CATAPRES TABLETS 300 MICROGRAMS. 0.3 Milligram Tablets
Страна: Ирландия
Език: английски
Източник: HPRA (Health Products Regulatory Authority)
Данни за продукта
(SPC)
19-04-2024
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Активна съставка:
CLONIDINE HYDROCHLORIDE
Предлага се от:
Boehringer Ingelheim Limited
INN (Международно Name):
CLONIDINE HYDROCHLORIDE
дозиране:
0.3 Milligram
Лекарствена форма:
Tablets
Вид предписание :
Product subject to prescription which may be renewed (B)
Статус Оторизация:
Withdrawn
Дата Оторизация:
2013-02-27
Данни за продукта
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
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