NAFTIDROFURYL Capsules Ref.[9627] Active ingredients: Naftidrofuryl

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Accord-UK Ltd (Trading style: Accord), Whiddon Valley, Barnstaple, Devon, EX32 8NS

Product name and form

NAFTIDROFURYL CAPSULES BP 100mg.

Pharmaceutical Form

Pink hard gelatin capsules.

Pink hard gelatin capsules (size 2) printed “C” and “NL” in black.

Qualitative and quantitative composition

Each hard gelatin capsule contains 100mg Naftidrofuryl oxalate PhEur.

Active Ingredient Description
Naftidrofuryl

Naftidrofuryl oxalate is a powerful vasodilator agent with an antagonist effect on 5-HT2 receptors of the smooth muscle cells. The vasodilator effect, which occurs in both the cerebral and peripheral circulation, is probably the main action. It is claimed that this action protects cells against the metabolic effects of ischaemia.

List of Excipients

The capsule contains:

Maize starch
Microcrystalline cellulose (E460)
Sodium starch glycollate
Colloidal silica
Stearic acid
Magnesium stearate

The capsule shell contains:

Erythrosine (E127)
Titanium dioxide (E171)
Gelatin

The printing ink contains:

Shellac (E904)
Propylene glycol (E1520)
Iron oxide black (E172)
Potassium hydroxide (E525)

Pack sizes and marketing

The product containers are rigid injection moulded polypropylene containers with snap-on polyethylene lids.

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) 250ยตm white rigid PVC/PVdC. (ii) Surface printed 20ยตm hard temper aluminium foil with 5-7g/Mยฒ PVC and PVdC compatible heat seal lacquer on the reverse side.

Pack sizes:

Al/PVC/PVDC: 28s, 30s, 56s, 60s, 84s, 90s, 100s, 112s, 120s, 168s, 180s

PP Tablet Container: 100s, 250s, 500s, 1000s

Marketing authorization holder

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

Marketing authorization dates and numbers

PL 0142/0429

22.12.98

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