HMG-LEPORI 75 I.U. POWDER AND SOLVENT FOR INJECTABLE SOLUTION

Introduction

Leaflet: information for the user

HMG-lepori 75 UI powder and solvent for injectable solution

Menotropin

Read the entire leaflet carefully before starting to use this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

side effects that are not listed in this leaflet.

Contents of the leaflet

1. What is HMG-lepori and what is it used for
2. What you need to know before starting to use HMG-lepori
3. How to use HMG-lepori
4. Possible side effects
5. Storage of HMG-lepori
6. Contents of the pack and further information

1. What is HMG-lepori and what is it used for

HMG-lepori contains menotropin (also called human menopausal gonadotropin or hMG).

It is an extract from the urine of postmenopausal women and contains two hormones called follicle-stimulating hormone (FSH) and luteinizing hormone (LH).

FSH and LH are present in both men and women and help the reproductive organs function normally.

In adult women, HMG-lepori is used:

• to help release an egg from the ovary (ovulation) in women who cannot ovulate and have not responded to treatment with a substance called "clomiphene citrate".
• to help develop multiple follicles (each containing an egg) in women undergoing assisted reproduction techniques (techniques that can help you become pregnant), such as "in vitrofertilization", "intratubal gamete transfer" or other assisted reproduction techniques.
• to help release an egg from the ovary (ovulation) in women who are not ovulating because their body produces very small amounts of gonadotropins (FSH and LH).

In adult men, HMG-lepori is used:

in combination with another hormone called "human chorionic gonadotropin" (hCG) to help produce sperm in men who are infertile due to low levels of certain hormones.

2. What you need to know before starting to use HMG-lepori

This medicine should be used under strict medical supervision.

This medicine should be used under strict medical supervision. Before starting treatment with HMG-lepori, you and your partner should be evaluated by a doctor to determine the causes of the infertility problem.

Do not use HMG-lepori

• If you are allergic to menotropin or any of the other components of this medicine (listed in section 6).
• If you have an increased size of the ovaries or cysts in the ovary that are not caused by a hormonal disorder (polycystic ovary syndrome).
• If you have vaginal bleeding of unknown origin.
• If you have ovarian, uterine, or breast cancer.
• If you have a tumor in the pituitary gland or hypothalamus (in the brain).
• If you have active thromboembolic problems (thrombosis).
• If you are pregnant or breastfeeding.
• If you have testicular, prostate, or breast cancer in men.

Do not use this medicine in case of disorders such as premature menopause, malformation of the sexual organs, primary testicular failure, uterine tumors that prevent a normal pregnancy, or postmenopausal period.

If you know you have any of these conditions, inform your doctor beforeusing this medicine .

Warnings and precautions

Consult your doctor before starting to use HMG-lepori.

Before starting treatment, the type of infertility of the couple and the possible existence of contraindications for pregnancy should be assessed. In particular, the presence of thyroid and adrenal gland disorders, as well as increased prolactin secretion (hormone secreted in a part of the nervous system called the pituitary gland), should be ruled out, and appropriate specific treatment should be initiated.

Ovarian hyperstimulation syndrome (OHSS)

This treatment increases the risk of developing a disease known as ovarian hyperstimulation syndrome (OHSS). This is rare if you are not ovulating and your treatment is administered as recommended. However, if unexpected ovarian hyperstimulation occurs, your treatment should be discontinued and you should avoid becoming pregnant. The initial signs of ovarian hyperstimulation are pain in the lower abdominal region, as well as nausea (feeling of discomfort), vomiting, weight gain, difficulty breathing, decreased urine output, and increased ovarian size. If these symptoms occur, you should be examined as soon as possible. In severe cases, although rare, the ovaries may become twisted and fluid may accumulate in the abdomen or thoracic cavity, potentially leading to a heart attack or stroke.

Multiple pregnancy

The occurrence of multiple pregnancies and births in patients receiving ovulation induction treatment increases compared to natural conception. However, this risk can be reduced if the recommended dose is used.

Multiple pregnancies and the characteristics of parents undergoing fertility treatments (e.g., maternal age, sperm characteristics) may be associated with an increased risk of maternal and newborn complications. There is a slight increase in the risk of ectopic pregnancy in women with damaged fallopian tubes.

Ectopic pregnancy

Because infertile women undergoing assisted reproduction and, in particular, in vitrofertilization (IVF), often have tubal abnormalities, the incidence of ectopic pregnancies (outside the uterus) may increase. It is therefore important to confirm early by ultrasound that a pregnancy is intrauterine.

Abortion

We should note that women with fertility problems have a higher rate of spontaneous abortions than the normal population.

Tumors of the reproductive system

There are reports of ovarian tumors and other reproductive system tumors, benign and malignant, in women undergoing multiple infertility treatments. It has not been demonstrated that treatment with gonadotropins increases the initial risk of these tumors in infertile women.

Blood coagulation problems (thromboembolic episodes)

Women at risk of blood clots should inform their doctor, as gonadotropins may increase their risk.

Allergic reactions

Although there is no information on allergic reactions with HMG-lepori, you should inform your doctor if you have allergic reactions to similar medicines.

Children and adolescents

HMG-lepori is not indicated in children and adolescents under 18 years of age.

Use of HMG-lepori with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medicine.

The use of HMG-lepori with other hormones or drugs used in the treatment of infertility may increase the follicular response.

Pregnancy, breastfeeding, and fertility

HMG-lepori should not be used if you are pregnant or breastfeeding.

Driving and using machines

No studies have been conducted on the effect on the ability to drive or use machines.

However, it is very rare for HMG-lepori to affect the ability to drive and use machines.

Important information about some of the components of HMG-lepori

This medicine contains less than 23 mg (1 mmol) of sodium per dose, so it is considered essentially "sodium-free".

Use in athletes

Male athletes are informed that this medicine contains chorionic gonadotropin, which can produce a positive result in doping tests.

3. How to use HMG-lepori

Follow your doctor's instructions for administering this medicine exactly. If you are in doubt, consult your doctor again.

The solution to be injected should be prepared in aseptic conditions immediately before use. The solvent is injected into the vial of powder, which dissolves rapidly to form a clear solution. It should be administered immediately by intramuscular injection. Each vial is for single use.

• Women who do not ovulate (do not produce eggs):

Treatment will begin within the first 7 days of the menstrual cycle (day 1 is the first day of the period). Treatment should be administered daily for at least 7 days.

The initial dose is usually 75-150 UI daily (1-2 vials), which may be adjusted according to the individual patient's response (up to a maximum of 225 UI, 3 vials of powder). This individual dose should be administered for at least 7 days before adjusting the dose. The recommended dose increase is 37.5 UI per adjustment, and should not exceed 75 UI. The treatment cycle should be abandoned if there is no adequate response after 4 weeks.

When an optimal response is obtained, a single injection of another hormone called human chorionic gonadotropin (hCG: 5000 to 10000 UI, or hCG-r: 250 mcg) will be administered the day after the last injection of HMG-lepori. The patient is recommended to have intercourse on the same day and the day after administration of hCG. Intrauterine insemination (injection of sperm directly into the uterus) can be performed alternatively. Your doctor should closely monitor your progress for at least 2 weeks after administration of hCG/hCG-r.

Your doctor will monitor the effect of HMG-lepori treatment. Depending on the progress, your doctor will decide to discontinue treatment with HMG-lepori and not administer the hCG/hCG-r injection. In this case, you should use a contraceptive method (condom) or not have sexual intercourse until the next period begins.

II. Women in assisted reproduction programs:

If you are also receiving treatment with GnRH agonists, treatment with HMG-lepori should begin approximately 2 weeks after starting treatment with GnRH agonists, continuing both treatments until adequate follicular development is achieved.

In patients who do not receive GnRH agonists, treatment with HMG-lepori should begin on day 2 or 3 of the menstrual cycle (day 1 is the first day of the period).

Treatment will be administered daily for at least 5 days. The recommended initial dose of HMG-lepori is 150-225 UI (2-3 vials of powder).

This dose may be increased according to your response to treatment, up to a maximum of 450 UI (6 vials) per day. Treatment is not usually recommended for more than 20 days.

If there are sufficient egg sacs (follicles), a single injection of human chorionic gonadotropin (hCG: 5000 to 10000 UI or hCG-r: 250 micrograms) will be administered to induce ovulation (release of an egg).

Your doctor should closely monitor your progress for at least 2 weeks after administration of hCG/hCG-r.

Your doctor will monitor the effect of HMG-lepori treatment. Depending on the progress, the doctor will decide to discontinue treatment with HMG-lepori and not administer the hCG/hCG-r injection. In this case, you should use a contraceptive method (condom) or not have sexual intercourse until the next period begins.

III. Women who are not ovulating because their body produces very small amounts of FSH and LH:

The recommended initial dose of HMG-Lepori is 75 UI per day, along with 75-150 UI of FSH. Treatment should be adapted to the individual patient's response.

If it is considered appropriate to increase the dose of FSH, the dose adjustment should be made preferably at intervals of 7-14 days and preferably with increments of 37.5-75 UI. It may be acceptable to prolong the duration of treatment for up to 5 weeks.

When an optimal response is obtained, a single injection of human chorionic gonadotropin (hCG: 5000 to 10000 UI or hCG-r: 250 micrograms) should be administered 24-48 hours after the last injection of HMG. The patient is recommended to have intercourse on the same day as the administration of hCG, as well as the day after.

If an excessive response is obtained, treatment should be discontinued and hCG should not be administered. Treatment should be restarted in the next cycle with a lower dose of FSH than in the previous cycle.

IV. Infertility in men:

Treatment will consist of a dose of HMG-lepori of 150 UI, 3 times a week, along with hCG, for a minimum of 4 months. If there is no response, treatment can be continued for several months.

HMG-lepori is administered slowly into the muscle by injection.

Each vial is for single use, and the injection should be administered immediately after reconstitution.

If you use more HMG-lepori than you should

The effects of an overdose of HMG-leporiare unknown, although it is likely that ovarian hyperstimulation syndrome (see section 2) may occur.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount used or ingested.

If you forget to use HMG-lepori

Do not administer a double dose to make up for forgotten doses. Consult your doctor as soon as you realize you have forgotten to administer a dose.

If you have any other questions about the use of this medicine, ask your doctor.

4. Possible side effects

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

The reported side effects are:

Frequent, may affect up to 1 in 10 people:

• headache,
• feeling of swelling,
• diarrhea,
• ovarian hyperstimulation syndrome,
• pain at the injection site.

Uncommon, may affect up to 1 in 100 people:

• nausea,
• abdominal pain,
• slow digestion,
• fatigue,
• difficulty breathing (dyspnea),
• redness and itching after injection,
• breast enlargement,
• breast pain,
• hot flashes,
• dizziness,
• feeling of lack of energy (lethargy),
• mood changes,
• sleepiness,
• increased thyroid gland activity,
• nosebleeds,
• increased bleeding time (test to evaluate clot formation when bleeding),
• cystitis (urinary tract infection).

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

• pain, redness, and hematoma at the injection site
• blood clot formation (thromboembolism).

Reporting side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of HMG-lepori

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

Do not store above 25°C.

Keep the powder and solvent vials in the outer packaging to protect them from moisture.

Do not use after the expiration date shown on the carton and on the vials, after EXP. The expiration date is the last day of the month indicated.

Use immediately after reconstitution. The solution should be clear and colorless.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and further information

Composition of HMG-lepori

• The active substance is menotropin (human menopausal gonadotropin, hMG), which corresponds to 75 UI of follicle-stimulating hormone (FSH) activity and 75 UI of luteinizing hormone (LH) activity.
• The other components are:

For the powder: lactose.

For the solvent: sterile physiological solution.

Appearance of the product and pack contents

HMG-lepori is presented as a powder and solvent for injectable solution.

Box with 1 vial of powder + 1 vial of solvent.

Box with 10 vials of powder + 10 vials of solvent.

The powder is a hardened mass of white to off-white color, and the solvent is a clear, colorless solution.

Marketing authorization holder and manufacturer

Marketing authorization holder:

ANGELINI PHARMA ESPAÑA, S.L.

c/ Antonio Machado, 78-80

3rd floor, module A-Australia Building

08840 Viladecans, Barcelona (Spain)

Manufacturer:

Labiana Pharmaceuticals, S.L.

• Casanova 27-31

08757 Corbera de Llobregat

Barcelona

Date of last revision of this leaflet:March 2015

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS)

http://www.aemps.gob.es/