Menopur

Package leaflet: Information for the patient

MENOPUR 1200 IU solution for injection in an auto-injector
Menotropinum
Please read the entire leaflet carefully before using this medicine, as it contains important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm others, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

1. What MENOPUR is and what it is used for
2. Important information before using MENOPUR
3. How to use MENOPUR
4. Possible side effects
5. How to store MENOPUR
6. Contents of the pack and other information

1. What MENOPUR is and what it is used for

MENOPUR is a solution for injection in a semi-automatic auto-injector. The injection is administered subcutaneously (under the skin), usually in the abdomen.
The active substance in MENOPUR is highly purified menotropin. Menotropin is derived from urine of postmenopausal women and contains three hormones: follicle-stimulating hormone (FSH), human chorionic gonadotropin (hCG), and luteinizing hormone (LH).
To achieve full biological LH activity, hCG derived from urine of pregnant women may be added.
FSH, hCG, and LH are natural hormones produced in the female body. They support the proper functioning of the reproductive organs.

What MENOPUR is used for
MENOPUR is used to treat infertility in women in the following two situations:
i. in women who are unable to become pregnant because their ovaries do not produce oocytes (including cases of polycystic ovary syndrome). MENOPUR is used in women who have previously been treated with a medicine called clomiphene citrate, but this treatment was ineffective;
ii. in women undergoing assisted reproductive technology programs, such as in vitro fertilisation/embryo transfer (IVF/ET), gamete intra-fallopian transfer (GIFT), or intracytoplasmic sperm injection (ICSI).

How MENOPUR works
MENOPUR supports the ovaries in developing multiple ovarian follicles, in which oocytes can mature (multiple follicular development).

2. Important information before using MENOPUR

What to check before starting treatment with MENOPUR
Before starting treatment with MENOPUR, your doctor should carefully evaluate the causes of infertility
in both partners. In particular, the following conditions should be ruled out, as they require different,
specific treatment:
hypothyroidism and adrenal insufficiency;
high levels of a hormone called prolactin – known as hyperprolactinemia;
pituitary gland tumours – a gland located at the base of the brain;
tumours of the hypothalamus – an area located below a part of the brain called the thalamus.
If any of the above conditions are present in the patient, you must inform your doctor before starting
treatment with MENOPUR.

When not to use MENOPUR
Do not use MENOPUR if:
you are allergic to menotropin or any of the other ingredients of this medicine (listed in section 6);
you have tumours of the uterus, ovaries, breasts, or parts of the brain such as the pituitary gland or
hypothalamus;
you have ovarian cysts or enlarged ovaries not caused by polycystic ovary syndrome;
you have congenital malformations of the uterus or other reproductive organs;
you have vaginal bleeding of unknown cause;
you have uterine fibroids – these are non-cancerous tumours in the uterus;
you are pregnant or breastfeeding.

Warnings and precautions

Ovarian Hyperstimulation Syndrome (OHSS)
A serious side effect of this medicine, especially in women with polycystic ovary syndrome, is
"Ovarian Hyperstimulation Syndrome" or "OHSS" (see section 4).
You must inform your doctor immediately if you experience symptoms of OHSS, even if:

• several days have passed since the last dose of the medicine;
• you have already stopped using MENOPUR.

These symptoms may indicate excessive ovarian activity, which can be severe. In such cases, your doctor will discontinue treatment with MENOPUR and initiate appropriate hospital treatment.
Following the recommended dose and careful monitoring during treatment reduces the likelihood of these symptoms occurring.

Tests and examinations
During treatment with this medicine, your doctor will usually arrange for ultrasound scans (USG) and sometimes blood tests to monitor your response to treatment.

Risks associated with pregnancy
Hormonal treatment with medicines such as MENOPUR may increase the risk of:
ectopic pregnancy (pregnancy outside the uterus) in women with previously diagnosed fallopian tube disease;
miscarriage;
multiple pregnancy (twins, triplets, etc.);
congenital malformations (birth defects).
In some women treated for infertility, tumours of the ovaries or other reproductive organs have developed.
It is not currently known whether this was caused by hormonal treatment such as MENOPUR.

Blood clots
The risk of developing blood clots in veins or arteries is higher in women who are pregnant.
Infertility treatment may increase the risk of blood clots, especially if:
you are overweight;
you have a blood clotting disorder called "thrombophilia";
you or a family member have had blood clots in the past.
You should inform your doctor if you think this applies to you.

Children and adolescents
The use of MENOPUR in children and adolescents is not recommended.

MENOPUR with other medicines
Tell your doctor about all medicines you are currently taking, have recently taken, or plan to take.
Clomiphene citrate is another medicine used in the treatment of infertility. If MENOPUR is used at the same time as clomiphene citrate, the effect on the ovaries may be enhanced.

Pregnancy and breastfeeding
MENOPUR must not be used during pregnancy or breastfeeding.

Driving and using machines
It is unlikely that MENOPUR will affect your ability to drive or operate machinery.

Important information about some of the ingredients of MENOPUR
MENOPUR contains less than 1 mmol of sodium (23 mg) per dose, meaning that the medicine is considered essentially "sodium-free".

3. How to use MENOPUR

This medicine should always be used exactly as your doctor has instructed. If you are in any doubt, consult your doctor.

Women who do not produce eggs (anovulation)
Treatment should begin within the first 7 days of the menstrual cycle.
Day 1 is the first day of menstruation.
The medicine should be administered daily for at least 7 days.

What dose of MENOPUR should be used?
The initial dose is usually between 75 IU (international units) and 150 IU per day.
Depending on the patient's response, the dose may be increased up to a maximum of 225 IU.
The prescribed dose should be maintained for at least 7 days before any dose adjustment is made by the doctor.
It is recommended that each dose increase should be by 37.5 IU, but not more than 75 IU.
Your doctor will monitor your response to treatment with MENOPUR. The treatment cycle should be discontinued if there is no response after 4 weeks.

When there is a satisfactory response to treatment with MENOPUR:
The patient will receive a single injection of a hormone called human chorionic gonadotropin (hCG).
The dose will range from 5,000 IU to 10,000 IU.
The hCG injection will be given the day after the last MENOPUR injection.
It is recommended to have sexual intercourse on the day of hCG administration and the following day. Alternatively, insemination (direct placement of sperm into the uterus) may be performed.
The patient should remain under close medical supervision for at least 2 weeks.

When there is no response to treatment with MENOPUR:
Your doctor will monitor your response to MENOPUR treatment.
Depending on treatment progress, the doctor may decide to discontinue MENOPUR and not administer hCG.

Women undergoing assisted reproductive technology (ART) programs
Women participating in assisted reproductive programs will also receive a medication that supports the action of a hormone called gonadotropin-releasing hormone (GnRH). This medication is known as a "GnRH agonist." Administration of MENOPUR should begin approximately 2 weeks after starting treatment with the GnRH agonist.
The patient may also receive a medication known as a "GnRH antagonist."
Administration of MENOPUR should begin on day 2 or 3 of the menstrual cycle (day 1 being the first day of menstrual bleeding).

What dose of MENOPUR should be used?
MENOPUR should be administered daily for at least 5 days.
The initial dose of MENOPUR is usually between 150 IU and 225 IU.
Depending on the patient's response, the dose may be increased up to a maximum of 450 IU per day.
The dose should not be increased by more than 150 IU at any one time.
Treatment usually should not last longer than 20 days.
Once a sufficient number of ovarian follicles of appropriate size have developed, the patient will receive a single injection of hCG, up to 10,000 IU, to trigger ovulation (release of the egg).
The patient should remain under close medical supervision for at least 2 weeks after the hCG injection.
Your doctor will monitor your response to MENOPUR treatment.
Depending on treatment progress, the doctor may decide to discontinue MENOPUR and not administer hCG.
In such cases, the patient will be advised to use a mechanical contraceptive method (e.g., condom).
Otherwise, sexual intercourse should be avoided until the next menstrual period begins.

How to use MENOPUR
You must strictly follow the "Instructions for Use" provided in the package with the pre-filled pen.
The first MENOPUR injection should be administered under the supervision of a doctor or nurse. The doctor will decide whether the patient may self-administer subsequent injections at home, after proper training.
MENOPUR is administered as a subcutaneous injection (under the skin), usually in the abdomen.
Each pre-filled pen may be used for multiple injections.

If you use more MENOPUR than you should
If you have used more MENOPUR than prescribed, inform your doctor immediately.

If you forget to use MENOPUR
Do not use a double dose to make up for a missed dose. If you miss a dose of MENOPUR, inform your doctor.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.

Serious adverse reactions

Ovarian hyperstimulation syndrome (OHSS)

Contact your doctor immediately if any of the following symptoms occur, as they may be signs of OHSS:

• abdominal pain or bloating;
• feeling unwell (feeling sick);
• diarrhoea;
• rapid weight gain;
• difficulty breathing;
• reduced frequency of urination.

If any of these symptoms occur, contact your doctor immediately, even if the symptom appears several days after the last dose of MENOPUR or if the patient has stopped using MENOPUR. The patient may require urgent medical attention. These adverse reactions may indicate excessive ovarian activity, known as ovarian hyperstimulation syndrome (OHSS). In severe cases of OHSS, complications such as accumulation of fluid in the abdominal cavity, pelvic cavity or pleural cavity, difficulty breathing, reduced frequency or volume of urine, blood clot formation in blood vessels (thromboembolic disorders), and ovarian torsion have rarely occurred.

Allergic (hypersensitivity) reactions

Inform your doctor immediately if any of the following occur:

• rash;
• itching;
• swelling of the throat and difficulty breathing.

If any of these symptoms occur, contact your doctor immediately.

Other adverse reactions

The following adverse reactions occur frequently, i.e. in 1 to 10 out of 100 treated patients:

• headache;
• feeling sick (nausea);
• abdominal pain or bloating;
• pelvic pain;
• injection site reactions such as pain, redness, swelling, itching or bruising.

The following adverse reactions occur uncommonly, i.e. in 1 to 10 out of 1,000 treated patients:

• feeling unwell (vomiting);
• abdominal discomfort;
• diarrhoea;
• feeling tired;
• dizziness;
• fluid-filled cysts in the ovaries (ovarian cysts);
• breast discomfort, including breast pain, breast tenderness, feeling of discomfort, nipple pain and breast swelling;
• hot flushes.

The following adverse reactions occur rarely, i.e. in 1 to 10 out of 10,000 treated patients:

• acne.

In addition to the above, the following adverse reactions have been observed, but their frequency is unknown:

• visual disturbances;
• fever;
• feeling unwell;
• weight gain;
• muscle and joint pain;
• ovarian torsion, as a complication of increased ovarian activity caused by excessive stimulation;
• urticaria;
• blood clots, as a complication of increased ovarian activity caused by excessive stimulation.

Reporting of adverse reactions

If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:

Aleje Jerozolimskie 181C, 02-222 Warsaw
Tel: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl

Adverse reactions can also be reported to the marketing authorization holder.

By reporting adverse reactions, additional information on the safety of this medicine can be collected.

5. How to store MENOPUR

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label of the pre-filled syringe and on the outer carton after "EXP". The expiry date refers to the last day of the stated month.
Before use:
Store in a refrigerator at a temperature of 2°C to 8°C.
Do not freeze.
After opening:
Use each pre-filled syringe within 28 days of opening. Store below 25°C.
The syringe must always be stored with the protective cap in place to protect from light.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What MENOPUR contains

• The active substance is highly purified menotropin (human menopausal gonadotropin, hMG)

MENOPUR 1200 IU solution for injection in a pre-filled pen:
One multidose automatic pen contains menotropin equivalent to follicle-stimulating hormone (FSH) biological activity of 1200 IU and luteinizing hormone (LH) biological activity of 1200 IU.
Other components are:
Phenol
Methionine
Arginine hydrochloride
Polysorbate 20
Sodium hydroxide
Dilute hydrochloric acid
Water for injections

What MENOPUR looks like and contents of the pack
MENOPUR is a clear, colourless solution for injection in a pre-filled pen.
MENOPUR 1200 IU solution for injection in a multidose automatic pen is available in packs containing 1 pen and 21 injection needles.

Marketing Authorisation Holder and Importer:
Ferring GmbH
Wittland 11, D-24109 Kiel, Germany

Local representative of the Marketing Authorisation Holder:
Ferring Pharmaceutical Poland Sp. z o.o.
ul. Szamocka 8
01-748 Warsaw
Tel.: + 48 22 246 06 80

This medicinal product is authorised in the European Economic Area countries under the following names:
Belgium, Czech Republic, Ireland, Luxembourg, Slovakia: Menotropin Ferring
Bulgaria, Croatia, Cyprus, Denmark, Estonia, Finland, Greece, Hungary, Iceland, Latvia, Lithuania, Malta, Norway, Poland, Portugal, Romania, Slovenia, Spain, Sweden: Menopur
Germany: Menogon HP
Italy: Meropur