Menopur

PATIENT INFORMATION LEAFLET

For Internal Use - Internal

Enclosed leaflet: patient information

MENOPUR 1200 IU solution for injection in a pre-filled pen injector

Menotropin

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• 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.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 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 pen injector. The injection is administered subcutaneously (under the skin) - usually in the abdomen. MENOPUR contains menotropin, which is a mixture of two natural hormones called follicle-stimulating hormone (FSH) and luteinizing hormone (LH). These hormones enable the normal functioning of the reproductive organs. The FSH and LH hormones contained in menotropin are obtained from the urine of post-menopausal women.

• hormone follicle-stimulating (FSH) and
• hormone luteinizing (LH). They enable the normal functioning of the reproductive organs. The FSH and LH hormones contained in menotropin are obtained from the urine of post-menopausal women.

What MENOPUR is used for

MENOPUR is used to treat women who are unable to become pregnant, in the following situations: in women who are unable to 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 been treated for infertility with a medicine called "clomiphene citrate" but it has been ineffective; in women participating in assisted reproduction programs, such as in vitro fertilization (IVF) or embryo transfer (ET), gamete intrafallopian transfer (GIFT), or intracytoplasmic sperm injection (ICSI).

How MENOPUR works

MENOPUR supports the production of multiple ovarian follicles by the ovaries, in which eggs can develop. This is called the development of multiple ovarian follicles. For Internal Use - Internal

2. Important information before using MENOPUR

What to check before starting MENOPUR

Before starting MENOPUR, the doctor must assess the causes of fertility disorders in both partners. In particular, check if the following diseases do not occur, which require different, appropriate treatment: hypothyroidism and adrenal insufficiency; high levels of a hormone called prolactin - hyperprolactinemia; pituitary tumors - a gland located at the base of the brain; hypothalamic tumors - an area located under the part of the brain called the hill. If the patient has any of the above diseases, they must inform their doctor before starting treatment with MENOPUR.

When not to use MENOPUR

if the patient is allergic to menotropin or any of the other ingredients of this medicine (listed in section 6); if the patient has tumors of the uterus, ovaries, breast, or parts of the brain, such as the pituitary gland or hypothalamus; if the patient has ovarian cysts or ovarian enlargement - not caused by polycystic ovary syndrome; if the patient has developmental abnormalities of the uterus or other genital organs; if the patient has vaginal bleeding of unknown cause; if the patient has uterine fibroids - these are non-cancerous tumors in the uterus; if the patient is 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). The patient should immediately inform their doctor if they experience symptoms of OHSS, even if: it has been several days since the last dose of the medicine; the patient has stopped using MENOPUR. These may be symptoms of excessive ovarian activity, which can be severe. In such a case, the doctor will discontinue MENOPUR treatment and initiate appropriate hospital treatment.

• the medicine has been administered for several days
• the patient has stopped using MENOPUR. These may be symptoms of excessive ovarian activity, which can be severe. In such a case, the doctor will discontinue MENOPUR treatment and initiate appropriate hospital treatment.

Adhering to the recommended dose and carefully monitoring the treatment reduces the likelihood of these symptoms.

Tests and examinations

During MENOPUR treatment, the doctor usually refers the patient for ultrasound examinations (USG) and sometimes for blood tests to check the response to treatment.

Pregnancy-related risks

Hormone treatment, such as MENOPUR, may increase the risk of: ectopic pregnancy in women with previously diagnosed tubal diseases; miscarriage; multiple pregnancy (twins, triplets, etc.); physical defects present in the child at birth (congenital defects). 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. For Internal Use - Internal

Blood clots

The likelihood of blood clots in veins or arteries is higher in pregnant women. Infertility treatment may increase the likelihood of blood clots, especially if: the patient is overweight; the patient has a blood clotting disorder "thrombophilia"; blood clots have occurred before or in a family member. The patient should inform their doctor if they think this applies to them.

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.

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.

Important information about some ingredients of MENOPUR

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

3. How to use MENOPUR

This medicine should always be used exactly as prescribed by the doctor. In case of doubt, consult a doctor.

Women who do not produce eggs (do not ovulate)

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. How much MENOPUR to use? The initial dose is usually 75 IU (International Units) to 150 IU per day. Depending on the patient's response, the dose can be increased - up to a maximum of 225 IU. The prescribed dose should be administered for at least 7 days before the doctor changes the dose. It is recommended to increase the dose by 37.5 IU, but not more than 75 IU, at each change. The doctor will monitor the treatment results. The treatment cycle should be discontinued if no response to treatment is observed 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 be 5,000 IU to 10,000 IU. The patient will receive hCG the day after the last MENOPUR injection. For Internal Use - Internal The patient is advised to have sexual intercourse on the day of hCG administration and the next day. Alternatively, insemination (intrauterine insemination) can be performed. The patient remains under the doctor's close observation for at least 2 weeks. When there is no response to MENOPUR treatment: the doctor will monitor the treatment results. Depending on the progress of the treatment, the doctor may decide to discontinue MENOPUR administration and refrain from administering hCG.

Women participating in assisted reproduction programs

Patients participating in an assisted reproduction program will also receive a medicine that supports the action of a hormone called "gonadotropin-releasing hormone" (GnRH) - an agonist. MENOPUR administration should start about 2 weeks after starting GnRH agonist treatment. The patient may also receive a medicine called a GnRH antagonist. MENOPUR administration should start on the 2nd or 3rd day of the menstrual cycle (1st day of menstrual bleeding is the 1st day of the cycle). How much MENOPUR to use? MENOPUR should be administered daily for at least 5 days. The initial dose of MENOPUR is usually 150 IU to 225 IU. Depending on the patient's response to treatment, this dose may be increased to a maximum of 450 IU per day. The dose should not be increased by more than 150 IU at a time. Treatment usually should not last longer than 20 days. After confirming a sufficient number of appropriately sized ovarian follicles, the patient will receive a single injection of hCG at a dose of up to 10,000 IU to induce ovulation (egg release). The patient remains under the doctor's close observation for at least 2 weeks after hCG administration. The doctor will monitor the treatment results. Depending on the progress of the treatment, the doctor may decide to discontinue MENOPUR administration and refrain from administering hCG. In such a case, the patient will be instructed to use a mechanical contraceptive method (e.g., a condom). Otherwise, the patient should refrain from sexual intercourse until the next menstruation.

Using MENOPUR

Very carefully follow the "Instructions for use" provided with the pen injector packaging. The first MENOPUR injection should be performed under the supervision of a doctor or nurse. The doctor will decide whether the patient can self-administer subsequent injections at home - after complete training. MENOPUR will be administered subcutaneously (under the skin), usually in the abdomen. Each pre-filled pen injector can be used for multiple injections.

Using a higher dose of MENOPUR than recommended

In case of using a higher dose of MENOPUR than recommended, the doctor should be informed. For Internal Use - Internal

Missing a dose of MENOPUR

A double dose should not be used to make up for a missed dose. In case of missing a dose of MENOPUR, the doctor should be informed.

4. Possible side effects

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

Serious side effects

Ovarian Hyperstimulation Syndrome (OHSS)

Immediately inform the doctorif the patient experiences any of the following symptoms, which may be symptoms of OHSS: abdominal pain or bloating; nausea; diarrhea; weight gain; breathing difficulties; decreased urination frequency.

If any of these symptoms occur, immediately contact the doctor, even if the symptom appears several days after the last dose of the medicine or if the patient has stopped using MENOPUR.

The patient may need urgent medical attention.These side effects may indicate excessive ovarian activity, which is known as ovarian hyperstimulation syndrome (OHSS). In severe cases of OHSS, rare complications have occurred, such as fluid accumulation in the abdominal cavity, pelvic cavity, or pleural cavity, breathing difficulties, and decreased urination frequency or amount, blood clots in blood vessels (thromboembolic disorders), and ovarian torsion.

Allergic reactions (hypersensitivity)

Immediately inform the doctorif the following occurs: rash; itching; swelling of the throat and breathing difficulties. If any of these symptoms occur, immediately contact the doctor.

Other side effects

The following side effectsoccur frequently, i.e., in 1 to 10 out of every 100 treated patients: headache; nausea; abdominal pain or bloating; pelvic pain; reactions at the injection site, such as pain, redness, swelling, itching, or bruising. The following side effectsoccur infrequently, i.e., in 1 to 10 out of every 1,000 treated patients: vomiting; abdominal discomfort; diarrhea; fatigue; dizziness; ovarian cysts; breast symptoms, 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 treated patients: acne. In addition to the above, the following side effectshave been observed, whose frequencyis unknown: vision disorders; fever; nausea; weight gain; muscle and joint pain; ovarian torsion, as a complication of increased ovarian activity caused by excessive stimulation; hives; blood clots, as a complication of increased ovarian activity caused by excessive stimulation.

Reporting side effects

If side effects occur, including any side effects not listed in the 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, website: https://smz.ezdrowie.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 use this medicine after the expiry date stated on the label of the pre-filled pen injector and the carton after "EXP". The expiry date refers to the last day of the month stated. Before use: Store in a refrigerator at a temperature of 2°C to 8°C. Do not freeze. After opening: Use each pre-filled pen injector within 28 days of opening. Store below 25°C. The pen injector should always be stored with the cap on to protect it from light. Medicines should not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

For Internal Use - Internal

What MENOPUR contains

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

MENOPUR 1200 IU solution for injection in a pre-filled pen injector: One pre-filled pen injector contains menotropin in an amount equivalent to 1200 IU FSH (follicle-stimulating hormone) and 1200 IU LH (luteinizing hormone). The other ingredients are: phenol; methionine; arginine hydrochloride; polysorbate 20; sodium hydroxide; hydrochloric acid; water for injections

What MENOPUR looks like and what the pack contains

MENOPUR is a clear and colorless solution for injection in a pre-filled pen injector. MENOPUR 1200 IU solution for injection in a pre-filled pen injector is available in packs containing 1 pen injector and 21 injection needles.

Marketing authorization holder and importer:

Ferring GmbH, Wittland 11, D-24109 Kiel, Germany. Local representative of the marketing authorization holder: Ferring Pharmaceutical Poland Sp. z o.o., ul. Szamocka 8, 01-748 Warsaw, Tel.: +48 22 246 06 80

This medicine is authorized in the Member States of the European Economic Area 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; Date of last revision of the leaflet:July 2024; For Internal Use - Internal; Instructions for use

MENOPUR pre-filled pen injector

Menotropinum, solution for injection

Before the first injection, a healthcare professional (doctor, nurse, or pharmacist) should demonstrate how to properly prepare and inject MENOPUR. Read this instruction carefully before using the MENOPUR pen injector and every time you receive a new pen injector. There may be new information.

• Wash your hands.
• Make sure you are using a pen injector with the correct strength.
• Check the expiration date on the pen injector label.

Attaching the needle - (Steps 2 to 6)

Important:

• Always attach a new needle for each injection.
• Use only single-use needles with a locking mechanism, which are provided with the pen injector.

For Internal Use - Internal

2.

• Remove the pen injector cap.
• Check if the pen injector is damaged.
• Check if the solution is clear and does not contain undissolved particles.
• Do not use the pen injector if it is damaged, contains particles, or the solution is cloudy.

3.

• Remove the protective film from the needle.

For Internal Use - Internal

4.

• Insert the needle into the pen injector.
• When the needle is securely locked, you should hear or feel a click.

5.

• Remove the outer needle cap.
• Do notdiscard the outer needle cap. It will be needed to remove and dispose of the needle after injection.

6.

• Remove and discard the inner needle cap.

Removing air bubbles - (Steps 7 to 9)

• Before using the pen injector for the first time, air bubbles must be removed from the cartridge to ensure proper dose setting.
• Air removal is only performed before the first use of the pen injector.
• Perform Steps 7 to 9, even if you do not see air bubbles.
• If the pen injector has been used before, proceed directly to Step 10.

7.

• Turn the dose setting knob clockwise until the drop symbol is in line with the dose indicator.

For Internal Use - Internal

• If an incorrect dose is set for air removal, the dose can be corrected up or down without losing medicine by turning the dose setting knob in either direction until the drop symbol is in line with the dose indicator.

Dose indicator
Drop symbol

Dose indicator
Drop symbol

8.

• Hold the pen injector vertically with the needle pointing upwards.
• Tap the cartridge with your finger so that any air bubbles in the cartridge move to the top.

9.

• Holding the pen injector with the needle still pointing upwards (away from the face), press the dose button all the way down until the number "0" is in line with the dose indicator. Check if a drop of liquid appears at the tip of the needle.

For Internal Use - Internal

• If a drop does not appear, repeat Steps 7 to 9 (air removal) until a drop appears.
• If a drop still does not appear after 5 attempts, remove the needle (see Step 13), attach a new needle (see Steps 3 to 6), and repeat the air removal (see Steps 7 to 9).
• If a drop still does not appear after using a new needle, try a new pen injector.

Setting the dose - (Step 10)

• Turn the dose setting knob clockwise until the prescribed dose is in line with the dose indicator in the dose window.
• The dose can be corrected up or down without losing medicine by turning the dose setting knob in either direction until the correct dose is in line with the dose indicator.
• Do not press the dose button while setting the dose to avoid losing medicine. See "Examples of dose setting" on pages 20 to 21.

Dose indicator
Dose display window

For Internal Use - Internal
For Internal Use - Internal
where examples are given on how to calculate and record a divided dose.

Injecting the dose - (Steps 11 to 12)

Important:

• Read the description of Steps 11 and 12 on pages 14 to 15 before performing the injection.
• The medicine should be injected under the skin of the abdominal area near the navel.
• Each subsequent injection should be performed in a different location to reduce the risk of skin reactions, such as redness and irritation.
• Do not inject into an area that is painful (tender), bruised, red, hardened, scarred, or stretched.

11.

• Hold the pen injector so that the dose window is visible during injection.
• Grasp a skin fold and insert the needle straight into the skin, as demonstrated by a healthcare professional. Do not press the dose button yet. (See Figure 11).
• Place your thumb on the dose button.
• Press the dose button all the way down and hold it.
• Hold the dose button down and when the number "0" is in line with the dose indicator, wait for 8 seconds (count slowly to eight) (See Figure 12). This ensures that the full dose is administered.

seconds

12.

• After holding the dose button down for 8 seconds, release the dose button. Then, slowly remove the needle from the injection site, pulling it straight out of the skin.
• If blood appears at the injection site, gently press a swab or cotton ball to the site.

Warning:

• Do not tilt the pen injector during injection and needle removal.
• Tilting the pen injector may cause the needle to bend or break.
• If the broken needle remains in the body or under the skin, seek medical attention immediately.

Removing the needle - (Step 13)

13.

For Internal Use - Internal

• Carefully place the outer needle cap on the needle, pressing it firmly (See Figure 13A).
• Unscrew the needle by turning it counterclockwise to detach it from the pen injector (See Figures 13B and 13C).
• Dispose of the used needle carefully (See Figure 13D).
• See "Disposal" on page 18.

Outer needle cap
Inner needle cap
Warning:

• Always remove the needle after each use. Needles are for single use only.
• Do not store the pen injector with the needle attached.

Replacing the pen injector cap - (Step 14)

14.

• Place the pen injector cap firmly to protect it between injections.

Warning:

• The pen injector cap will not fit on the needle.
• When the pen injector is not in use, it should be protected with the cap.

Disposal

Needles:

Used needles should be placed in a puncture-resistant container, such as a sharps disposal container, immediately after use. For Internal Use - Internal If a sharps disposal container is not available, a container that meets the following requirements can be used: it is made of heavy-duty plastic; it can be closed with a tight-fitting, puncture-resistant lid to prevent sharps from coming out; it is upright and stable during use; it is leak-proof; and it is properly labeled as a hazardous waste container.

• it is made of heavy-duty plastic,
• it can be closed with a tight-fitting, puncture-resistant lid to prevent sharps from coming out,
• it is upright and stable during use,
• it is leak-proof, and
• it is properly labeled as a hazardous waste container.

The sharps disposal container should be disposed of when it is almost full. Ask a doctor, nurse, or pharmacist about the proper disposal method. Do not dispose of a filled sharps disposal container in the household trash unless local regulations permit it.

MENOPUR pen injectors:

• Ask a pharmacist how to dispose of unused medicines.

The following pages provide more information on the following topics:

:

• Examples of dose setting.................. pages 20 to 21
• Administering a divided dose of MENOPUR.................. page 22
• Divided doses .................................................. page 23

And also:

• Frequently asked questions……………........................... page 24
• Warnings............................................................................ page 25
• Contact.................................................................................. page 25

Examples of dose setting

Examples of dose setting on the MENOPUR pen injector.

The table on the right shows examples of prescribed doses, how to set the example prescribed doses, and the appearance of the dose window for the example prescribed doses.

For Internal Use - Internal

Administering a divided dose of MENOPUR

If it is not possible to set the full prescribed dose on the pen injector, it means that there is not enough medicine left in the pen injector to administer the full dose. The patient will have to administer part of the prescribed dose using the current pen injector and the remaining part of the dose using a new pen injector (divided dose injection). Alternatively, the current pen injector can be discarded (disposed of) and a new pen injector can be used to administer the full prescribed dose in 1 injection. If the divided dose injection method is chosen, follow the instructions below and record the amounts of medicine to be administered as shown in the divided dose log on page 23.

• Column A shows examples of prescribed doses. Record the prescribed dose in Column A.
• Column B shows examples of the dose value remaining in the pen injector (which is the value that can be set on the pen injector).
• Record the dose value remaining in the pen injector in Column B. Perform the injection using the remaining medicine in the pen injector.
• Prepare and prime a new pen injector (Steps 1 to 9).
• Calculate and record the remaining dose to be injected in Column C, subtracting the value from Column B from the value from Column A. If necessary, check the calculations on a calculator.
• If necessary, see "Examples of dose setting" on pages 20 to 21.
• In case of doubts about calculating the divided dose, consult a healthcare professional.
• Inject the remaining part of the dose (value from Column C) using the new pen injector to complete the prescribed dose.

Divided dose log

Most Frequently Asked Questions

For Internal Use - Internal

• 1. Do I need to vent the injector before each injection?
• No. Venting must be performed only before administering the first injection with a new injector.
• 2. How will I know that the injection is complete?
• The dose button is pressed to the end.
• The number "0" is set on the dose indicator line.
• Count slowly to 8 while holding the dose button pressed with the needle still inserted under the skin.
• 3. Why do I need to count to 8 while holding the dose button pressed?
• Holding the dose button for 8 seconds allows for the injection of the entire dose and its absorption under the skin.
• 4. What if the dose setting dial cannot be set to the required dose?
• The cartridge in the injector may not contain enough medication to administer the prescribed dose.
• The injector does not allow setting a dose larger than the dose remaining in the cartridge.
• You can inject the remaining medication in the injector and complete the administration of the prescribed dose using a new injector (split dose) or use a new injector to administer the entire prescribed dose.
• 5. What if I don't have enough needles?
• If you need additional needles, you should contact your doctor. You should only use the needles provided with the MENOPUR injector or prescribed by your doctor.

Warnings

• Do not use an injector that has been dropped or has hit a hard surface.
• If the dose button does not press easily, do not force it. You should change the needle. If the dose button still does not press easily after changing the needle, you should use a new injector.
• Do not attempt to repair a damaged injector. If the injector is damaged, you should contact a medical professional or a local representative of the responsible entity.

Contact

In case of any questions or problems with the injector, you should contact a medical professional or a representative of the responsible entity.
The local representative of the responsible entity:
Ferring Pharmaceutical Poland Sp. z o.o.
Szamocka 8
01-748 Warsaw
Phone: + 48 22 246 06 80
Last update: March 2025
For Internal Use - Internal