Danazol 100mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Danazol

Available from:

Actavis UK Ltd

ATC code:

G03XA01

INN (International Name):

Danazol

Dosage:

100mg

Pharmaceutical form:

Oral capsule

Administration route:

Oral

Class:

Schedule 4 (CD Anab)

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 06070200; GTIN: 5012617008374

Patient Information leaflet

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29 Mar 2019
15:30
Danazol 100 mg 28
Label Leaflet
1706718
1464200
1706718
PL 04569/0136
N/A
LL0440AL
235
N/A
373563
1
United Kingdom
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5016695040028
N/A
4
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52 x 101 mm
7pt
7pt
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MA No.
Packing Site/Printer
Supplier Code
Sign-offs
v3/July 2017
Pharma Code
SAP No.
Vendor Job No.
Trackwise Proof No.
Client Market
Keyline/Drawing No.
Barcode Info
3D Render ID
29 Mar 2019
15:30
Danazol 100 mg 28
Label Leaflet
1706718
1464200
1706718
PL 04569/0136
N/A
LL0440AL
235
N/A
373563
1
United Kingdom
N/A
5016695040028
N/A
4
Myriad Pro
52 x 101 mm
7pt
7pt
Keyline
Braille
Varnish
Free
danazol
capsul-
es
#100 mg
danazol
capsul-
es
#100 mg
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Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Danazol Capsules 100mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 100 mg danazol.
Excipient with known effect;
Each capsule contains 45 mg lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsule.
Size 3 capsule, light grey body, dark grey cap, marked in black “DL
100” and “G”
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Danazol capsules are recommended for the treatment of:
1.
Endometriosis. To control pain, pelvic tenderness and other associated
symptoms and to resolve or reduce the extent of endometriotic foci.
Danazol capsules
may be used as sole therapy, in preparation for or following surgery
or in patients not
responding to other treatments.
2.
Dysfunctional uterine bleeding presenting as menorrhagia. To control
excessive blood loss and to control associated dysmenorrhoea.
3.
For the treatment of severe cyclical mastalgia with or without
nodularity
(fibrocystic disease) unresponsive to counselling or simple
analgesics. To reduce
pain, tenderness and nodularity.
4.
For the control of benign, multiple or recurrent breast cysts in
conjunction
with aspiration.
5.
Severe symptomatic gynaecomastia, both idiopathic as well as drug
induced,
to reduce the size of the breast and to control associated pain and
tenderness.
6.
Pre-operative thinning of the endometrium prior to hysteroscopic
endometrial
ablation.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults
The usual range of dosage is 200 mg to 800 mg daily in up to four
divided doses.
Danazol should be given as a continuous course, dosage being adjusted
according to the
severity of the condition and the patient’s response. A reduction in
dosage once a satisfactory
response has been achieved may prove possible. In fertile females,
Danazol should be started
during menstruation, preferably on the first day, to avoid exposing a
pregnancy to its possible
effects. Where doubt exists, appropriate checks should be made to
exclu