Menopur

Leaflet attached to the packaging: patient information

MENOPUR, 150 IU FSH + 150 IU LH, powder and solvent for solution for injection

for injection
Menotropin

You should read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult your doctor.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor. See section 4.

Table of contents of the leaflet:

• 1. What is Menopur and what is it 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 is Menopur and what is it used for

Menopur is a powder (in this case, it is a solid, compact mass) that must be dissolved in a liquid (solvent) before use. The medicine is administered as a subcutaneous or intramuscular injection. Menopur (highly purified menotropin obtained from the urine of postmenopausal women) contains two hormones: follicle-stimulating hormone (FSH) and luteinizing hormone (LH). FSH and LH are hormones produced in the body of a woman and a man. They enable the normal functioning of the reproductive organs. Menopur is used to treat infertility in the following situations: in women who cannot become pregnant because their ovaries do not produce eggs (also in the case of so-called polycystic ovary syndrome). Menopur is used in women who have already been treated with clomiphene citrate for infertility, but the medicine has been ineffective; in women participating in assisted reproduction programs, such as in vitro fertilization and embryo transfer, gamete intrafallopian transfer, and intracytoplasmic sperm injection. Menopur supports the production of multiple ovarian follicles by the ovaries, in which eggs can develop (development of multiple ovarian follicles); in men whose testes produce insufficient sperm due to a deficiency of gonadotropins (hormones produced by the pituitary gland and affecting the testes).

2. Important information before using Menopur

Before starting treatment with Menopur, the doctor must assess the causes of fertility disorders in both partners. In particular, it is necessary to check if the following diseases are present, which require different, appropriate treatment: hypothyroidism and adrenal insufficiency; high levels of the hormone prolactin (hyperprolactinemia); pituitary tumors (a gland located at the base of the brain); tumors of the hypothalamus (an area located under the part of the brain called the hill). If the patient has been diagnosed with any of the above diseases, they should inform their doctor before starting treatment with Menopur.

When not to use Menopur

In women and men: if the patient is allergic to menotropin or any of the other ingredients of this medicine (listed in section 6); if pituitary or hypothalamic tumors have been diagnosed. In women: if the patient is pregnant or breastfeeding; if the patient has ovarian cysts or ovarian enlargement not caused by polycystic ovary syndrome; if the patient has vaginal bleeding of unknown cause; if the patient has tumors of the uterus, ovaries, or breast; if the patient has developmental abnormalities of the genital organs that prevent the development of pregnancy; if the patient has uterine fibroids that prevent the development of pregnancy; if the patient has premature menopause. In men: if the patient has prostate cancer; if the patient has testicular tumors.

Warnings and precautions

Caution should be exercised if the patient experiences: abdominal pain; abdominal distension; nausea; vomiting; diarrhea; weight gain; breathing difficulties; decreased frequency or amount of urine. The above symptoms should be reported to the doctor immediately, even if they occur a few days after the last dose of the medicine. They may be symptoms of excessive ovarian activity, which can be severe. If these symptoms worsen, fertility treatment should be discontinued and appropriate treatment should be initiated in the hospital. Adhering to the recommended dose and carefully monitoring the course of treatment reduces the likelihood of these symptoms. These symptoms may also occur when Menopur is discontinued. If any of these symptoms occur, the doctor should be contacted immediately. During treatment with Menopur, the doctor usually refers the patient for ultrasound examinations (using ultrasound) and sometimes for blood tests to check the response to treatment. Hormone treatment such as Menopur may increase the risk of: ectopic pregnancy (outside the uterus) in women with previously diagnosed fallopian tube diseases; miscarriage; multiple pregnancy (twins, triplets, etc.); congenital defects (physical defects present in the child at birth). In some women treated for infertility, ovarian or other reproductive organ tumors have developed. It is not yet known whether this was caused by hormone treatment such as Menopur. The risk of blood clots in veins or arteries is higher in pregnant women. Fertility treatment may increase the risk of blood clots, especially if the patient is overweight or if blood clots have occurred previously in the patient or in their family (relatives). The patient should inform their doctor if they think this applies to them. Menopur, in combination with a hormone called human chorionic gonadotropin (hCG), may be administered in the treatment of male infertility.

Children and adolescents

The use of Menopur in children and adolescents is not appropriate.

Menopur and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. Clomiphene citrate is another medicine used to treat infertility. If Menopur is administered at the same time as clomiphene citrate, the effect on the ovaries may be enhanced. Menopur can be used in combination with Bravelle. See section 3.

Pregnancy and breastfeeding

Menopur should not be used during pregnancy or breastfeeding.

Driving and using machines

It is unlikely that Menopur will affect the ability to drive and use machines.

Menopur contains sodium chloride

Menopur contains less than 1 mmol of sodium chloride (23 mg) per dose, which means the medicine is considered "sodium-free".

3. How to use Menopur

This medicine should always be used as directed by the doctor. If you have any doubts, you should consult your doctor. Women who do not ovulate (do not produce eggs) Treatment should start 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. The initial dose is usually 75 IU (International Units) FSH + 75 IU LH to 150 IU FSH + 150 IU LH (i.e., from ½ vial to 1 vial of powder) per day, but it can be adjusted according to the patient's response to a maximum of 225 IU FSH + 225 IU LH (i.e., 1 vial and ½ vial of powder) per day. The specified dose should be administered for at least 7 days before the dose is changed. It is recommended to increase the dose by 37.5 IU FSH + 37.5 IU LH (i.e., ¼ vial of powder) at each change, but not more than 75 IU FSH + 75 IU LH (i.e., ½ vial of powder). The treatment cycle should be discontinued if no response is observed after 4 weeks. When a satisfactory response is achieved, the next day after the last injection of Menopur, another hormone - hCG should be administered in a single injection at a dose of 5000 IU to 10,000 IU. It is recommended to have sexual intercourse on the day of administration and the next day after administration of hCG. Alternatively, insemination (administration of semen directly into the uterus) can be performed. The patient remains under close supervision of the doctor for at least 2 weeks after administration of hCG. The doctor will check the results of using Menopur. Depending on the progress of treatment, the doctor may decide to discontinue Menopur and refrain from administering hCG. In such a case, the patient will be instructed to use a mechanical contraceptive method (e.g., condom) or abstain from sexual intercourse until the next menstruation. Women participating in assisted reproduction programs If the patient has also been treated with a GnRH agonist (a medicine that supports the action of gonadotropin-releasing hormone), administration of Menopur should start about 2 weeks after the start of GnRH agonist treatment. If the patient has also been treated with a GnRH antagonist, administration of Menopur should start on the 2nd or 3rd day of the menstrual cycle (the 1st day of menstruation is the 1st day of the cycle). The medicine should be administered daily for at least 5 days. The initial dose of Menopur is usually 150 IU FSH + 150 IU LH to 225 IU FSH + 225 IU LH (i.e., from 1 vial to 1 vial and ½ vial of powder) per day. Depending on the patient's response to treatment, this dose may be increased to a maximum of 450 IU FSH + 450 IU LH (i.e., 3 vials of powder) per day. The dose should not be increased by more than 150 IU FSH + 150 IU LH (i.e., 1 vial of powder) at a time. Treatment usually should not last longer than 20 days. After a sufficient number of appropriately sized ovarian follicles has been observed, the patient receives a single injection of hCG at a dose of up to 10,000 IU to induce ovulation (release of the egg). The patient remains under close supervision of the doctor for at least 2 weeks after administration of hCG. The doctor will check the results of using Menopur. Depending on the progress of treatment, the doctor may decide to discontinue Menopur and refrain from administering hCG. In such a case, the patient will be instructed to use a mechanical contraceptive method (e.g., condom) or abstain from sexual intercourse until the next menstruation. Men: Treatment starts with the administration of hCG 3 times a week at a dose of 1000 IU to 3000 IU until a normal testosterone level is achieved in the blood serum. Then, Menopur is administered intramuscularly at a dose of 75 IU FSH + 75 IU LH to 150 IU FSH + 150 IU LH (i.e., from ½ vial to 1 vial of powder) 3 times a week for several months.

INSTRUCTIONS FOR USE

If the doctor has prescribed self-injection of Menopur, all instructions provided should be followed. The first injection of Menopur should be performed under the supervision of a doctor. RECONSTITUTION (DISSOLUTION) OF MENOPUR:Menopur is a powder and must be reconstituted (dissolved) before injection. The liquid used for dissolution is supplied with the powder. Menopur should be reconstituted immediately before use. To do this, you should:

• Put a thick, long needle (reconstitution needle) firmly on the syringe.

reconstitute the powder.

• Break the top of the ampoule with the solvent at the point indicated by the dot.
• Insert the needle into the ampoule with the solvent.
• Draw all the liquid from the ampoule into the syringe.
• Insert the needle through the rubber stopper of the vial with the powder and slowly

inject all the liquid. Aim for the vial wall to avoid creating bubbles.

• The powder should dissolve quickly (within 2 minutes), forming a clear solution.

• To facilitate reconstitution of the powder, the vial can be swirled. Do not

shake, as this may cause air bubbles to form. If the solution is not clear orif it contains permanent particles, it should not be used.

• Draw the solution back into the syringe.

If the doctor has prescribed more than one vial of Menopur for each injection, the solution obtained after reconstituting the powder from the first vial can be injected into the second vial with the powder. This procedure can be repeated with subsequent vials of powder - up to 3 vials of powder, but only if the doctor has prescribed it. If the doctor has prescribed Bravelle with Menopur, the two medicines can be mixed. To do this, Menopur should be reconstituted, the resulting solution should be slowly injected into the vial with Bravelle, wait for Bravelle to dissolve, draw the solution containing both medicines into the syringe, and inject subcutaneously. This procedure allows avoiding the injection of each medicine separately. ADMINISTRATION OF MENOPUR:

• After drawing the prescribed dose of the medicine into the syringe, the needle

should be changed to a short, thin needle (injection needle).

• Hold the syringe with the needle upwards and gently tap the syringe with your finger so that air bubbles collect at the top. Press the syringe plunger gently until the first drop of liquid appears at the tip of the needle.
• The patient is informed by the doctor or nurse where to inject the medicine (e.g., front of the thigh, abdomen, etc.).
• Disinfect (disinfect) the skin at the injection site.
• To perform the injection, a skin fold should be created between

fingers and the needle should be inserted quickly at an angle of 90 degrees (perpendicularly). Inject the solution by pressing the syringe plunger, and then remove the needle.

• After removing the needle, press the injection site to stop bleeding. Gentle massage at the injection site helps the solution spread under the skin.
• Used items should not be thrown into household waste bins, but disposed of in an appropriate manner.

Use of a higher dose of Menopur than recommended

In the event of using a higher dose of Menopur than recommended, the doctor should be informed.

Missing a dose of Menopur

A double dose should not be used to make up for a missed dose. If a dose of Menopur is missed, the doctor should be informed.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Hormones used to treat infertility, such as Menopur, can cause excessive ovarian activity, leading to a condition called ovarian hyperstimulation syndrome (OHSS), especially in women with polycystic ovary syndrome. Symptoms include: abdominal pain, abdominal distension, nausea, vomiting, diarrhea, weight gain. In severe cases of OHSS, rare complications such as fluid accumulation in the abdominal cavity, pelvic cavity, and (or) pleural cavity, breathing difficulties, and decreased frequency or amount of urine, blood clots in blood vessels (thromboembolic disorders), and ovarian torsion have occurred. If any of these symptoms occur, the doctor should be contacted immediately, even if they occur a few days after the last dose of the medicine. During treatment, allergic reactions (hypersensitivity) may occur. Symptoms of such reactions may include: rash, itching, throat swelling, and breathing difficulties. If any of these symptoms occur, the doctor should be contacted immediately. The following side effectsoccur frequently, i.e., in 1 to 10 out of every 100 patients treated: abdominal pain; headache; nausea; abdominal distension; pelvic pain; excessive ovarian stimulation causing high activity (ovarian hyperstimulation syndrome); reactions at the injection site, such as pain, redness, bruising, swelling, and (or) itching. The following side effectsoccur infrequently, i.e., in 1 to 10 out of every 1000 patients treated: vomiting; abdominal complaints; diarrhea; fatigue; dizziness; fluid-filled blisters in the ovaries (ovarian cysts); breast complaints, including breast pain, breast tenderness, discomfort, nipple pain, and breast swelling; hot flashes. The following side effectsoccur rarely, i.e., in 1 to 10 out of every 10,000 patients treated: acne; rash. In addition to the above, the following side effectshave been observed after the marketing authorization of Menopur, and their frequencyis unknown: vision disorders; fever; malaise; allergic reactions; weight gain; muscle and joint pain (e.g., back pain, neck pain, and pain in the arms and legs); ovarian torsion, as a complication of increased ovarian activity caused by excessive stimulation; itching; hives; blood clots, as a complication of increased ovarian activity caused by excessive stimulation.

Reporting side effects

If side effects occur, including those not listed in this leaflet, the doctor should be informed. Side effects can be reported directly to the Department of Drug Safety Monitoring 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, e-mail: ndl@urpl.gov.pl Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Menopur

The medicine should be stored out of sight and reach of children. Do not store above 25°C. Store in the original packaging to protect from light. Do not use this medicine after the expiry date stated on the carton and labels of the vial and ampoule after the EXP. The expiry date refers to the last day of the given month. Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of unused medicines. This will help protect the environment.

6. Contents of the pack and other information

What Menopur contains

• The active substance of the medicine is highly purified menotropin (Menotropinum) (human menopausal gonadotropin, hMG) in an amount equivalent to 150 IU FSH (follicle-stimulating hormone) and 150 IU LH (luteinizing hormone).
• Other ingredients are:
• powder: lactose monohydrate, polysorbate 20, sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment)
• solvent: sodium chloride, hydrochloric acid 10% (for pH adjustment), water for injections

What Menopur looks like and contents of the pack

Menopur is a powder and solvent for solution for injection. The carton contains 1 vial or 5 vials of clear glass containing the powder. The carton also contains the same number of clear glass ampoules containing the solvent. Not all pack sizes may be marketed.

Marketing authorization holder:

Ferring GmbH Wittland 11 D-24109 Kiel Germany

Manufacturer/Importer:

Ferring GmbH Wittland 11 D-24109 Kiel Germany

Date of last revision of the leaflet:

To obtain additional information on the medicine, you should contact the representative of the marketing authorization holder: Ferring Pharmaceuticals Poland Sp. z o.o. ul. Szamocka 8, 01-748 Warsaw Tel.: +48 22 246 06 80, Fax: +48 22 246 06 81