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DANAZOL 200MG HARD CAPSULES

Active substance(s): DANAZOL

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Tell your doctor as soon as possible if
you have any of the following side
effects (frequency not known):
Hair loss (similar to male baldness)
More hair than usual on the body or
face
Sore throat, hoarse voice or your voice
sounds higher or lower than usual
Skin rashes or blistering. Changes in
skin colour or sensitivity to the sun.
Blood in the urine
Migraines which are worse than usual
Your epilepsy gets worse
Stomach or chest pain
Tell your doctor or pharmacist if
any of the following side effects
(frequency not known) gets serious
or lasts longer than a few days:
Putting on weight, or increased
appetite
Spots, acne, greasy skin or rashes
Changes to your menstrual period,
vaginal dryness, changes to your sex
drive (libido)
High temperature with skin rashes
Backache, muscle cramps, twitching
of the muscles, pain or swelling in
your
joints, arms or legs
Headache, feeling tired
Flushing
Feeling depressed, anxious or more
nervous than usual
If your breasts get smaller
Water retention or bloating
Feeling sick, dizzy or balance
problems (vertigo)
Palpitations, fast heart beat, high
blood pressure
Lowered fertility in men (may be
caused by a lowering in the level of
sperm)
Tell your doctor or pharmacist if any of
the side effects get serious or lasts
longer than a few days, or if you notice
any side effects not listed in this leaflet.

Reporting of side effects
Also you can help to make sure that
medicines remain as safe as possible by
reporting any unwanted side effects via the
internet at www.mhra.gov.uk/yellowcard.
Alternatively you can call Free phone 0808
100 3352 (available from 10 a.m. to 2 p.m.
Mondays to Fridays) or fill in a paper form
available from your local pharmacy.
5. How to store Danazol
Keep out of the sight and reach of children.
Do not take your medicine after the expiry
date which is stated on the carton and
blister label after „Exp‟. The expiry date
refers to the last day of that month.
Do not store above 25 C. Store in a dry
place.
If your capsule become discoloured or
show any signs of deterioration, you
should seek the advice of your pharmacist.
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.
6. Further Information
What Danazol contains
The active ingredient is danazol.
Each
7. capsule contains 200mg danazol.
The other ingredients are lactose, maize
starch, talc, magnesium stearate, gelatin,
titanium dioxide (E171), red iron oxide
(E172), yellow iron oxide (E172).
What Danazol looks like and contents of
the pack
Capsules with white coloured body and
orange cap with “D200” printed on them in
black ink.
Capsules are supplied in blister packs
containing 60 capsules.
Manufactured by: Sanofi Synthelabo Ltd,
Edgefield Avenue, Fawdon, Newcastle
Upon Tyne, UK.
Procured from within the EU and
repackaged by the Product Licence
holder: B&S Healthcare, Unit 4, Bradfield
Road, Ruislip, Middlesex, HA4 0NU, UK.
Danazol 200mg Hard Capsules
PL NO: 18799/2285
Leaflet date: 06.11.2013

POM

PACKAGE LEAFLET:
INFORMATION FOR THE USER

Danazol 200mg Hard
Capsules
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.
The name of your medicine is Danazol
200mg Hard Capsules but will be referred
to as Danazol throughout this leaflet.
Please note that the leaflet also contains
information about other strength Danazol
100mg Hard Capsules.
In this leaflet:
1. What Danazol is and what it is used for
2. Before you take Danazol
3. How to take Danazol
4. Possible side effects
5. How to store Danazol
6. Further Information
1. What Danazol is and what
it is used for
Danazol 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 Danazol as well. Danazol
can also be used on its own, where
other treatments have not worked
Breast cysts (lumps) which may be
painful, but not malignant. Danazol is
used where other treatments have not
worked or when they cannot be taken

2. Before you take Danazol
Do not take this medicine and tell your
doctor if:
You are allergic (hypersensitive) to
danazol or any of the other ingredients
of Danazol (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 cancer which is
affected by hormones
You have unusual vaginal bleeding
which has not been checked by a
doctor
Do not take if any of the above apply to
you. If you are not sure, talk to your doctor
or pharmacist before taking Danazol.
Take special care with Danazol
Check with your doctor or pharmacist
before taking your medicine if:
 You have any liver or kidney problems
 You have an illness which could be
made worse by fluid retention
 You have high blood pressure or heart
disease
 You have diabetes
 You have an illness in which the blood
gets thicker (called „polycythaemia‟)
 You have fits (epilepsy)
 You have blood fat problems (called
„lipid disorders‟)
 You have ever had a bad reaction to a
hormonal treatment similar to Danazol
 You get migraines
 You have cancer or possible breast
cancer
If you are not sure if any of the above
apply to you, talk to your doctor or
pharmacist before taking Danazol.

Taking other medicines
Please tell your doctor or pharmacist if you
are taking or have recently taken any other
medicines. This includes medicines you
buy without a prescription, including herbal
medicines. This is because Danazol can
affect the way some other medicines work.
Also some medicines can affect the way
Danazol works.
In particular, tell your doctor if you are
taking any of the following:
Steroids such as testosterone,
estrogen, 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.
Danazol may increase the effect of the
following medicines:
Medicines for epilepsy, fits or
convulsions (anti-convulsants)
Medicines used to thin the blood
(anti-coagulants such as warfarin)
Anaesthetics (see „Operations or tests‟
section below)
Ciclosporin and tacrolimus - used to
stop the rejection of organs after a
transplant. 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
Danazol may lower the effect of the
following medicines:
Medicines for diabetes
Medicines for high 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.

If you have to take Danazol for more than
six months your doctor will arrange for an
ultrasound test to check your liver.
Taking Danazol with food and drink
Do not drink alcohol while you are taking
Danazol. This is because drinking alcohol
while taking Danazol can make you feel
sick or short of breath.
Pregnancy and breast-feeding
Do not take Danazol if you are pregnant,
might become pregnant or think you may
be pregnant. If you think you may have
become pregnant while taking Danazol,
stop taking it straight away and talk to your
doctor.
Do not breast-feed if you are taking
Danazol. This is because small amounts
may pass into mothers‟ milk. If you are
planning to breast-feed, talk to your doctor
or pharmacist.
Ask your doctor or pharmacist for advice
before taking any medicine if you are
pregnant or breast-feeding.
Important information about some of
the ingredients of Danazol
This medicine contains lactose, which is a
type of sugar. If you have been told by
your doctor that you cannot tolerate or
digest some sugars, talk to your doctor
before taking this medicine.
3 3. How to take Danazol
4.
Always
take Danazol exactly as your doctor
has told you. You should check with your
doctor or pharmacist if you are not sure.
Taking this medicine
Take this medicine by mouth
Swallow the capsules whole with a
drink of water
If you feel the effect of your medicine is
too weak or too strong, do not change
the dose yourself, but ask your doctor
It is important that you do not become
pregnant while taking Danazol. Start
taking the capsules on the first day of
your period. Use reliable contraception
(such as an Intra Uterine Device or
barrier method in conjunction with
contraceptive foam or jelly). The
contraceptive pill should not be used
until your treatment with Danazol has
finished

How much to take
The usual dose depends on your needs
and the illness being treated:
Endometriosis: 200 to 800mg a day
for three to six months
Breast cysts: 300mg a day for three
to six months
The dose for each day may be split
between two and four separate doses.
DO NOT TAKE more than 8 of the 100mg
capsules or 4 of the 200mg capsules in
one day.
If you take more Danazol than you
should
If you take more capsules than you should,
tell a doctor or go to a hospital casualty
department straight away. Take the
medicine pack with you. This is so the
doctor knows what you have taken.
If you forget to take Danazol
If you forget a dose, take it as soon as you
remember it. However, if it is nearly time
for the next dose, skip the missed dose.
Do not take a double dose to make up for
a forgotten dose.
If you stop taking Danazol
Keep taking Danazol until your doctor tells
you to stop taking it. Do not stop taking
Danazol just because you feel better. If
you stop your illness may get worse.
Blood tests
Your doctor may carry out regular blood
tests to check your liver is working properly
and your blood levels are normal.
Also, taking Danazol may affect the results
of some other blood tests. These include
the following tests:
Hormone testosterone levels
Liver and thyroid function
Lipids (fats), sugars and protein levels
in your blood
If you are going to have a blood test, it is
important to tell your doctor you are taking
Danazol.
If you have any further questions
on the use of this product, ask your
doctor or pharmacist.

4. Possible side effects
5.
Like all medicines, Danazol can cause side
effects, although not everybody gets them.
Stop taking Danazol and see a doctor or
go to a hospital straight away if:
You have an allergic reaction. The
signs may include a rash, swallowing
or breathing problems, swelling of your
lips, face, throat or tongue
Pain or tightness in the chest, jaw or
arm. These could be signs of a heart
attack
Stop taking Danazol and tell a doctor
straight away if you notice any of the
following side effects (frequency not
known) – you may need urgent medical
treatment:
Severe headache and vomiting (being
sick)
Clitoris becomes larger
Blurred vision, problems with eyesight,
difficulty wearing contact lenses
Liver problems that may cause the
eyes or skin to go yellow (jaundice)
Liver injury that may cause pain in the
liver or liver failure that may cause a
swollen abdomen, mental
disorientation and confusion.
Pain when moving arms or legs (this
may be due to a blood clot)
Feeling weak together with numb arms
or legs which you may not be able to
move (this may be a stroke)
Bruising more easily, getting more
infections than usual. These could be
signs of a blood problem
Any other severe symptoms which you
cannot explain

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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.

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