Trasicor 80mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Oxprenolol hydrochloride

Available from:

Sigma Pharmaceuticals Plc

ATC code:

C07AA02

INN (International Name):

Oxprenolol hydrochloride

Dosage:

80mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02040000

Summary of Product characteristics

1. NAME OF THE MEDICINAL PRODUCT
Trasicor 80 mg Tablets.
Oxprenolol 80 mg Tablets.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 80 mg of oxprenolol hydrochloride.
Excipients with known effect:
Sodium starch glycollate
(21.3 mg/ tablet)
For the full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Film-coated tablets.
Light yellow, round, biconvex, film-coated tablets, impressed OXP 80
on one face and no
marking on the other.
4.1 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 monotherapy or for use in combination with other
antihypertensives, e.g. with a
diuretic, peripheral vasodilator, calcium channel blocker or ACE
inhibitor.
Disturbances of cardiac rhythm: Especially supraventricular
tachycardia, atrial fibrillation and
digitalis-induced arrhythmias, ventricular tachycardia.
Short-term relief of functional cardiovascular disorders due to
adrenergic hyperactivity: Such as
cardiac neurosis, hyperkinetic heart syndrome and anxiety-induced
cardiovascular disorders.
4.2 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.
If the maximum recommended dose is insufficient to produce the desired
response appropriate
combined therapy should be considered.
When discontinuing prolonged treatment with a beta-blocker, the
medication should not be
interrupted abruptly, but withdrawn gradually.
Higher doses using conventional Trasicor Tablets may be administered
in two or more divided
doses.
Elderly _ _
No special dosage regime is necessary but concurrent hepatic
insufficiency should be taken into
account.
_Paediatric population _
No adequate experience has been acquired on the use of Trasicor
Tablets in children.
Adults
_Hypert