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Amlodipine
Rosemont Pharmaceuticals Ltd
C08CA01
Amlodipine
2 mg/ml
Oral Solution
Oral use
150ml
POM - Prescription Only Medicine
Rosemont Pharmaceuticals Ltd
Calcium channel blockers, selective calcium channel blockers with mainly vascular effects
Hypertension; chronic stable angina pectoris; vasospastic (Prinzmetal's) angina
Authorised
2015-02-17
AMLODIPINE 1MG/ML ORAL SOLUTION 18.02.15 TWO 262 1 of 2 1MG/ML N/A - YES - 150 x 500mm (folded 150 x 37mm) 1 Black Keyline 150ML P0782 AMLODIPINE 1MG/ML ORAL SOLUTION READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. n Keep this leaflet. You may need to read it again. n If you have any further questions, ask your doctor or pharmacist. n 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. n 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 Oral Solution is and what it is used for 2. Before you take Amlodipine Oral Solution 3. How to take Amlodipine Oral Solution 4. Possible side effects 5. How to store Amlodipine Oral Solution 6. Further information 1. WHAT AMLODIPINE ORAL SOLUTION IS AND WHAT IT IS USED FOR The name of your medicine is Amlodipine 1mg/ml Oral Solution (called Amlodipine in this leaflet). Amlodipine belongs to a group of medicines called calcium antagonists. Amlodipine is used to treat high blood pressure (hypertension) or a certain type of chest pain called angina, a rare form of which is Prinzmetal’s or variant angina. In patients with high blood pressure your medicine works by relaxing blood vessels, so that blood passes through them more easily. In patients with angina Amlodipine works by improving blood supply to the heart muscle which then receives more oxygen and as a result chest pain is prevented. Your medicine does not provide immediate relief of chest pain from angina. 2. BEFORE YOU TAKE AMLODIPINE ORAL SOLUTION DO NOT TAKE AMLODIPINE IF: n you are allergic (hypersensitive) to Amlodipine, or any of the other ingredients of your medicine listed in section 6, or to any other calcium antagonists. This may be itching, reddening of the skin or difficu 전체 문서 읽기
Amlodipine 2mg/ml Oral Solution Summary of Product Characteristics Updated 18Jun2015 | Rosemont Pharmaceuticals Limited 1. Name of the medicinal product Amlodipine 2mg/ml Oral Solution 2. Qualitative and quantitative composition Each ml contains 2 mg of amlodipine (as besilate). Excipients with known effect: Liquid Maltitol (E965) – 0.14 g/ml Glycerol (E422) – 1 g/ml For a full list of excipients, see section 6.1. 3. Pharmaceutical form Oral Solution A clear, pale straw coloured viscous liquid. 4. Clinical particulars 4.1 Therapeutic indications Hypertension Chronic stable angina pectoris Vasospastic (Prinzmetal's) angina 4.2 Posology and method of administration Posology _Adults_ For both hypertension and angina the usual initial dose is 5 mg (2.5 ml) of amlodipine once daily which may be increased to a maximum dose of 10 mg (5 ml) depending on the individual patient's response. In hypertensive patients, amlodipine has been used in combination with a thiazide diuretic, alpha blocker, beta blocker, or an angiotensin converting enzyme inhibitor. For angina, amlodipine may be used as monotherapy or in combination with other antianginal medicinal products in patients with angina that is refractory to nitrates and/or to adequate doses of beta blockers. No dose adjustment of amlodipine is required upon concomitant administration of thiazide diuretics, beta blockers, and angiotensinconverting enzyme inhibitors. Special populations _Elderly_ Amlodipine used at similar doses in elderly or younger patients is equally well tolerated. Normal dosage regimens are recommended in the elderly, but increase of the dosage should take place with care (see sections 4.4 and 5.2). _Hepatic impairment_ Dosage recommendations have not been established in patients with mild to moderate hepatic impairment 전체 문서 읽기