Active ingredients: Danazol
Danol 100mg Capsules.
Capsule, hard.
Capsule with a grey cap and opaque white body containing a white or almost white powder, with ‘D100’ printed in black ink.
Each capsule contains 100mg of danazol.
Also contains 62 mg of lactose monohydrate.
For a full list of excipients, see section 6.1.
Danazol is a synthetic steroid derived from ethisterone an is indicated for the treatment of endometriosis and benign fibrocystic breast disease.
Capsule:
Maize starch
Lactose monohydrate
Purified talc
Magnesium stearate
Cap:
Titanium dioxide (E171)
Gelatin
Black iron oxide
Capsule Shell Body (size 3):
Titanium dioxide (E171)
Gelatin
Black Ink:
Shellac Glaze 45% (20% esterified) in ethanol
Iron oxide black (E172)
Propylene glycol (E1520)
Ammonium hydroxide 28%
Or
Shellac
Propylene glycol
Strong ammonia solution
Potassium hydroxide
Black iron oxide (E172)
PVC blister pack compound of polyvinyl chloride (thickness 250µm) sealed to aluminium foil (thickness 20µm). The blisters are then packed in a cardboard carton.
Pack sizes: 50, 60 and 100 capsules.
Not all pack sizes may be marketed.
Aventis Pharma Limited, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK
Trading as: Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK
PL 04425/0194
Date of First Authorisation: 10 June 1974
Date of Latest Renewal: 2 April 2002