This booklet tells you about oral contraceptives in general and about Femodene in detail. Please read it carefully to get the best from Femodene. If you are in any doubt about these instructions contact your doctor, pharmacist or Family Planning clinic.

(the menstrual cycle)

You can usually become pregnant (conceive) from when you start to have periods, up until you are in your late 40s. Every menstrual cycle takes about 28 days. About halfway through this cycle an egg is released from one of your ovaries into a fallopian tube. This is called ovulation.

The egg travels down the fallopian tube towards your womb. When you make love, your partner's penis releases millions of sperm into your vagina. Some of these sperm travel up through your womb into your fallopian tubes. If there is an egg in one of these tubes, and a sperm reaches it, you can become pregnant. This is called 'conception'.

A fertilised egg gets embedded in the lining of your womb and takes 9 months to grow into a baby. As an egg can live for up to 2 days, and sperm for up to 5 days, you can become pregnant if you have made love up to 5 days before ovulation and for some time afterwards. If a sperm does not fertilise an egg, the egg is lost at the end of the menstrual cycle with the lining of your womb. This is called a 'period'.

Your menstrual cycle is controlled by two sex hormones made by your ovaries: one called oestrogen, the other progesterone (a progestogen). Oestrogen increases during the first half of your menstrual cycle, and makes your womb develop a thick lining, ready to receive the egg if conception happens. Progesterone comes later in the cycle and changes the lining of the womb still further to prepare it for pregnancy.

If you do not become pregnant, you make less of these hormones and this causes the lining of your womb to break down and the lining leaves your body as a period. But during pregnancy, your ovaries, and then the placenta (this attaches the growing baby to the womb and gives it food), carry on making progesterone and oestrogen to stop any more eggs being released.

A pill such as Femodene contains hormones which are like those your body produces (oestrogen and progestogen). These help stop you from getting pregnant, just as your natural hormones would stop you conceiving again when you are already pregnant.

The combined contraceptive pill protects you against getting pregnant in 3 ways:

• No egg is released to be fertilised by sperm.
• The fluid in the neck of your womb thickens so it is more difficult for sperm to enter it.
• The lining of your womb does not thicken enough for an egg to grow in it.

The pill is one of the most effective contraceptives apart from sterilisation. But this can only be true when it is taken correctly. So you must follow your doctor's instructions and take the tablets exactly as it says in the next section of this booklet.

The name of your medicine is: Femodene

Each memo strip of Femodene contains 21 white sugar-coated tablets containing 75 micrograms of the progestogen gestodene and 30 micrograms of the

oestrogen ethinyloestradiol(ethinylestradiol}.Progestogen and oestrogen are both female types of hormone.

Femodene also contains the following inactive ingredients: lactose, maize starch, povidone, magnesium stearate (E572), sodium calcium edetate, sucrose, macrogol 6000, calcium carbonate (E170), talc, montan glycol wax.

Each pack of Femodene contains 3 memo strips of 21 tablets. Packs containing 1 memo strip of 21 tablets are also available to doctors.

Femodene is a combined oral contraceptive pill. Combined oral contraceptives contain two female types of hormone, oestrogen and progestogen.

Schering Health Care Ltd

The Brow, Burgess Hill, West Sussex, RH15 9NE

Product licence number 0053/0179

Femodene is manufactured by: Schering AG, Berlin, Germany.

Femodene is a low dose combined oral contraceptive. When used as instructed you are very unlikely to become pregnant.

Before taking Femodene, tell your doctor if you have any of these:

• you are pregnant or think you may be pregnant.
• blood clots in the legs, lungs, eyes, or anywhere else or have ever had these. If you have had a heart attack or if you have any medical condition which makes you more at risk of developing blood clots.
• abnormal red blood cells (sickle-cell anaemia).
• disorders of blood fat (lipid) metabolism.
• cancer of the breast or of the lining of the womb (mammary or endometrial carcinoma) or have ever had either of these conditions.
• abnormal bleeding from your vagina of unknown cause.
• certain types of jaundice (Dubin-Johnson or Rotor syndromes).
• severe diabetes with changes to the blood vessels.
• liver tumours or have ever had these.
• any other long or short-term liver disease.
• allergy to any of the ingredients of Femodene.

Do not take Femodene if you have had any of these conditions when you were pregnant:

• itching of your whole body (pruritus of pregnancy.
• the rash known as herpes gestationis.
• worsening of inherited deafness (otosclerosis).
• yellowing of the skin ( jaundice).

Before you start taking Femodene your pelvic organs, breasts and blood pressure should be checked by your doctor and these checks should be repeated regularly. The doctor will also make sure you are not pregnant.

If anyone in your family has had any illness caused by blood clots, or a heart attack, or a stroke at a young age, tell your doctor.

The following conditions need watching carefully while you are taking the pill:

If you have:

• severe depressive states, past or present. - varicose veins.
• diabetes (diabetes mellitus) or a tendency towards diabetes.
• high blood pressure (hypertension).
• fits (epilepsy).
• the inherited form of deafness known as otosclerosis.
• the disease of the nervous system called multiple sclerosis.
• the inherited disease called porphyria.
• calcium deficiency with cramps (tetany).
• the movement disorder called Sydenham's chorea.
• breast problems, past or present.
• diseases of the heart and blood vessels (cardio vascular diseases).

or, if:

• you have had inflamed veins (phlebitis).
• anyone in your family has had breast cancer.
• anyone in your family has had any illness caused by blood clots, or a heart attack or stroke at a young age.

If any of these conditions gets worse or you have

them for the first time, this may be a sign that you should stop taking Femodene.

When you stop taking Femodene it may take some

time for your regular periods to return.

Some medicines may stop Femodene from working

Properly.

If you are taking any other medicine while you are

taking Femodene, be sure to tell your doctor (or dentist). Your doctor (or dentist) can tell you whether you should use extra contraceptive precautions and for how long.

Medicines which can sometimes stop Femodene from working properly are antibiotics {such as ampicillin and rifampicin); griseofulvin (which is used to treat fungal infections); phenylbutazone (which is used as an anti-inflammatory drug to treat some types of joint diseases) phenytoin, primidone, phenobarbitone and some other medicines used in people with epilepsy, and carbamazepine (which can be used to treat epilepsy or other illnesses).

If you are taking any of these medicines you might still be able to use Femodene, but you will also need to use an extra contraceptive method Condoms or cap plus spermicide) while you are taking the other medicine and for 7 days after you stop taking it. If your present pack ends before these 7 days, start the next pack the next day without a break. This means taking a pill every day during your normal 7 pill-free days.

If you run two packs together you may not have a period until the end of two packs, but this is not harmful. If you do not have a period after the second pack, you must talk to your doctor before you start the next pack.

If you are taking rifampicin you will need to use another method of contraception as well as Femodene. You should do this while you are taking the rifampicin and for 4 weeks after you stop.

If you are diabetic your doctor may alter the dose of medicine required to treat your diabetes.

If you are in doubt check with your doctor, pharmacist or Family Planning clinic.

Being sick or having very bad diarrhoea may stop Femodene from working properly and make it less effective. Carry on taking Femodene as usual, and also use another method of contraception, {condom or cap plus spermicide) until 7 days after you have recovered from the stomach upset. If you finish your pack before these 7 days, start the next pack the next day without a break. This means taking a pill every day during your normal 7 pill-free days. If you run two packs together you may not have a period until the end of two packs, but this is not harmful. If you do not have a period after the second pack, you must talk to your doctor before starting the next pack. If your stomach upset continues for some time, consult your

doctor who may consider another form of contraception.

It has been suggested, on the basis of statistical evidence, that the risk of developing various disorders of the circulation of the blood is slightly greater in women who take the combined pill than in those who do not. This can lead to, for example, deep vein thrombosis (blood clot in the leg), strokes (blood clots and haemorrhages from the blood vessels of the brain), heart attacks or pulmonary embolism (blood clots blocking the arteries of the lungs). People do not always fully recover from these disorders, and, very rarely, they are fatal. Studies suggest that these disorders occur less often with modern low-dose oral contraceptives than with older pills.

Certain conditions increase the risk of thrombosis. They include:

• smoking.
• obesity.
• some diseases of the heart and blood vessels.
• diabetes.
• migraine.
• a major operation or period of immobilisation (e.g. you are in bed after an accident or operation or you have a plaster cast on a broken leg).
• if any members of your family have suffered from thromboembolic diseases {e.g. deep vein thrombosis, stroke or heart attack) at a young age.
• varicose veins.

If any of these conditions apply to you before you decide to take Femodene or while you are taking Femodene you must discuss them with your doctor.

The risk of arterial thrombosis (e.g. heart attack and stroke) associated with the pill increases with age and this risk is increased by cigarette smoking. For this reason, the use of combined pills by women in the older age-group, especially those who also smoke, is discouraged.

Signs and symptoms of blood clots are given in the section Reasons for stopping Femodene immediately .

The pill does give a substantial degree of protection against cancers of the ovary and the lining of the womb. An increased risk of cervical cancer in long-term users of the pill has been reported in some studies. It is uncertain whether this increased risk is caused by the pill as it could be due to the effects of sexual behaviour and other factors.

The evidence linking use of the pill and breast cancer is unclear. Some studies suggest an increased risk of breast cancer in women below the age of 35, the risk increasing the longer the pill is used. Any possible increased risk of breast cancer with combined pills is, however, likely to be small.

The combination of ethinyloestradiol and gestodene, like other contraceptives, has been linked with an increased incidence of abnormal growths in the rat liver, but it is unclear whether this could happen in humans. On rare occasions, the use of the pill has led to liver diseases such as jaundice and benign liver tumours and, very rarely, it has been associated with some forms of malignant liver tumours (cancer) in long-term users. Liver tumours may lead to life-threatening intra-abdominal haemorrhage (bleeding in the abdomen). Therefore, if you have pain in the upper abdomen that does not soon clear up, tell your doctor. Also, if your skin becomes yellow ( jaundice) you must tell your doctor.

If you think you might be pregnant, stop taking Femodene and consult your doctor immediately. Use another method of contraception such as a condom until you see your doctor.

Certain conditions may sometimes get worse during use of the pill. The diseases are those listed under "What you should know before taking Femodene".

If you experience any of the following conditions, take no further tablets of Femodene and consult your