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DANAZOL CAPSULES 100MG

Active substance(s): DANAZOL / DANAZOL / DANAZOL

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danazol
capsules
#100 mg
100
mg

Danazol
capsules

danazol
capsules
#100 mg

28 capsules

Each capsule contains: Danazol 100 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 below 25°C. Keep the
container tightly closed in order to protect from
light and moisture.
PL 04569/0136   POM 1009345

LL0440AJ

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

1 121
30

100
mg

Danazol
capsules
28 capsules

Each capsule contains: Danazol 100 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 below 25°C. Keep the
container tightly closed in order to protect from
light and moisture.
PL 04569/0136   POM 1009345

LL0440AJ

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

01

1 121

What Danazol looks like and the contents of
the pack
Danazol capsules 100 mg are capsules with a
light grey body and a dark grey cap marked in
black 'DL 100' and 'G'
Danazol capsules 200 mg are capsules with a
white body and an orange cap marked in black
'DL 200' and 'G'
Danazol Capsules are available in either:
• polypropylene containers with
polyethylene caps
• plastic/aluminium foil blister strips
• HDPE containers with polyethylene
snap closures.

platelets in your blood. You may also notice
that you bruise or bleed easily or unexpectedly
• an increase in certain types of white blood cells
• raised levels of an enzyme (creatine
phosphokinase), which maybe an indicator of
muscle damage
• changes in the level of fat (lipid) in your blood
• an increase in liver enzymes (which are used to
check how the liver is working)

Marketing Authorisation Holder
Mylan, Potters Bar, Hertfordshire, EN6 1TL,
United Kingdom
Manufacturer
Generics [UK] Limited, Potters Bar, Hertfordshire,
EN6 1TL, United Kingdom

Danazol may also affect the results of certain
tests for thyroid function and specific tests which
show activity relating to the production of red
blood cells.

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

These changes do not usually cause symptoms and
return to normal when you stop taking Danazol.

This leaflet was last revised in 10/2016.

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.

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

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 talk to your doctor or pharmacist before
taking Danazol.
• if you have taken Danazol or a similar medicine
before and had side effects such as water
retention, voice changes, growth of facial hair

Your doctor may take regular blood samples to
check your blood and to check that your liver and
thyroid are working properly.
If you are going to have a blood test, it is
important to tell your doctor you are
taking Danazol.

02

24

Package leaflet: Information for the patient

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 an illness which could be made
worse by fluid retention

Danazol Capsules 100 mg
Danazol Capsules 200 mg
danazol

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.

Rare side effects:
• sensitivity of the skin to sunlight.
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.
Changes in blood tests
During treatment with Danazol, if you have blood
tests, your doctor may notice:
• changes in the number of red blood cells or

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

Do not use this medicine if you notice Danazol
capsules look damaged in any way.
Do not throw away any medicines via wastewater
or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These
measures will help protect the environment.

The other ingredients are: lactose monohydrate
(see section 2 'Danazol contains lactose'),
cellulose microcrystalline, silica colloidal
anhydrous, povidone K30, lactose anhydrous,
sodium starch glycolate, sodium laurilsulfate
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).

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

Other medicines and Danazol
Tell your doctor or pharmacist if you are
taking, have recently taken or might take any
other medicines.
In particular, tell your doctor if you are taking any
of the following;
• 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.

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

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.

If any of the following happen, stop taking
Danazol and tell your doctor immediately
or go to your nearest hospital emergency
department:

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.

3. How to take Danazol

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).

Danazol may increase the effect of the
following medicines:
• medicine to treat epilepsy, fits or convulsions
such as carbamazepine, phenytoin,
phenobarbital (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)
• 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.

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.

Take this medicine by mouth.
Swallow Danazol capsules whole with a glass
of water.
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 contraceptive
foam or jelly). The contraceptive pill should not

14

• 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
• you may also have flushing, vaginal dryness or
irritation, reduction in breast size and, in men,
lowering of sperm count during treatment.
• dizziness, a spinning feeling (vertigo)
• headaches which may be severe (migraine)
• feeling sick (nausea)
• changes in skin colour (pigmentation),
flaking, peeling, red skin, unusual bruising or
bleeding under the skin which may be seen as
purple spots

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 dose.

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

17

26

Do not take Danazol if you:
• are allergic to danazol or 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)

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

13

09

2. What you need to know before you take
Danazol

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.

Do not take Danazol if you are breast-feeding.
Danazol may reach your baby through the breast

22

1. What Danazol is and what it is used for

27

milk. If you are planning to breastfeed, talk to
your doctor or pharmacist.

Pregnancy and breast-feeding
Do not take Danazol if you are pregnant, think
you may be pregnant or are planning to have
a baby. 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.

18

Elderly patients
Danazol should not be given to the elderly.

04

Do not use this medicine after the expiry date
which is stated on the carton after 'EXP'. The
expiry date refers to the last day of that month.

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

08
Children and adolescents
Danazol should not be given to children
and adolescents.

23

Containers: Keep the container tightly closed in
order to protect from light and moisture.

• allergic reactions which may include signs
such as skin rash, sudden swelling of the face,
lips, tongue and/or throat which may cause
difficulty breathing or swallowing
• skin rashes, which may be severe and occur
with fever and/or swelling of the face
• an increase in the pressure of the fluid which
surrounds the brain, which can lead to changes
in eye sight such as blurred vision
• 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
19

• back ache, pain in the arms and legs, severe
muscle cramps, muscle tremors or twitches,
muscle or joint pain or swelling
• racing or irregular heart beat
• 
high blood pressure or if you already have had a
high blood pressure condition, 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
• feeling tired, mood changes
• changes in sex drive (libido)
• increased appetite, anxiety, nervousness,
depression
• breathlessness, swelling or inflammation of the
lungs (interstitial pneumonitis)
• chest or stomach pain

6. Contents of the pack and other information

03

12

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

28

What is 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.

• a reduction in the number of white blood cells
which help fight infection. This may be seen in
blood tests or you may notice an increase in
the number of infections such as sore throat,
mouth ulcers and fever that you get
• voice changes such as hoarseness or a sore
throat, growth of facial or body hair, muscle
development, or enlarged clitoris (part of the
female sex organs)
• liver problems which may cause yellowing of
your skin or whites of the eyes, dark urine, pale
stools (jaundice), non-cancerous and cancerous
tumours and blood-filled cysts in the liver
• liver injury that may cause pain in the liver or
liver failure that may cause a swollen abdomen,
mental disorientation and confusion

11

07

• If you get any side effects, talk to your doctor
or pharmacist. This includes any possible
side effects not listed in this leaflet. See
section 4.

05

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.

• 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

25

29

20

06

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

10

Reporting side effects
If you get any side effects, talk to your doctor
or pharmacist. This includes any side effects
not listed in this leaflet. You can also report side
effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide
more information on the safety of this medicine.

• blood-filled cysts in the spleen, which may
rupture and cause bleeding
• an inflamed pancreas causing abdominal pain
with sickness
• fits (epilepsy) may get worse if you suffer from
fits, or you may develop epilepsy if you are
prone to developing the condition.
These are serious side effects. You may need
medical attention.

5. How to store Danazol
Keep this medicine out of the sight and reach
of children.

Other side effects include:
• weight gain, acne or greasy skin, hair loss
(similar to male baldness)
• visual disturbances which may take the form of
blurring or difficulty in focusing and in wearing
contact lenses

Store below 25°C.
Blister packs: Store in the original package in
order to protect from light and moisture.
21

16

You must take Danazol as a continuous course.
Your doctor may adjust your dose according to
your response. Once your condition has improved,
they may advise you to take a lower dose.

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.

If you feel the effect of your medicine is too weak
or too strong, do not change the dose yourself,
but ask your doctor.

Before an operation for endometriosis, the
recommended dose is 400 mg to 800 mg daily for
3 to 6 weeks.

be used until your treatment with Danazol
has finished.

• alpha calcidol (a form of vitamin D) used for
vitamin D deficiency and illnesses where there
is not enough calcium in the blood.
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
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.

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:
15

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

Expand Transcript

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.

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