AMLODIPINE ZENTIVA

Posology Adults For both hypertension and angina the usual initial dose is 5 mg 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. Swallow whole with a glass of water.

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 Very rare Leukocytopenia, system disorders thrombocytopenia Immune system disorders Very rare Allergic reactions Metabolism and nutrition disorders Very rare Hyperglycaemia Psychiatric disorders Uncommon Rare Depression, mood changes (including anxiety), insomnia Confusion Nervous system disorders Common Uncommon Very rare Not known Somnolence, dizziness, headache (especially at the beginning of the treatment) Tremor, dysgeusia, syncope, hypoaesthesia, paraesthesia Hypertonia, peripheral neuropathy Extrapyramidal disorder Eye disorders Common Visual disturbance (including diplopia) Ear and labyrinth disorders Uncommon Tinnitus Cardiac disorders Common Uncommon Very rare Palpitations Arrhythmia (including bradycardia, ventricular tachycardia and atrial fibrillation) Myocardial infarction Vascular disorders Common Uncommon Very rare Flushing Hypotension Vasculitis Respiratory, thoracic and mediastinal disorders Common Uncommon Dyspnoea Cough, rhinitis Gastrointestinal disorders Common Uncommon Very rare Abdominal pain, nausea, dyspepsia, altered bowel habits (including diarrhoea and constipation) Vomiting, dry mouth Pancreatitis, gastritis, gingival hyperplasia Hepatobiliary disorders Very rare Hepatitis, jaundice, hepatic enzyme increased* Skin and subcutaneous tissue disorders Uncommon Very rare Not known Alopecia, purpura, skin discolouration, hyperhidrosis, pruritus, rash, exanthema, urticaria Angioedema, erythema multiforme, exfoliative dermatitis, Stevens- Johnson syndrome, Quincke oedema, photosensitivity Toxic epidermal necrolysis Musculoskeletal and connective tissue disorders Common Uncommon Ankle swelling, muscle cramps Arthralgia, myalgia, back pain Renal and urinary disorders Uncommon Micturition disorder, nocturia, increased urinary frequency Reproductive system and breast disorders Uncommon Impotence, gynaecomastia General disorders and administration site conditions Very common Common Uncommon Oedema Fatigue, asthenia 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.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

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. Excipients This medicinal product 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.