CELIPROLOL HYDROCHLORIDE Film-coated tablet (2017)
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Περιεχόμενα
Name of the medicinal product
Celiprolol hydrochloride 400 mg film-coated Tablets.
Qualitative and quantitative composition
Each tablet contains 400 mg celiprolol hydrochloride. Each tablet contains 3.6mg lactose. For the full list of excipients, see section 6.1.
Pharmaceutical form
Film-coated tablet. White coloured, capsule shaped, biconvex film coated tablets, debossed with 400 on one side of the breakline and a deep breakline on the other side. The tablet can be divided into equal ...
Therapeutic indications
Celiprolol is indicated for the treatment of hypertension.
Posology and method of administration
Adults The initial dose is 200 mg orally, taken once daily with a glass of water. Celiprolol should be taken on rising, one hour before meals, or 2 hours after meals. If response is inadequate, the dose ...
Contraindications
Hypersensitivity to celiprolol hydrochloride or to any of the excipients listed in section 6.1. Celiprolol is also contraindicated in patients with: Second or third degree heart block; Severe bradycardia ...
Special warnings and precautions for use
Although cardiac selective beta blockers may have less effect on lung function than non-selective beta blockers, as with all beta blockers, these should be avoided in patients with chronic obstructive ...
Interaction with other medicinal products and other forms of interaction
Combinations not recommended Celiprolol should not be prescribed for patients being treated with theophylline (see Section 4.3 Contraindications). It has been shown that the bioavailability of celiprolol ...
Pregnancy and lactation
Pregnancy The safety of celiprolol product for use in human pregnancy has not been established. An evaluation of experimental animal studies does not indicate direct or indirect harmful effects with respect ...
Effects on ability to drive and use machines
It has been shown that driving ability is unlikely to be impaired in patients taking Celiprolol. However, it should be taken into account that occasional dizziness or fatigue may occur as well as the potential ...
Undesirable effects
Beta-adrenoceptor blockers may mask the symptoms of thyrotoxicosis or hypoglycaemia (in particular, tachycardia). Occasional side effects, which are usually mild and transient have occurred. These include ...
Overdose
No data are available regarding overdose in humans. The most common symptoms to be expected following overdosage with a beta-adrenoceptor blocking drug are bradycardia, hypotension, bronchospasm and acute ...
Pharmacodynamic properties
Pharmacotherapeutic group: Betablocking agents, selective ATC Code: C07AB08 Mode of Action Celiprolol is a vasoactive, beta-1 selective adrenoceptor antagonist with partial beta-2 agonist activity indicated ...
Pharmacokinetic properties
Celiprolol is a hydrophilic compound that is incompletely absorbed from the gastrointestinal tract. Bioavailability of orally administered celiprolol ranges from 30 to 70% depending upon the dose administered. ...
Preclinical safety data
Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential and reproductive toxicity.
List of excipients
Microcrystalline cellulose Mannitol Croscarmellose sodium Colloidal anhydrous silica Magnesium stearate Film coating material: Hypromellose Titanium dioxide (E171) Macrogol 400 Lactose monohydrate
Incompatibilities
Not applicable.
Shelf life
3 years.
Special precautions for storage
Store in the original container.
Nature and contents of container
Blister strips comprising of white opaque PVC film with a backing of aluminium foil coated with heat seal lacquer. Pack of 10, 20, 28, 30, 50, 56 and 100 tablets.
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Ranbaxy (UK) Limited, 5th floor, Hyde Park, Hayes 3, 11 Millington Road, Hayes, UB3 4AZ, United Kingdom
Marketing authorization number(s)
PL 14894/0046
Date of first authorization / renewal of the authorization
27/06/2007
Date of revision of the text
20/07/2017
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