A GUIDE FOR PATIENTS

Farlutal 100, Farlutal 250 and Farlutal 500 Tablets
Medroxyprogesterone acetate tablets 100 mg, 250 mg and 500 mg

Please read this leaflet carefully before you use your medicine. This leaflet provides you with useful information about your medicine. If you have any questions about anything, please ask your doctor or pharmacist (chemist).

REMEMBER:

This medication is for YOU. Only a doctor can prescribe it for you. Never give it to others. It may harm them even if their symptoms are the same as yours.

What is your medicine?

The name of your medicine is Farlutal 100, Farlutal 250 or Farlutal 500. Each tablet contains either 100 mg, 250 mg or 500 mg medroxyprogesterone acetate. The tablets also contain the following inactive ingredients: lactose, crospovidone, polyvinylpyrrolidone, polysorbate, microcrystalline cellulose, magnesium stearate and purified water.

Farlutal 100 is available in packs of 100 tablets, Farlutal 250 is available in packs of 50 tablets and Farlutal 500 is available in packs of 56 tablets.

Farlutal contains medroxyprogesterone acetate, which is a drug similar to the natural hormone, progesterone. Farlutal can slow down the growth of certain tumours that are sensitive to hormones.

What is your medicine for?

Farlutal may be used to treat a range of tumours that are affected by hormones, such as in the breast, lining of the womb, prostate gland or kidney cells. It can help ease the pain and make you feel better.

Before taking your medicine

If you can answer "Yes" to any of the following questions, you should not take these tablets. Tell your doctor or pharmacist.

• Have you ever had a bad reaction to medroxyprogesterone acetate, or any of the other ingredients listed in these tablets?
• Have you ever suffered from inflamed veins or any condition related to clots in the blood vessels, e.g. a stroke, heart attack, angina, clots in the lungs or legs?
• Do you suffer from narrowing of the arteries or have just had surgery?
• Do you have secondary tumour that has infected your bones (osseous metastases)?
• Do you think you may have been pregnant, but that you might have miscarried early?
• Have you ever had problems with your liver?
• Do you know if your blood calcium balance is disturbed or has been in the past?
• Do you have any vaginal bleeding that is not as a result of your period?
• Are you pregnant, trying to become pregnant or breastfeeding?
• Have you ever had an acute attack of porphyria?
• Do you think you may have breast cancer? If you have, is it at an early stage?

If the following applies to you, speak to your doctor or pharmacist before using Farlutal; they may need to decide whether Farlutal is the most suitable treatment for you:

• Do you suffer from diabetes or high blood pressure?
• Do you suffer from asthma, migraine or epilepsy?
• Do you have a heart condition or problems with your kidneys?
• Have you ever been treated for depression?
• Do you have high cholesterol levels?
• Has any member of your family ever suffered from heart disease or blood clots?
• Are you severely overweight?
• Do you suffer from systemic lupus erythematosus, a disease of the skin in which there are red scaly patches, especially over the nose and cheeks?
• Have you recently had major surgery and you are not able to move for long periods of time?

Tell your doctor or pharmacist if you are taking any other medicines, even those which you can buy over the counter. In particular, your doctor or pharmacist should be informed if you are taking any of the following medicines:

 

• Medicine to treat epilepsy, such as phenobarbital, phenytoin or carbamazepine.
• Medicine to treat infections, such as rifampicin, rifabutin, nevirapine, efavirenz, ritonavir or nelfinavir.
• Herbal preparations containing St John's Wort.
• Aminoglutethimide or other medicines to treat breast cancer.
• Cyclosporin, used in organ transplantation.
• Medicine to thin your blood (anti-coagulants)
• Pain killers containing non-steroidal anti-inflammatory drugs.
• Medicine to treat high blood pressure.

Farlutal may also interfere with certain laboratory tests that you may be given.

Farlutal should only be given to you by doctors or nurses experienced in giving chemotherapy.

If you are not sure about any of the conditions or treatments listed above, speak to your doctor or pharmacist for advice.

How to use your medicine

The dose of Farlutal your doctor prescribes will depend on your particular condition.

• In the treatment of breast cancer, the usual dose for adults is 400 to 1500 mg daily, although up to 2000 mg may be used. Your doctor will tell you exactly how many tablets to take and how often. Sometimes you may be given injections as well as your tablets, in which case the number of tablets may vary.
• For other types of tumour, the usual daily dose is 100 - 600 mg daily.

Farlutal tablets are not recommended for children.

The tablets should be swallowed with plenty of water. You can break the tablets in half to make them easier to swallow if necessary.

What might happen while you are taking your medicine

Farlutal may sometimes cause the following side-effects, tell your doctor if any of these trouble you:

• Breast pain, tenderness or discharge of milk, unrelated to breast-feeding.
• Changes in your periods, or they may stop altogether.
• Sweating, cramps in your legs at night, or trembling in your hands.
• Your face may look rounder, your legs, ankles or feet may feel swollen or you may put on weight.
• Jaundice (yellowing of the skin) may occur occasionally.
• Cervical erosion (also called ectropion) may occur; this develops when the cells of the inner lining of the cervix appear on the outside and change to become more protective.
• Confusion, dizziness, fatigue, loss of concentration, sleeplessness or sleepiness, headaches, nervousness or feeling of euphoria.
• Constipation, diarrhoea, dry mouth, liver problems, feeling or being sick.
• If you suffer from diabetes, you may need to adjust your diabetic medication.
• Changes in appetite
• Fluid retention
• Allergic skin reactions
• Acne, skin rashes, itchy skin sometimes accompanied by hives.
• Mental depression, you may feel low, lack energy or interest in family, work etc.
• Hair loss or abnormal hairiness
• Tiredness, drowsiness, or unable to sleep properly
• Abnormal pigmentation/darkening of the skin, possibly patchy
• Changes in libido (sex-drive)
• Muscle, stomach cramps or involuntary spasms.
• Feeling unwell or feverish.
• Head or heart problems, high blood pressure, an irregular heart beat or a feeling that you heart is beating faster than normal, blood clots in the veins or lungs.
• Blood disorders

If any of the following side effects occur, tell you doctor or pharmacist at once:

• Unexpected vaginal bleeding.
• Migraine headaches or eye problems such as blurred vision, double vision, partial or total loss of vision.
• Pains in the chest or painful swelling of a leg, breathlessness, or tingling and numbness in any part of the body - these can sometimes be symptoms of thrombosis.

If you suffer from any other unwanted effects while taking your medicine, please tell your doctor or pharmacist.

Your ability to drive or to operate machines is not affected by Farlutal. However, you should consult your doctor if you need to drive or work machinery in case your general medical condition or other medicines you may be taking might affect your ability to do these things.

Storing your medicine

Keep your tablets in a dry place where children can not reach them. Your medicine could harm them.

If your doctor decides to stop the treatment, return any unused tablets to the pharmacist. Only keep them if your doctor tells you to.

The tablets should not be used after the expiry date printed on the pack.