PACKAGE LEAFLET: INFORMATION FOR THE USER. <Product name> 5 mg tablets <Product name> 10 mg tablets Amlodipine maléate

Transcription

1 FL HU, SK, LU, NL, LV, BE, AT PACKAGE LEAFLET: INFORMATION FOR THE USER <Product name> 5 mg tablets <Product name> 10 mg tablets Read all of this leaflet carefully before you start taking this medicine. Keep this leaflet. You may need to read it again. Ifyou 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 gets serious, or ifyou notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What <Product name> is and what it is used for 2. Before you take <Product name> 3. How to take <Product name> 4. Possible side effects 5. How to store <Product name> 6. Further information 1. WHAT <PRODUCT NAME> IS AND WHAT IT IS USED FOR Amlodipine belongs to a group of medicines called calcium antagonists. It helps to lower blood pressure and works by relaxing blood vessels. It also provides relief from heart-associated chest pain (stable angina pectoris). <Product name> is used to treat: high blood pressure (hypertension) a type of chest pain called stable angina pectoris (a resuh of lack of oxygen supply to the heart muscle) and a rare form called Prinzmetal's or variant angina. 2. BEFORE YOU TAKE <PRODUCT NAME> Do not take <Produci aamo ifyou are allergic (hypersensitive) to amlodipine, other calcium antagonists (dihydropyridines) or any of the other ingredients of <Product name> ifyou have very low blood pressure ifyou have shock suffer from heart failure (the heart fails to pump blood adequately) after a recent heart attack ( within the first 28 days) have a narrowed heart valve (aortic stenosis) whereby pumping the blood by the left ventricle is rendered difficult. have a form of chest pain called unstable angina pectoris. Take special care with <Product name> if your heart has a decreased cardiac reserve. Your doctor will prescribe <Product name> with caution. ifyou suffer from heart failure. Your doctor will treat you with caution. SmPCPIL001002/l Updated: Page 1 of 6

2 if your liver does not work properly. Your doctor will prescribe <Product name>with caution since the exact dosage has not been established. Ifyou are an elderly person, your doctor will increase the dose with caution. Ifyou think that any of the above warnings apply to you, either now or in the past, tell your doctor. Taking other medicines Please tell your doctor or pharmacist ifyou are taking or have recently taken any other medicines, including medicines obtained without a prescription. Caution: The remarks in this leaflet on other medicines refer to the medicines that you have been taking before and those that you may start taking during treatment with <Product name>. It is possible the medicines mentioned below are known to you by an other name (the brand name). In this section only the name of active ingredient or the group of active ingredients is used and not the brand name. Therefore you should read carefully the package and the leaflet of the other medication(s) you are using to see what the active ingredient(s) is(are). Some medicines can interact with <Product name>. This means that the action of both medicines can be changed. Tell your doctor ifyou take any of the following medicines:: diltiazem (for treatment of increased blood pressure and angina pectoris), ketoconazole and itraconazole ( anti-fungal medication), and ritonavir (for treatment of HIV-infection); these medicines might increase the therapeutic effect and side effects of <Product name>. rifampicine (used to treat tuberculosis and lepra) and St. John's wort (used to treat depression). Other blood pressure lowering medicines such as beta-blockers, ACE-inhibitors, alpha-blockers and diuretics. <Product name>can increase the effect of these medicines. Use of <Product name> together with a beta-blocker in patients at risk (for example after a heart attack), might result in heart failure, low blood pressure or another heart attack.. Pregnancy and breast-feeding Ask your doctor or pharmacist for advice before taking any medicine. <Product name> should not be used during pregnancy, unless your doctor finds it necessary. It is recommended to discontinue breast feeding during the treatment with Amlosyl 5 mg and 10 mg. Ifyou are pregnant or breastfeeding, do not take this medicine until you have talked to your doctor. Consult your doctor immediately ifyou become pregnant while taking this medicine. Driving and using machines Your ability to react may be impaired if dizziness, headache, fatigue or sickness appear. If any of these apply to you make sure that you feel well enough to drive a vehicle or operate machinery. 3. HOW TO TAKE <PRODUCT NAME> Always take <Product name> exactly as your doctor has told you. You should check with your doctor or pharmacist ifyou are not sure. Adults: In the treatment of both high blood pressure and angina pectoris the usual starting dose is 5 mg a day taken as a single dose. Your doctor may need to increase the dose to a maximum of 10 mg a day in order to get the best effect. SmPCPILOO 1002/ Updated: Page 2 of6

3 Elderly: The same usual doses are applicable for the elderly. Your doctor will increase the dose with caution. Children: <Product name>is not applicable to children. Impaired kidney fiinction No precautions need to be taken concerning the usual dose if your kidneys do not work properly (see adults). Impaired liver function The exact dosage in patients with impaired liver function has not yet been established. Therefore, your doctor will decide the dosing regimen which he will prescribe with caution. You must swallow <Product name>tablets whole with a glass of water. Take your tablets every day, at the same time each day. You can take the medicine regardless of the time of your meals. Keep taking your tablets for as long as your doctor has told you to. Usually, <Product name>is prescribed for a long time. Ifyou decide to stop taking the drug, tell your doctor first. Ifyou think that the effect of <Product name>is too strong or too weak, consult your doctor or pharmacist. Ifyou take more <Product name> than you should Ifyou have taken more <Product name>than you should, contact your doctor or pharmacist immediately. Ifyou take too many tablets, the following symptoms may appear: very low blood pressure, headache, drowsiness, nausea, stomach ache, the feeling of quicker or irregular heartbeat and dizziness. If this happens, lie dovra, put your legs in elevated position and support them with a pillow. Ifyou forget to take <Product name> Ifyou miss a dose you can take it up to 12 hours after the usual time, and then take your next tablet at the usual time. If more than 12 hours have passed after the missed dose, just take your next dose at the scheduled time. Do not take a double dose to make up for a forgotten tablet dose. Ifyou stop taking <Product name> Ifyou stop taking the drug abruptly, symptoms of the disease can reappear. Ifyou have any further questions on the use of this product, ask your doctor or pharmacist POSSIBLE SIDE EFFECTS Like all medicines, <Product name> can cause side effects, although not everybody gets them. Common affecting more than 1 of 100 patients Uncommon affecting more than 1 of 1000, but in less than 1 of 100 patients Rare affecting more than 1 of 10000, but in less than 1 of 1000 patients Very rare affecting less than 1 of patients Common side effects are: Nervous system: headache (particularly at the beginning of treatment), dizziness Heart: feeling of quicker or irregular heart beat (palpitations) SmPCPILOO 1002/ Updated: Page3 of 6

4 Lungs and chest: difficulty in breathing Alimentary canal: stomach ache, sickness (nausea), indigestion Skin and tissues under the skin: flushing and feeling warm Muscles and joints: muscle cramps Urinary system: increased urinary frequency Body as a whole: ankle swelling (peripheral oedema), fatigue, loss of strength Uncommon side effects are: Blood and lymph: decreased number of platelets (thrombocytopenia) accompanied ynth bruises and bleeding tendency, decreased number of white blood cells (leukopenia) accompanied with increased risk for infections Hormonal system: enlargement of breasts in males (gynaecomastia) Mental changes: sleep disturbances, irritation, depression Nervous system: abnormal sensations such as tingling or prickling (paresthesia), numbness or loss of sensation in the arms and legs (peripheral neuropathy) Eyes and ears: visual disorders and ringing in the ears (tinnitus) Heart: fainting (syncope), accelerated heartbeat, chest pain Blood vessels: low blood pressure (hypotension), inflammation of blood vessel (vasculitis) Lungs and chest: cough Alimentary canal: vomiting, diarrhoea, constipation, swelling of the gums, dry mouth, inflammation of the pancreas (pancreatitis) Skin and tissues under the skin: skin rash, itching, urticaria, hair loss Muscles and joints: back pain, muscle pain, joint pain Reproductive system: impotence Body as a whole: increase or decrease of body weight, feeling unwell (malaise), increased sweating (diaphoresis) Rare side effects are: Mental changes: confiision, mood changes and anxiety Liver and bile: elevated liver enzyme levels in blood, jaundice (yellowing of the skin or eyes), inflammation of the liver (hepatitis) Very rare side effects are: Metabolism and nutrition: excess sugar in blood (hyperglycaemia) Nervous system: involuntary quivering (tremor) Alimentary canal: inflammation of the stomach (gastritis) Skin and tissues under the skin: swelling of the face, tongue or throat (angioedema) Very rarely, allergic reactions occur which can sometimes be serious. These include: itching skin rash severe skin reactions such as red and moist irregular spots or skin inflammation with skin peeling off serious allergic reaction with red skin eruption all over the body,(high) fever, joint pain and eye inflammation serious allergic reactions with swelling of face, tongue, voice box or throat with difficulty in breathing and swelling of joints. Ifyou experience any of the serious allergic reactions, stop taking the drug and contact your doctor immediately SmPCPILOOl 002/ Updated: Page 4 of6

5 At the begirming of treatment some patients have experienced heart attack (myocardial infarction), irregular heart beat (arrhythmia) and chest pain but the relationship to treatment with the medicine has been uncertain. If any of the side effects gets serious, or ifyou notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. 5. HOW TO STORE <PRODUCT NAME> Keep out of the reach and sight of children. Do not store above 30 C. Store in the original package in order to protect from light and moisture. Do not use <Product name> after the expiry date which is stated on the packaging. The expiry date refers to the last day ofthat 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 What <Product name> contains The active substance is amlodipine. Each tablet contains 5 mg amlodipine equivalent to 6.42 mg amlodipine maléate or 10 mg amlodipine equivalent to mg amlodipine maléate. The other ingredients are microcrystalline cellulose, pregelatinised starch (maize origin), sodium starch glycollate (type A), colloidal anhydrous silica and magnesium stéarate. What <Product name> looks like and contents of the pack The 5 mg tablets are white, round, slightly biconvex, bevel-edged, with a score on one side and a diameter of 8 mm. The 10 mg tablets are white, round, slightly biconvex, bevel-edged, with a score on one side and a diameter 10 mm. For each strength, boxes of 10, 14, 20, 28, 30, 50, 50 x 1, 56, 60, 90, 98, 100, 100 x 1, 200 and 250 tablets in blisters are available Marketing Authorisation Holder To be completed nationally Manufacturer KRKA, d.d.. Novo mesto, Smarjeska cesta 6, 8501 Novo mesto, Slovenia This medicinal product is authorised in the Member States of the EEA under the following names: Name of the Member State Netherlands Austria Belgium Name of the medicinal product Amlodipine Krka 5 mg Tablets Amlodipine Krka 10 mg Tablets AmIodinova 5 mg Tablets AmIodinova 10 mg Tablets Doc Amlodipine 5 mg Tablets SmPCPILOO 1002/ Updated: Page 5 of6

6 Finland Hungary Slovakia Latvia Luxembourg Doc Amlodipine 10 mg Tablets Amlodipine Ivax 5 mg Tablets Amlodipine Ivax 10 mg Tablets Tenox 5 mg Tablets Tenox 10 mg Tablets Tenox 5 mg Tablets Tenox 10 mg Tablets Tenox 5 mg Tablets Tenox 10 mg Tablets Amlodipine Krka 5 mg Tablets Amlodipine Krka 10 mg Tablets This leaflet was last approved in SmPCPILOOl 002/ Updated: Page 6 of6