NIFOPRESS RETARD

Posology Dosage regimen The recommended starting dose of is 10mg every 12 hours swallowed with water with subsequent titration of dosage according to response. Nifopress Retard tablets permit titration of the initial dosage, which 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 Paediatric population The safety and efficacy of Nifopress Retard in children below 18 years of age has not been established.

1. Older people (> 65 years) The pharmacokinetics of Nifopress Retard are altered in the elderly so that lower maintenance doses of nifedipine may be required. Patients with hepatic impairment Nifedipine is metabolised primarily by the liver and therefore patients with mild, moderate or severe liver dysfunction should be carefully monitored and a dose reduction may be necessary.

2). 2). Method of administration Oral use. As a rule, tablets are swallowed whole with a little liquid, either with or without food. 5).

9%). The frequencies of ADRs reported with nifedipine-containing products are summarised 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), rare (≥ 1/10,000 to < 1/1,000) and Not known (frequency cannot be estimated from the available data).

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 (incl.

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

6) Exacerbation of angina pectoris may occur frequently at the start of treatment with short acting formulations of nifedipine. The occurrence of myocardial infarction has been described although it is not possible to distinguish such an event from the natural course of ischaemic heart disease.

Gingival hyperplasia and, in older men, gynaecomastia have been reported but these are usually reversible on drug withdrawal. Hypersensitivity reactions such as skin rashes and abnormalities of liver function have occurred. These symptoms disappear upon discontinuation of nifedipine.

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.

Nifedipine may enhance the effects of other antihypertensive agents such as beta-blockers (although this combination is well tolerated) resulting in postural hypotension. Nifedipine will not prevent the occurrence of rebound effects following the discontinuation of other antihypertensive agents.

Caution should be exercised in patients with hypotension as there is a risk of further reduction in blood pressure and care must be exercised in patients with very low blood pressure (severe hypotension with systolic pressure less than 90 mm Hg).

Cardiac ischaemic pain has been reported to have occurred in some patients within 1-4 hours of receiving nifedipine. In such cases treatment should be discontinued. V. magnesium sulphate, 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. Nifopress Retard must not be used in cases of cardiogenic shock, clinically significant aortic stenosis, unstable angina, or during or within 4 weeks of a myocardial infarction. Nifopress Retard should not be used for the treatment of acute attacks of angina.

The safety of Nifopress Retard in malignant hypertension has not been established. Nifopress Retard should not be used for secondary prevention of myocardial infarction. Owing to the duration of action of the formulation, Nifedipine should not be administered to patients with hepatic impairment.

Nifedipine should not be administered to patients with a history of gastro- intestinal obstruction, oesophageal obstruction, or any degree of decreased lumen diameter of the gastro-intestinal tract. Nifedipine must not be used in patients with a Kock pouch (ileostomy after Proctocolectomy).

5).