Catapres Tablets 100 micrograms

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

CLONIDINE HYDROCHLORIDE

Available from:

Boehringer Ingelheim International GmbH

ATC code:

C02AC; C02AC01

INN (International Name):

CLONIDINE HYDROCHLORIDE

Dosage:

100 microgram(s)

Pharmaceutical form:

Tablet

Therapeutic area:

Imidazoline receptor agonists; clonidine

Authorization status:

Marketed

Authorization date:

1979-04-01

Summary of Product characteristics

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