Before you are given it

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

For men and women:

• uncontrolled pituitary gland or hypothalamic problems
• An underactive thyroid gland (hypothyroidism)
• Adrenal glands that are not working properly (adrenocortical insufficiency)
• High prolactin levels in the blood (hyperprolactinemia)
• Any other medical conditions (for example, diabetes, heart disease, or any other long-term disease).

If you have any of the conditions listed above, you may not be able to use Pregnyl or you may need a dosage adjustment or special tests during treatment.

Tell your doctor if you have or have had any other medical conditions.

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Allergic reactions

Allergic reactions, both generalised and local, including swelling of the face, lips, tongue, and/or throat that may cause difficulty in breathing or swallowing (angioedema and anaphylaxis) have been reported. If you have an allergic reaction, stop taking Pregnyl and seek immediate medical assistance (see also Side Effects).

Misuse for weight control

Pregnyl should not be used for body weight reduction. HCG has no effect on fat metabolism, fat distribution or appetite.

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If you are a woman:

Chance of having ovarian hyperstimulation syndrome (OHSS)

Treatment with gonadotrophic hormones like Pregnyl may cause ovarian hyperstimulation syndrome (OHSS). In rare cases, severe OHSS may be life-threatening. Therefore, close supervision by your doctor is very important. To check the effects of treatment, your doctor will do ultrasound scans of your ovaries. Your doctor may also check blood hormone levels. (See Side Effects).

OHSS causes fluid to build up suddenly in your stomach and chest areas and can cause blood clots to form. Call your doctor right away if you have:

• severe abdominal swelling and pain in the stomach area (abdomen)
• feeling sick (nausea)
• vomiting
• sudden weight gain due to fluid build up
• diarrhoea
• decreased urine output
• trouble breathing

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Ovarian torsion

Ovarian torsion is the twisting of an ovary. Twisting of the ovary could cause the blood flow to the ovary to be cut off.

Before you start to use this medicine, it is important to inform your doctor if you:

• have ever had ovarian hyperstimulation syndrome OHSS
• are pregnant or think you may be pregnant
• have ever had stomach (abdominal) surgery

Chance of having multiple births or birth defects
In pregnancies occurring after treatment with gonadotrophic preparations, there is an increased risk of having twins or multiple pregnancies. Multiple pregnancies carry an increased health risk for both the mother and her babies during pregnancy and around the time of birth.

Multiple pregnancies and characteristics of the patients undergoing fertility treatment (e.g. age of the female, sperm characteristics) may be associated with an increased risk of congenital abnormalities.

Chance of having pregnancy complications
In women undergoing fertility treatment there is a slightly increased risk of a pregnancy outside of the uterus (an ectopic pregnancy). Therefore, your doctor should perform an early ultrasound examination to exclude the possibility of pregnancy outside the uterus.

Miscarriage
In women undergoing fertility treatment there may be a slightly higher risk of miscarriage.

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Chance of having a blood clot (thrombosis)

Treatment with Pregnyl (like pregnancy itself) may increase the risk of the formation of a blood clot in a blood vessel (thrombosis), most often in the veins of the legs or the lungs.

Blood clots can lead to serious medical conditions, such as:

• blockage in your lungs (pulmonary embolus)
• stroke
• heart attack
• blood vessel problems (thrombophlebitis)
• reduced blood flow to the vital organs that may result in organ damage
• reduced blood flow to your arm or leg that may result in a loss of your arm or leg.

Tell your doctor, before starting treatment, especially if:

• you already know that you have an increased risk of blood clots

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If you are a man:

Antibody formation
If the treatment with Pregnyl is not working, consult your doctor who may perform additional tests.

Treatment with Pregnyl (hCG) can cause the body to produce substances that act against hCG (antibodies to hCG). In rare cases this could result in ineffective treatment.

Androgen production
Treatment with hCG lead to increased androgen (male sexual hormone) production. Therefore extra supervision by your doctor is necessary

• in the treatment of boys who have not reached puberty. This is because Pregnyl can cause early sexual development and delay growth.
• if you have or have ever had:
  – heart or blood vessel disease
  – kidney disease
  – epilepsy
  – migraine headaches

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Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.

For up to ten days after administration, Pregnyl may result in a false positive pregnancy test.

How Pregnyl is given

Your doctor will decide the dose of Pregnyl.

Females may require only one injection.

Males may receive a series of injections 2 to 3 times a week for several weeks or months.

Things you must not do

Do not use this medicine to treat any other complaints unless your doctor tells you to.

Do not give your medicine to anyone else, even if they have the same condition as you.

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Side Effects

Tell your doctor as soon as possible if you do not feel well while you are using Pregnyl.

If any of the following happen, tell your doctor immediately or go to Accident and Emergency at your nearest hospital:

• You have pain in the stomach (abdomen) or any of the other symptoms of ovarian hyperstimulation, even if they occur some days after the administration of Pregnyl has been given.

. Your doctor will do ultrasound scans of your ovaries to carefully monitor the number of maturing follicles. Your doctor may also check blood hormone levels. Ovarian overstimulation may develop into a medical condition call ovarian hyperstimulation syndrome (OHSS), which can be a serious medical problem. In more severe cases this may lead to enlargement of the ovaries, collection of fluid in the abdomen and/or chest (which may cause sudden weight gain due to fluid build-up) or clots in the blood vessels.

• Signs of an allergic reaction such as shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the skin.
• Signs of a blood clot such as pain, warmth, redness, numbness, or tingling in your arm or leg; confusion, extreme dizziness or severe headache. This condition is rare.