雷贝拉唑钠肠溶片说明书(欧盟)

PACKAGE LEAFLET: INFORMATION FOR THE USER Rabeprazole Sodium 10mg Gastro-resistant tablets and Rabeprazole Sodium 20mg Gastro-resistant tablets Rabeprazole Sodium 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. What is in this leaflet: 1. What Rabeprazole is and what it is used for 2. What you need to know before you take Rabeprazole 3. How to take Rabeprazole 4. Possible side effects 5. How to store Rabeprazole 6. Contents of the pack and other information 1. WHAT RABEPRAZOLE IS AND WHAT IT IS USED FOR The name of your medicine is Rabeprazole Sodium 10mg Gastro-resistant tablets or Rabeprazole Sodium 20mg Gastro-resistant tablets (called Rabeprazole throughout this leaflet). Rabeprazole is a medicine that reduces the production of stomach acid (proton pump inhibitor). It belongs to a group of medicines called ‘proton pump inhibitors’. Rabeprazole is used • for the treatment of duodenal ulcers • for the treatment of benign gastric ulcers • symptomatic treatment of erosive or ulcerative gastro-oesophageal reflux disease, commonly referred to as inflammation of the gullet caused by acid and associated with heartburn • for long-term treatment of gastro-oesophageal reflux disease • for the symptomatic treatment of moderate and severe forms of reflux oesophagitis • for the long-term treatment of conditions whereby too much stomach acid is produced (e.g. Zollinger-Ellison syndrome) 2. WHAT YOU KNEED TO KNOW BEFORE YOU TAKE RABEPRAZOLE Do not take Rabeprazole • if you are allergic to rabeprazole or any of the other ingredients of this medicine (listed in section 6). • if you are pregnant or breast-feeding. Warnings and precautions Talk to your doctor or pharmacist before taking rabeprazole: • if you are allergic to other proton pump inhibitors • if you are suffering from severe liver problems Rabeprazole may hide the symptoms of other diseases. Therefore, if any of the following happen to you before you start taking rabeprazole 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). Taking a proton pump inhibitor like Rabeprazole, 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. Children: Rabeprazole should not be given to children as there is no experience with Rabeprazole in children. Other medicines and Rabeprazole Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. If you are also being treated with antibiotics in combination with Rabeprazole, please follow the instructions for using these (which are given in their respective package leaflets). Please tell your doctor if you are taking one of the following medicines: • Medicines to treat fungal infections (e.g. ketoconazole or itraconazole). • Atazanavir for the treatment of HIV infection, which you should not take together with Rabeprazole 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. There are no adequate data from the use of rabeprazole in pregnant women. Therefore you must not take Rabeprazole if you are pregnant or think you might be pregnant. It is not known whether the active substance passes into breast milk. Therefore you must not take Rabeprazole if you are breastfeeding. Driving and using machines It is unlikely that Rabeprazole would affect your ability to drive and use machines. However, occasionally Rabeprazole can cause drowsiness. Therefore, you should not drive or use machines if you feel drowsy. 3. HOW TO TAKE RABEPRAZOLE Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Directions for use: Swallow Rabeprazole tablets whole (not chewed or crushed) before breakfast with a glass of water. Unless otherwise prescribed by your doctor, the usual dose is: Treatment of duodenal ulcers, benign gastric ulcers The usual dose is 20 mg rabeprazole once daily. Symptomatic treatment of erosive or ulcerative gastro-oesophageal reflux disease The usual dose is 20 mg rabeprazole once daily. Symptomatic treatment of moderate to very severe gastro-oesophageal reflux disease The usual dose is 10 mg rabeprazole once daily. Long-term treatment of gastro-oesophageal reflux disease Depending on your response to the treatment your doctor will decide on the dose of 10 mg or 20 mg rabeprazole once daily. Long-term treatment of patients with conditions whereby too much stomach acid is produced (e.g. Zollinger-Ellison syndrome) The usual recommended starting dose is 60 mg rabeprazole once daily. Thereafter, your doctor should individually adjust your dose. The daily dose can be increased to 120 mg rabeprazole which may require divided doses (60 mg twice daily). Patients with impaired kidney or liver function If you belong to this patient group, talk to your doctor. However, a dosage adjustment or change in dose is usually not required. Patients with severe liver problems should be closely monitored by their doctor. How long you should take Rabeprazole tablets Duodenal ulcers generally heal within four weeks. If a four-week course of treatment is not sufficient, healing will be achieved in almost all cases within four weeks of further treatment. For benign gastric ulcers, a six-week course of treatment is required in most cases. If this is not sufficient, healing will be achieved in most cases within six weeks of further treatment. For erosive or ulcerative gastro-oesophageal reflux disease a four to eight weeks course of treatment is required. THESE SIGNATURES ARE FOR ZENTIVA HEAD OFFICE USE ONLY FOR ZENTIVA USE ONLY FOR SCHAWK USE ONLY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Brand: RABEPRAZOLE SODIUM 10MG 20MG PIL UK Category: LEAFLET Argus Code: 2810 Spec No: 48248 Supersedes: 00000 Core Spec No: 00000 Ticket No: 333735 Date: 10-AUG-12 Issue No: 7 Operator: JR Page: 1 of 2 Unwind: N/A Size: 148 x 420mm Win/RFL Ref: N/A Barcode: N/A Mag: N/A BWR: N/A BWR to be assigned by printer. Fonts: Helvetica No. colours and varnish: 1 Artwork Approval Reason for Circulation: Zentiva Regulatory Approved: Yes No N/A Date: Signature: Zentiva - Head of Regulatory Approved: Yes No N/A Date: Signature: Other - as required Approved: Yes No Date: Signature: 48248 00000000 Zentiva Black Cutter For long-term maintenance treatment of gastro-oesophageal reflux disease your doctor will advise you on how long to take your tablets. If you are on a long-term treatment you need to see you doctor at regular intervals for review of your tablets and symptoms. If you have moderate to very severe symptoms of gastro-oesophageal reflux disease, your treatment is expected to continue for up to 4 weeks. If your symptoms do not resolve within four weeks consult your doctor. If your symptoms return, following this four week treatment, your doctor may then tell you to take 10mg rabeprazole as and when you require it in order to control your symptoms. In patients with conditions where too much stomach acid is produced (e.g. Zollinger-Ellison syndrome), there are no limits on the length of treatment and should be continued for as long as it is required. If you take more Rabeprazole than you should If you have taken more Rabeprazole than you should, or if children have been taking medicine by accident, please contact your doctor or the hospital to get an opinion of the risk and advice on action to be taken. If you forget to take Rabeprazole If you forget to take a dose, just take it immediately when you remember, and then continue as usual. Do not take a double dose to make up for a forgotten dose. If you stop taking Rabeprazole Always talk to your doctor, before stopping treatment with Rabeprazole on your own initiative or ending treatment before you should. If you have any further questions on the use of this product, ask your doctor or pharmacist. 4. POSSIBLE SIDE EFFECTS Like all medicines, this medicine can cause side effects, although not everybody gets them. The assessment of side effects is based on the following frequencies: If you notice any of the following serious side effects, stop taking Rabeprazole and contact a doctor immediately: • Severe reactions of the skin and mucous membranes accompanied by blistering (erythema multiforme, toxic epidermal necrolysis, Stevens-Johnson syndrome). • Swelling of the face, low blood pressure and shortness of breath. Other possible side effects Common side effects (affects less than 1 in 10 people) Infection, sleeplessness, headache, dizziness, cough, inflammation of the throat, rhinitis, diarrhoea, feeling sick, being sick, abdominal pain, constipation, wind, non-specific pain, back pain, weakness, flu-like illness. Uncommon side effects (affects less than 1 in 100 people) Nervousness, sleepiness, bronchitis, sinusitis, digestive disorders, belching, itchy skin, muscle pain, leg cramps, joint pain, urinary tract infection, chest pain, chills, fever, increased liver enzymes, rash and dry mouth, fracture of the hip, wrist or spine (if rabeprazole is used in high doses and over long durations). Rare side effects (affects less than 1 in 1,000 people) Reduced or increased amount of white blood cells, reduced amount of blood platelets. Anorexia, depression, vision disturbances, gastritis, sore mouth (stomatitis), taste disturbances, sweating, inflamed kidneys (interstitial nephritis), weight gain. Skin rash, redness of skin, itching and skin blisters, acute generalised reactions for example facial swelling, low blood pressure and shortness of breath, liver problems have been reported, which resolve after stopping treatment. Very rare side effects (affects less than 1 in 10,000 people) Severe reactions of the skin and mucous membranes accompanied by blistering (Stevens-Johnson syndrome, erythema multiforme). Not known (frequency cannot be estimated from the available data) Low blood sodium, confusion, swelling of lower arms and legs (peripheral oedema), development of breasts in men (gynaecomastia). If you are on rabeprazole 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 you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. 5. HOW TO STORE RABEPRAZOLE Keep this medicine out of the sight and reach of children. Do not use Rabeprazole after the expiry date which is stated on the blister and outer carton after “EXP”. The expiry date refers to the last day of that month. This medicinal product does not require any special storage conditions. 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. FURTHER INFORMATION What Rabeprazole contains: The active substance is: rabeprazole sodium Each Rabeprazole Sodium 10mg gastro-resistant tablet contains 10mg of rabeprazole sodium, equivalent to 9.42mg rabeprazole Each Rabeprazole Sodium 20mg gastro-resistant tablet contains 20mg of rabeprazole sodium, equivalent to 18.85mg rabeprazole The other ingredients are: Tablet core: Mannitol, magnesium oxide, sodium edetate, crospovidone type A, calcium stearate, povidone Tablet coating: triethyl citrate, methacrylic acid-ethyl acrylate copolymer (1:1), ethylcellulose, hypromellose, sodium carbonate, anhydrous, titanium dioxide (E171), macrogol 400, yellow iron oxide (E172). Rabeprazole Sodium 10mg gastro-resistant tablets additionally contain red iron oxide (E172). What Rabeprazole looks like and contents of the pack: Rabeprazole 10 mg are pink, round, gastro-resistant tablets. Rabeprazole 20 mg are yellow, round, gastro-resistant tablets. They are supplied in blister packs of 5, 7, 14, 15, 25, 28, 30, 50, 56, 75, 98, 120 tablets. Not all pack sizes may be marketed. Marketing authorisation holder Zentiva, One Onslow Street, Guildford, Surrey, GU1 4YS, UK MANUFACTURER Sofarimex – Ind. Quimica e Farmaceutica, S.A. Av. Das Indústrias – Alto do Colaride 2735-213 Cacém Portugal Or S.C. Zentiva S.A. B-dul. Theodor Pallady nr.50 Sector 3, Bucuresti Cod 032266 Romania This leaflet was last revised in July 2012. 48248 THESE SIGNATURES ARE FOR ZENTIVA HEAD OFFICE USE ONLY FOR ZENTIVA USE ONLY FOR SCHAWK USE ONLY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Brand: RABEPRAZOLE SODIUM 10MG 20MG PIL UK Category: LEAFLET Argus Code: 2810 Spec No: 48248 Supersedes: 00000 Core Spec No: 00000 Ticket No: 333735 Date: 10-AUG-12 Issue No: 7 Operator: JR Page: 2 of 2 Unwind: N/A Size: 148 x 420mm Win/RFL Ref: N/A Barcode: N/A Mag: N/A BWR: N/A BWR to be assigned by printer. 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