Land: Ierland
Taal: Engels
Bron: HPRA (Health Products Regulatory Authority)
CLONIDINE HYDROCHLORIDE
Boehringer Ingelheim Limited
CLONIDINE HYDROCHLORIDE
0.3 Milligram
Tablets
Product subject to prescription which may be renewed (B)
Withdrawn
2013-02-27
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Catapres Tablets 300 micrograms 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains clonidine hydrochloride 300 micrograms. For excipients see 6.1. 3 PHARMACEUTICAL FORM Tablet White, round, flat, bevel-edged tablets impressed with the motif 03C on one side and the Boehringer Ingelheim symbol on the reverse. 03C 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Catapres tablets are indicated for the treatment of hypertension that has failed to respond adequately to other anti- hypertensives. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults only: The usual initial dosage is 0.05 to 0.10 mg three times daily with subsequent gradual increments to the level of optimal control generally in the daily dose range of 0.3 to 1.2mg in divided doses although higher levels may be required. Should clonidine be added to other anti-hypertensive therapy dosage of the latter should be gradually reduced as the clonidine is introduced. Patients undergoing anaesthesia should continue their Catapres treatment before, during and after anaesthesia using oral or intravenous administration according to individual circumstances. _PAEDIATRIC POPULATION:_ There is insufficient evidence for the application of clonidine in children and adolescents younger than 18 years. Therefore the use of clonidine is not recommended in paediatric subjects under 18 years. 4.3 CONTRAINDICATIONS Catapres should not be used in children (please refer to section 4.4 Special Warnings and Precautions for Use) or in patients with known hypersensitivity to the active ingredient or other components of the product and in patients with severe bradyarrhythmia resulting from either sick sinus syndrome or AV block of 2nd or 3rd degree. In case of rare hereditary Lees het volledige document