CORACTEN XL

Posology Normally treatment is initiated with one 30mg Coracten XL capsule every 24 hours. Dosage may be titrated to a higher level as clinically warranted. The dose may be adjusted to 90mg every 24 hours. 5). Duration of treatment Treatment may be continued indefinitely.

Elderly (≥ 65 years) The pharmacokinetics of nifedipine are altered in the elderly so that lower maintenance doses of nifedipine may be required. Hepatic impairment As Coracten XL is a long acting formulation, it should not be administered to patients with hepatic impairment.

2). Paediatric population The safety and efficacy of Coracten XL in children below 18 years has not been established. 1 Method of administration Oral use. The capsules should be swallowed whole with a little fluid. e. at the same time each day, preferably during the morning.

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 Leukopenia Immune system disorders Allergic reaction Allergic oedema / angioedema (incl. larynx oedema 1) 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 infarction2 Myocardial ischemia (due to excessive fall in blood pressure) Vascular disorders Oedema (incl.

Hypotension Flushing System Organ Class (MedDRA) Common Uncommon Rare Not known peripheral oedema) Vasodilatation Syncope Respiratory, thoracic, and mediastinal disorders Nosebleed Nasal congestion Dyspnea Pulmonary oedema* Gastrointestinal disorders Constipation Gastrointestinal and abdominal pain Nausea Dyspepsia Flatulence Dry mouth Gingival hyperplasia Vomiting Gastrooesophagea l 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 (long-term therapy) General disorders and administration site conditions Feeling unwell Unspecific pain Chills Fever 1 = may result in life-threatening outcome.

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 beta-blockers 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 anti-hypertensive therapy.

Nifedipine is metabolised via the cytochrome P450 3A4 system. 5). g. g. g. ketoconazole) • the antidepressants nefazodone and fluoxetine • quinupristin/dalfopristin • valproic acid • cimetidine. 5). This medicinal product contains lactose monohydrate.

Coracten XL capsules are contra-indicated in patients with known hypersensitivity to nifedipine or other dihydropyridines because of the theoretical risk of cross reactivity. 1. 6). Coracten XL capsules 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. Coracten XL capsules 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 Coracten XL capsules in malignant hypertension has not been established.

Coracten XL capsules should not be used for secondary prevention of myocardial infarction. Coracten XL capsules are contra-indicated in patients with acute porphyria. Coracten XL should not be used in patients with Kock pouch (ileostomy after proctocolectomy).

5). 5).