NIFEDIPINE

Adults:

The recommended starting dose is 5mg, every 8 hours, swallowed with water, with subsequent titration of dosage according to response. The dosage may be adjusted to 20mg, every 8 hours. Patients on concomitant therapy and patients with liver dysfunction should be carefully monitored.

Nifedipine is metabolised primarily by the liver. Dosage adjustments should not be required for patients with renal impairment.

Elderly (>65 years):

The pharmacokinetics of nifedipine are altered in the elderly so that lower maintenance doses of nifedipine may be required.

Paediatric population:

The safety and efficacy of Nifedipine in children under the age 18 years have not been established. 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) 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 (incl.

larynx oedema*) Pruritus Urticaria Rash Anaphylactic/ anaphylactoid reaction Systemic allergic reactions Psychiatric Disorders Anxiety reactions Sleep disorders Mood changes Depression Metabolism and Nutrition Disorders Hyperglycaemia Nervous System Disorders Headache Vertigo Migraine Dizziness Tremor Par-/ Dysaesthesia Hypoaesthesia Somnolence Lethargy Cerebral ischemia (due to excessive fall in blood pressure) Eye Disorders Visual disturbances Eye pain Transient blindness (due to excessive fall in blood pressure) Cardiac Disorders Tachycardia Palpitations Chest pain (Angina Pectoris) Myocardial infarction1 Myocardial ischemia (due to excessive fall in blood pressure) Vascular Disorders Oedema (incl.

6) 1= 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. 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 or search for MHRA Yellow Card in the Google Play or Apple App Store.

Nifedipine capsules are not beta-blockers and therefore give no protection against the dangers of abrupt beta-blocker withdrawal; any such withdrawal should be a gradual reduction of the dose of beta-blocker, preferably over 8-10 days.

Nifedipine capsules 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. Nifedipine capsules 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 90 mm Hg). Treatment with short-acting nifedipine induces an exaggerated fall in blood pressure with reflex tachycardia which can cause cardiovascular complications such as myocardial and cerebrovascular ischaemia.

As with other vasoactive substances, angina pectoris may very rarely occur (data from spontaneous reports) with immediate release nifedipine, especially at the start of the treatment. Data from clinical studies confirm that the occurrence of angina pectoris attacks is uncommon.

In patients suffering from angina pectoris an increase in frequency, duration and severity of angina pectoris attacks may occur, especially at the start of the treatment. The occurrence of myocardial infarction has been described in isolated cases, although it was not possible to distinguish this from the natural course of the underlying disease.

Nifedipine capsules should not be used during pregnancy unless the clinical condition of the woman requires treatment with nifedipine. 6). 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. 6). Nifedipine capsules must not be used in cases of cardiogenic shock, clinically significant aortic stenosis, unstable angina, or during or within 4 weeks of an acute myocardial infarction. Nifedipine should not be used for the treatment of acute attacks of angina, or in patients who have had ischaemic pain following its administration previously.

The safety of nifedipine in malignant hypertension has not been established. Nifedipine capsules should not be used for secondary prevention of myocardial infarction. Nifedipine capsules are contra-indicated in patients with acute porphyria.

Nifedipine capsules should not be used in patients with Kock pouch (ileosetomy after proctocolectomy). 5).