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TRASICOR Film-coated tablets (2017)

Αναφορές

Βιβλιογραφική αναφορά

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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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