Active ingredients: Bendroflumethiazide

Product name and form


Pharmaceutical Form

White uncoated tablets.

Qualitative and quantitative composition

Each tablet contains 2.5mg Bendroflumethiazide PhEur.

Excipient with known effect: Each 2.5mg tablet contains 50.00mg Lactose.

For the full list of excipients, see section 6.1.

Active Ingredient

Bendroflumethiazide inhibits the renal tubular absorption of salt and water by its action at the beginning of the distal convoluted tubule. Sodium and chloride ions are excreted in equivalent proportions.

List of Excipients

Also contains:

Magnesium stearate
Maize starch
Pregelatinised maize starch
Stearic acid

Pack sizes and marketing

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.

Marketing authorization holder

Accord-UK Ltd (Trading style: Accord), Whiddon Valley, Barnstaple, Devon, EX32 8NS

Marketing authorization dates and numbers

PL 0142/0380