NEOZIPINE XL

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:

Prophylactic antianginal efficacy is maintained when patients are switched from other calcium antagonists such as diltiazem or verapamil to Neozipine XL. Patients switched from other calcium antagonists should initiate therapy at the recommended initial dose of 30 mg Neozipine XLonce-daily.

Subsequent titration to a higher dose may be initiated as warranted clinically. 5). Duration of treatment Treatment may be continued indefinitely. 2). Paediatric population The safety and efficacy of nifedipine in children under the age 18 years have not been established.

1

Adverse drug reactions (ADRs) based on placebo-controlled studies with nifedipine sorted by CIOMS III categories of frequency (clinical trial data base: nifedipine n=2,661; placebo n=1,486; status: 22Feb 2006 and the ACTION study: nifedipine n=3,825; placebo n=3,840) are listed below.

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 postmarketing surveillance, and for which a frequency could not be estimated, are listed under “Not known”. System Organ Class Common Uncommon Rare Not Known Blood and lymphatic system disorders Agranulocytosis, Leucopenia Immune System Disorders Allergic reaction, Allergic oedema/angioede ma (incl.

peripheral oedema) Vasodilatation Hypotension, Syncope 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.

Bezoar Dysphagia, Intestinal obstruction, Intestinal ulcer, Vomiting, Gastroesophageal sphincter insufficiency Hepatobiliary Disorders Transient Increase in liver enzymes Jaundice Skin and subcutaneous tissue disorders: Erythema Rash, Pruritus, Urticaria Toxic epidermal necrolysis, palpable purpura.

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.

Nifedipine tablets must be swallowed whole; under no circumstances should they be bitten, chewed or broken up. 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 blood pressure less than 90 mm Hg).

Neozipine XL 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, refer to section

1. Neozipine 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. Neozipine XL should not be used for the treatment of acute attacks of angina.

The safety of Neozipine XL in malignant hypertension has not been established. Neozipine XL should not be used for secondary prevention of myocardial infarction. Owing to the duration of action of the formulation, Neozipine XL should not be administered to patients with hepatic impairment.

Neozipine XL 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. Neozipine XL must not be used in patients with a Kock pouch (ileostomy after proctocolectomy).

Neozipine XL is contra-indicated in patients with inflammatory bowel disease or Crohn's disease. 5).