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Active substance(s): DANAZOL

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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
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)

6. Further Information
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: 08453 727101
Zentiva, k.s.
U Kabelovny 130
Dolní Mecholupy
102 37, Prague 10
Czech Republic
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 03/2017.
© sanofi, 1974 - 2017
ZV/576 54

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

5. How to store Danol
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.


2. Before you take Danol

Danol 100mg Capsules
Danol 200mg Capsules

Do not take this medicine and tell your doctor if:
䘗㻃 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
䘗㻃 You have a rare inherited illness which affects your
metabolism (called ‘porphyria’)
䘗㻃 You are pregnant, might become pregnant, or think
you may be pregnant.
䘗㻃 You are breast-feeding
䘗㻃 You have severe kidney, liver or heart disease
䘗㻃 You have ever had blood clots (thrombosis)
䘗㻃 You have a type of cancer which is affected by
䘗㻃 You have unusual vaginal bleeding which has not
been checked by a doctor
䘗㻃 You are taking cholesterol lowering medicine
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.


Is this leaflet hard to see or read?
Phone 08453 727101 for help
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
• 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

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

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

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.

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.

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.

In particular, tell your doctor if you are taking any of the
• Steroids such as testosterone, estrogen, progesterone
(including ‘the Pill’ or hormone replacement therapy known as HRT)
• Statins such as simvastatin. 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 (anticonvulsants)
• Medicines used to thin the blood (anti-coagulants such as
• 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

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

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.

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

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.

3. How to take Danol
Always take Danol exactly as your doctor has told you. You
should check with your doctor or pharmacist if you are not

Danol may lower the effect of the following medicines:
• Medicines for diabetes
• Medicines for high blood pressure (anti-hypertensives)
• Medicines for migraine

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
• 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

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.

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.

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 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)
• Pain in the liver or liver failure may cause a swollen
abdomen, mental disorientation and confusion (this may
be due to a liver injury or non-cancerous liver tumour).
• 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

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.
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.

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

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

+ 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.