Land: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
CLONIDINE HYDROCHLORIDE
Boehringer Ingelheim International GmbH
C02AC; C02AC01
CLONIDINE HYDROCHLORIDE
100 microgram(s)
Tablet
Imidazoline receptor agonists; clonidine
Marketed
1979-04-01
Health Products Regulatory Authority 17 April 2019 CRN0090S5 Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Catapres Tablets 100 micrograms 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains clonidine hydrochloride 100 micrograms. For excipients see 6.1 3 PHARMACEUTICAL FORM Tablet. White, round, flat, bevel-edged tablets impressed with the motif 01C on one side and the Boehringer Ingelheim symbol on the reverse. 01C 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 1.2 mgin 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. _RENAL INSUFFICIENCY:_ Dosage must be adjusted - according to the individual antihypertensive response which can show high variability in patients with renal insufficiency - according to the degree of renal impairment 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 b Lestu allt skjalið