CORACTEN SR

Posology The recommended starting dose of Coracten SR capsules is 10mg every 12 hours swallowed with water with subsequent titration of dosage according to response. The dose may be adjusted to 40mg every 12 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 Caution should be exercised in treating patients with hepatic impairment.

In these patients the use of one 10mg Coracten SR capsule every 12 hours, together with careful monitoring, is suggested when commencing therapy. 2). Paediatric population The safety and efficacy of Coracten SR capsules in children below 18 years of age has not been established.

1. Method of administration Oral use. 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) Commo n Uncom mon Rare Not known Blood and lymphatic system disorders Agranulo cytosis Leukopen ia Immune system disorders Allergic reaction Allergic oedema / angioede ma (incl. larynx oedema 1) Pruritus Urticaria Rash Anaphyla ctic/ anaphylac toid reaction Systemic allergic reactions Psychiatric disorders Anxiety reactions Sleep disorders Mood changes Depressio n Metabolism and nutrition disorders Hypergly caemia System Organ Class (MedDRA) Commo n Uncom mon Rare Not known Nervous system disorders Headach e Vertigo Migraine Dizzines s Tremor Par-/ Dysaesth esia Hypoaest hesia Somnolen ce Lethargy Cerebral ischemia (due to excessive fall in blood pressure) Eye disorders Visual disturban ces Eye pain Transient blindness (due to excessive fall in blood pressure) Cardiac disorders Tachycar dia Palpitati ons Chest pain (Angina Pectoris) Myocardi al infarction 2 Myocardi al ischemia (due to excessive fall in blood pressure) Vascular disorders Oedema (incl.

periphera l oedema) Vasodila tation Hypoten sion Syncope Flushing System Organ Class (MedDRA) Commo n Uncom mon Rare Not known Respiratory , thoracic, and mediastinal disorders Noseblee d Nasal congesti on Dyspnea Pulmonar y oedema* Gastrointest inal disorders Constipa tion Gastroint estinal and abdomin al pain Nausea Dyspepsi a Flatulenc e Dry mouth Gingival hyperpla sia Vomiting Gastrooes ophageal sphincter insufficie ncy Diarrhoea Hepatobilia ry disorders Transient increase in liver enzymes Jaundice Intra- hepatic cholestasi s Skin and subcutaneo us tissue disorders Erythem a Toxic Epidermal Necrolysi s Photosens itivity allergic reaction Palpable purpura Telangiec tasia Erythema multiform e Pemphigo id reaction Exfoliativ e dermatitis Purpura Musculoske letal and connective Muscle cramps Joint Arthralgia Myalgia Worsenin System Organ Class (MedDRA) Commo n Uncom mon Rare Not known tissue disorders swelling g of myastheni a gravis Renal and urinary disorders Polyuria Dysuria Increased frequency of micturitio n Reproducti ve system and breast disorders Erectile dysfuncti on Gynaeco mastia (long- term therapy) General disorders and administrati on site conditions Feeling unwell Unspecif ic pain Chills Fever 1 = may result in life-threatening outcome.

Nifedipine should be used with caution in patients who are hypotensive (severe hypotension with systolic blood pressure less than 90 mm Hg). 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. 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.

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. Nifedipine is not a beta-blocker and therefore 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-blockers and other antihypertensive agents, but the possibility of an additive effect resulting in postural hypotension and/or cardiac failure must be borne in mind.

Nifedipine will not prevent possible rebound effects after cessation of other antihypertensive therapy. 6). In patients with impaired liver function, careful monitoring, and in severe cases, a dose reduction may be necessary. 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 sucrose and lactose monohydrate. Patients with rare hereditary problems of fructose intolerance, galactose intolerance, total lactase deficiency, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

Coracten SR 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 SR 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 SR 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 SR capsules in malignant hypertension has not been established.

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

5).