HALF BETA-PROGRANE Sustained release capsule Ref.[49926] Active ingredients: Propranolol

Posology

Adults

Hypertension

The usual starting dose is one 160 mg Beta-Prograne Sustained-Release capsule daily, taken either morning or evening. An adequate response is seen in most patients at this dosage. If necessary, it can be increased in 80 mg Half Beta-Prograne increments until an adequate response is achieved (up to a maximum of 320 mg daily).

A further reduction in blood pressure can be attained if a diuretic or other antihypertensive agent is given in addition.

Angina, essential tremor, thyrotoxicosis, prophylaxis of migraine

Adequate control is gained in most patients on one Half Beta-Prograne 80 mg capsule per day (either morning or evening). If necessary, further control may be gained by increasing the dose in 80 mg increments (one Half Beta-Prograne 80mg Capsule) to a maximum of 240 mg per day, taken either morning or evening, which may be administered in the most convenient form using either Beta-Prograne 160 mg Capsules or Half Beta-Prograne 80mg Capsules.

Situational and generalised anxiety

Half Beta-Prograne 80 mg Sustained-Release Capsule taken daily should be sufficient to provide short-term relief of acute situational anxiety. Generalised anxiety, requiring longer term therapy, usually responds adequately at the same dosage. In individual cases, the dosage may be increased to one Beta-Prograne 160 mg Sustained-Release Capsule per day. Treatment should be continued according to patient’s response. Patients should be reviewed after 6 to 12 months' treatment.

Portal Hypertension

Since portal blood pressure cannot normally be monitored directly, dosage should be titrated to achieve approximately 25% reduction in resting heart rate. Dosing should begin with one Half Beta-Prograne 80 mg Sustained-Release Capsule daily, increasing to one Beta-Prograne 160 mg Sustained-Release Capsule daily depending on heart rate response. Further Half Beta-Prograne 80 mg Sustained-Release Capsule increments may be added up to a maximum dose of 320 mg once daily.

Patients who are already established on equivalent daily doses of Beta-Prograne should be transferred to the equivalent doses of Half Beta-Prograne 80 mg Sustained-Release or Beta-Prograne 160 mg Sustained-Release daily, taken either morning or evening.

Older People

Evidence concerning the relation between blood level and age is conflicting. Treatment should start with one Half Beta-Prograne 80 mg Sustained-Release Capsule once daily. The dose may be increased to one Beta-Prograne 160 mg Sustained-Release Capsule daily or higher as appropriate.

Paediatric population

Beta-Prograne 160 mg Sustained-Release Capsules and Half Beta-Prograne 80mg Sustained-Release Capsules are not intended for use in children.

Method of administration

For oral administration.

Propranolol is known to cause severe toxicity when used in overdose. Patients should be informed of the signs of overdose and advised to seek urgent medical assistance if an overdose of propranolol has been taken.

Clinical features

Cardiac

Bradycardia, hypotension, pulmonary oedema, syncope and cardiogenic shock may develop. QRS complex prolongation, ventricular tachycardia, first to third degree AV block, ventricular fibrillation or asystole may also occur. Development of cardiovascular complications is more likely if other cardioactive drugs, especially calcium channel blockers, digoxin, cyclic antidepressants or neuroleptics have also been ingested. Older patients and those with underlying ischaemic heart disease are at risk of developing severe cardiovascular compromise.

CNS

Drowsiness, confusion, seizures, hallucinations, dilated pupils and in severe cases coma may occur. Neurological signs such as coma or absence of pupil reactivity are unreliable prognostic indicators during resuscitation.

Other features

Bronchospasm, hyperkalaemia and occasionally CNS-mediated respiratory depression may occur.

Management

In cases of overdose or extreme falls in heart rate or blood pressure, treatment with propranolol must be stopped. Management should include general symptomatic and supportive measures including a clear airway and monitoring of vital signs until stable. In symptomatic patients, or patients with an abnormal ECG, early discussion with critical care should be considered.

Consult national clinical guidance for further information on the management of overdose.

5 years.

Store below 25°C. Store in the original package in order to protect from light and moisture.

Blister packs:

PVC: Colourless 250 micron thickness

Aluminium: 25 microns thickness

28 capsules per pack, 14 capsules per blister strip.

Not all packs sizes may be marketed.

No special requirements for disposal. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.