PACKAGE LEAFLET: INFORMATION FOR THE USER. Amlodipine Apotex 5 mg tablets Amlodipine Apotex 10 mg tablets. Amlodipine besilate

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1 PACKAGE LEAFLET: INFORMATION FOR THE USER Amlodipine Apotex 5 mg tablets Amlodipine Apotex 10 mg tablets Amlodipine besilate Read all of this leaflet carefully before you start using 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 side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What Amlodipine Apotex is and what it is used for 2. Before you use Amlodipine Apotex 3. How to use Amlodipine Apotex 4. Possible side effects 5. How to store Amlodipine Apotex 6. Further information 1. What Amlodipine Apotex is and what it is used for Amlodipine Apotex contains amlodipine. Amlodipine is one of the group of medicines called calcium antagonists. Calcium antagonists lower the blood pressure by relaxing the blood vessels. They also reduce the load against which the heart works, so these tablets can be used to treat a certain type of chest pain called angina. If you have angina, you suffer from a crushing pain in your chest. Amlodipine can be used for: A high blood pressure Various forms of angina. Amlodipine can be used alone or in combination with other medicines to treat angina.. 2. Before you use Amlodipine Apotex Do not take Amlodipine Apotex: If you are allergic (hypersensitive) to amlodipine or other calcium antagonists in the same group as amlodipine (called dihydropyridine derivatives), or any of the other ingredients of Amlodipine Apotex. These are listed in section 6. What Amlodipine Apotex contains. You can recognise an allergic reaction by, for instance, skin rash, itching, difficulty in breathing and/or swollen face/mouth. If you get any of these symptoms, stop taking Amlodipine Apotex and tell your doctor immediately. if your blood pressure is too low. in case of shock (very severe drop in blood pressure with loss of consciousness) and shock caused by acute pump failure of the heart. If your heart has difficulty in pumping blood around the body (heart failure) in the first 28 days after an acute heart attack. If you are suffering from a disorder that affects the blood flow from the heart.

2 If you are not sure whether any of the above warnings apply to you, always tell your doctor or pharmacist. Take special care with Amlodipine Apotex: If your heart has difficulty in pumping blood around the body (heart failure). If you have impaired liver function; Amlodipine should then be used with caution because the precise dosing needed in this case is not known. If you have a steep rise in blood pressure that can lead to a stroke or organ failure (hypertensive crisis) If any of the above apply to you, talk to your doctor who will decide what to do. Using other medicines Please tell your doctor or pharmacist if you are using or have recently used any other medicines, including medicines obtained without a prescription. Some medicines can interact with Amlodipine Apotex. This means that the action of both medicines can be changed. Tell your doctor if you take any of the following medicines: Diltiazem (medicine for high blood pressure and heart rhythm disorders) and erythromycin (medicine to treat certain infections): diltiazem and erythromycin inhibit the breakdown of amlodipine in the liver and so may increase the effect of amlodipine. Other medicines that inhibit breakdown in the liver, such as ketoconazole, itraconazole (medicine used to treat fungal infections) and ritonavir (a medicine used in the treatment of HIV/AIDS) can cause a further increase in the effect of amlodipine. The effect of amlodipine may be reduced by medicines that speed up the breakdown of amlodipine, such as rifampicin (used in certain infections) and St. John s wort (a herbal remedy used to treat depression, which can be obtained without a prescription). Amlodipine can increase the blood pressure-lowering effect of other medicines used to treat high blood pressure (such as beta-blockers, ACE inhibitors, alpha-blockers and diuretics). Pregnancy and breast-feeding There is not enough information available on the use of amlodipine during pregnancy in humans to establish if it can be harmful. Amlodipine should only be taken during pregnancy if there are no other options and strictly following the doctor s orders. There is no information on the use of Amlodipine during breast-feeding. You should not breast-feed when taking Amlodipine. Ask your doctor or pharmacist before taking or using any medicine. Driving and using machines Amlodipine may cause dizziness, headache, tiredness or nausea. If you suffer from these side effects, you should be careful when driving and/or using machines. Important information about some of the ingredients of Amlodipine Apotex These tablets contain lactose. If your doctor has told you that you have an intolerance to some sugars, talk to your doctor before taking this medicine. Children Safety and effectiveness have been studied in 6-17 year old boys and in girls. Amlodipine Apotex has not been studied in children under the age of 6 years. For more information, talk to your doctor. 3. How to take Amlodipine Apotex Always take Amlodipine Apotex exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Dosage

3 The dose is determined by the doctor; in some cases, this dose may differ from the recommended dosage. If you are not sure, always ask your doctor. The usual dose is as follows: Adults Starting dose for high blood pressure and angina: 5 mg once a day. Maximal dose for high blood pressure and angina: if the desired effect has not been achieved within 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 Apotex 5 mg tablets as these tablets are not manufactured to break into two equal halves. Elderly patients In elderly patients, the dose does not need to be adjusted. However, care should be taken if the dose is increased. If your kidneys are not working properly If your kidneys are not working properly, it is not necessary to adjust the dose. Amlodipine cannot be removed from the blood stream by dialysis (an artificial kidney). If your liver is not working properly The precise dosage for patients with an impaired liver function has not been studied. If your liver is not working properly, amlodipine should be used with caution (see also the section Take special care with Amlodipine Apotex). How to take Amlodipine Apotex Take the tablets with plenty of fluids, for instance a glass of water. The tablets may be taken before, during or after a meal. If you take more Amlodipine Apotex that you should If you take more Amlodipine Apotex than you should, contact your doctor or pharmacist immediately. What you can do yourself is to get the patient to lie down flat with arms and legs elevated (for instance, by using a couple of pillows). When too many Amlodipine Apotex tablets have been taken, the following symptoms can occur: extreme dizziness and/or light-headedness, difficulty in breathing, and an increased need to pass urine. If you forget to take Amlodipine Apotex If you forget to take a tablet, just take it as soon as you remember if this is up to 12 hours after your usual time for taking this medicine. If you should have taken the dose more than 12 hours ago, then skip this forgotten dose and take the next tablet at the usual time. Do not take a double dose to make up for a forgotten dose of Amlodipine Apotex. If you stop taking Amlodipine Apotex Your doctor has told how long you should take Amlodipine Apotex for. If you suddenly stop the treatment, your original symptoms may return. Do not stop the treatment prematurely without discussing this first with your doctor. If you have any further questions on the use of this product, ask you doctor or pharmacist. 4. Possible side effects Like all medicines, Amlodipine may cause side effects, although not everybody gets them. Below you will find a list of possible side effects with the following frequencies: Very common: Affecting more than 1 in 10 users

4 Common: Affecting more than 1 in 100 but less than 1 in 10 users Uncommon: Affecting more than 1 in 1000 but less than 1 in 100 users Rare: Affecting more than 1 in 10,000 but less than 1 in 1000 users Very rare: Affecting less than 1 in 10,000 users and in isolated cases Blood and lymphatic system disorders: Very rare: Low white blood cells with higher chance of infections (leucopenia); low blood platelets with a chance of bruising (thrombocytopenia) Immune system disorders Very rare: Allergic reactions Psychiatric disorders: Uncommon: Sleep disorders; mood changes including anxiety; depression Rare: Confusion Metabolism and nutrition disorders: Very rare: Excess sugar in the blood (hyperglycaemia) Nervous system disorders: Common: Headache (particularly in the beginning of the treatment); sleepiness; dizziness Uncommon: Involuntary shaking (tremor); pins and needles in hands and legs (paresthesia); taste changes; fainting (syncope) Very rare: numbness, tingling, a burning sensation or weakness of hands and feet due to nerve problems (peripheral neuropathy);,increased stiffness of muscles (hypertonia) Eye disorders: Uncommon: Problems with sight, including double vision Ear and labyrinth disorders: Uncommon: Ringing in the ears (tinnitus) Cardiac disorders: Uncommon: Fluttery or throbbing heartbeat (palpitations) Very rare: Heart attach (myocardial infarction), heart rhythm disorders (including decreased or increased heart rate and irregular heartbeat) Vascular disorders: Common: Hot flushes Uncommon: Low blood pressure (hypotension); Very rare: Inflammation of blood vessels (vasculitis) Respiratory, thoracic and mediastinal disorders: Uncommon: Shortness of breath (dyspnoea); runny nose (rhinitis); Very rare: Cough Gastrointestinal disorders: Common: Nausea; stomach ache Uncommon: Vomiting; indigestion (dyspepsia); altered bowel habits including diarrhoea and constipation; dry mouth Very rare: Inflammation of the stomach (gastritis); inflamed pancreas causing severe pain in the abdomen radiating to the back (pancreatitis); swelling of the gums (gingival hyperplasia) Hepatobiliary disorders:

5 Very Rare: Excess liver enzymes in the blood indicating liver dysfunction; jaundice; inflammation of the liver (hepatitis) Skin and subcutaneous tissue disorders: Uncommon: (Widespread) skin rash; itching; red or purple skin patches (purpura); increased sweating (hyperhydrosis); hair loss; discolouration of the skin Very rare: Sudden swelling of the skin or throat/tongue with difficulty in breathing and/or itching or skin rash (angio-oedema). Contact your doctor immediately if this happens. Allergic reactions including rash with irregular red patches (erythema multiforme); nettle rash (hives); severe hypersensitivity reaction with fever, redness of the skin, joint pain and/or eye disorders (Stevens Johnson syndrome); skin inflammation with scaling (exfoliative dermatitis); sensitivity to light (photosensitivity). Musculoskeletal and connective tissue disorders: Common: Swelling of the ankles Uncommon: Muscle cramps; back pain; muscle pain; joint pain Renal and urinary disorders: Uncommon: Increased need to pass urine; problems with passing urine; excessive urination at night (Nycturia miction disorders) Reproductive system and breast disorders: Uncommon: Impotence; enlargement of male breasts (gynaecomastia) General disorders and administration site conditions: Common: Swelling due to water retention (oedema); fatigue. Uncommon: Chest pain; pain; a general feeling of being unwell (malaise); lack or loss of strength and energy (asthenia). Investigations: Uncommon: Weight gain or loss If any of these side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell you doctor or pharmacist. 5. How to store Amlodipine Apotex Keep out of the reach and sight of children. This medicinal product does not require any special storage conditions. Expiry date Do not use Amlodipine Apotex after the expiry date which is stated on the box after Do not use after or on the blister pack after EXP. The expiry date refers to the last day in 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 Apotex contains The active substance in Amlodipine Apotex is amlodipine. Amlodipine Apotex 5 mg Tablets contain amlodipine besilate corresponding to 5 mg amlodipine per tablet. Amlodipine Apotex 10 mg Tablets contain amlodipine besilate corresponding to 10 mg amlodipine per tablet. The other ingredients are: Microcrystalline cellulose, lactose monohydrate, cornstarch and magnesium stearate (E470B). What Amlodipine Apotex look like and the contents of the pack

6 Amlodipine Apotex are tablets. Amlodipine Apotex 5 mg Tablets are off-white to white round tablets. The tablets have the inscription APO on one side and the inscription AML and 5 on the other side. Amlodipine Apotex 10 mg Tablets are off-white to white round tablets. The tablets have the inscription APO on one side and the inscription AML and 10 on the other side. The 5 mg and 10 mg tablets are in a box with 4, 28, 30, 56, 60, 84, 98, 100 and 120 tablets in an aluminium/pvc/pvdc blister pack and in HDPE jars with a polypropylene lid of 30, 90, 100 or 1000 tablets. It is possible that these packages are not all available on the market. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: Apotex Europe Ltd Rowan House, 41 London Street Reading Berkshire RG1 4PS UK Manufacturers: Apotex Nederland BV Archimedesweg CN Leiden The Netherlands OR (for Greece only) DEMO S.A. 21st Km National Road Athens-Lamia, Kryoneri, Athens, Greece This leaflet was last approved in {MM/YYYY} <to be completed nationally> This medicinal product is authorised in the Member States of the EEA under the following names: Amlodipine Apotex 5 mg tabletten Belgium Amlodipine Apotex 10 mg tabletten Czech rep APO-AMLO 5 APO-AMLO 10 Denmark Amlodipin Apotex 5 mg tabletter - Amlodipin Apotex 10 mg tabletter - Spain Amlodipino APOTEX 5 mg comprimidos Amlodipino APOTEX 10 mg comprimidos Poland Apo-Amlo 5 Apo-Amlo 10 UK Amlodipine 5mg Tablet

7 The Netherlands Amlodipine 10mg Tablet Amlodipine Apotex 5 mg Tabletten Amlodipine Apotex 10 mg Tabletten This leaflet was last approved in