ADANIF XL

Posology In mild to moderate hypertension, the recommended initial dose is one 20mg tablet once-daily. In severe hypertension, the recommended initial dose is one 30mg tablet once-daily. If necessary, the dosage can be increased according to individual requirements up to a maximum of 90mg once-daily.

For the prophylaxis of angina pectoris, the recommended initial dose is one 30mg tablet once-daily. The dosage can be increased according to individual requirements up to a maximum of 90mg once-daily. Patients in whom hypertension or anginal symptoms are controlled on other nifedipine containing preparations may be safely switched to Adanif XL.

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

Subsequent titration to a higher dose may be initiated as warranted clinically. 5). Duration of treatment Treatment may be continued indefinitely. Additional information on special populations Paediatric population The safety and efficacy of Adanif XL Tablets in children under the age of 18 years have not been established.

Currently available data for the use of nifedipine in hypertension are described in section 5. Elderly Based on pharmacokinetic data for Adanif XL Tablets no dose adaptation in elderly people above 65 years is necessary. 2). Method of administration Oral use.

The tablets should be swallowed whole with a glass of water, either with or without food. e. at the same time each day, preferably during the morning. Adanif XL Tablets must be swallowed whole; under no circumstances should they be bitten, chewed or broken up.

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”. 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 Psychiatric Disorders Anxiety reactions Sleep disorders Depression Metabolism and Nutrition Disorders Hyperglycaemia Nervous System Disorders Headache Vertigo Migraine Dizziness Tremor Par-/Dysaesthesia Hypoaesthesia Somnolence Eye Disorders Visual disturbances Eye pain Cardiac Disorders Tachycardia Palpitations Chest pain (Angina pectoris) Vascular Disorders Oedema (incl.

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.

Adanif XL 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 90mm Hg).

Adanif XL Tablets should not be used during pregnancy unless the clinical condition of the woman requires treatment with nifedipine. 6). V. magnesium sulphate, 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).. • Adanif XL Tablets 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. • Adanif XL Tablets should not be used for the treatment of acute attacks of angina.

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

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

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