• Capsule shell: gelatine. The 10 mg capsules also contain the colouring agents quinoline yellow (E 104) and titanium dioxide (E 171).
What Omeprazole looks like and contents of the pack
• Omeprazole 10 mg: Opaque yellow capsule containing off-white to cream-white spherical microgranules
Pack sizes:
o Blisters of 7, 14 or 28 capsules. o HDPE bottles of 7, 14 or 28 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorization Holder:
CHEMO IBERICA, S.A.
Gran Via Carlos III, 98, 7th, 08028 Barcelona SPAIN
Manufacturer:
LABORATORIOS LICONSA, S.A.
Av. Miralcampo, N° 7, Poligono Industrial Miralcampo 19200 Azuqueca de Henares (Guadalajara)
SPAIN
This medicinal product is authorised in the Member States of the EEA under the following names:
The Netherlands:
Kruidvat maagzuurremmer Omeprazol 10 mg, maagsapresistente capsule, hard Czech Republic:
Moprilic 10 mg, enterosolventni tvrde tobolky Poland:
Bostomac
Portugal:
Moprilic 10 mg capsulas gastrorresistentes Spain:
Omeprazol Chemo Iberica 10 mg capsulas dura gastrorresistente United Kingdom:
Omeprazole 10 mg gastro-resistant capsules, hard
This leaflet was last revised in
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