Slow-Trasicor 160mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Oxprenolol hydrochloride

Available from:

Advanz Pharma

ATC code:

C07AA02

INN (International Name):

Oxprenolol hydrochloride

Dosage:

160mg

Pharmaceutical form:

Modified-release tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02040000; GTIN: 5060064170410

Summary of Product characteristics

OBJECT 1
SLOW TRASICOR TABLETS 160 MG
Summary of Product Characteristics Updated 08-Feb-2017 | Concordia
International - formerly AMCo
1. Name of the medicinal product
Slow Trasicor 160 mg Tablets.
2. Qualitative and quantitative composition
Each tablet contains 160 mg of oxprenolol hydrochloride
Excipients with known effect:
Lactose crystalline (BP DC Sperolac 100)
(35 mg/tablet)
Lactose granules (Granulac 200)
(132 mg/tablet + 1.752 mg/tablet coating)
Glycerol palmitostearate (EP type 1, Precirol AT05)
(10 mg/tablet)
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated Tablets
White, round, slightly biconvex, coated tablets with bevelled edges
and the imprint 'SLOW TRASICOR'
on one side.
4. Clinical particulars
4.1 Therapeutic indications
Slow Trasicor Tablets are indicated in adults for the treatment of:
Hypertension: As monotherapy or for use in combination with other
antihypertensives, e.g. with a
diuretic, peripheral vasodilator, calcium channel blocker or ACE
inhibitor.
Angina Pectoris: For long-term prophylactic use (if necessary nitrates
should be employed for alleviating
acute attacks).
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abruptly, but withdrawn gradually.
The sustained-release formulation provides a longer pharmacological
action from a given dose, thus
allowing once daily administration. When the dose is raised to more
than one Slow Trasicor tablet, it is
usual for this to continue to be given once daily.
Oxprenolol is only gradually released from the sustained-release
tablet, extending the duration of effect.
The occurrence of high p