• Meriofert is used to promote ovulation in women who are not ovulating and who have not responded to other treatment (clomiphene citrate).
• Meriofert is used to bring about the development of several follicles (and therefore several eggs) in women receiving fertility treatment.

Meriofert is a highly purified human Menopausal gonadotrophin, belonging to a group of medicines called gonadotrophins. Each vial contains freeze-dried powder with 75 IU human follicle stimulating hormone activity (FSH) and 75 IU human luteinising hormone activity (LH).

Human Menopausal Gonadotrophin (hMG) is extracted from urine of post-menopausal women. Human Chorionic Gonadotrophin (hCG), a hormone naturally extracted from urine of pregnant women, is added to contribute to the total LH activity.

Each vial contains freeze-dried powder with 150 IU human follicle stimulating hormone activity (FSH) and 150 IU human luteinising hormone activity (LH). Human Menopausal Gonadotrophin (hMG) is extracted from urine of post-menopausal women. Human Chorionic Gonadotrophin (hCG), a hormone naturally extracted from urine of pregnant women, is added to contribute to the total LH activity. This medicinal product must be used under the supervision of your doctor.

You and your partner’s fertility will be evaluated before your treatment is started.

Do not use Meriofert if you have any of the following:

• Enlarged ovaries or cysts not caused by a hormonal disorder (polycystic ovarian disease).
• Bleeding of unknown cause.
• Cancer of the ovaries, uterus or breast.
• Abnormal swelling (tumour) of the pituitary gland or hypothalamus (brain).
• Hypersensitivity (allergy) to menotrophin or any of the ingredients in Meriofert

This medicine should not be used if you have an early menopause, a malformation of the sexual organs or certain tumours of the womb that would make a normal pregnancy impossible.

Warnings and Precautions

Although no allergic reactions to Meriofert have yet been reported, you should tell your doctor if you have an allergic reaction to similar medicines.

This treatment increases your risk of developing a condition known as ovarian hyperstimulation syndrome (OHSS) (see Possible side effects). If ovarian hyperstimulation occurs then your treatment will be stopped and pregnancy will be avoided. The first signs of ovarian hyperstimulation are pain in the lower abdominal region as well as nausea (feeling sick), vomiting and weight gain. If these symptoms occur you should be examined by your doctor as soon as possible. In serious, but rare cases, the ovaries can become enlarged and fluid can build up in the abdomen or chest.

The drug used to bring about the final release of mature eggs (containing human chorionic gonadotrophin-hCG) can increase the likelihood of OHSS. It is therefore not advisable to use hCG in cases where OHSS is developing and you should not have sexual intercourse even if using a barrier method of contraception for at least 4 days.

It should be noted that women with fertility problems have a higher rate of miscarriages than the normal population.

In patients having treatment to help ovulation, the occurrence of multiple pregnancies and births is increased compared to natural conception. However, this risk can be minimised by using the recommended dose.

There is a slightly increased risk of extra-uterine pregnancy (an ectopic pregnancy) in women with damaged fallopian tubes.

Multiple pregnancies and characteristics of the parents undergoing fertility treatments (e.g. maternal age, sperm characteristics) may be associated with an increased risk of birth defects.

Treatment with Meriofert, just as pregnancy itself, may increase the chance of having thrombosis. Thrombosis is 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 chance of having thrombosis.
• If you, or anyone in your immediate family, have ever had a thrombosis.
• If you are severely overweight.

Children

The medicine is not intended for use in children.

Other medicines and Meriofert

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines.

Pregnancy, breast-feeding and fertility

Meriofert should not be used if you are pregnant or breast-feeding.

Driving and using machines

Meriofert has no or negligible influence on the ability to drive and use of machinery.

Meriofert contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per reconstituted solution, that it is to say essentially “sodium free”.

Dosage and duration of the treatment:

Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.

Women who are not ovulating and are having irregular periods or no periods at all:

As a general rule, the first injection of one Meriofert 75 IU vial is given during the first week of the cycle after spontaneous or induced menses.

Subsequently, Meriofert is injected daily at the dosage prescribed by the physician and the treatment will continue until one or more ripe follicle have developed in the ovary. Your physician will adjust the Meriofert dosage depending on the ovarian response, which is determined by clinical examinations.

As soon as one follicle reaches the required development stage, the Meriofert treatment will be withheld and ovulation will be triggered with another hormone (chorionic gonadotropin, hCG).

Ovulation generally takes place after 32 to 48 hours.

In this phase of the treatment, fertilization is possible. You will be advised to have sexual intercourse every day starting from the day preceding the administration of hCG. If pregnancy is not achieved in spite of ovulation, the treatment can be repeated.

Women undergoing ovarian stimulation for multiple follicular development prior to in vitro fertilisation or other assisted reproductive techniques:

The aim of this method is to obtain concomitant multiple follicular development. The treatment will start on the 2nd or 3rd day of the cycle with injections of 150-300 IU of Meriofert (1-2 vials of Meriofert 150 IU). Your physician may decide to administer higher dosages if required. The injected dosage of Meriofert is higher than in the method used for natural fertilization. The continuation of the treatment is adjusted individually by the physician.

As soon as a sufficient number of follicles has developed, the treatment with Meriofert is withheld and ovulation is triggered by injecting another hormone (chorionic gonadotropin, hCG).

How Meriofert should be given:

Meriofert is given by injection under your skin (by the subcutaneous route) or into your muscle (intramuscular injection).

Each vial should be used only once and the injection should be used as soon as it is prepared.

After suitable advice and training your doctor may ask you to inject Meriofert yourself.

For the first time, your doctor must:

• Let you practise giving yourself a subcutaneous injection,
• Have shown you the possible places where you can inject yourself,
• Have shown you how to prepare the solution for injection,
• Have explained how to prepare the right dose of injection.

Before injecting Meriofert yourself, read the following instructions carefully.

How to prepare and inject Meriofert using 1 vial of powder:

The solution must be prepared just before injection. One vial is for single use only. The medicinal product must be reconstituted under aseptic conditions.

Meriofert must only be reconstituted with the solvent provided in the package.

Prepare a clean surface and wash your hands before the solution is reconstituted. It is important that your hands and the items you use are as clean as possible.

Set out all the following items on the clean surface:

• Two cotton wool alcohol swabs (not provided),
• One vial containing Meriofert powder,
• One solvent in ampoule,
• One syringe (not provided),
• One needle for preparing the injection (not provided),
• A fine bore needle for subcutaneous injection (not provided).

Like all medicines, Meriofert can cause side effects, although not everybody gets them. The following side effect is important and will require immediate action if you experience it. You should stop taking Meriofert and see your doctor immediately if the following occurs:

Common: may affect up to 1 in 10 people:

• Ovarian Hyperstimulation Syndrome (symptoms include ovarian cyst formation or enlargement of existing cysts, lower stomach pain, feeling thirsty and sick, and sometimes being sick, passing reduced quantities of concentrated urine and weight gain) (see Section 2 for additional information). The following side-effects have also been reported:

The following side-effects have also been reported:

Very Common: may affect more than 1 in 10 people

• Headache
• Swollen or bloated stomach

Common: may affect up to 1 in 10 people

• Abdominal pain or discomfort
• Pelvic pain
• Back pain
• Sensation of heaviness
• Breast discomfort
• Dizziness
• Hot flushes
• Thirst
• Feeling sick
• Tiredness
• Feeling generally unwell
• Injection site reaction such as pain and inflammation (frequency higher with IM than SC).

Rare: may affect up to 1 in 1,000 people

• Ovarian torsion (twisting of the ovary which causes extreme pain in the lower abdomen)

Very rare: may affect up to 1 in 10,000 people

• Thromboembolism (formation of a clot in a blood vessel that breaks loose and is carried by the blood stream to block another vessel).

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed here.

You can also report side effects directly via the Yellow Card Scheme www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

Keep this medicine out of the sight and reach of children.

Do not store above 25° C. Keep the vial and the ampoule of solvent in the outer carton in order to protect from light.

Do not use this medicine after the expiry date which is stated on the outer carton, the vial and the ampoule of solvent. The expiry date refers to the last day of the month.

Use immediately after reconstitution.

Do not use Meriofert if you notice the solution does not look clear. After reconstitution the solution must be clear and colourless.

Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Meriofert contains

The active substance is menotrophin.

Each vial contains freeze-dried powder with 75 IU human follicle stimulating hormone activity (FSH) and 75 IU human luteinising hormone activity (LH).

Human menopausal Gonadotrophin (hMG) is extracted from urine of post-menopausal women.

Human Chorionic Gonadotrophin (hCG), an hormone extracted from urine of pregnant women, is added to contribute to the total LH activity.

Each vial contains freeze-dried powder with 150 IU human follicle stimulating hormone activity (FSH) and 150 IU human luteinising hormone activity (LH).

Human menopausal Gonadotrophin (hMG) is extracted from urine of post-menopausal women.

Human Chorionic Gonadotrophin (hCG), a hormone extracted from urine of pregnant women, is added to contribute to the total LH activity.

If multiple vials of powder are used, the amount of menotrophin contained in 1 ml of reconstituted solution will be as follows:

Meriofert 75 IU

powder and solvent for solution for injection

Meriofert 150 IU

powder and solvent for solution for injection

The other excipients are

For the powder: lactose monohydrate. For the solvent: 9 mg/ml sodium chloride and water for injections.

What Meriofert looks like and contents of the pack

Powder: white to almost white lyophilized powder

Solvent: clear and colourless solution. Meriofert is presented as a powder and solvent for solution for injection.

1 set contains the following:

• One vial containing a white to almost white powder
• One ampoule (1 ml) containing a clear and colourless solution

It comes in pack sizes of 1, 5 or 10 sets. Not all pack sizes may be marketed.

Marketing Authorisation Holder:

IBSA Farmaceutici Italia srl

Via Martiri di Cefalonia, 2

26900 Lodi – Italy

Manufacturer:

IBSA Farmaceutici Italia srl

Via Martiri di Cefalonia, 2

26900 Lodi – Italy

Batch release for UK(NI) only:

IBSA Pharma Limited

Units 4-6 Colonial Business Park,

Colonial Way,

Watford WD24 4PR, UK

This medicinal product is authorized in the Member States of the EEA under the following names: (The strength and pharmaceutical form are identical in all countries, only the trade name changes)

Austria: Meriofert

Belgium: Fertinorm

Bulgaria: Meriofert

Cyprus: Meriofert

Czech Republic: Meriofert

Denmark: Meriofert

Greece: Meriofert

Hungary: Meriofert

Luxembourg: Fertinorm

Romania: Meriofert

Slovakia: Meriofert

The Netherlands: Meriofert

United Kingdom: Meriofert