DAZOLIT

Posology Adults For both hypertension and angina the usual initial dose is 5 mg Amlodipine once daily which may be increased to a maximum dose of 10 mg 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 angiotensin-converting enzyme inhibitors.

Special populations Elderly patients Amlodipine used at similar doses in elderly or younger patients is equally well tolerated. 2). 2). The pharmacokinetics of amlodipine have not been studied in severe hepatic impairment. Amlodipine should be initiated at the lowest dose and titrated slowly in patients with severe hepatic impairment.

Patients with renal impairment Changes in amlodipine plasma concentrations are not correlated with degree of renal impairment, therefore the normal dosage is recommended. Amlodipine is not dialysable. Paediatric population Children and adolescents with hypertension from 6 years to 17 years of age.

5 mg once daily as a starting dose, up-titrated to 5 mg once daily if blood pressure goal is not achieved after 4 weeks. 2). Children under 6 years old No data are available. Method of administration Tablet for oral administration. This medicine can be taken before or after food and drinks.

The tablet should be placed on the tongue and allowed to disintegrate before swallowing with or without water, according to patient preference. Do not take Amlodipine with grapefruit juice.

Summary of the safety profile The most commonly reported adverse reactions during treatment are somnolence, dizziness, headache, palpitations, flushing, abdominal pain, nausea, ankle swelling, oedema and fatigue. Tabulated list of adverse reactions The following adverse reactions have been observed and reported during treatment with amlodipine with the following frequencies: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).

Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. System organ class Frequency Adverse reactions Blood and lymphatic system disorders Very rare Leukocytopenia, thrombocytopenia Immune system disorders Very rare Allergic reactions Metabolism and nutrition disorders Very rare Hyperglycaemia Uncommon Depression, mood changes (including anxiety), insomnia Psychiatric disorders rare confusion.

Common Somnolence, dizziness, headache (especially at the beginning of the treatment) Uncommon Tremor, dysgeusia, syncope, hypoaesthesia, paraesthesia Very rare Hypertonia, peripheral neuropathy Nervous system disorders Not known Extrapyramidal disorder Eye disorders common Visual disturbance (including diplopia) Ear and labyrinth disorders Uncommon Tinnitus Common Palpitations Uncommon Arrhythmia (including bradycardia, ventricular tachycardia and atrial fibrillation) Cardiac disorders Very rare Myocardial infarction Common Flushing Uncommon Hypotension Vascular disorders Very rare Vasculitis Common DyspnoeaRespiratory, thoracic and mediastinal disorders Uncommon Cough, rhinitis Common Abdominal pain, nausea, dyspepsia, altered bowel habits (including diarrhoea and constipation) Uncommon Vomiting, dry mouth Gastrointestinal disorders Very rare Pancreatitis, gastritis, gingival hyperplasia Hepatobiliary disorders Very rare Hepatitis, jaundice, hepatic enzyme increased* Uncommon Alopecia, purpura, skin discolouration, hyperhidrosis, pruritus, rash, exanthema, urticaria Very rare Angioedema, erythema multiforme, exfoliative dermatitis, Stevens- Johnson syndrome, Quincke oedema, photosensitivity Skin and subcutaneous tissue disorders Not known Toxic epidermal necrolysis Common Ankle swelling, muscle crampsMusculoskeletal and connective tissue disorders Uncommon Arthralgia, myalgia, back pain Renal and urinary disorders Uncommon Micturition disorder, nocturia, increased urinary frequency Reproductive system and breast disorders Uncommon Impotence, gynaecomastia Very common Oedema Common Fatigue, asthenia General disorders and administration site conditions Uncommon Chest pain, pain, malaise Investigations Uncommon Weight increased, weight decreased *mostly consistent with cholestasis Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

The safety and efficacy of amlodipine in hypertensive crisis has not been established. Patients with cardiac failure Patients with heart failure should be treated with caution. 1). Calcium channel blockers, including amlodipine, should be used with caution in patients with congestive heart failure, as they may increase the risk of future cardiovascular events and mortality.

Patients with hepatic impairment The half-life of amlodipine is prolonged and AUC values are higher in patients with impaired liver function; dosage recommendations have not been established. Amlodipine should therefore be initiated at the lower end of the dosing range and caution should be used, both on initial treatment and when increasing the dose.

Slow dose titration and careful monitoring may be required in patients with severe hepatic impairment. 2). Patients with renal impairment Amlodipine may be used in such patients at normal doses. Changes in amlodipine plasma concentrations are not correlated with degree of renal impairment.

Amlodipine is not dialysable. Sodium This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

1. severe hypotension. shock (including cardiogenic shock). , high grade aortic stenosis). haemodynamically unstable heart failure after acute myocardial infarction