Amlodipine 5 mg/10 mg Tablets

AMLODIPINE 5/10 mg PD is indicated:

Hypertension

• for treatment of mild to moderate hypertension, alone or in combination with other antihypertensives.

Coronary artery disease

• Angina pectoris for treatment of angina pectoris.
• Chronic stable angina AMLODIPINE 5/10 MG PD is indicated for first line treatment of myocardial ischaemia, whether due to fixed obstruction (stable angina) and/or vasospasm/vasoconstriction (Prinzmetal's or variant angina) of coronary vasculature. AMLODIPINE 5/10 MG PD may be used alone, as monotherapy, or in combination with other antianginal medicines.
• Coronary artery disease to reduce the risk of coronary revascularisation and the need for hospitalisation due to angina in patients with coronary artery disease to reduce the risk of fatal coronary heart disease and non-fatal myocardial infarction, and to reduce the risk of stroke.

Contraindications:

AMLODIPINE 5/10 mg PD is contraindicated in patients with:

• Hypersensitivity to amlodipine, dihydropyridines or to any of the ingredients of AMLODIPINE.5/10 mg PD
• shock, including cardiogenic shock
• haemodynamically unstable heart failure after acute myocardial infarction (during the first 28 days)
• unstable angina pectoris
• should not be used for acute reduction of blood pressure
• pregnancy and lactation
• concomitant use with grapefruit juice (see section 4.5)
• severe hypotension
• obstruction of the outflow tract of the left ventricle (e.g. high grade aortic stenosis).

Special warnings and precautions for use

The safety and efficacy of amlodipine in hypertensive crisis has not been established.

Concomitant therapy with potent cytochrome CYP3A4 medicines Potent CYP3A4 inhibitors such as ketoconazole, itraconazole or ritonavir, may enhance the blood pressure lowering effect of AMLODIPINE 5/10 mg PD when taken together (see section 4.5).

Adults: An initial dose of 5 mg AMLODIPINE 5/10 mg PD once daily is recommended which may be increased to 10 mg once a day after 10 - 14 days of therapy if there is no improvement.

No dose reduction is required when adding AMLODIPINE 5/10 mg PD to thiazide diuretics, beta-blockers, or angiotensin-converting enzyme inhibitors.

Method of administration

Tablet for oral use. AMLODIPINE 5/10 MG PD can be administered with or without the intake of food.

Missed dose

Doctors should advise patients who forget to take AMLODIPINE 5/10 MG PD to take a dose as soon as possible and then continue with the normal dose. Patients should not take a double dose to compensate for the missed dose.

Undesirable effects

a) 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.

b) Tabulated summary of adverse reactions

System Organ Class Frequency Adverse Event

Blood and lymphatic system disorders Less frequent Thrombocytopenia, leucocytopenia, haemorrhage, blood dyscrasias

Immune system disorders Less frequent Hypersensitivity reactions: pruritus, rash, angioedema and erythema multiforme

Metabolism and nutrition disorders Less frequent Hyperglycaemia

Psychiatric disorders Less frequent Depression, mood changes (including anxiety), insomnia confusion

Nervous system disorders Frequent Less frequent Headache, somnolence, dizziness Hypertonia, hypoaesthesia /paraesthesia, peripheral neuropathy, tremor, increased sweating, taste perversion, hypertonia, extrapyramidal disorder

Eye disorders Less frequent Visual disturbances (including diplopia)

Ear and labyrinth disorders Less frequent Tinnitus

Cardiac disorders Frequent Less frequent Palpitations Myocardial infarction, dysrhythmia (including ventricular tachycardia and atrial fibrillation), chest pain, bradycardia

Vascular disorders Frequent Less frequent Flushing, peripheral oedema Hypotension (including orthostatic hypotension), syncope, vasculitis

Respiratory, thoracic and mediastinal disorders Less frequent Coughing, dyspnoea, rhinitis

Gastrointestinal disorders Frequent Less frequent Nausea, abdominal pain Altered bowel habits, constipation, diarrhoea, vomiting, dyspepsia, pancreatitis, dry mouth, gingival hyperplasia

Hepatobiliary disorders Less frequent Hepatitis, jaundice, raised liver enzymes (mostly consistent with cholestasis)

Skin and subcutaneous tissue disorders Less frequent Alopecia exanthema, pruritus, purpura, skin discolouration, hyperhidrosis, rash, angioedema, erythema multiforme, urticaria, exfoliative dermatitis, Stevens-Johnson syndrome, photosensitivity, Quincke oedema

Frequency unknown Toxic epidermal necrolysis

Musculoskeletal and connective tissue disorders Frequent Less frequent Ankle swelling, muscle cramps Arthralgia, asthenia, back pain, myalgia

Renal and urinary disorders Less frequent Increased urinary frequency, micturition disorder, nocturia

Reproductive system and breast disorders Less frequent Sexual dysfunction, gynaecomastia

General disorders and administration site conditions Frequent Less frequent Facial oedema, upper extremity oedema, fatigue Chest pain, pain, malaise

Investigations Less frequent Weight increase/decrease

c) Paediatric population Adverse events were similar to those seen in adults. In a study of 268 children, the most frequently reported adverse events were headaches, dizziness, vasodilation, epistaxis, abdominal pain, asthenia.

Special precautions for storage

Store at or below 25 °C. Keep the blister in the outer carton until required for use.