COMPOSITION: Each tablet contains : Amlodipine Besilate B.P. Equivalent to Amlodipine 5mg, 10mg DESCRIPTION : Amlodura is a calcium antagonist that inhibits calcium ion influx across cell membrane selectively, with a greater effect on vascular smooth muscle cells than on cardiac muscle cells. The mechanism of antihypertensive action of Amlodipine is due to a direct relaxant effect on the vascular smooth muscle. The exact mechanism by which amlodipine relieve angina have not been fully determined but amlodipine reduce the total ischemic burden by the following two actions: - In exertional angina : Amlodipine reduce the peripheral resistance (after load) against which the heart works, 

and reduce the rate pressure product, and thus myocardial energy consumption and oxygen requirement - In patients with prinzmetal's or variant angina : Amlodipine dialate the main coronary arteries and coronary 

arterioles both in normal and ischemic regions, this dilatation increase myocardial oxygen delivery. The Amlodipine is well absorbed and not affected by consumption of food. Peak blood concentrations occurring after 6 - 12 hours. It has a prolonged terminal elimination half life of 30-50 hours and steady-state plasma concentration are achieved after 7 - 8 days of administration. Amlodipine is extensively metabolized in the liver to inactive metabolites, and 60% of metabolites excreted in the urine. INDICATIONS : Amlodura is indicated for : - Treatment of Hypertension, It can be used alone or in combination with other antihypertensive agents. - Treatment of Chronic stable angina, It may be used alone or in combination with other antianginal agents. - Treatment of Vasospastic angina (prinzmetal's or variant angina). 

It may be used alone or in combination with other antianginal drugs. DOSAGE & ADMINISTRATION: - The usual initial dose for both hypertension and angina is 5mg Amlodipine once daily, which may be increased 

to a maximum dose of 10mg depending on the individual patients response. - Renal failure patients use normal dose of Amlodipine. - Elderly or patient with hepatic insufficiency can start with 2.5mg once daily & can combine Amlodipine with 

other antihypertensive drugs. RESTRICTIONS ON USE : Contraindications Amlodipine is contraindicated in the following cases: - Hypersensitivity to amlodipine or dihydropyridine. - Unstable angina and for 8 days after myocardial infarction. Precautions Caution should be exercised when administering amlodipine in patients with severe aortic stenosis, heart failure or severe hepatic impairment. Pregnancy and lactation Use in pregnancy is only recommended if the potential benefit justifies the potential risk to the fetus. It's not recommended to use amlodipine for nursing mothers. DRUG INTERACTION : Amlodipine can be administered with other antihypertensive, NSAIDs, nitrates, antibiotics, digoxin and oral hypoglycemic drugs. ADVERSE REACTIONS : The most commonly observed side effects were headache, edema, fatigue, somnolence, nausea, abdominal pain, flushing, palpitations, and dizziness. STORAGE INSTRUCTIONS: Store between 15-30°C in a dry place, protect from light. PRESENTATIONS : Amlodura 5 : Pack of 30 tablets and hospital packs of different sizes. Amlodura 10: Pack of 10 or 30 tablets and hospital packs of different sizes. 

INSTRUCTIONS TO THE PATIENT - Medicament is a product which affects your health, and its consumption contrary to instructions is dangerous for you. - Follow strictly the doctor's prescription, the method of use and the instructions of the pharmacist who sold the medicament. - The doctor and the pharmacist are experts in medicine, its benefits and risks. - Do not by yourself interrupt the period of treatment prescribed for you. - Do not repeat the same prescription without consulting your doctor. 

Keep medicament out of reach of children 

012-06-072 3/16 

Council of Arab Health Ministars 

Union of Arab Pharmacists 

Shoa 

Mfd. By 

Shiba Pharma P.O. Box : 4265 Sana'a /Yemen.