PACKAGE LEAFLET: INFORMATION FOR THE USER. <Amlodipine 5 mg and 10 mgtablets> Amlodipine maleate

Transcription

1 PACKAGE LEAFLET: INFORMATION FOR THE USER <Amlodipine 5 mg and 10 mgtablets> Amlodipine maleate 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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What <Amlodipine> is and what it is used for 2. Before you take <Amlodipine> 3. How to take <Amlodipine> 4. Possible side effects 5. How to store <Amlodipine> 6. Further information 1. WHAT <AMLODIPINE> IS AND WHAT IT IS USED FOR <Amlodipine> belongs to a group of drugs called calcium-channel blockers. It relieves heart problems by widening blood vessels to allow more blood to flow through. This helps to reduce blood pressure and relieve the strain on the heart muscle. <Amlodipine> is used to treat: - high blood pressure - various types of angina (chest pain), except unstable angina <Amlodipine Tablets> do not provide immediate relief of chest pain from angina. 2. BEFORE YOU take <Amlodipine> Do not take <Amlodipine> if you: - are allergic (hypersensitive) to <Amlodipine> or any other ingredients of the medicine - are allergic (hypersensitive) to any other calcium channel blockers e.g. nifedipine, felodipine - are suffering from shock (including shock induced by a heart condition) - have very low blood pressure - suffer from aortic stenosis (a narrowing of the main artery leading from the heart) - have suffered from heart failure following a heart attack. If you are not sure whether any of the above applies to you, ask your pharmacist or your doctor. Take special care with <Amlodipine> Tell your doctor before you start to take this medicine if you: - have any liver problems - have heart failure. Children Safety and effectiveness have been studied in 6-17-year-old boys and in girls. <Amlodipine> has not been studied in children under the age of 6 years. For more information, talk to your doctor. NL-H PL.doc / Version 1.2 December

2 Taking other medicines Some medicines (including medicines obtained without prescription, herbal medications or natural products) may interact with <Amlodipine>. This means that the action of both medicines can be changed. It is therefore important to tell your doctor if you take any of the following medicines: - Medicines that can lower blood pressure, e.g. beta blockers, ACE inhibitors, alpha-1 blockers and diuretics. Amlodipine may enhance the blood pressure-lowering effects of these medicines. - Diltiazem (heart medicine) may intensify the effect of amlodipine. - Ketoconazole and itraconazole (antifungal medicines) may intensify the effect of amlodipine. - HIV protease inhibitors (antiviral medicines to treat HIV infections, e.g. ritonavir) may intensify the effect of amlodipine. - Erythromycin (an antibiotic) may intensify the effect of amlodipine. - Rifampicin (an antibiotic) may reduce the effect of amlodipine. - St. John s wort (Hypericum perforatum; herbal medicine for depression) may reduce the effect of amlodipine. Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Pregnancy and breast-feeding Do not take <Amlodipine> if you are pregnant or trying to become pregnant. <Amlodipine> should only be used during pregnancy if your doctor decides that it is absolutely necessary. There is no information on the use of <Amlodipine> during breast-feeding. If it is essential that you continue taking <Amlodipine>, then you should stop breast-feeding during treatment. Ask your doctor or pharmacist for advice before taking any medicine. Driving and using machines Taking <Amlodipine> may cause dizziness, headache, fatigue or nausea. Do not drive or operate machinery if you are affected. 3. HOW TO TAKE <AMLODIPINE> Always take <Amlodipine> Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The tablets should be swallowed preferably with a glass of water. The usual dose is: Adults The starting dose is one 5 mg tablet, once a day. Your doctor may increase this, after 2-4 weeks, to a maximum of 10 mg once a day. Elderly patients There is no special dosage for the elderly; however, care must be taken when the dose is increased. If you have kidney problems The normal dosage is recommended. Amlodipine cannot be removed from the blood by dialysis (artificial kidney). <Amlodipine> should be administered with particular caution to patients NL-H PL.doc / Version 1.2 December

3 undergoing dialysis. If you have liver problems The exact dose needed for patients with liver problems has not been determined. If you have liver problems, <Amlodipine> should be used very carefully (see also the section Take special care with <Amlodipine> ). Children For children (6-17 years old), the recommended usual starting dose is 2.5 mg a day. The maximum recommended dose is 5 mg a day. Amlodipine 2.5 mg is not currently available and the 2.5 mg dose cannot be obtained with <Amlodipine> 5 mg as these tablets are not manufactured to break into two equal halves. If you take more <Amlodipine> than you should If you (or someone else) swallow a lot of the tablets all together, or if you think a child has swallowed any of the tablets, contact your doctor or go to your nearest hospital casualty department immediately. An overdose is likely to cause severe low blood pressure. Please take this leaflet, any remaining tablets and the container with you to the hospital or doctor so that they know which tablets were consumed. The person concerned should be made to lie down with their arms and legs up (resting on a couple of cushions, for example). Symptoms of an overdose are extreme dizziness and/or feeling very light-headed, problems with breathing, having to urinate very often. If you forget to take <Amlodipine> If you forget to take a tablet, take one as soon as you remember, unless it is nearly time to take the next one. Do not take a double dose to make up for a forgotten dose. Take the remaining doses at the correct time. If you stop taking <Amlodipine> Do not stop taking your medicine without talking to your doctor first even if you feel better. If you stop treatment suddenly, your symptoms may come back. If you have any further questions on the use of this product, ask your doctor or pharmacist. 4. POSSIBLE SIDE EFFECTS Like all medicines, <Amlodipine> can cause side effects, although not everybody gets them. If the following happens, stop taking the tablets and tell your doctor immediately or go to the casualty department at your nearest hospital: - an allergic reaction (swelling of the lips, face or neck leading to severe difficulty in breathing; hives, mild to more severe skin rashes that may involve blistering and peeling of the skin). This is a very serious but rare side effect. You may need urgent medical attention or hospitalisation. The following side effects have been reported at the approximate frequencies shown: Common (affecting one to 10 users in 100): - sleepiness - headaches (especially at the beginning of treatment) - feeling hot or becoming flushed in the face - nausea - tiredness - dizziness NL-H PL.doc / Version 1.2 December

4 - stomach ache - swelling of the ankles or limbs. Uncommon (affecting one to 10 users in 1,000): - runny and itchy nose - a general feeling of being unwell - increased sweating - dry mouth, change in or loss of the sense of taste - shortness of breath - sleeplessness - problems with sight - ringing in the ears - mood changes including anxiety, depression - abnormal heart rate - low blood pressure (feeling dizzy or faint) - altered or increased need to pass water, including during the night - vomiting - pain in the joints or muscles - hair loss - diarrhoea or constipation - indigestion - pain, including in the back or chest - trembling or shaking - enlargement of the breasts in men - increase or decrease in weight - impotence - skin rash and pruritus (itchy skin) - skin discolouration, purple skin patches - muscle cramps - numbness or a tingling sensation of the skin - fainting - lack of energy, physical weakness. Rare (affecting one to 10 users in 10,000): - confusion. Very rare (affecting fewer than one user in 10,000): - allergic reactions including swelling of the face and throat - allergic skin rash with irregular red spots, caused by medicines (erythema exsudativum multiforme), itchy rash, severe allergic reactions with blistering eruptions of the skin and mucous membranes (exfoliative dermatitis, Stevens-Johnson syndrome) - sensitivity of the skin to light - increased blood sugar levels, which may be experienced as an increase in appetite or thirst - inflammation of the stomach lining resulting in persistent stomach pain, indigestion and flatulence - inflammation of the pancreas, which causes severe pain in the abdomen and back - swollen gums - jaundice (yellowing of the skin and whites of the eyes) - hepatitis (inflammation of the liver) - increased level of liver enzymes in the blood indicating liver problems - tense muscles - a disorder of the nerves which can cause weakness, pain, tingling or numbness - unusual bleeding or unexplained bruising - a blood disorder which may be characterised by fever, chills, a sore throat or ulcers in the mouth or throat - inflammation of the blood vessels, which may produce purplish spots on the skin that do not turn white when pressed NL-H PL.doc / Version 1.2 December

5 - cough - heart attack, irregular heartbeat. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. 5. HOW TO STORE <AMLODIPINE> Keep out of the reach and sight of children. Do not store above 25 C. Store in the original package in order to protect from light and moisture. Do not use <Amlodipine> after the expiry date that is stated on the outer packaging. 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 What <Amlodipine Tablets > contain - The active ingredient is amlodipine (as maleate). - The other ingredients are microcrystalline cellulose, anhydrous calcium hydrogen phosphate, sodium starch glycolate and magnesium stearate. What <Amlodipine Tablets > look like and contents of the pack - The 5 mg tablets are white, oval-shaped tablets with AM 5 on one side, plain on the other side. They are available in pack sizes* of 20, 28, 30, 50, 100, 200 and 300 tablets. - The 10 mg tablets are white, oval shaped tablets with AM 10 and a breakline on one side, plain on the other side. The tablets can be divided into equal halves. They are available in pack sizes* of 14, 20, 28, 30, 50, 100, 200 and 300 tablets. *Not all pack sizes may be marketed. Marketing Authorisation Holder <To be completed nationally> Manufacturer <To be completed nationally> Pharmachemie B.V., Swensweg 5, Postbus 552, 2003 RN Haarlem, the Netherlands OR TEVA UK Ltd, Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG, United Kingdom OR Oy Galena Ltd, Sammonkatu 10, P.O. Box 1450, Kuopio, Finland OR Teva Pharmaceutical Works Private Limited Company, Pallagi út 13, 4042 Debrecen, Hungary This medicinal product is authorised in the Member States of the EEA under the following names: Germany: Italy: Netherlands: Spain: Amlo-TEVA 5 mg & 10 mg Tabletten Amlodipina Teva 5 mg & 10 mg Compresse Amlodipine 5 mg & 10 mg Pharmachemie; tabletten Amlodipino Teva 5 mg & 10 mg comprimidos EFG NL-H PL.doc / Version 1.2 December

6 United Kingdom: Amlodipine 5 mg & 10 mg Tablets Marketing Authorisation Number: This leaflet was last revised in: December NL-H PL.doc / Version 1.2 December