TENSIPINE MR

Method of Administration Oral use. As a rule, tablets are swallowed whole with a little liquid, either with or without food. 5). Dosage regimen The recommended starting dose of Tensipine MR is 10mg every 12 hours swallowed with water with subsequent titration of dosage according to response.

The dose may be adjusted to 40mg every 12 hours, to a maximum daily dose of 80mg. 5). Duration of treatment Treatment may be continued indefinitely. Additional information on special populations Children and adolescents The safety and efficacy of nifedipine in children below 18 years of age has not been established.

1. Elderly patients The pharmacokinetics of nifedipine are altered in the elderly so that lower maintenance doses of nifedipine may be required compared to younger patients. Patients with hepatic impairment Nifedipine is metabolized primarily by the liver and therefore patients with liver dysfunction should be carefully monitored and in severe cases, a dose reduction may be necessary.

Patients with renal impairment Based on pharmacokinetic data, no dosage adjustment is required in patients with renal impairment.

Ischaemic pain has been reported in a small proportion of patients within one to four hours of the introduction of Tensipine MR therapy. Although a "steal" effect has not been demonstrated, patients experiencing this effect should discontinue Tensipine MR.

9%). The frequencies of ADRs reported with nifedipine-containing products are summarized in the table below. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. Frequencies are defined as common (≥ 1/100 to <1/10), uncommon (≥ 1/1,000 to <1/100) and rare (≥1/10,000 to <1/1,000).

The ADRs identified only during the ongoing postmarketing surveillance, and for which a frequency could not be estimated, are listed under ‘Not known’. System Organ Class (MedDRA) Common Uncommon Rare Not Known Blood and Lymphatic System Disorders Agranulocytosis Leucopenia Immune System Disorders Allergic reaction Allergic oedema/ angioedema (inc.

larynx oedema*) Pruritus Urticaria Rash Anaphylatic/ anaphylactoid reaction Psychiatric Disorders Anxiety reactions Sleep disorders Metabolism and Nutrition Disorders Hyperglycaemia Nervous System Disorders Headache Vertigo Migraine Dizziness Tremor Par- /Dysaesthesia Hypoaesthesia Somnolence Eye Disorders Visual disturbances Eye pain Cardiac Disorders Tachycardia Palpitations Chest pain (Angina Pectoris) Vascular Disorders Oedema (inc.

6) In dialysis patients with malignant hypertension and hypovolaemia a distinct fall in blood pressure can occur as a result of vasodilation. 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

Tensipine MR is not a beta-blocker and therefore gives no protection against the dangers of abrupt beta-blocker withdrawal; any such withdrawal should be by gradual reduction of the dose of beta-blocker preferably over 8 - 10 days.

Tensipine MR may be used in combination with beta-blocking drugs and other antihypertensive agents but the possibility of an additive effect resulting in postural hypotension should be borne in mind. Tensipine MR will not prevent possible rebound effects after cessation of other antihypertensive therapy.

Care must be exercised in patients with very low blood pressure (severe hypotension with systolic pressure less than 90mm HG), in cases of manifest heart failure and in the case of severe aortic stenosis. Tensipine MR should not be used during pregnancy unless the clinical condition of the woman requires treatment with nifedipine.

6). V. magnesium sulfate, owing to the possibility of an excessive fall in blood pressure, which could harm both mother and foetus. For further information regarding use in pregnancy, refer to section

1. 3). Tensipine MR must not be used in cases of cardiogenic shock, clinically significant aortic stenosis, unstable angina, or during or within one month of a myocardial infarction. Tensipine MR should not be used for the treatment of acute attacks of angina.

The safety of Tensipine MR in malignant hypertension has not been established. Tensipine MR should not be used for secondary prevention of myocardial infarction. 5).