TRASICOR Film-coated tablets (2017)
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Περιεχόμενα
Name of the medicinal product
Trasicor 20 mg Tablets. Oxprenolol 20 mg Tablets.
Qualitative and quantitative composition
Each tablet contains 20 mg of oxprenolol hydrochloride. Excipients with known effect: Sucrose powder (86 mg/tablet) Wheat starch (39.6 mg/tablet) For the full list of excipients, see section 6.1.
Pharmaceutical form
Film-coated tablets. White, round, biconvex, film-coated tablets, impressed OXP 20 on one face and no marking on the other.
Therapeutic indications
Trasicor Tablets are indicated in adults for the treatment of: Angina Pectoris: For long-term prophylactic use (if necessary nitrates should be employed for alleviating acute attacks). Hypertension: As ...
Posology and method of administration
Posology The dosage should be individualised. Before raising the dosage, the heart rate at rest should always be checked. If it is 50-55 beats/min, the dosage should not be increased, see contraindications. ...
Contraindications
Hypersensitivity to oxprenolol and related derivatives, cross-sensitivity to other beta-blockers or to any of the excipients listed in section 6.1. Cardiogenic shock. Second or third degree atrioventricular ...
Special warnings and precautions for use
As beta-blockers increase the AV conduction time, beta-blockers should only be given with caution to patients with first degree AV block. Beta-blockers should not be used in patients with untreated congestive ...
Interaction with other medicinal products and other forms of interaction
The antihypertensive effect of oxprenolol is enhanced by concomitant treatment with other antihypertensives. Calcium channel blockers: Oxprenolol should not be used with calcium-channel blockers with negative ...
Pregnancy and lactation
Pregnancy Oxprenolol should not be given during pregnancy unless there are no safer alternatives. As in the case of any form of drug therapy, oxprenolol should be employed with caution during pregnancy, ...
Effects on ability to drive and use machines
Patients receiving oxprenolol should be warned that dizziness, fatigue or visual disturbances (see section 4.8) may occur, in which case they should not drive, operate machinery or do anything else requiring ...
Undesirable effects
Side-Effects Frequency estimate: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the ...
Overdose
Symptoms Poisoning due to an overdosage of beta-blocker may lead to pronounced hypotension, bradycardia, hypoglycaemia, heart failure, cardiogenic shock, conduction abnormalities (first or second degree ...
Pharmacodynamic properties
Pharmacotherapeutic group: Beta blocking agent, non selective ATC code: C07AA Oxprenolol, the active substance of Trasicor Tablets, is a non-selective, lipophilic betablocker exerting a sympatholytic effect ...
Pharmacokinetic properties
Absorption In the gastrointestinal tract, oral oxprenolol is rapidly and completely absorbed. Food has no significant effect on absorption. Peak plasma concentrations are achieved approximately 1 hour ...
Preclinical safety data
None stated.
List of excipients
Calcium phosphate tribasic Magnesium stearate Polyvinylpyrrolidone (K25) Sucrose Talc Wheat starch Coating Hydroxypropyl methylcellulose Kollidon VA64 Purified talc Titanium dioxide E171
Incompatibilities
Not applicable.
Shelf life
Shelf life: 5 years.
Special precautions for storage
Protect from moisture.
Nature and contents of container
PVC* Blister packs of 56 and 100 tablets. * PVC 250 micron, aluminium foil 20 micron. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
None.
Marketing authorization holder
Amdipharm UK Limited, Regency House, Miles Gray Road, Basildon, Essex, SS14 3AF, United Kingdom
Marketing authorization number(s)
PL 20072/0018
Date of first authorization / renewal of the authorization
Date of first authorisation: 1 January 2005 Date of latest renewal: 20 September 2005
Date of revision of the text
01/01/2017
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