Active substance: DANAZOL

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Keep this medicine in a safe place where
children cannot see or reach it.
Do not use Danol after the expiry date
which is stated on the carton and blister.
The expiry date refers to the last day of
that month.
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.

5. How to store Danol

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
• Palpitations, fast heart beat, high blood
• 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 Freephone 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.


What Danol contains
• Each 100mg capsule contains 100mg of
the active substance, danazol
• Each 200mg capsule contains 200mg of
the active substance, danazol
• The other ingredients are maize starch,
lactose monohydrate, talc and
magnesium stearate. The capsules
contain titanium dioxide (E171) and
gelatin. The 100mg capsule also contains
black iron oxide (E172). The 200mg
capsule also contains red iron oxide
(E172) and yellow iron oxide (E172). The
black ink used to print on the capsules
contains shellac, shellac glaze, propylene
glycol and black iron oxide (E172).
What Danol looks like and contents of
the pack
Danol 100mg capsules are grey and white
with D 100 printed on it in black ink.
Danol 200mg capsules are orange and white
with D 200 printed on them in black ink.
Danol capsules are supplied in cartons of
50, 60 and 100 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Marketing Authorisation Holder
One Onslow Street
Tel: 01483 505515
Fax: 01483 535432
email: uk-medicalinformation@sanofi.com
Fawdon Manufacturing Centre
Edgefield Avenue
Tyne & Wear
This leaflet does not contain all the
information about your medicine. If you
have any questions or are not sure about
anything, ask your doctor or pharmacist.
This leaflet was last revised in 07/2013
© sanofi, 1974 - 2013

6. Further Information

Danol contains a medicine called danazol.
It works by changing the way some
hormones act in your body. It is used to
• 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

1. What Danol is and what
it is used for

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
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

Is this leaflet hard to see or read?
Phone 01483 505515 for help


Danol 100mg Capsules
Danol 200mg Capsules



2. Before you take Danol


Take special care with Danol
Check with your doctor or pharmacist
before taking your medicine if:
L You have any liver or kidney problems
L You have an illness which could be
made worse by fluid retention
L You have high blood pressure or heart
L You have diabetes
L You have an illness in which the blood
gets thicker (called ‘polycythaemia’)
L You have fits (epilepsy)
L You have blood fat problems (called
‘lipid disorders’)
L You have ever had a bad reaction to a
hormonal treatment similar to Danol
L You get migraines
L 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 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
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
 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 Danol.

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 Danol
can affect the way some other medicines
work. Also some medicines can affect the
way Danol 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. Danol may increase the
risk of muscle weakness or rapid
breakdown of muscle.
Danol 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. Danol 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
Danol may lower the effect of the
following medicines:
• Medicines for diabetes
• Medicines for high blood pressure
• Medicines for migraine
Operations or tests
If you are due to have an operation, tell
your doctor you are taking Danol. This is
because Danol can increase the effect of
some anaesthetics.
If you have to take Danol for more than six
months your doctor will arrange for an
ultrasound test to check your liver.

Always take Danol 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 Danol. 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 Danol has finished

3. How to take Danol

Important information about some of
the ingredients of Danol
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.

Taking Danol with food and drink
Do not drink alcohol while you are taking
Danol. This is because drinking alcohol
while taking Danol can make you feel sick
or short of breath.
Pregnancy and breast-feeding
Do not take Danol if you are pregnant, might
become pregnant or think you may be
pregnant. If you think you may have become
pregnant while taking Danol, stop taking it
straight away and talk to your doctor.
Do not breast-feed if you are taking Danol.
This is because small amounts may pass
into mothers’ milk. If you are planning to
breast-feed, talk to your doctor or
Ask your doctor or pharmacist for advice
before taking any medicine if you are
pregnant or breast-feeding.

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

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 Danol 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 Danol.

If you stop taking Danol
Keep taking Danol until your doctor tells
you to stop taking it. Do not stop taking
Danol just because you feel better. If you
stop your illness may get worse.

If you forget to take Danol
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 take more Danol 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.

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


4. Possible side effects
Like all medicines, Danol can cause side
effects, although not everybody gets them.
Stop taking Danol 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 Danol and tell a doctor
straight away if you notice any of the
following side effects (frequency not
known) – you may need urgent medical
• 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
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

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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.