Menopur

Package leaflet: Information for the patient

MENOPUR 600 IU solution for injection in pre-filled pen
Menotropinum
Read all of this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet:

1. What MENOPUR is and what it is used for
2. What you need to know before you use 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 injection pen. The injection is administered subcutaneously (an "under-the-skin" injection), usually in the abdomen.
The active substance in MENOPUR is highly purified menotropin. Menotropin is obtained from the 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 obtained from the urine of pregnant women may be added.
FSH, hCG, and LH are natural hormones produced in a woman's body. They support the normal function of the reproductive organs.

What MENOPUR is used for
MENOPUR is used in the treatment of infertility in women in the following two situations:

• in women who are unable to become pregnant because their ovaries do not produce eggs (including women with polycystic ovary syndrome); MENOPUR is used in women who have already been treated with a medicine called clomiphene citrate, but this treatment was ineffective;
• in women participating in assisted reproductive technology programs, such as in vitro fertilization/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 eggs can grow (multiple follicular development).

2. Information before using MENOPUR

What should be checked before starting treatment with MENOPUR
Before starting treatment with MENOPUR, your doctor must evaluate the causes of infertility in both partners. In particular, the following conditions should be ruled out, as they require different, specific treatments:

• hypothyroidism or adrenal insufficiency;
• high levels of a hormone called prolactin – known as hyperprolactinemia;
• tumors of the pituitary gland – a gland located at the base of the brain;
• tumors of the hypothalamus – an area located below the thalamus in the brain.
  If you have any of the conditions listed above, you must inform your doctor before starting treatment with MENOPUR.

When not to use MENOPUR

• if you are allergic to menotropin or any of the other ingredients of this medicine (listed in section 6);
• if you have tumors of the uterus, ovaries, breasts, or areas of the brain such as the pituitary gland or hypothalamus;
• if you have ovarian cysts or enlarged ovaries not caused by polycystic ovary syndrome;
• if you have congenital malformations of the uterus or other reproductive organs;
• if you have vaginal bleeding of unknown cause;
• if you have uterine fibroids – benign tumors of the uterus;
• if 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 (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, or
• you have already stopped using MENOPUR.
  These symptoms may indicate excessive ovarian activity, which can become severe. In such cases, your doctor will discontinue treatment with MENOPUR and initiate appropriate hospital treatment.
  Following the recommended dosage and careful monitoring during treatment reduces the likelihood of these symptoms occurring.

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

Risks associated with pregnancy
Hormonal treatment such as with MENOPUR may increase the risk of:

• ectopic pregnancy (pregnancy outside the uterus) in women with previously diagnosed tubal disease;
• miscarriage;
• multiple pregnancy (twins, triplets, etc.);
• congenital malformations (birth defects).
  In some women treated for infertility, tumors of the ovaries or other reproductive organs have developed. It is currently unknown 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. Fertility 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
MENOPUR should not be used in children and adolescents.

MENOPUR and other medicines
You should tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Clomiphene citrate is another medicine used in infertility treatment. 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 certain ingredients of MENOPUR
MENOPUR contains less than 1 mmol of sodium (23 mg) per dose, meaning the medicine is considered essentially "sodium-free".

3. How to use MENOPUR

This medicine should always be used exactly as directed by your doctor. If you are unsure, 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.

How much 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 at a time.
Your doctor will monitor the treatment results with MENOPUR. The treatment cycle should be discontinued if there is no response after 4 weeks.

When the response to MENOPUR treatment is satisfactory:
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 remains under close medical supervision for at least 2 weeks.

When there is no response to MENOPUR treatment:
Your doctor will monitor the results of MENOPUR therapy.
Depending on treatment progress, the doctor may decide to discontinue MENOPUR and withhold hCG administration.

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

How much MENOPUR should be used?
MENOPUR should be administered daily for at least 5 days.
The usual starting dose of MENOPUR is between 150 and 225 IU.
Depending on the patient's response, this 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.
Typically, treatment should not last longer than 20 days.
Once a sufficient number of appropriately sized ovarian follicles 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 remains under close medical supervision for at least 2 weeks after hCG administration.
Your doctor will monitor the response to MENOPUR treatment.
Depending on treatment progress, the doctor may decide to discontinue MENOPUR and withhold hCG administration.
In such a case, the patient will be advised to use a mechanical method of contraception (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 pen package.
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, following complete training.
MENOPUR will be administered by subcutaneous injection (under the skin), usually in the abdominal area.
Each pre-filled pen may be used for multiple injections.

If you use more MENOPUR than you should
If you use 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)
You should contact your doctor immediately if you experience any of the following symptoms,
which may be signs of OHSS:
abdominal pain or abdominal distension;
feeling unwell (feeling sick);
diarrhea;
weight gain;
difficulty breathing;
reduced frequency of urination.
If any of these symptoms occur, you should contact your doctor immediately,
even if the symptom appears several days after the last dose of the medicine or if you have stopped using
the medicine MENOPUR. You 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 rarely occurred, 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.
Allergic (hypersensitivity) reactions
You should contact your doctor immediately if the following occur:
rash;
itching;
throat swelling and difficulty breathing.
If any of these symptoms occur, you should contact your doctor immediately.
Other adverse reactions
The following adverse reactions occur frequently, i.e. in 1 to 10 out of every 100 treated patients:
headache;
feeling unwell (nausea);
abdominal pain or distension;
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 every 1,000 treated
patients:
feeling unwell (vomiting);
abdominal discomfort;
diarrhea;
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 every 10,000 treated
patients:
acne.
In addition to the above, other adverse reactions have been observed, the frequency of which
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, you should 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.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store MENOPUR

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label of the prefilled pen 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 prefilled pen within 28 days of opening. Store below 25°C.
The pen should always be stored with the cap on to protect it from light.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the package and other information

What MENOPUR contains

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

MENOPUR 600 IU solution for injection in a pre-filled pen:
One multidose automatic pen contains menotropin equivalent to follicle-stimulating hormone (FSH) activity of 600 IU and luteinizing hormone (LH) activity of 600 IU.
Other ingredients are:
Phenol
Methionine
Arginine hydrochloride
Polysorbate 20
Sodium hydroxide
Hydrochloric acid, diluted
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 600 IU solution for injection in a multidose automatic pen is available in packs containing 1 pen and 12 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 Member States 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