DANAZOL CAPSULES 200MG

Active substance: DANAZOL

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danazol
capsules
#200 mg

danazol
capsules
#200 mg

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32

Danazol
capsules

200
mg

56 capsules

Each capsule contains: Danazol 200 mg.
Also contains: lactose.
Dosage: For oral use as directed by a doctor.
Read the enclosed leaflet.
Keep out of the sight and reach of children.
Protect from light. Store in a dry place below 25°C.
PL 4569/0137

REVERSE

POM

Leave Blank
Glue Area

10005387

Mylan, Potters Bar,
Herts, EN6 1TL, U.K.

TBC

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POM

10005387

Mylan, Potters Bar,
Herts, EN6 1TL, U.K.

This leaflet was last revised in: 08/2013.

TBC

• If you get any of the side effects, talk to your
doctor or pharmacist. This includes any
possible side effects not listed in this leaflet.

(danazol)

In this leaflet:
1. What Danazol is and what it is used for.
2. What you need to know before you take danazol.
3. How to take Danazol.
4. Possible side effects.
5. How to store Danazol.
6. Contents of the pack and other information.

Danazol Capsules are available in either:
• polypropylene containers with polyethylene caps
• plastic/aluminium foil blister strips
• HDPE containers with polyethylene snap closures.

Read all of this leaflet carefully before you
start taking this medicine because it contains
important information for you.
• 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
only. Do not pass it on to others. It may harm
them, even if their signs of illness are the
same as yours.

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Danazol belongs to a group of medicines called
antigonadotropins. Danazol lowers the amount of
some hormones (gonadotrophins) in your body. It is
used to treat:
• endometriosis (where the tissue that normally
lines your womb and is shed during your period
grows outside your womb). You may also be given
Danazol before or after surgery for endometriosis
• painful or heavy periods (menorrhagia)
• painful breast disease, but not malignant. This
may be connected with your periods or caused by
cysts (lumps) in the breast. Danazol is used where
other treatments have not worked or when they
cannot be taken
• enlarged breasts (in both men and women).

What Danazol looks like and the contents of
the pack
Danazol capsules 100 mg are capsules with a light
grey body, dark grey cap marked in black 'DL 100'
and 'G'.

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Changes in the number of cells in your blood or in
the level of fat (lipid) in your blood, thyroid tests
and liver tests may also occur. These do not usually
cause symptoms and return to normal when you
stop taking Danazol.

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Warnings and precautions
If any of the following conditions applies to you, or
if you have had any of them in the past, you must
tell your doctor or pharmacist before you start to
take Danazol:

Keep out of the sight and reach of children. You
should keep your capsules in their original
packaging to protect them from light. Keep your
capsules in a dry place below 25°C. Do not use
Danazol after the expiry date which is stated on the

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• raised levels of an enzyme (creatine
phosphokinase) which is an indicator of
muscle damage
• racing or irregular heart beat
• if you have high blood pressure it may get worse
• if you are diabetic, your blood sugar levels may be
affected. Even if you are not diabetic you may get
low blood sugar
• if you suffer from fits (epilepsy) this may get
worse, and you may develop epilepsy if you are
prone to the condition
• feeling tired or feverish, mood changes
• changes in sex drive (libido)
• increased appetite, anxiety, nervousness,
depression
• breathlessness, swelling or inflammation of the
lungs (interstitial pneumonitis)

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• if you have an illness which could be made worse
by fluid retention.

These are serious side effects. You may need
medical attention.

• medicines used to prevent rejection of organ
transplants such as ciclosporin, tacrolimus.
Danazol can increase the levels of these
medicines in your blood and may damage
your kidneys
• alpha calcidol (a form of vitamin D) used for
vitamin D deficiency and illnesses where there is
not enough calcium in the blood.

Children
Danazol should not be given to children.
Elderly Patients
Danazol should not be given to the elderly.

In particular, tell your doctor if you are taking any of
the following:

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Like all medicines, this medicine can cause side
effects, although not everybody gets them.

Pregnancy and breast-feeding
Do not take Danazol if you are pregnant, think you
may be pregnant or are trying to become pregnant.
Danazol may harm your unborn child. If you are of
child-bearing age you must use reliable
contraception during treatment, but not the
contraceptive pill. If you think you may have
become pregnant, stop taking Danazol
immediately and tell your doctor.

Menorrhagia: the recommended dose is 200 mg
daily for 3 months.

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Your doctor may take regular blood samples to
check your blood and to check that your liver and
thyroid are working properly.

Description Danazol 200mg 56

MA No. 04569/0137
Packing Site/Printer Gerard
Supplier Code NA
Pharma Code NA
Sign-offs

If you take more Danazol than you should
If you accidentally take too many capsules, contact
your doctor or nearest hospital emergency
department immediately for advice. Take the
medicine pack with you. This is so the doctor knows
what you have taken.
If you forget to take Danazol
Unless it is nearly time for your next dose, take it as
soon as you remember. Do not take a double dose
to make up for a forgotten capsule.
If you stop taking Danazol
Do not stop or change your treatment before
talking to your doctor. Do not stop taking Danazol
just because you feel better. If you stop, your illness
may get worse.

Vendor Job No. 215412

Adults: The recommended dose is 200 mg to
800 mg each day in up to four divided doses.
DO NOT TAKE more than 8 of the 100 mg capsules
or 4 of the 200 mg capsules in one day. Your dose
will depend on your needs and medical condition:

Keyline/Drawing No. NA
Barcode Info 5016695560281

Endometriosis: the recommended dose is 200 mg
to 800 mg daily for three to six months. Normally
you will need to take Danazol for 6 months, but you
may have to take it for up to 9 months. If your
endometriosis is severe, or if your bleeding
continues after 2 months of treatment, your doctor
may give you a higher dose.
Before an operation for endometriosis, the
recommended dose is 400 mg to 800 mg daily for 3
to 6 weeks.

Time: 10:35

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No. of colours

Dimensions 101 x 47 mm

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Date: 05/09/2013

TrackWise PR No. NA

• numbness or weakness of the face or limbs, these
may be signs of a stroke
• numbness/pain in the arms or legs, which may be
caused by a blood clot
• pain or tightness in the chest, jaw or arm, these
may be signs of a heart attack
• water retention, voice changes such as
hoarseness or a sore throat, growth of facial hair
or muscle development
• liver problems which may cause yellowing of your
skin or whites of the eyes, dark urine, pale stools,
tumours and blood-filled cysts in the liver,
abdominal pain which may be severe
• an inflamed pancreas causing abdominal pain
with sickness
• fits.

Before starting your course of treatment, your
doctor will check if you are pregnant. If you are of
child bearing age, you should start treatment on the
first day of your period to avoid exposing a
pregnancy to its possible effects. Use reliable
contraception (such as an Intra Uterine Device or
barrier method in conjunction with contraceptivefoam or jelly). The contraceptive pill should not be
used until your treatment with Danazol has finished.
You must take Danazol as a continuous course. Your
doctor may adjust your dose according to your
response. Once your condition has improved, he
may advise you to take a lower dose.
If you feel the effect of your medicine is too weak or
too strong, do not change the dose yourself, but ask
your doctor.

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Affiliate Item Code 10005387

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Take this medicine by mouth.
Swallow Danazol capsules whole with a glass
of water.

Component Type Label Leaflet

Some rare side effects that may occur if Danazol is
taken for a long time: If you have hereditary
angioedema (an inherited condition causing
swelling of the skin, lungs and digestive system) you
may get blood in your urine.

Driving and using machines
Danazol is not known to affect your ability to drive
or use machines. However, some side effects such
as dizziness, a spinning feeling, and changes in
eyesight may occasionally occur. If affected, you
should not drive or use machines.

Always take this medicine exactly as your doctor has
told you. Check with your doctor or pharmacist if
you are not sure.

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• you may also have flushing, vaginal dryness or
irritation, reduction in breast size and lowering of
sperm count during treatment
• dizziness, a spinning feeling (vertigo)
• headaches which may be severe
• feeling sick (nausea), being sick (vomiting)
• confusion, collapse
• skin rashes, which may be severe and occur with
fever and/or facial swelling, changes in skin
colour (pigmentation), flaking, peeling, red skin,
unusual bruising or bleeding of the skin, more
frequent infections
• back ache, pain in the arms and legs, severe
muscle cramps, muscle tremors or twitches,
muscle or joint pain or swelling

Rare side effects:
• enlarged clitoris (part of the female sex organs)
• sensitivity of the skin to sunlight.

Ask your doctor or pharmacist for advice before
taking any medicine if you are pregnant or
breast-feeding.

3. HOW TO TAKE DANAZOL

Enlarged breasts: the recommended dose is
400 mg daily for 6 months. If you are a young adult,
the starting dose may be 200 mg daily. If your
condition does not improve in the first two months,
your doctor may increase the dose to 400 mg daily.

• chest or stomach pain
• water retention or bloating, which may
occasionally lead to a feeling of tingling or
numbness in the hands, sometimes known as
carpal tunnel syndrome.

Do not take Danazol if you are breast-feeding.
Danazol may reach your baby through the breast
milk. If you are planning to breast-feed, talk to your
doctor or pharmacist.

Danazol contains lactose. If you have been told
by your doctor that you have an intolerance to
some sugars, contact your doctor before taking
this medicine.

Breast disease: the recommended dose is 200 mg to
300 mg daily for 3 to 6 months. To treat breast cysts
the usual dose is 300 mg daily for 3 to 6 months

• if you have taken Danazol or a similar medicine
before and had side effects such as water
retention, voice changes, growth of facial hair or
muscle development
• if you have any liver or kidney problems
• if you have high blood pressure or heart disease
• if you have diabetes mellitus (high blood sugar)
• if you have a blood problem with increased
amount of red blood cells, where the blood gets
thicker (polycythaemia)
• if you have fits (epilepsy)
• if you have problems with fat metabolism
(lipid disorders)
• if you have a history of blood clots
• if you get migraines
• if you are having treatment to remove a tumour
• if you may have breast cancer

If you have to take Danazol for more than six
months your doctor will arrange for an ultrasound
test to check your liver.

Danazol with food, drink and alcohol
Do not drink alcohol during treatment. This is
because drinking alcohol whilst taking Danazol can
make you feel sick or short of breath.

If any of the following happen, stop taking
Danazol and tell your doctor immediately or go to
your nearest hospital emergency department:
• allergic reactions such as skin rash, swelling of the
face, lips, tongue and/or throat which may cause
difficulty breathing or swallowing
• an increase in the pressure of the fluid which
surrounds the brain, which can lead to changes in
eye sight such as blurred vision

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If you are having tests, tell your doctor. This is
because Danazol treatment may interfere with
laboratory tests of male sex hormone (testosterone),
fats (lipids), sugars and plasma proteins.

If you are going to have a blood test, it is important
to tell your doctor you are taking Danazol.

4. POSSIBLE SIDE EFFECTS

What Danazol contains
The active substance is danazol. Each 100 mg
capsule contains 100 mg danazol. Each 200 mg
capsule contains 200 mg danazol.

Operations or tests
If you are due to have an operation, tell your doctor
you are taking Danazol. This is because Danazol can
increase the effect of some anaesthetics.

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If you have any further questions on the use of this
product, ask your doctor or pharmacist.

6. CONTENTS OF THE PACK AND OTHER
INFORMATION

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Danazol may lower the effect of the following
medicines:
• anti-diabetic medication including insulin
• medicines used to lower blood pressure
(anti-hypertensives)
• medicines for migraine.

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Do not take Danazol if you:
• are allergic to danazol or to any of the other
ingredients of this medicine (listed in Section 6).
Signs of an allergic reaction include: a rash,
swallowing or breathing problems, swelling of
your lips, face, throat or tongue
• are pregnant, might become pregnant or think
you may be pregnant or are breast-feeding (see
section 'Pregnancy and breast-feeding')
• have severe kidney, liver or heart disease
• or a member of your family have porphyria (a
disorder of metabolism)
• have blood clots in your circulation or have a
history of such events (thromboembolic disease)

Danazol may increase the effect of the following
medicines:
• medicine to treat epilepsy, fits or convulsions
such as carbamazepine, phenytoin
(anti-convulsants)
• anticoagulants such as warfarin (to thin the
blood) as your dosage will need to be adjusted
• anaesthetics (see 'Operations or tests' section
below)

Other medicines and Danazol
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines.

Other side effects include:
• weight gain, acne or greasy skin, more hair than
usual on the body or face or hair loss (similar to
male baldness)
• visual disturbances which may take the form of
blurring or difficulty in focusing and in wearing
contact lenses
• menstrual changes such as irregular periods,
spotting or loss of periods. Your periods will
usually return to normal 60 to 90 days after
treatment, but sometimes you may have
persistent loss of periods

carton after 'EXP'. The expiry date refers to the last
day of that month. Do not use this medicine if you
notice Danazol capsules look damaged in any way.
Medicines should not be disposed of via wastewater
or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These
measures will help to protect the environment.

• steroids such as testosterone, oestrogen,
progesterone (including 'the pill' or hormone
replacement therapy - known as HRT)
• statins such as simvastatin, atorvastatin and
lovastatin. Danazol may increase the risk of
muscle weakness or rapid breakdown of muscle.

Do not take this medicine if any of the above apply
to you. If you are not sure, talk to your doctor or
pharmacist before taking Danazol.

5. HOW TO STORE DANAZOL

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2. WHAT YOU NEED TO KNOW BEFORE YOU
TAKE DANAZOL

• have a type of tumour (called an androgen
dependent tumour) that is affected by steroids
• have unexpected bleeding from your vagina
which has not been checked by a doctor.

If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

The pack sizes available in all pack types are 28, 30,
50, 56, 60, 84, 90, 100, 112 and 250.
Not all pack sizes may be marketed.

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1. WHAT DANAZOL IS AND WHAT IT IS USED FOR

The other ingredients are: hydrous lactose,
microcrystalline cellulose, colloidal silicon dioxide,
povidone K30, anhydrous lactose, sodium starch
glycolate, sodium lauryl sulphate and magnesium
stearate. Capsule shell contains: gelatin, titanium
dioxide (E171); and for 100 mg only: iron oxide black
(E172) ; and for 200 mg only: iron oxide red (E172),
iron oxide yellow (E172), erythrosine (E127).

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Danazol capsules 200 mg are capsules with a white
body and an orange cap, marked in black 'DL 200'
and 'G'.

DANAZOL CAPSULES 100 mg
DANAZOL CAPSULES 200 mg

Gerard Laboratories,
35/36 Baldoyle Industrial Estate,
Grange Road, Dublin 13, Ireland.

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56 capsules

Each capsule contains: Danazol 200 mg.
Also contains: lactose.
Dosage: For oral use as directed by a doctor.
Read the enclosed leaflet.
Keep out of the sight and reach of children.
Protect from light. Store in a dry place below 25°C.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Manufacturer
Generics [UK] Limited, Potters Bar, Hertfordshire,
EN6 1TL, United Kingdom.

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Danazol
capsules

200
mg

PL 4569/0137

Marketing Authorisation Holder
Mylan, Potters Bar, Hertfordshire,
EN6 1TL, United Kingdom.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Watch this video series to learn about managing severe allergies (anaphylaxis).

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