NIFEDIPRESS MR

Posology The recommended starting dose of NIFEDIPRESS MR and DEXIPRESS MR is 10 mg every 12 hours swallowed with water with subsequent titration of the dosage according to response. NIFEDIPRESS MR and DEXIPRESS MR permit titration of initial dosage, which may be adjusted upwards to 40 mg every 12 hours, to a maximum daily dose of 80 mg.

5). Duration of treatment Treatment may be continued indefinitely. Additional information on special populations Paediatric population The safety and efficacy of NIFEDIPRESS MR and DEXIPRESS MR in children below 18 years of age has not been established.

1. Older people (>65 years) The pharmacokinetics of NIFEDIPRESS MR and DEXIPRESS MR are altered in the older people so that lower maintenance doses of nifedipine may be required. Patients with hepatic impairment Nifedipine is metabolised primarily by the liver and therefore patients with mild, moderate or severe liver dysfunction should be carefully monitored and a dose reduction may be necessary.

2). 2). Method of administration Oral use. As a rule, tablets must be swallowed whole with a little liquid, either with or without food. 5). The tablets should not be crushed, chewed, divided or dissolved.

9%). Most side-effects are consequence of the vasodilatory effect 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/angio edema (incl. larynx oedema1) 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 System Organ Class (MedDRA) Common Uncommon Rare Not known 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 infraction2 Myocardial ischemia (due to excessive fall in blood pressure) Vascular Disorders Oedema(incl.

peripheral oedema) Vasodilatation Hypotension Syncope Flushing Respiratory, Thoracic and Mediastinal Disorders Nasal congestion Nosebleed Dyspnoea Pulmonary oedema* Gastrointestinal Disorders Constipation Gastrointestin al and abdominal pain Nausea Dyspepsia Flatulence Dry mouth Gingival hyperplasia Vomiting Gastroesophageal sphincter insufficiency Diarrhoea Hepatobiliary Disorders Transient increase in liver enzymes Jaundice Intra-hepatic cholestasis System Organ Class (MedDRA) Common Uncommon Rare Not known Skin and Subcutaneous Tissue Disorders Erythema Toxic Epidermal Necrolysis Photosensitivity allergic reaction Palpable purpura Talengiectasis 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 2 = The occurrence of myocardial infraction 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.

NIFEDIPRESS MR and DEXIPRESS MR are not a beta-blockers and therefore give 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.

NIFEDIPRESS MR and DEXIPRESS MR 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.

NIFEDIPRESS MR and DEXIPRESS MR will not prevent possible rebound effects after cessation of other antihypertensive therapy. Nifedipine should be used with caution in patients who are hypotensive (severe hypotension with systolic pressure less than 90 mmHg).

Excessive falls in blood pressure may result in transient blindness. 8). NIFEDIPRESS MR and DEXIPRESS MR 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 NIFEDIPRESS MR and DEXIPRESS MR 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 vasodilator effects of nifedipine.

Although a ‘steal’ effect has not been demonstrated, patients experiencing this effect should discontinue nifedipine therapy. 6). In patients with mild, moderate or severe impaired liver function, careful monitoring and a dose reduction may be necessary.

2). Therefore, nifedipine should be used with caution in patients with severe hepatic impairment. Nifedipine is metabolised via the cytochrome P450 3A4 system. 5). g. 5). Since these medicinal products contain lactose, patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

2.

NIFEDIPRESS MR and DEXIPRESS MR is contra-indicated in patients with known hypersensitivity to nifedipine or other dihydropyridines because of the theoretical risk of cross reactivity. 1. 6). NIFEDIPRESS MR and DEXIPRESS MR 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. NIFEDIPRESS MR and DEXIPRESS MR 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 NIFEDIPRESS MR and DEXIPRESS MR in malignant hypertension has not been established. NIFEDIPRESS MR and DEXIPRESS MR should not be used for secondary prevention of myocardial infarction. NIFEDIPRESS MR and DEXIPRESS MR is contra-indicated in patients with acute porphyria.

NIFEDIPRESS MR and DEXIPRESS MR should not be used in patients with Kock pouch (ileosetomy after proctocolectomy). 5).