PACKAGE LEAFLET: INFORMATION FOR THE USER Amlodipine CF 5 mg tablets Amlodipine CF 10 mg tablets 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 CF tablets are and what are they used for? 2. Before you take Amlodipine CF tablets 3. How to take Amlodipine CF tablets 4. Possible side effects 5. How to store Amlodipine CF tablets 6. Further information 1. What Amlodipine CF tablets are and what are they used for? Amlodipine belongs to a group of medicines known as calcium-channel blockers (calcium antagonists). Calcium-channel blockers lower blood pressure by relaxing the blood vessel walls. They also have an effect on the heart, so that they can be used for angina (angina pectoris). Amlodipine is used for: High blood pressure Various types of angina (angina pectoris) except for unstable angina Amlodipine may be used to treat angina on its own or together with other medicines. 2. BEFORE YOU TAKE AMLODIPINE CF TABLETS Do not take Amlodipine CF tablets If you are allergic (hypersensitive) to amlodipine or similar calcium-channel blockers (the so-called dihydropyridine derivatives), or to any of the other ingredients. If you have very low blood pressure. Page 1
If you are suffering from shock (a very severe lowering of blood pressure by which you become unconscious). If you have heart failure after an acute heart attack. If the blood flow from your heart is obstructed. If you are not sure whether any of the above applies to you, ask your pharmacist or your doctor. Take special care with Amlodipine CF tablets If you have heart failure. If you are undergoing dialysis; your doctor will prescribe you amlodipine with particular caution. If you have liver problems; amlodipine must be used very carefully because the required dosage is not known exactly in this situation. If you are aged 65 or older; any increase in the dosage must be carried out very carefully. Taking other medicines Please note: the following comments can also apply to medicines that you have used some time ago or that you may use in the near future. Tell your doctor or pharmacist if you are taking other medicines or if you have recently taken other medicines. This includes medicines that you can buy without a prescription. The effect of amlodipine may be increased by medicines that slow the breakdown of amlodipine in the liver, such as Diltiazem (a medicine to treat high blood pressure and problems with heart rhythm) HIV-protease-inhibitors (to treat HIV infection/aids) such as ritonavir Erythromycin (to treat certain infections) Ketoconazole, itraconazole (medicines for fungal infections). The effect of amlodipine may be reduced by medicines that increase the breakdown of amlodipine, such as Rifampicin (used for certain infections) or St. John s wort (this medicine can lighten the mood and lift the spirits e.g. in patients with depressive mood). Grapefruit juice, cimetidine, aluminium/magnesium (medicines for indigestion) or sildenafil (a medicine for impotence) do not change the effect of amlodipine. Amlodipine may increase the effect of other medicines used to lower blood pressure. Amlodipine does not change the effect of atorvastatin, digoxin, warfarin or ciclosporin. Amlodipine has no effect on laboratory tests. Pregnancy There is very little information on whether it is harmful to take amlodipine during pregnancy. Amlodipine should only be used during pregnancy if your doctor decides that it is absolutely necessary. Ask your doctor or pharmacist for advice before taking any medicine. Breast-feeding There is no information on the use of amlodipine while breast-feeding. You are advised not to breastfeed when using amlodipine. Ask your doctor or pharmacist for advice before taking any medicine. Page 2
Children and adolescents Safety and effectiveness have been studied in 6-17 year old boys and in girls. Amlodipine CF has not been studied in children under the age of 6 years. For more information, talk to your doctor. Driving and using machines Amlodipine may cause dizziness, tiredness, or make you feel sick. These side effects are more likely to occur after initiation of treatment or after dosage increase. If you have any of these side effects, you should not drive and/or use machinery. Important information about some of the ingredients of Amlodipine CF tablets Amlodipine CF contains lactose (milk sugar). 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 AMLODIPINE CF TABLETS Dosage Always take Amlodipine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Taking the tablets Oral use. Take the tablets with plenty of liquid, for example a glass of water. The tablets may be taken before, during or after a meal. Adults Starting dose for high blood pressure and angina: 5 mg once a day. Maximum dose for high blood pressure and angina: if there has been insufficient effect after 2-4 weeks, the dose may be increased to a maximum of 10 mg once a day. 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 CF 5 mg tablets as these tablets are not manufactured to break into two equal halves. Elderly There is no special dosage for the elderly; however, care must be taken when the dose is increased. If you have kidney problems If you have kidney problems, the dose does not need to be changed. Amlodipine cannot be removed from the blood by dialysis (artificial kidney). If you go for kidney dialysis, amlodipine should be taken with particular caution. Page 3
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 CF tablets). If you think that the effect of Amlodipine CF tablets is too strong or too weak, discuss this with your doctor or pharmacist. If you take more Amlodipine CF tablets than you should If you or someone else has taken too much amlodipine, contact your doctor or pharmacist immediately. 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 CF tablets: If you have forgotten to take a tablet, you can still take it up to 12 hours after you usually take your tablet. If it is more than 12 hours after the time that you should have taken the tablet, you should not take the missed dose and you should take the next tablet at the usual time. Never take a double dose of Amlodipine tablets to make up for the dose that you have missed. If you stop taking Amlodipine CF tablets Your doctor has told you how long you should take amlodipine. If you stop the treatment suddenly, your symptoms may come back. Do not stop the treatment earlier than agreed without discussing this with your doctor. 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. You should stop taking Amlodipine CF and see your doctor immediately if you experience symptoms of angioedema such as swollen face, tongue or pharynx difficulty to swallow hives and difficulties to breath allergic reactions including severe skin reactions, such as skin rash with irregular red patches (erythema multiforme); serious allergic reaction with fever, red patches, joint pain and/or eye problems (Stevens Johnson syndrome); extreme redness and scaling of the skin (exfoliative dermatitis) chest pain or an assumed heart attack a yellow discolouration of the eye whites or skin. These may be signs of jaundice A list of possible side effects is given below. Common (affects 1 to 10 users in 100): Page 4
drowsiness dizziness Headache (especially in the beginning of the treatment) flushing stomach ache feeling sick swelling of the ankles oedema (abnormal accumulation of fluid beneath the skin) tiredness Uncommon (affects 1 to 10 users in 1,000): problems with sleeping mood changes including anxiety depression uncontrolled shaking (tremor) taste disturbances fainting (syncope) reduced sense of touch or sensation (hypoestesia) unpleasant tingling feeling in arms or legs (paraesthesia) problems with sight (including double vision) ringing in the ear (tinnitus) palpitations decreased blood pressure (hypotension) shortness of breath (dyspnoea) running nose (rhinitis) being sick indigestion (dyspepsia) altered bowel habits (including diarrhoea and constipation) dry mouth hair loss appearance of red or purple discolorations on the skin, caused by bleeding underneath the skin (purpura) skin discolouration increased sweating itching suddenly appearing redness of the skin (rash) joint pain muscle pain muscle cramps backache problems with urination increased need to urinate during the night increased need to urinate impotence enlargement of male breasts (gynaecomastia) chest pain Page 5
feeling weak pain feeling unwell increase or decrease in weight Rare (affects 1 to 10 users in 10,000): feeling confused Very rare (affects less than 1 user in 10,000): low numbers of white blood cells giving a higher risk of infections (leucopenia) low numbers of platelets with the risk of bruising (thrombocytopaenia) allergic reactions increase in blood sugars (hyperglycaemia) increased tightness of muscle tone (hypertonia) a burning sensation or weakness of hands and feet (peripheral neuropathy) heart attack irregular heart beat decreased heart rate increased heart rate inflamed blood vessel (vasculitis) coughing inflammation of the pancreas, together with extreme pain in the upper abdomen (below the ribs) that spreads to the back (pancreatitis) inflammation of the stomach lining (gastritis) swelling of the gums inflammation of the liver jaundice increase of liver enzymes in the blood indicating abnormal liver function sudden swelling of the face, tongue or pharynx with difficulty breathing and swallowing and hives (angio-oedema, quincke oedema)) skin rash with irregular red patches (erythema multiforme) hives extreme redness and scaling of the skin (exfoliative dermatitis). serious allergic reaction with fever, red patches, joint pain and/or eye problems (Stevens Johnson syndrome) increased sensitivity to sun light (photosensitivity) 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. 5. HOW TO STORE AMLODIPINE CF TABLETS Keep out of the reach and sight of children. Do not use after the expiry date stated on the pack after EXP. The expiry date refers to the last day of that month. Page 6
Amlodipin CF 5 mg: Do not store above 25 C. Amlodipin CF 10 mg: Do not store above 30 C. 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 CF tablets contain Amlodipine CF 5 mg tablets The active substance is amlodipine (in the form of amlodipine maleate); each tablet contains an amount of amlodipine maleate corresponding to 5 mg amlodipine. The other ingredients are: lactose monohydrate, povidone K30, povidone K90, microcrystalline cellulose (E460), crospovidone, sodium stearyl fumarate. Amlodipine CF 10 mg tablets The active substance is amlodipine (in the form of amlodipine maleate); each tablet contains an amount of amlodipine maleate corresponding to 10 mg amlodipine. The other ingredients are: lactose monohydrate, povidone K30, povidone K90, microcrystalline cellulose (E460), crospovidone, sodium stearyl fumarate. What Amlodipine CF tablets look like and contents of the pack Amlodipine CF 5 mg tablets: Amlodipine CF 5 mg tablets are white, round tablets. The tablets are packed in cartons containing aluminium-aluminium blister packs with 10, 20, 28, 30, 50, 98, 100 and 300 (10 x 30) tablets. Amlodipine CF 10 mg tablets: Amlodipine CF 10 mg tablets are white, round tablets with a break score on both sides. The tablets can be divided into equal halves. The tablets are packed in cartons containing aluminium-aluminium blister packs with 10, 14, 20, 28, 30, 50, 98 and 100 tablets. Not all pack sizes may be marketed. Marketing Authorisation Holder [To be completed nationally] Manufacturer For NL: Centrafarm Services B.V. Nieuwe Donk 9, 4870 AG Etten Leur, The Netherlands Page 7
For BE and LU: Sanico N.V. Veedijk 59, Industriezone 4, 2300 Turnhout, Belgium Clonmel Healthcare Ltd. Waterford Road, Clonmel, Co. Tipperary, Ireland For IT: Doppel Farmaceutici S.R.I. Via Volturno, 48 Quinto De Stampi, 20089 Rozzano (MI), Italy Cosmo S.p.A. Via Cristoforo Colombo, 1, 20020 Lainate (MI), Italy For PT: STADA Arzneimittel AG Stadastrasse 2-18, 61118 Bad Vilbel, Germany This medicinal product is authorised in the Member States of the EEA under the following names: BE: IT: LU: NL: Amlostad Lipres Amlostad Amlodipine CF This leaflet was last approved in {MM/YYYY}. Page 8