Omeprazole 10 Mg and 20 Mg Gastro-Resistant Capsules

Omeprazole 10 mg and 20 mg Gastro-resistant capsules

Read all of this leaflet carefully before Children you start taking this medicine because it Some children with chronic illnesses may contains important information for you. require long-term treatment although it is • Keep this leaflet. You may need to read not recommended. Do not give this medicine to children under 1 year of age or weigh less it again. than 10kg. • If you have any further questions, ask your doctor or pharmacist. Other medicines and Omeprazole • This medicine has been prescribed for capsules you only. Do not pass it on to others. It Tell your doctor or pharmacist if you are may harm them, even if their signs of taking, have recently taken or might take any illness are the same as yours. other medicines. This is because Omeprazole • If you get any side effects, talk to your can affect the way some medicines work doctor or pharmacist. This includes any and some medicines can have an effect on possible side effects not listed in this Omeprazole. leaflet. See section 4. Do not take Omeprazole if you are taking a medicine containing nelfinavir (used to treat What is in this leaflet HIV infection). 1 What Omeprazole capsules are Tell your doctor or pharmacist if you are and what they are used for taking any of the following medicines: 2 What you need to know before • Ketoconazole, itraconazole, posaconazole you take Omeprazole capsules or voriconazole (used to treat infections 3 How to take Omeprazole capsules caused by a fungus) • Digoxin (used to treat heart problems) 4 Possible side effects • Diazepam (used to treat anxiety, relax 5 How to store Omeprazole capsules muscles or in epilepsy) 6 Contents of the pack and other • Phenytoin (used in epilepsy). If you are taking phenytoin, your doctor will need to information monitor you when you start or stop taking Omeprazole 1 What Omeprazole capsules are • Medicines that are used to thin your blood, and what they are used for such as warfarin or other vitamin K blockers. Your doctor may need to monitor you when Omeprazole capsules contain the active you start or stop taking Omeprazole substance omeprazole. It belongs to a group • Rifampicin (used to treat tuberculosis) of medicines called ‘proton pump inhibitors’. • Atazanavir (used to treat HIV infection) They work by reducing the amount of acid • Tacrolimus (in cases of organ that your stomach produces. transplantation) • Methotrexate (used to treat arthritis, Crohn’s Omeprazole is used to treat the following or psoriasis) conditions: • St John’s wort (Hypericum perforatum) (used to treat mild depression) In adults: • Cilostazol (used to treat intermittent • ‘Gastro-oesophageal reflux disease’ (GORD). claudication) This is where acid from the stomach escapes • Saquinavir (used to treat HIV infection) into the gullet (the tube which connects • Clopidogrel (used to prevent blood clots your throat to your stomach) causing pain, (thrombi)) inflammation and heartburn. • Erltinib (used in some cancers) • Ulcers in the upper part of the intestine • Clarithromycin (to treat infections) (duodenal ulcer) or stomach (gastric ulcer), If your doctor has prescribed the antibiotics prevention of reoccurrence of ulcers. amoxicillin and clarithromycin as well • Ulcers which are infected with bacteria as Omeprazole to treat ulcers caused called ‘Helicobacter pylori’. If you have this by Helicobacter pylori infection, it is very condition, your doctor may also prescribe important that you tell your doctor about any antibiotics to treat the infection and allow other medicines you are taking. the ulcer to heal. • Ulcers caused by medicines called NSAIDs Pregnancy and breast-feeding (Non-Steroidal Anti-Inflammatory Drugs). If you are pregnant or breast-feeding, think Omeprazole can also be used to stop ulcers you may be pregnant or are planning to from forming if you are taking NSAIDs. have a baby, ask your doctor or pharmacist • Too much acid in the stomach caused by for advice before taking this medicine. Your a growth in the pancreas (Zollinger-Ellison doctor will decide whether you can take syndrome). Omeprazole during this time. Your doctor will decide whether you can take In children: Omeprazole if you are breastfeeding. Children over 1 year of age and 10kg • ‘Gastro-esophageal reflux disease’ (GORD). Driving and using machines This is where acid from the stomach escapes Omeprazole is not likely to affect your into the gullet (the tube which connects ability to drive or use any tools or machines. your throat to your stomach) causing pain, Side effects such as dizziness and visual inflammation and heartburn. disturbances may occur (see section 4). If In children, the symptoms of the condition affected, you should not drive or operate can include the return of stomach contents machinery. into the mouth (regurgitation), being sick (vomiting) and poor weight gain. Omeprazole capsules contain sucrose Omeprazole capsules contain sucrose. If you Children and adolescents over 4 years of age have been told by your doctor that you have • Ulcers which are infected with bacteria an intolerance to some sugars, contact your called ‘Helicobacter pylori’. If your child doctor before taking this medicinal product. has this condition, your doctor may also prescribe antibiotics to treat the infection 3 How to take Omeprazole capsules and allow the ulcer to heal. Always take this medicine exactly as your 2 What you need to know before doctor or pharmacist has told you. Check you take Omeprazole capsules with your doctor or pharmacist if you are not sure. Do not take Omeprazole capsules and tell Your doctor will tell you how many capsules your doctor if you: to take and how long to take them for. This • are allergic to omeprazole or any of the will depend on your condition and how old other ingredients of this medicine (listed in you are. section 6). • are allergic to medicines containing other Doses: proton pump inhibitors (e.g. pantoprazole, • Adult lansoprazole, rabeprazole, esomeprazole). To treat symptoms of GORD such as • are taking a medicine containing nelfinavir heartburn and acid regurgitation: (used for HIV infection) • If your doctor has found that your food pipe (gullet) has been slightly damaged, the If you are not sure, talk to your doctor or recommended dose is 20mg once a day for pharmacist before taking Omeprazole. 4-8 weeks. Your doctor may tell you to take a dose of 40mg for a further 8 weeks if your Warnings and precautions gullet has not yet healed. Talk to your doctor or pharmacist before • The recommended dose once the gullet has taking Omeprazole capsules healed is 10mg once a day. Omeprazole may hide the symptoms of other • If your gullet has not been damaged, the diseases. Therefore, if any of the following recommended dose is 10mg once a day. happen to you before you start taking Omeprazole or while you are taking it, talk to To treat ulcers in the upper part of the your doctor straight away if: intestine (duodenal ulcer): • you lose a lot of weight for no reason and • The recommended dose is 20mg once a day have problems swallowing. for 2 weeks. Your doctor may tell you to take • you get stomach pain or indigestion. the same dose for a further 2 weeks if your • you begin to vomit food or blood. ulcer has not yet healed. • you pass black stools (blood-stained • If the ulcer does not fully heal, the dose faeces). can be increased to 40mg once a day for 4 • you experience severe or persistent weeks. diarrhoea, as omeprazole has been associated with a small increase in To treat ulcers in the stomach (gastric ulcer): infectious diarrhoea. • The recommended dose is 20mg once a day • You have severe liver problems. for 4 weeks. Your doctor may tell you to take • you have ever had a skin reaction after the same dose for a further 4 weeks if your treatment with a medicine similar ulcer has not yet healed. to Omeprazole Capsules that reduces • If the ulcer does not fully heal, the dose stomach acid. can be increased to 40mg once a day for 8 • you get a rash on your skin, especially in weeks. areas exposed to the sun tell your doctor as soon as you can, as you may need to stop To prevent the duodenal and stomach your treatment with Omeprazole Capsules. ulcers from coming back: Remember to also mention any other ill- • The recommended dose is 10mg or 20mg effects like pain in your joints once a day. Your doctor may increase the • you take atazanavir dose to 40mg once a day. • your body does not absorb vitamin B12 (cobalamin) very well To treat duodenal and stomach ulcers • you are due to have a specific blood test caused by NSAIDs (Non-Steroidal Anti- (Chromogranin A) Inflammatory Drugs): • The recommended dose is 20mg once a day Taking a proton pump inhibitor like for 4–8 weeks. Omeprazole, especially over a period of more than one year, may slightly increase To prevent duodenal and stomach ulcers if your risk of fracture in the hip, wrist or spine. you are taking NSAIDs: Tell your doctor if you have osteoporosis • The recommended dose is 20mg once a day. or if you are taking corticosteroids (which To treat ulcers caused by Helicobacter can increase the risk of osteoporosis). Your pylori infection and to stop them coming doctor will probably keep you under regular back: surveillance. You should report any new and • The recommended dose is 20mg exceptional symptoms and circumstances Omeprazole twice a day for one week. whenever you see your doctor. • Your doctor will also tell you to take two antibiotics among amoxicillin, clarithromycin and metronidazole.

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Omeprazole 10mg & 20mg Gastro-resistant Capsules PIL- UK

approved for print/date Item number: BBBA3101 Colours Non Printing Colours 1. Black 1. Originator: R.Wrey Dimensions: 140 x 540 Origination Date: 03/10/18 Min Body Text Size: 8pt 2. 2. Revision Date: 08/10/18 Supplier: Liconsa 3. 3. Revised By: R.Wrey 4. 5. Proof Round Technical Date sent: 03/10/18 6. 3 Approval Date received: 04/10/18 [email protected]

FMD info NA (not a carton)  No  Yes  Details * Please note that only Artwork Studio is permitted to make changes to the above artwork. Version 2 No changes are permitted by any 3rd party other than added notes and mark ups for required changes. 01.11.2017 To treat too much acid in the stomach caused Uncommon side effects (may affect up to 1 by a growth in the pancreas (Zollinger- in 100 people) Ellison syndrome): • Swelling of the feet and ankles. • The recommended dose is 60mg daily. • Disturbed sleep (insomnia). • Your doctor will adjust the dose depending • Dizziness, tingling feelings such as “pins and on your needs and will also decide how long needles”, feeling sleepy. you need to take the medicine for. • Spinning feeling (vertigo). • Changes in blood tests that check how the Use in children liver is working. To treat symptoms of GORD such as • Skin rash, lumpy rash (hives) and itchy skin. heartburn and acid regurgitation: • Generally feeling unwell and lacking energy. • Children over 1 year of age and with a • Increased risk of fracture of the hip, wrist or body weight of more than 10kg may take spine. Omeprazole. The dose for children is based on the child’s weight and the doctor will Rare side effects (may affect up to 1 in decide the correct dose. 1,000 people) • Blood problems such as a reduced number To treat ulcers caused by Helicobacter of white cells or platelets. This can cause pylori infection and to stop them coming weakness, bruising or make infections more back: likely. • Children aged over 4 years may take • Low levels of sodium in the blood. This may Omeprazole. The dose for children is based cause weakness, being sick (vomiting) and on the child’s weight and the doctor will cramps. decide the correct dose. • Feeling agitated, confused or depressed. • Your doctor will also prescribe two • Taste changes. antibiotics called amoxicillin and • Blurred vision. clarithromycin for your child. • Suddenly feeling wheezy or short of breath (bronchospasm). Patients with kidney or liver problems • Dry mouth. • Dose adjustment is not required in patients • An inflammation of the inside of the mouth. with kidney problems • Hair loss (alopecia). • Patients with liver problems may require an • Skin rash on exposure to sunshine. smaller dose of 10-20mg a day. • Joint pains (arthralgia) or muscle pains (myalgia). Taking this medicine • Severe kidney problems (interstitial • It is recommended that you take your nephritis). capsules in the morning. • Increased sweating. • You can take your capsules with food or on • Liver problems, including jaundice which an empty stomach. can cause yellow skin, dark urine, and • Swallow your capsules whole with half a tiredness. glass of water. Do not chew or crush the • An infection called “thrush” which can affect capsules. This is because the capsules the gut and is caused by a fungus. contain coated pellets which stop the medicine from being broken down by the Very rare side effects (may affect up to 1 in acid in your stomach. It is important not to 10,000 people) damage the pellets. • Aggression. • Seeing, feeling or hearing things that are What to do if you or your child have not there (hallucinations). trouble swallowing the capsules • Severe liver problems leading to liver failure - Open the capsules and swallow the and inflammation of the brain. contents directly with half a glass of water • Muscle weakness. or put the contents into a glass of still • Enlarged breasts in men. (non-fizzy) water, any acidic fruit juice Do not be concerned by this list of possible (e.g. apple, orange or pineapple) or apple side effects. You may not get any of them. sauce. - Always stir the mixture just before drinking Not known (frequency cannot be it (the mixture will not be clear). Then drink estimated from the available data) the mixture straight away or within 30 • If you are on Omeprazole for more than minutes. three months it is possible that the levels - To make sure that you have drunk all of of magnesium in your blood may fall. the medicine, rinse the glass very well with Low levels of magnesium can be seen as half a glass of water and drink it. The solid fatigue, involuntary muscle contractions, pieces contain the medicine - do not chew disorientation, convulsions, dizziness, or crush them. increased heart rate. If you get any of these - Alternatively you or your child can suck symptoms, please tell your doctor promptly. the capsule and swallow the pellets with Low levels of magnesium can also lead to half a glass of water. The pellets must not a reduction in potassium or calcium levels be chewed. in the blood. Your doctor may decide to perform regular blood tests to monitor your If you take more Omeprazole levels of magnesium. capsules than you should • Inflamed colon causing watery diarrhoea If you (or someone else) swallow a lot of (microscopic colitis). capsules at the same time, or you think a • Rash, possible with pain in the joints. child may have swallowed any, contact your Reporting of side effects nearest hospital casualty department or tell If you get any side effects, talk to your doctor, your doctor immediately. Take this leaflet pharmacist or nurse. This includes any and any remaining capsules that you have to possible side effects not listed in this leaflet. show the doctor. You can also report side effects directly via Symptoms of an overdose may include the Yellow Card Scheme at: feeling or being sick, dizziness, stomach www.mhra.gov.uk/yellowcard or search for pain, diarrhoea, headache, depression and MHRA Yellow Card in the Google Play or confusion. Apple App Store. If you forget to take Omeprazole By reporting side effects you can help capsules provide more information on the safety of Do not take a double dose to make up for a this medicine. forgotten dose. If you forget to take a dose take it as soon as you remember it and then 5 How to store Omeprazole take the next dose at the right time. capsules If you stop taking Omeprazole Store below 25°C. Store in the original capsules package to protect from moisture. Keep Do not stop treatment early otherwise this medicine out of the sight and reach of your symptoms may reappear. Talk to your children. doctor before you stop taking the capsules Do not use Omeprazole capsules after the and follow his advice. expiry date stated on the carton. The expiry date refers to the last day of that month. If you have any further questions on the Do not throw away any medicines via use of this medicine, ask your doctor or wastewater or household waste. Ask your pharmacist. pharmacist how to throw away medicines you no longer use. These measures will help 4 Possible side effects protect the environment.

Like all medicines, this medicine can cause 6 Contents of the pack and other side effects, although not everybody gets them. information What Omeprazole capsules contain If you notice any of the following rare • The active substance (the ingredient that but serious side effects, stop taking makes the capsule work) is Omeprazole. Omeprazole and contact a doctor Each capsule contains either 10mg or 20mg immediately: of omeprazole. Rare side effects (may affect up to 1 in • The other ingredients are sugar spheres 1,000 people) (consisting of corn starch and sucrose), • Sudden wheezing, swelling of your lips, sodium lauryl sulfate, disodium phosphate, tongue and throat or body, rash, fainting mannitol, hypromellose, polyethylene glycol or difficulties in swallowing (severe allergic 6000, talc, polysorbate 80, titanium dioxide, reaction). Eudragit L30-D55 (poly(methacrylic acid, Very rare side effects (may affect up to 1 in ethyl acrylate)). Capsules consist of gelatin 10,000 people) and contain the colours quinoline yellow • Reddening of the skin with blisters or (E104) and titanium dioxide (E171). peeling. There may also be severe blisters and bleeding in the lips, eyes, mouth, What Omeprazole capsules look like nose and genitals. This could be ‘erythema and contents of the pack multiforme’, ‘Stevens-Johnson syndrome’ or 10mg capsules are hard gelatine capsules ‘toxic epidermal necrolysis’. of size 3, Opaque yellow cap and body, • Yellow skin, dark urine and tiredness which containing white to off-white spherical can be symptoms of liver failure. pellets. • Shortness of breath, tiredness, dizziness, 20mg capsules are hard gelatin capsules bleeding or bruising may be caused by of size 2, Opaque yellow cap and body, a reduction in red, white blood cells and containing white to off-white spherical platelets (pancytopenia). A blood test may pellets. be required. • Omeprazole may in very rare cases affect Pack sizes are 7, 10, 14, 15, 20, 21, 28, 30, 50, the white blood cells leading to immune 56, 60, 84, 90, 98, 100 capsules (blister packs); deficiency. If you have an infection with 30, 90 (tablet containers). symptoms such as fever with a severely reduced general condition or fever with Not all pack sizes may be marketed. symptoms of a local infection such as pain in the neck, throat or mouth or difficulties Marketing Authorisation Holder in urinating, you must consult your doctor Accord, Barnstaple, EX32 8NS, UK as soon as possible so that a lack of white blood cells (agranulocytosis) can be ruled Manufacturer out by a blood test. It is important for you Laboratorios Liconsa S.A., Avda. Miralcampo, to give information about your medicine at No. 7, Poligono Industrial Miralcampo, 19200 this time. Azuqueca de Henares (Guadalajara), Spain Date of revision: October 2018 Side effects may occur with certain frequencies, which are defined as follows: If you would like a Tell your doctor if you notice any of the following side effects or notice any other leaflet with larger effects not listed: text, please contact Common side effects (may affect up to 1 in 01271 385257. 10 people) • Headache. • Diarrhoea, stomach pain, constipation, wind (flatulence). • Feeling sick (nausea) or being sick (vomiting). • Benign polyps in the stomach.

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Omeprazole 10mg & 20mg Gastro-resistant Capsules PIL- UK