VALNI

Posology Adults The recommended dose is one tablet (20 mg) every 12 hours. The dosage may be increased up to 40 mg every 12 hours to achieve the desired effect. Paediatric population The safety and efficacy of nifedipine in children under the age of 18 years has not been established.

1. Elderly There are no special dosage requirements for the elderly, however, the pharmacokinetics of nifedipine are altered in the elderly so that lower maintenance doses of nifedipine may be required compared to younger patients. Hepatic Impairment Patients with hepatic dysfunction must be carefully monitored when treatment is commenced as Nifedipine is primarily metabolised in the liver.

If hepatic function is impaired, the dosage requirements of nifedipine should be established before use of Valni 20 Retard. Renal Impairment Dosage adjustments should not be required for patients with renal impairment. Treatment with Valni 20 Retard may be continued long term.

Method of Administration Oral administration. It is recommended that these tablets are swallowed with a glass of water. These tablets must be swallowed whole and not broken or chewed. 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 post-marketing 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 oedema*) Pruritus Urticaria Rash Anaphylactic/ Anaphylactoid reaction Metabolism and Nutrition Disorders Hyperglycaemia Psychiatric Disorders Anxiety reactions Sleep disorders Depression Nervous System Disorders Headache Migraine Vertigo Dizziness Tremor Dysaesthesia Paraesthesia Lethargy Hypoaesthesia Somnolence Eye disorders Visual disturbances Eye pain Cardiac Disorders Tachycardia Palpitations Chest pain (Angina pectoris) Vascular Disorders Oedema (incl.

6) Exacerbation of angina pectoris may occur frequently at the start of treatment with short acting formulations of nifedipine. 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.

Gingival hyperplasia and, in older men, gynaecomastia have been reported but these are usually reversible on drug withdrawal. Hypersensitivity reactions such as skin rashes and abnormalities of liver function have occurred. These symptoms disappear upon discontinuation of nifedipine.

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.

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 pressure less than 90 mm Hg).

Nifedipine 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, see section

1. or other dihydropyridines because of the theoretical risk of cross reactivity. Nifedipine should not be used in cases of cardiogenic shock, clinically significant aortic stenosis, unstable angina, or during or within one month of a myocardial infarction.

Nifedipine should not be used for the treatment of acute attacks of angina. The safety of nifedipine in malignant hypertension has not been established. Nifedipine should not be used for secondary prevention of myocardial infarction.

Owing to the duration of action of the formulation, Nifedipine should not be administered to patients with hepatic impairment. Nifedipine should not be administered to patients with a history of gastro- intestinal obstruction, oesophageal obstruction, or any degree of decreased lumen diameter of the gastro-intestinal tract.

Nifedipine must not be used in patients with a Kock pouch (ileostomy after proctocolectomy). Nifedipine is contra-indicated in patients with inflammatory bowel disease or Crohn's disease. 5).