Azol 200

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Danazol 200mg

Available from:

Viatris Limited

INN (International Name):

Danazol 200 mg

Dosage:

200 mg

Pharmaceutical form:

Capsule

Composition:

Active: Danazol 200mg Excipient: Colloidal silicon dioxide Erythrosine Gelatin   Iron oxide red Iron oxide yellow Lactose Lactose monohydrate Magnesium stearate Microcrystalline cellulose Povidone Sodium laurilsulfate Sodium starch glycolate TekPrint black SW-9008 Titanium dioxide  

Units in package:

Bottle, plastic, HDPE bottle/PP cap, 30's, 30 capsules

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Cipla Ltd

Therapeutic indications:

Endometriosis: Danazol is indicated for use in the treatment of endometriosis amenable to hormonal management. Menorrhagia: Danazol is indicated for the short-term (up to 6 months) management of primary menorrhagia. Fibrocystic Disease of the Breast: Danazol is indicated for the treatment of fibrocystic disease of the breast in both pre- and post-menopausal women. Hereditary Angioedema: Danazol is indicated for the prophylaxis of attacks of hereditary angioedema of a severe or life-threatening nature, in male and female patients.

Product summary:

Package - Contents - Shelf Life: Bottle, plastic, HDPE bottle/PP cap - 30 capsules - 36 months from date of manufacture stored at or below 30°C - Bottle, plastic, HDPE bottle/PP cap - 50 capsules - 36 months from date of manufacture stored at or below 30°C - Bottle, plastic, HDPE bottle/PP child resistant cap - 100 capsules - 36 months from date of manufacture stored at or below 30°C

Authorization date:

1988-12-16

Patient Information leaflet

Page 1 of 4
NEW ZEALAND CONSUMER MEDICINE INFORMATION
AZOL 100 & AZOL 200
_DANAZOL CAPSULES 100 MG & 200 MG_
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Azol.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Azol against
the benefits they expect it will have
for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE. You may need to read it
again.
WHAT AZOL IS USED
FOR
Azol is used in the following
conditions:

ENDOMETRIOSIS – the inner
lining of the uterus (womb) is
called the endometrium. Each
month, the endometrium is
shed as the menstrual period.
In endometriosis, a tissue
similar to the lining of the
uterus also grows outside the
uterus, particularly on the
ovaries. As this tissue cannot
be shed a part of the
menstrual period, it causes
pain and possibly contributes
to infertility.

MENORRHAGIA - abnormally
heavy or long menstrual
periods

SEVERE FIBROCYSTIC BREAST
DISEASE – breast lumps or
cysts which are very painful

HEREDITARY ANGIOEDEMA - an
inherited condition associated
with repeated episodes of
stomach upset and swelling of
the throat, which may cause
difficulty in swallowing or
breathing.
Azol contains the active ingredient
danazol, which alters the level or
the way certain chemicals in the
body work.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED FOR
YOU.
Your doctor may have prescribed it
for another reason.
Azol is available only with a doctor’s
prescription.
Azol is not recommended for use in
children, as the safety and
effectiveness in children has not
been established.
There is no evidence that Azol is
addictive.
BEFORE YOU TAKE AZOL
_WHEN YOU MUST NOT TAKE _
_IT_
DO NOT TAKE AZOL IF YOU HAVE AN
ALLERGY TO:

any medicine containing
dazazol.

any of the ingredients listed at
the en

Summary of Product characteristics

Page 1 of 12
NEW ZEALAND DATA SHEET
AZOL 100 & AZOL 200
1. PRODUCT NAME
Azol 100, 100 mg, capsule.
Azol 200, 200 mg, capsule.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 100 mg or 200 mg of danazol.
Azol 100 and Azol 200 contains lactose.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Azol 100 mg capsule: light grey body with dark grey cap, marked G on
the cap and DL100 on the
body in black (size 3 capsule).
Azol 200 mg capsule: white body with orange cap, marked G on the cap
and DL200 on the body in
black (size 1 capsule).
4. CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS _
ENDOMETRIOSIS:
Danazol is indicated for use in the treatment of endometriosis
amenable to hormonal management.
MENORRHAGIA:
Danazol is indicated for the short-term (up to 6 months) management of
primary menorrhagia.
FIBROCYSTIC DISEASE OF THE BREAST:
Danazol is indicated for the treatment of fibrocystic disease of the
breast in both pre- and post-
menopausal women.
HEREDITARY ANGIOEDEMA:
Danazol is indicated for the prophylaxis of attacks of hereditary
angioedema of a severe or life-
threatening nature, in male and female patients.
Page 2 of 12
_4.2 _
_DOSE AND METHOD OF ADMINISTRATION _
Therapy in female patients should begin during menstruation, otherwise
appropriate tests should be
performed to ensure the patient is not pregnant. A non-hormonal method
of contraception should be
recommended.
ENDOMETRIOSIS:
200 – 800 mg danazol daily in two to four divided doses. It is
recommended that treatment be initiated
with a dosage of 800 mg daily in 4 divided doses. In some patients, it
may be possible to maintain
improvement with a reduced dosage once a satisfactory response has
been obtained. Treatment
should continue uninterrupted for 3 to 6 months, but may be extended
to 9 months if necessary.
Shorter courses have been used as adjuncts to surgery.
MENORRHAGIA:
A course of 200 – 400 mg danazol daily in divided doses for up to 6
months. 200 mg is usually
sufficient to reduce menstrual blood