This booklet is designed to help you to use Schering PC4 correctly, and to answer many of the questions that you may have about emergency contraception. Please read it carefully to get the best from Schering PC4. If you are in any doubt about these instructions contact your doctor, pharmacist or Family Planning clinic.

If you have sex and do not use contraception you can get pregnant. Your ovaries release an egg each month (ovulation) which travels to a fallopian tube. 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, the egg is fertilised. The fertilised egg then travels to the womb and gets embedded in the lining of the womb. If the egg attaches to the lining of the womb it starts to grow into a baby. It can take 3 days for the fertilised egg to travel to the womb.

Schering PC4 stops the fertilised egg from attaching itself to the lining of the womb. It can only do this if it is taken within three days of unprotected intercourse. Therefore, this medicine can only be used within three days (72 hours) of unprotected sex.

After you have unprotected sex you may or may not become pregnant. It is therefore very difficult to know how many pregnancies have been stopped by Schering PC4.

The important thing is that very few women are pregnant after taking Schering PC4 correctly.

Schering PC4 is only an emergency contraceptive. This means that you should not use it as your normal contraceptive. You should discuss a regular contraceptive with your doctor. In another emergency, Schering PC4 can be used again but not before you have had a period.

Schering PC4 contains the same sex hormones that are contained in a number of oral contraceptives. The reasons for not using oral contraceptives and the same precautions should be applied to Schering PC4 also. They are listed later in this booklet and you should refer to them.

The name of your medicine is: Schering PC4

Each pack of Schering PC4 contains 4 white sugar-coated tablets. Each tablet contains 500 micrograms of the progestogen norgestrel and 50 micrograms of the oestrogen ethinyloestradiol (INN ethinylestradiol). Progestogen and oestrogen are both female types of hormone.

Each tablet also contains the following inactive ingredients: lactose, maize starch, povidone, talc, magnesium stearate (E572), sucrose, polyethylene glycol 6000, calcium carbonate (E170), montan glycol wax.

Each pack of Schering PC4 contains a strip of 4 tablets.

Schering PC4 is an emergency contraceptive.

The product licence is held by: Schering Health Care Ltd, The Brow, Burgess Hill, West Sussex RH15 9NE.

Product licence number: 0053/0162.

Schering PC4 is manufactured by: Schering AG, Berlin, Germany.

• You are pregnant or think you may already be pregnant.
• Your period is late.
• Since your last period you have had unprotected sex which occurred more than 72 hours ago.

Also, you must not take this medicine if you have any

of these:

• 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 Schering PC4.

Do not take this medicine if you have had any of these

conditions when you were pregnant:

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

Before you take this medicine your pelvic organs, breasts and blood pressure will normally be checked by your doctor. The doctor will also make sure you are not pregnant.

If you have:

• severe depressive states, past or present.
• diabetes (diabetes mellitus) or a tendency towards diabetes.
• high blood pressure (hypertension).
• fits (epilepsy).
• the inherited form of deafness known as otosclerosis.
• the inherited disease called porphyria.
• calcium deficiency with cramps (tetany).
• diseases of the heart and blood vessels (cardiovascular diseases).
• kidney diseases.
• disturbed liver function.
• you are very overweight (obese).
• gallstones.
• migraine.

or, if:

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

Some medicines may stop Schering PC4 from working properly. If you are taking any other medicine while you are taking Schering PC4, be sure to tell your doctor. Medicines which may stop Schering PC4 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 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, or diseases of the small bowel that interfere with the absorption of food, might also reduce the effect of your medicine.

Although Schering PC4 protects against implantation of a fertilised egg in the womb, it appears to offer no protection against the rare abnormal implantations that occur in the uterine tubes or other abnormal sites (ectopic pregnancies). Therefore, if you should become pregnant despite taking this medicine, there may be a greater chance than usual that the pregnancy is ectopic.

When this medicine is used during breast-feeding the amount of milk may be reduced. Very small amounts of the active ingredients of Schering PC4 are found in breast milk.

Experts believe that this medicine is not capable of causing abnormalities to the developing child if it is taken within 72 hours of unprotected sex and in the absence of a pre-existing pregnancy.

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 (oestrogen-progestogen combinations like Schering PC4) 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.

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 mobilisation (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.

The following may be symptoms of blood clot formation or symptoms of an inflammation of veins combined with the formation of blood clots (thrombophlebitis)—unusual pains in your leg or unusual swelling of your arms or leg, sharp pains in your chest or sudden shortness of breath, crushing pains or feelings of heaviness in your chest, coughing for no apparent reason, or if one side of your body suddenly becomes very weak or numb.

If any of these conditions apply to you before you decide to take Schering PC4 or while you are taking it you must discuss them with your doctor.

older age-group, especially those who also smoke, is discouraged.

Take 2 tablets as soon as possible after you have had unprotected sex (but no later than 72 hours).

Take the other 2 tablets 12 hours after the first dose.

Nausea/vomiting is less likely if the tablets are taken after a light meal.

It is important to leave no longer than 12 hours between the 2 doses.

This is all your need to do unless you are sick (vomit) within 2 hours of taking either dose.

If you are sick within 2 hours of taking the first 2 tablets you should take the other 2 tablets in the pack at once and contact your doctor immediately for more tablets.

If you are sick within 2 hours of taking the second 2 tablets you should contact your doctor immediately.

You may feel sick, and if you actually vomit within 2 hours of taking your tablets you must follow the advice given above.

Your next period may be earlier or later than the expected time. If your next period is delayed by more than two weeks you should visit your doctor for a pregnancy test.

You should either not have sex or use another method of contraception (condoms or cap plus spermicide) until your next period. Discuss your future contraceptive needs with your doctor and choose a regular method of contraception.

It is suggested that you should visit your doctor three weeks after taking Schering PC4 to discuss your future contraceptive needs and to make sure that you are not pregnant.

You must take both doses and leave no longer than 12 hours between the 2 doses. If you are late taking the second dose, take it as soon as you remember and contact your doctor for advice as soon as possible as you may need an additional dose.

There have been no reports of serious ill-effects from overdosage. Contact your doctor or pharmacist if you are at all worried.

Nausea, vomiting, breast discomfort and headaches have been reported. Disturbance of the pattern of menstrual bleeding is usual.

If you think that you have an unwanted effect due to Schering PC4, even if it has not been mentioned, or you have a serious reaction as described earlier in this booklet, tell your doctor or pharmacist about it.

Expiry date: The expiry date is printed on the pack. Do not use after this date.

Storage: Keep all medicines out of the reach of children.

Date of last revision of this booklet: 10 January 1996.