Do not use Puregon if you:

• are allergic (hypersensitive) to follitropin beta or to any of the ingredients in Puregon listed at the end of this leaflet.

• have a tumour of the ovary, breast, uterus, testis, or brain (pituitary gland or hypothalamus)

• are pregnant or breast feeding

• have heavy or irregular vaginal bleeding where the cause is not known

• suffer from primary ovarian failure

• have ovarian cysts or enlarged ovaries not caused by polycystic ovarian disease (PCOD)

• have malformations of the sexual organs which make a normal pregnancy impossible

• have fibroids in the uterus which make a normal pregnancy impossible

• suffer from primary testicular failure

Take special care with Puregon. Tell your doctor if you have experienced an allergic reaction to neomycin and/or streptomycin (antibiotics) in the past. Puregon may contain traces of these antibiotics.

In Women.

Close supervision by your doctor is very important. Usually ultrasound scans of the ovaries are regularly made, and blood or urine samples are regularly taken. The results of these tests allow your doctor to choose the correct dose of Puregon from day to day. This is very important since too high a dose of FSH may lead to rare but serious complications in which the ovaries become overstimulated. This condition is called Ovarian HyperStimulation Syndrome (OHSS). This may be noticed as pain in the stomach (abdomen), feeling sick or diarrhoea . Regular monitoring of the response to FSH-treatment helps to prevent ovarian overstimulation. So contact your doctor without delay if you are experiencing significant stomach pain, also if this occurs some days after the last injection has been given. Treatment with Puregon (like pregnancy) may increase the risk of Thrombosis (the formation of a blood clot in a blood vessel, most often in the veins of the legs or the lungs). Please discuss this with your doctor, before starting treatment, especially if:

• You already know you have an increased risk of thrombosis

• You, or anyone in your immediate family, have ever had a thrombosis

• You are severely overweight

In Men

Elevated FSH blood levels are indicative of testicular damage. Puregon is usually not as effective in such cases. To monitor your treatment, your doctor may ask you for a semen analysis to be performed 4 to 6 months after the beginning of treatment.

Do not use Puregon if the packaging is torn or shows signs of tampering.

Do not use Puregon after the expiry date printed on the pack has passed.

If it has expired or is damaged, return it to your pharmacist or clinic for disposal.

Talk to your doctor if you are not too sure about using Puregon.

Before you start to use Puregon

You and your partner's fertility should be assessed to see if Puregon is appropriate for you.

Tell your doctor if you are breastfeeding or intend to breastfeed.

Tell your doctor if you have allergies to any other medicines, foods or preservatives.

Tell your doctor if you have or have had any of the following medical conditions:

• Thyroid disorder

• Adrenal gland disorder

• Ovarian cyst

• Cancer or a tumour of the breast, ovary, uterus, prostate, hypothalamus or pituitary gland

• polycystic ovarian disease (irregular or no periods, acne, obesity, excess hair growth)

• unexplained vaginal bleeding

If you have any of the above conditions, tell your doctor before you start to use Puregon. Tell your doctor if you have or have had any other medical conditions.