NIMODREL XL

Posology In mild to moderate hypertension, the recommended initial dose is one 20 mg tablet once-daily. In severe hypertension, the recommended initial dose is one 30 mg tablet once-daily. If necessary, the dosage can be increased according to individual requirements up to a maximum of 90 mg once-daily.

For the prophylaxis of angina pectoris, the recommended initial dose is one 30 mg tablet once-daily. The dosage can be increased according to individual requirements up to a maximum of 90 mg once-daily. Prophylactic antianginal efficacy is maintained when patients are switched from other calcium antagonists such as diltiazem or verapamil to Adipine XL.

Patients switched from other calcium antagonists should initiate therapy at the recommended initial dose of 30 mg Adipine XL once-daily. Subsequent titration to a higher dose may be initiated as warranted clinically. 5). Duration of treatment Treatment may be continued indefinitely.

Additional information on special populations Paediatric population The safety and efficacy of Adipine XL in children below 18 years has not been established. 1 Elderly Based on pharmacokinetic data for Adipine XL no dose adaptation in elderly people above 65 years is necessary.

2). Method of administration Oral use. The tablets should be swallowed whole with a glass of water, either with or without food. e. at the same time each day, preferably during the morning. Adipine XL tablets must be swallowed whole; under no circumstances should they be bitten, chewed or broken up.

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/angioede ma (incl.

larynx oedema*) Pruritus Urticaria Rash Anaphylactic/ anaphylactoid reaction 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 Eye Disorders Visual disturbances Eye pain Cardiac Disorders Tachycardia Palpitations Chest pain (Angina pectoris) Vascular Disorders Oedema (incl.

6) There have also been reports of gynaecomastia in older men on long-term therapy, but this usually regresses when treatment is withdrawn. Myocardial infarction is also known to occur although it is not possible to distinguish it 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.

Adipine XL tablets must be swallowed whole; under no circumstances should they be bitten, chewed or broken up. 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 blood pressure less than 90 mm Hg).

Adipine XL 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. 5). The safety of nifedipine prolonged release tablets has not been established in patients with malignant hypertension.