Danazol 200mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Danazol

Available from:

A A H Pharmaceuticals Ltd

ATC code:

G03XA01

INN (International Name):

Danazol

Dosage:

200mg

Pharmaceutical form:

Oral capsule

Administration route:

Oral

Class:

Schedule 4 (CD Anab)

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 06070200; GTIN: 5025903003489

Patient Information leaflet

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21 Mar 2019
18:30
Danazol 200 mg 56
Label Leaflet
1706719
1424941
1706719
04569/0137
N/a
LL0441aK
236
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370083
3
United Kingdom
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5016695560281
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v3/July 2017
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Barcode Info
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21 Mar 2019
18:30
Danazol 200 mg 56
Label Leaflet
1706719
1424941
1706719
04569/0137
N/a
LL0441aK
236
N/a
370083
3
United Kingdom
N/a
5016695560281
4
Myriad Pro
52 x 101 mm
7pt
6pt
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danazol
capsul-
es
#200 mg
Danazol
capsul-
es
#200 mg
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Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Danazol Capsules 200mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 200 mg danazol.
Excipient with known effect:
Each capsule contains 90 mg lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsule.
Size 1 capsule, white body and orange cap, marked in black “DL
200” 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
exclude pr