NIFEDIPINE

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. Patients in whom hypertension or anginal symptoms are controlled on Nifedipine capsules or Nifedipine modified release tablets may be safely switched to Nifedipine prolonged release tablets.

Prophylactic anti-anginal efficacy is maintained when patients are switched from other calcium antagonists such as diltiazem or verapamil to Nifedipine prolonged release tablets. Patients switched from other calcium antagonists should initiate therapy at the recommended initial dose of 30 mg Nifedipine prolonged release tablets 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 Nidef / Nifedipine Prolonged Released Tablets in children below 18 years has not been established.

1. Elderly Based on pharmacokinetics data for nifedipine 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. Nidef / Nifedipine Prolonged Released Tablets must be swallowed whole; under no circumstances should they be bitten, chewed or broken up. 5).

9%). Most side-effects are consequences of the vasodilatory effects of nifedipine. 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 oedema1) Pruritus Urticaria Rash Anaphlactic/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 blodd 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 infarction2 Myocardial ischemia (due to excessive fall in blood pressure) Vascular Disorders Oedema (incl.

Peripheral oedema) Hypotension Syncope Flushing System Organ Class (MedDRA) Common Uncommon Rare Not Known Vasodilatation Respiratory, Thoracic, and Mediastinal Disorders Nosebleed Nasal congestion Dyspnoea Pulmonary oedema* Gastrointestinal Disorders Constipation Gastrointestinal and abdominal pain Nausea Dyspepsia Flatulence Dry mouth Gingival hyperplasia Vomiting Gastroesophageal sphincter insufficiency Diarrhoea Dysphagia Intestinal ulcer Hepatobiliary Disorders Transient increase in liver enzymes Jaundice Intra-hepatic cholestasis Skin and Subcutaneous Tissue Disorders Erythema Toxic Epidermal Necrolysis Photosensitivity allergic reaction Palpable purpura Telangiectasia Erythema multiforme Pemphigoid reaction Exfoliative dermatitis Purpura Musculoskeletal and Connective Tissue Disorders Muscle cramps Joint swelling Arthralgia Myalgia Worsening of myasthenia gravis Renal and Urinary Disorders Polyuria Dysuria Increased frequency of micturition Reproductive System and Breast Disorders Erectile dysfunction Gynaecomastia (lon-term therapy) General Disorders and Administration Site Conditions Feeling unwell Unspecific pain Chills Fever 1 = may result in life-threatening outcome 2 = 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.

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 or search for MHRA Yellow Card in the Google Play or Apple App Store.

Nifedipine should be used with caution in patients who are hypotensive 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).

The use of Nifedipine in diabetic patients may require adjustment of their diabetic therapy. In dialysis patients with malignant hypertension and irreversible renal failure with hypovolaemia, a significant drop in blood pressure may occur due to the vasodilator effects of nifedipine.

Nifedipine should be used with caution in patients whose cardiac reserve is poor; in patients with heart failure or significantly impaired left ventricular function. Deterioration of heart failure has occasionally been observed with nifedipine.

In patients with impaired liver function careful monitoring and, in severe cases, a dose reduction may be necessary. Excessive falls in blood pressure may result in transient blindness. 8). Although a ‘steal’ effect has not been demonstrated, patients experiencing this effect should discontinue nifedipine therapy.

Since nifedipine has no beta-blocking activity, it gives no protection against the dangers of abrupt withdrawal of beta-blocking drugs. Withdrawal of any previously prescribed betablockers should be gradual, preferably over 8 to 10 days.

Nifedipine 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 will not prevent possible rebound effects after cessation of other antihypertensive therapy.

Nifedipine is metabolised via the cytochrome P450 3A4 system. 5). , ketoconazole) - the antidepressants nefazodone and fluoxetine - quinupristin/dalfopristin - valproic acid - cimetidine. 5). This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

Nidef / Nifedipine Prolonged Released Tablets are contra-indicated in patients with known hypersensitivity to nifedipine or other dihydropyridines because of the theoretical risk of cross-reactivity. 1. 6). Nidef / Nifedipine Prolonged Released Tablets should not be used in clinically significant aortic stenosis, unstable angina, or during or within one month of a myocardial infarction.

They should not be used in patients in cardiogenic shock. Nidef / Nifedipine Prolonged Released Tablet 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 Nidef / Nifedipine Prolonged Released Tablet in malignant hypertension has not been established. Nidef / Nifedipine Prolonged Released Tablet should not be used for secondary prevention of myocardial infarction. Nidef / Nifedipine Prolonged Released Tablet should be contraindicated in patients with acute porphyria.

Nidef / Nifedipine Prolonged Released Tablet should not be used in patients with Kock pouch (ileostomy after proctocolectomy). 5). 5).