The name of your medicine is Profasi. It is a freeze dried powder available in 3 strengths containing 2000, 5000 or 10000 1 U of its active ingredient called human chorionic gonadotrophin (hCG). The 2000 IU strength is available in packs of 3 ampoules. The 5000 IU is available in packs of 1 and 10 ampoules. The 10000 IU strength is available in packs of 1 (single) ampoule.

As well as the active ingredient hCG, Profasi also contains other ingredients which are inactive. These vary within the different strengths as detailed below:

Profasi 2000 and 5000 contain lactose, potassium phosphate buffer, sodium hydroxide and acetic acid.

Profasi 10000 contains mannitol and sodium phosphate buffer.

The Product Licence/Authorisation holder is: Serono Laboratories (UK) Ltd., 99 Bridge Road East, Welwyn Garden City, Herts AL7 1BG.

Profasi 2000 IU and 5000 IU are manufactured by:

Laboratoires Serono SA, Zone Industrielle de l’Ouriettaz, 1170 Aubonne, Switzerland

or

Serono Pharma SpA, Via de Blasio, Zona Industriale di Modugno, 70123 Bari, Italy.

or

Industria Farmaceutica Serono SpA, Via Casilina 125, 00176 ROMA, Italy.

Laboratoires Serono SA, Zone Industrielle de L’Ouriettaz, 1170 Aubonne, Switzerland.

Profasi contains a hormone which is found naturally in the body. It is used to treat infertility caused by certain conditions in both men and women, which are as follows:

1. Women who are not producing eggs. Profasi is given after treatment with other medicines to bring about ovulation (the production of eggs).
2. Women undergoing an assisted conception technique eg in-vitro fertilisation (IVF) treatment. Other medicines are given first to produce follicles. Profasi is used to ripen (mature) these follicles.
3. Used with another medicine in men suffering from a condition called hypogonadotrophic hypogonadism which may make them infertile. Profasi is used to stimulate and maintain the production of sperm .
4. Used in men and boys with a condition called cryptorchidism. Profasi stimulates a group of cells which leads to the descent of the testes.

Your doctor can explain why Profasi has been given to you.

Although Profasi can be used in most people with the conditions stated above, there are certain people who should not be given the medicine. These people are listed below:

1. Women in which the treatment would not be expected to work eg women with blocked or damaged tubes (unless you are having IVF treatment).
2. Men or women suffering from hormonal disorders (thyroid, adrenals or prolactin) which have not been treated.

Speak to your doctor if you think that you are one of the people who should not be given Profasi.

Profasi may cause pain and soreness at the injection site.

Women: Occasionally, some people have a reaction to the treatment that you have been given/are taking and develop a condition called ovarian hyperstimulation. This is when the ovaries overreact to the treatment. This condition can cause various symptoms to occur. The most common is abdominal (stomach) pain. Rarely, the condition can be severe and you may need to be in hospital. To stop this ! condition developing or reduce the chances of it happening, it is important that it is your doctor who ! decides whether or not you should take the Profasi. h is, therefore, recommended that you see your doctor shortly before you are due to start the treatment with Profasi, so that he can check your ovarian response. It is important that if you have significant abdominal (stomach) pain or discomfort, you must NOT give yourself the injection of Profasi and that you speak to your doctor or nurse as soon as possible. The doctor will then decide whether or not to continue the treatment cycle. If you have to stop treatment, you S will be asked not to have sexual intercourse and usually you will have to rest.

Sometimes, multiple pregnancies occur following treatment. The majority of these are twins. It is very rare to have a large number of babies at the same time due to the treatment with Profasi.

Pregnancy loss (miscarriage) in women undergoing assisted conception techniques is higher than normal but much the same as rates found in women with other fertility problems.

The risk of the baby having any abnormalities is not ! increased by taking Profasi.

This medicine should not be used by girls or the elderly.

Men/boys: In men, high doses of Profasi could lead to a condition called oedema. This is when the body retains water. The most usual signs are swollen feet and hands. If this occurs, the amount of Profasi that you are given will probably be reduced.

In men or boys, the medicine may bring about puberty-like symptoms. If this happens at an early age, the treatment will probably be stopped.

Profasi is given by injection either under the skin or into a muscle.

Profasi is usually given by a doctor or a nurse although some patients are trained to give the injection themselves. If you are injecting yourself you should have been given instructions on this, ask your doctor or nurse if you are at all unsure about anything.

The amount of Profasi you will be given will depend, on your condition.

1. Women who are not producing eggs:

You will be given up to 10000 IU of Profasi after treatment with another medicine used to stimulate the development of the egg as part of a planned scheme.

2. Women undergoing assisted conception techniques:

Your doctor may want to test your blood or sperm during this time.

2. Cryptorchidism

Profasi will be given to you every day for several weeks, usually at a dose of 500-1000 IU although this may vary.

Your doctor will be able to explain more about your particular treatment.

Any medicines can cause side-effects. The following side-effects have been seen occasionally:

If you notice these or any other unwanted effects not mentioned above, then please tell your doctor.

Profasi should be stored below 25°C in a dark place, such as a cupboard. Once the medicine is reconstituted (made up with the solvent) it should be used immediately.

It is important not to use the medicine after the date shown on the ampoule or carton label.

The information in this leaflet relates only to Profasi.

Date of preparation: February 1996

Name and address of distributor in Ireland: Allphar Services Ltd Pharmaceutical Agents and Distributors, Burton Hall Park, Sandyford Industrial Estate, Foxrock, Dublin 18, Eire.