Danol 100mg capsules

Land: Verenigd Koninkrijk

Taal: Engels

Bron: MHRA (Medicines & Healthcare Products Regulatory Agency)

Werkstoffen:

Danazol

Beschikbaar vanaf:

Sanofi

ATC-code:

G03XA01

INN (Algemene Internationale Benaming):

Danazol

Dosering:

100mg

farmaceutische vorm:

Oral capsule

Toedieningsweg:

Oral

klasse:

Schedule 4 (CD Anab)

Prescription-type:

Valid as a prescribable product

Product samenvatting:

BNF: 06070200; GTIN: 5000283606598

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE USER
DANOL 100MG CAPSULES
DANOL 200MG CAPSULES
(danazol)
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READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them,
even if their symptoms are the same as yours.
•
If any of the side effects get serious, or if you notice any side
effects not listed in this
leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET:
1. What Danol is and what it is used for
2. Before you take Danol
3. How to take Danol
4. Possible side effects
5. How to store Danol
6. Further Information
1.
WHAT DANOL IS AND WHAT IT IS USED FOR
Danol contains a medicine called danazol. It works by changing the way
some hormones
act in your body. It is used to treat:
•
Endometriosis – an illness where some of the tissues that line the
womb are found
elsewhere in the body. One way of treating this is to have an
operation and to take
Danol as well. Danol can also be used on its own, where other
treatments have
not worked
•
Breast cysts (lumps) which may be painful, but not malignant. Danol is
used
where other treatments have not worked or when they cannot be taken.
2.
BEFORE YOU TAKE DANOL
DO NOT TAKE THIS MEDICINE AND TELL YOUR DOCTOR IF:
•
You are allergic (hypersensitive) to danazol or any of the other
ingredients of Danol
(listed in Section 6 Further Information). Signs of an allergic
reaction include: a rash,
swallowing or breathing problems, swelling of your lips, face, throat
or tongue
•
You have a rare inherited illness which affects your metabolism
(called ‘porphyria’)
•
You are pregnant, might become pregnant, or think you may be pregnant.
•
You are breast-feeding
•
You have severe kidney, liver or heart disease
•
You have ever had blood clots (thrombosis)
•
You have a type of cance

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Danol 100mg Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 100mg of danazol.
Also contains 62 mg of lactose monohydrate.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Capsule, hard
Capsule with a grey cap and opaque white body containing a white or
almost white
powder, with ‘D100’ printed in black ink.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Danol capsules are recommended for the treatment of
Endometriosis:
treatment
of
endometriosis-associated
symptoms
and/or
to
reduce the extent of endometriosis foci. Danazol may be used either in
conjunction
with
surgery
or,
as
sole
hormonal
therapy,
in
patients
not
responding to other treatments.
Benign fibrocystic breast disease: symptomatic relief of severe pain
and
tenderness. Danazol should be used only in patients not responsive to
other
therapeutic measures or for whom such measures are inadvisable.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Danol capsules should be given as a continuous course, dosage being
adjusted
according to the severity of the condition and patient's response. A
reduction
in dosage once a satisfactory response has been achieved may prove
possible.
In fertile females, Danol capsules 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
pregnancy before starting medication. Females of child-bearing age
should
employ non-hormonal contraception throughout the course of treatment.
In endometriosis, the recommended dosage is 200mg to 800mg daily in a
course of treatment lasting normally three to six months. Dosage
should be
increased if normal cyclical bleeding still persists after two months
therapy, a
higher dosage (not exceeding 800mg per day) may also be needed for
severe
disease.
In benign fibrocystic breast disease, treatment should commence at a
dose of
300mg daily, a course of treatme