BENDROFLUMETHIAZIDE Tablet Ref.[6440] Active ingredients: Bendroflumethiazide

Posology

It is recommended that the tablets should be taken in the morning to avoid nocturia.

Adults and children aged 12 years and over

Oedema: Initially 5-10mg once daily or on alternate days.

Maintenance: 2.5-10mg two or three times weekly.

Hypertension: 2.5-5mg once daily. When Bendroflumethiazide is used concurrently with other specific hypotensive agents, the dosage of such agents should be reduced and then adjusted as necessary.

Paediatric population

Children under 12 years: Initial dose of 400micrograms/kg of body weight daily reducing to the maintenance dose of 50-100micrograms/kg daily.

A more appropriate dosage form may be required.

Elderly

Dosage may need to be reduced in the elderly, especially where there is impairment of renal function.

Method of Adminstration

For oral administration.

Symptoms

Nausea, vomiting, diarrhoea, dehydration, dizziness, weakness, muscle cramps, diuresis, increased frequency of micturition with polyuria and thirst. Extreme cases may show depletion of intravascular volume, hypotension and peripheral circulatory failure. Hypokalaemia and mild hypoglycaemia are likely to be present if diuresis is profound. CNS depression (eg drowsiness, lethargy and coma) may occur without cardiovascular or respiratory depression.

Treatment

Activated charcoal may help reduce absorption of substantial amounts if given within one hour of ingestion. Treatment should be symptomatic and directed at fluid and electrolyte replacement which should be monitored together with the blood pressure and renal function. Hyponatraemia should be treated with water deprivation rather than by the administration of sodium chloride. Cathartics should be avoided.

Four years from the date of manufacture (PVC blister packs).

Three years from the date of manufacture (polypropylene containers; polyethylene containers; amber glass bottles.

Store below 25°C in a dry place.

The product containers are rigid injection moulded polypropylene or injection blow-moulded polyethylene containers with polyfoam wad or polyethylene ullage filler and snap-on polyethylene lids; in case any supply difficulties should arise the alternative is amber glass containers with screw caps and polyfoam wad or cotton wool.

Pack sizes: 90s, 100s, 112s, 120s, 168s, 180s, 250s, 500s, 1000s

The product may also be supplied in blister packs in cartons:

a) Carton: Printed carton manufactured from white folding box board.

b) Blister pack: (i) 250µm white rigid PVC. (ii) Surface printed 20µm hard temper aluminium foil with 5-7g/M² PVC and PVdC compatible heat seal lacquer on the reverse side.

Pack sizes: 28s, 30s, 56s, 60s, 84s

Product may also be supplied in bulk packs, for reassembly purposes only, in polybags contained in tins, skillets or polybuckets filled with suitable cushioning material. Bulk packs are included for temporary storage of the finished product before final packaging into the proposed marketing containers.

Maximum size of bulk packs: 50,000.

Not applicable.