CATAPRES Tablet (2023)
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Περιεχόμενα
Name of the medicinal product
Catapres Tablets 100 micrograms.
Qualitative and quantitative composition
Each tablet contains clonidine hydrochloride 100 micrograms. For excipients see 6.1.
Pharmaceutical form
Tablet. White, round, flat, bevel-edged tablets impressed with the motif 01C / 01C on one side.
Therapeutic indications
Catapres tablets are indicated for the treatment of hypertension that has failed to respond adequately to other anti-hypertensives.
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 mg in divided ...
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 ...
Special warnings and precautions for use
Clonidine should only be used with caution in patients with depression or a history thereof, with Raynauds disease, or other peripheral vascular occlusive disease. The product should only be used with ...
Interaction with other medicinal products and other forms of interaction
The reduction in blood pressure induced by clonidine can be further potentiated by concurrent administration of other hypotensive agents. This can be of therapeutic use in the case of other anti-hypertensive ...
Fertility, pregnancy and lactation
Pregnancy There are limited amount of data from the use of clonidine in pregnant women. This product should only be used in pregnancy if considered essential by the physician. Careful monitoring of mother ...
Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed. However, patients should be advised that they may experience undesirable effects such as dizziness, sedation and ...
Undesirable effects
Most adverse effects are mild and tend to diminish with continued therapy. Adverse events have been ranked under headings of frequency using the following convention: Very common ≥1/10, Common ≥1/100, ...
Overdose
Symptoms Manifestations of intoxication are due to a generalised sympathetic depression and include pupillary constriction, lethargy, bradycardia, hypotension, hypothermia, somnolence including coma and ...
Pharmacodynamic properties
Clonidine acts primarily on the central nervous system, resulting in reduced sympathetic outflow and a decrease in peripheral resistance, renal vascular resistance, heart rate and blood pressure. Renal ...
Pharmacokinetic properties
Absorption and distribution The pharmacokinetics of clonidine is dose-proportional in the range of 75-300 micrograms. Clonidine, the active ingredient of Catapres, is well absorbed and undergoes a minor ...
Preclinical safety data
There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
List of excipients
Lactose monohydrate Calcium hydrogen phosphate (anhydrous) Maize starch Colloidal silica (anhydrous) Povidone Modified starch (corn starch oxidized) Stearic acid
Incompatibilities
Not applicable.
Shelf life
36 months.
Special precautions for storage
Do not store above 30°C. Keep the blisters in the outer carton.
Nature and contents of container
Opaque PVC 250 μm/PVDC 40g/m² blisters with aluminium lidding foil 20 μm containing 50, 84, 100 or 250 tablets. Not all pack sizes are marketed.
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Glenwood GmbH, Pharmazeutische Erzeugnisse, Arabellastrasse 17, 81925 Munich, Germany
Marketing authorization number(s)
PA2256/003/001
Date of first authorization / renewal of the authorization
Date of first authorisation: 1st April 1979 Date of last renewal: 1st November 2005
Date of revision of the text
May 2023
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