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 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.

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:

x 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

x You have a rare inherited illness which affects your metabolism (called porphyria’)

x You are pregnant, might become pregnant, or think you may be pregnant.

x You are breast-feeding x You have severe kidney, liver or heart disease

x You have ever had blood clots (thrombosis)

x You have a type of cancer which is affected by hormones x 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. How to take Danazol

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

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