CATAPRES Tablet (2018)
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Περιεχόμενα
Name of the medicinal product
Catapres Tablets 100 micrograms.
Qualitative and quantitative composition
Each tablet contains 100 micrograms of clonidine hydrochloride. For excipients see 6.1.
Pharmaceutical form
Tablet. White, circular, flat, bevel-edged tablets impressed with the identifying code "01C / 01C" on one side and the company symbol on the reverse.
Therapeutic indications
Catapres is indicated for the treatment of all grades of essential and secondary hypertension.
Posology and method of administration
Catapres Tablets are for oral administration only. Adults Oral treatment should commence with 50-100 micrograms three times daily. This dose should be increased gradually every second or third day until ...
Contraindications
Catapres should not be used 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 ...
Special warnings and precautions for use
Caution should be exercised in patients with Raynauds disease or other peripheral vascular disease. As with all drugs used in hypertension Catapres should be used with caution in patients with cerebrovascular ...
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 antihypertensive ...
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 ≥/10, Common ≥1/100, <1/10, ...
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
Catapres has been shown to have both central and peripheral sites of action. With long-term treatment Catapres reduces the responsiveness of peripheral vessels to vasoconstrictor and vasodilator substances ...
Pharmacokinetic properties
Absorption and distribution The pharmacokinetics of clonidine is dose-proportional in the range of 75-300 micrograms; over this range, dose linearity has not been fully demonstrated. Clonidine, the active ...
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, dried Colloidal silica (anhydrous) Povidone Modified starch (corn starch, oxidized) Stearic acid
Incompatibilities
Not applicable.
Shelf life
Shelf life: 3 years.
Special precautions for storage
Do not store above 30°C. Keep the blisters in the outer carton.
Nature and contents of container
Opaque PVC 250µm thick/PVDC 40 g/m² blisters with aluminium lidding foil 20µm in packs of 100 tablets.
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Boehringer Ingelheim Limited, Ellesfield Avenue, Bracknell, Berkshire, RG12 8YS, United Kingdom
Marketing authorization number(s)
PL 00015/5009R
Date of first authorization / renewal of the authorization
10/05/2006
Date of revision of the text
June 2018
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