Epifasi contains the hormone known as human chorionic gonadotropin (hCG), which belongs to a group of medicines called gonadotropins. These are important for fertility and reproduction.

Epifasi is obtained from the urine of pregnant women. HCG has the same effect on the body as luteinising hormone (LH), which is produced in the pituitary gland of men and women. The pituitary is a small hormone-producing gland located at the base of the brain. Together with another pituitary hormone, follicle-stimulating hormone (FSH), LH regulates the function of the reproductive organs (ovaries in women and testicles in men). These hormones are necessary for the normal growth and ripening of egg and sperm cells.

In women

- In women, FSH and LH cause the monthly ripening of an egg cell in one of the ovaries. LH is also needed for ovulation: the release of the egg cell. If the body does not produce enough FSH and LH on its own, this can lead to low fertility. Daily injections of FSH can lead to ripening of the egg cell. Epifasi ensures that ovulation takes place afterwards.

- Epifasi can also be given in assisted reproductive techniques, both before and after ovulation.

In men

- In men, Epifasi can be used on its own or together with an FSH-containing product, when there is underdevelopment of the sex glands or when there are problems with the formation of sperm.

In boys

- In boys, Epifasi can be used for delayed puberty, on its own or together with an FSH-containing product.

- In some cases Epifasi can also be given to boys in whom one or both testicles has not descended.

Do not use Epifasi if you:

- Are allergic (hypersensitive) to Human Chorionic Gonadotrophin (HCG) or any of the other ingredients in Epifasi.

- Have a thyroid, adrenal or pituitary illness which is not being treated.

- Have cancer, (especially a hormone-dependent cancer of the breast, ovaries or womb).

- Have recently had unexpected vaginal bleeding.

- Have fibroids in the womb or abnormalities of the sexual organs which make a normal pregnancy impossible.

- Are a man and have, or suspect you have a hormone related tumour, such as testicular, prostate or breast cancer.

Take special care with Epifasi:

Medicines are not always suitable for everyone.

Tell your doctor before you use Epifasi if you suffer from or have suffered in the past from any of the following conditions:

Men with:

- Heart problems ,kidney problems ,high blood pressure ,epilepsy, or migraine

- Abnormalities of the sexual organs. Before treatment with Epifasi your doctor should have checked that your sexual organs are normal

- In women patients your doctor should have checked how your ovaries are working before starting treatment with Epifasi. Extra supervision may be necessary in some cases.

Children and adolescents:

Epifasi should be used carefully when treating boys who have not reached puberty. This is because it can cause early sexual development and may result in final adult height not being reached.

Other medicines and Epifasi

Some medicines can affect the way Epifasi works, or Epifasi may affect how other medicines work. For the ten days following your Epifasi injection a pregnancy test may give a false positive result.

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Fertility treatment

Close supervision of female patients undergoing fertility treatment is extremely important to avoid the rare complication of hyperstimulation of the ovaries. This side effect may be felt as pain in the stomach.

If you are troubled with stomach pains, contact your doctor straight away.

No one is sure if IVF treatment causes congenital malformations, or some cancers of the sex organs.

If you have risks factors for having a blood clot (for example being overweight, or if blood clots run in your family), the chance of having a blood clot may be increased during IVF treatment.

Being pregnant increases the chance of having a blood clot.

Pregnancy:

If treatment with Epifasi results in pregnancy, there is an increased chance having twins or multiple births. Multiple pregnancies carry an increased health risk for both the mother and her babies around the time of birth. There is also an increased chance of a miscarriage, or a pregnancy outside of the womb (an ectopic pregnancy). 

Dosage

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Your doctor will decide on the dose of Epifasi to be given and will supervise your first injection.

In female patients one injection is usually given to induce ovulation and up to 3 injections to support the luteal phase that follows.

In male patients (men and boys) the injections are given 2 or 3 times a week. The treatment will last from a few weeks to at least 3 months, depending on the problem being treated. The length of treatment depends on the time needed for development of sperm and the period in which an improvement can be expected.

How the injections are given

The powder for injection must be dissolved with the liquid from the other ampoule (the solvent). This solution must be used immediately after that. The Epifasi solution can be injected slowly into muscles (for instance, in the buttock, upper leg or upper arm) or just under the skin (for instance, in the lower abdomen). When injecting into a muscle, the injection must be given by the doctor or nurse. When given under the skin, injections may, in some cases, be given by yourself or your partner. Your doctor will tell you when and how to do this. If you are injecting yourself with Epifasi, follow the instructions in the next section, so that you administer Epifasi properly and with minimal discomfort from the injection.

Instructions for use

Step 1 – Preparing the injection syringe

The dry material in the glass ampoule must be dissolved in the solvent from the other glass ampoule. To do so, first break the top off the ampoule with the solvent. Hold a piece of gauze between the ampoule and your fingers to avoid cutting yourself on the broken edge of the glass. Draw the solvent up through the needle into the syringe. Then break the top off the ampoule with the dry material. Inject the solvent into the ampoule with the dry material. DO NOT SHAKE, but swirl gently until the solution is clear. Epifasi usually dissolves immediately. The prepared solution should not be used if it contains particles or is cloudy. Make sure that everything is carried out so that during reconstitution sterile conditions are maintained (e.g., never put the syringe down without first putting the protective cap on the needle). Draw the Epifasi solution up into the empty syringe, and replace the needle used for drawing up the solution with a sterile injection needle. Hold the syringe with the needle pointing upwards and gently tap the side to allow any air bubbles to rise to the top. Then, push the plunger until all the air is out of the syringe and only Epifasi solution is present in the syringe.

UNDER THE SKIN

Step 2 – The injection site

The best injection site for subcutaneous injection is in the abdomen around the navel, where there is a lot of loose skin and layers of fatty tissue. Other injection sites are also possible. Choose a slightly different place for each injection. Your doctor or nurse will tell you where to inject.

Step 3 - Preparing the injection site

Tap a few times on the injection site to stimulate tiny nerve endings. This reduces the pain when the needle goes into the subcutaneous tissue. Wash your hands and clean the injection site with a swab containing an antiseptic (for example chlorhexidine 0.5%) to remove any surface bacteria. Clean an area of about five centimetres (two inches) around the injection site and let the antiseptic dry for at least one minute before you go on to the next step.

Step 4 - Inserting the needle

Grasp a fold of skin between thumb and forefinger. With the other hand, stick the needle into the fold of skin at a 45-degree angle.

Step 5 - Checking the correct needle position

Pull the plunger of the syringe back gently, to check that the needle is in the correct position. If blood is drawn into the syringe, it means a vein has been punctured. If this happens, remove the needle from the skin and apply pressure on the injection site with a swab containing an antiseptic; bleeding should stop after about two minutes. Do not use the solution contaminated with blood. Start again from step 1 using a new syringe, new needles, and new ampoules of Epifasi and solvent.

Step 6 - Injecting the solution

Depress the plunger slowly and steadily. This way the solution will be injected properly without injuring the muscle or subcutaneous tissue.

Step 7 - Removing the syringe

With a quick movement, pull the needle out of the skin and apply pressure on the injection site with a swab containing an antiseptic. Gently massaging the skin – while you are still applying pressure – helps disperse the Epifasi solution more easily and reduces the pain. Any remaining solution should be discarded. Do not mix Epifasi with any other medicines.

Step 8 – Disposing the needles

Put the syringe back into the protective sheath to prevent injury.

Carefully dispose of all the needles you used. You can either dispose of needles in a sharps bin or take them to your pharmacy to be destroyed. Do not share your needles or syringes with others.

If you use more Epifasi than you should

If you used too much Epifasi, contact your doctor or pharmacist immediately.

The toxicity of Epifasi is very low, but a dose of Epifasi that is too high can cause ovarian hyperstimulation syndrome (see also section 2, ‘Warnings and precautions’ and section 4 on ‘Possible side effects’).

If you forget to use Epifasi

Never take a double dose to make up for a forgotten dose.

Tell your doctor that you missed a dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines,Epifasi can cause side effects,although not everybody gets them.

Serious side effects: Tell a doctor straight away

If you have an allergic reaction to Epifasi see a doctor straight away,

- Epifasi may cause reactions at the site of injection, such as bruising, pain, redness, swelling and rashes at the injection site.

- more widespread rash and fever may occur.

Contact a doctor immediately if you are a woman and experience:

Severe pain in the abdomen, feeling sick (nausea), diarrhoea, painful breasts, also if it occurs a few days after you receive your last injection, since it could be a sign of unwanted overstimulation of the ovaries (OHSS).

If you are a woman:

If your ovaries have been excessively stimulated by an FSH-containing preparation and Epifasi is given, it may lead to unwanted overstimulation of the ovaries. This condition (also called OHSS) can become very serious, but the risk can be minimised by careful monitoring of egg cell development during treatment. The first symptoms of ovarian overstimulation may be noticed as pain in the stomach (abdomen), feeling sick (nausea) or diarrhoea. In more severe cases symptoms may include enlargement of the ovaries, accumulation of fluid in the abdomen and/or chest, weight gain and the occurrence of blood clots in the circulation.

Contact your doctor without delay if you are experiencing significant abdominal pain, also if this occurs some days after the last injection has been given. The following side effects might be the result of OHSS:

- Pain in the stomach (abdomen).

- Feeling sick (nausea).

- Diarrhoea.

- Bloating.

- Ovarian cysts or enlargement of the ovaries.

- Painful breasts.

- Palpable ovarian cysts.

- Accumulation of fluid in the abdomen and/ or chest.

- Blood clots.

- Ovarian cysts prone to rupture.

- Weight gain.

If you are a man:

fluid may be retained in the tissues, usually marked by swelling of ankles or feet, and occasionally enlargement of the breast may occur. This can be caused by an increased androgen production by treatment with hCG.

If any of these signs appear, tell your doctor immediately.

Other possible side effects:

- Acne (in men).

- Fluid retention.

- Headache.

- Tiredness.

- Mood changes.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Keep out of the reach and sight of children.

Store at temperature not exceeding 30°C. Do not freeze.

Keep the ampoules in the outer container to protect from light.

Do not use Epifasi after the expiry date which is stamped on the pack. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.