Author: Unknown

PERGONAL^®

What you should know about PERGONAL
(menotrophin)
Please read this leaflet carefully before your treatment is started. This leaflet provides a summary of the information available on your medicine If you have any questions, or are not sure about anything, ask your doctor.

The name of your medicine is PERGONAL It is a freeze-dried powder available in packs of 1 or 10 ampoules. Each ampoule contains 75 IU of human follicle-stimulating hormone (FSH) and 75 IU of human luteinising hormone (LH)

What's in your medicine?
In addition to the active ingredients FSH and LH, PERGONAL also contains lactose. The PERGONAL powder is made up in sodium chloride salt solution.

The product licence/authorisation holder is:
Serono Laboratories (U.K.) Ltd.
99 Bridge Road East
Welwyn Garden City
Hertfordshire AL7 1BG

The product is manufactured by.
Laboratoires Serono S A.
Zone Industrielle de l'Ouriettaz
1170 Aubonne
Switzerland

Why PERGONAL?
PERGONAL is a combination of hormones which is used to treat infertility caused by certain conditions in both men and women, which are as follows:
(i)	used to treat women who are not having periods or are not producing eggs
(ii)	used along with other medicines for women undergoing multiple follicle development for assisted-conception techniques e g. in vitro fertilisation (IVF) treatment;
(iii)	used to stimulate the production of sperm in men suffering from a condition called hypogonadotrophic hypogonadism which may make you infertile.

Your doctor can explain why PERGONAL has been given to you

Who should not be given PERGONAL?
Although PERGONAL 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 e.g. women with blocked or damaged tubes (unless you are having IVF treatment).
2.	Men or women suffering from other hormonal disorders which have not been treated.
3.	Women who are pregnant or breast feeding.

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

Important Information you should know about PERGONAL
PERGONAL may cause pain and soreness at the injection site; on occasions fever and joint pains occur

Some patients have had allergic type reactions (rash, itching, etc.) possibly due to the lactose which is in the medicine. Tell your doctor if you think you might be allergic to the medicine.

A condition called ovarian hyperstimulation can occur This is when the ovaries overreact to the treatment. Your doctor will carry out tests, such as ultrasound, to minimise the chance of this occurring. This condition can cause various symptoms to occur. The most common is abdominal (stomach) pain If this happens, speak to the nurse or doctor responsible for your treatment as soon as you can. If you are injecting PERGONAL yourself then do not give any more injections until you have spoken to the nurse or doctor. The doctor will then decide whether or not to continue the treatment cycle. If you have to stop treatment you will be asked not to have sexual intercourse, and usually you will just have to rest. Rarely, the condition can be severe and you may need to be in hospital.

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 treatment with PERGONAL

There have been reports of ectopic pregnancies (a pregnancy where the embryo has implanted outside the womb} in women undergoing assisted conception techniques (e g. IVF). This has not been shown to be due to treatment with PERGONAL .

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

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

This medicine should not be used by children or the elderly

How will PERGONAL be given to you?
PERGONAL is given by injection into the muscle.

Women

Different doses are given depending on your treatment.

(l) Women who are not having periods or producing eggs
PERGONAL is given as a course of either daily injections or injections every other day. If you are receiving daily
(1)	injections you will probably start at a dosage of l or 2 ampoules. This may be increased or decreased at approximately one week intervals. If you are receiving alternative day injections you will probably receive 3-S ampoules of PERGONAL 3 times a week. Your doctor will be able to explain your treatment plan to you and will tell you when is the best time to have sexual intercourse. Your dosage may be changed during future cycles depending on how you respond to the treatment.
	
(2)	Women undergoing assisted conception techniques
PERGONAL will be used along with other medicines. You will probably be given 2-3 ampoules of PERGONAL a day. There are different dosage plans; your doctor can explain yours to you. Your treatment will be continued until the right response has occurred.
In both cases, your doctor will carry out tests throughout the treatment to check on how the treatment is going.
If an excessive response to the treatment occurs, it is possible that your doctor may stop your treatment during a cycle but your treatment may re-start at a different dose

Men
Your treatment may start by being given injections of another medicine twice a week. l ampoule of PERGONAL can then be added in three times a week. This treatment will carry on for at least four months. Your doctor may want
to test your sperm during this time. Your doctor will be able to explain more about your treatment.

Can PERGONAL cause side-effects?
Any medicine can cause side-effects. The following side-effects have been seen occasionally:

Women
Pain and redness at the injection site, allergic reactions (itching, rash, etc.), fever and joint pain, multiple pregnancies, and ovarian hyperstimulation (as already described earlier in the leaflet)

Men
No side-effects have been reported.

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

How to Store the Medicine
PERGONAL should be stored below 25°C in a dark place such as a cupboard. Once the medicine is reconstituted (made up with 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 PERGONAL.

Date of preparation: November 1993

Name and Address of Distributor In Ireland:
Allphar Services Ltd.
Pharmaceutical Agents and Distributors
Burton Hall Park
Sandyford Industrial Estate
Foxrock
Dublin 18

This is only a summary of the information that is available on PERGONAL. If you have any questions after reading this leaflet then please ask your doctor who has access to additional information.

Code N0330201A	7/94