Label: information for the user

HMG-lepori 75 UI powder and solvent for injectable solution

Menotropin

Read this label carefully before starting to use this medication, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, 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 any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label.

See section 4.

HMG-leporicontains menotropin (also known as human menopausal gonadotropin or hMG).

It is an extract of urine from 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 to function normally.

In adult women, HMG-lepori is used:

• to help release an egg from the ovary (ovulation) in women who cannot ovulate and who have not responded to treatment with a substance called "clomiphene citrate".
• to help develop multiple follicles (each containing an egg) in women undergoing assisted reproductive techniques (techniques that may help them become pregnant), such as "in vitro fertilization", "intratubal gamete transfer" or other assisted reproductive 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 males, HMG-lepori is used:

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

This medication must be used under strict medical supervision.

This medication must be used under strict medical supervision. Before starting treatment with HMG-lepori, you and your partner must be evaluated by a doctor to see 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 medication (including in section 6).
• If you have an enlarged ovary or ovarian cysts without being a consequence of 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.

This medication should not be used in cases of premature menopause, organ malformation, primary testicular failure, tumors of the uterus that prevent a normal pregnancy, or in the postmenopausal period.

If you know you have any of these conditions, inform your doctor before using this medication.

Warnings and precautions

Consult your doctor before starting to use HMG-lepori.

Before starting treatment, you must be evaluated for the type of infertility of the couple and the possible existence of contraindications for pregnancy. In particular, you must rule out the presence of thyroid and adrenal gland disorders, as well as an increase in prolactin secretion (hormone secreted in a part of the nervous system called the pituitary gland), and initiate the appropriate specific treatment.

Ovarian Hyperstimulation Syndrome (OHSS)

This treatment increases the risk of developing a condition known as ovarian hyperstimulation syndrome (OHSS). This is rare if you are not ovulating and your treatment is administered as recommended. However, if an unexpected hyperstimulation occurs, your treatment must be interrupted and you should avoid pregnancy. The initial signs of OHSS are lower abdominal pain, nausea (feeling of discomfort), vomiting, weight gain, difficulty breathing, decreased urine output, and enlarged ovaries. If these symptoms occur, you should be examined as soon as possible. In severe cases, although rare, the ovaries can become twisted and fluid can accumulate in the abdomen or thoracic cavity, leading to myocardial infarction or cerebral 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 characteristics of parents undergoing fertility treatments (e.g., maternal age, sperm characteristics) may be associated with an increased risk of maternal and neonatal complications. There is a slight increase in the risk of ectopic pregnancy in women with damaged fallopian tubes.

Ectopic Pregnancy

Due to the fact that infertile women undergoing assisted reproduction and, in particular, IVF (in vitro fertilization), often have tubal abnormalities, the incidence of ectopic pregnancies (outside the uterus) may be increased. Therefore, early ultrasound confirmation that a pregnancy is intrauterine is essential.

Abortion

We must warn that women with fertility problems have a higher rate of spontaneous abortions than the general population.

Reproductive System Tumors

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

Blood Coagulation Problems (Thromboembolic Episodes)

Women with a 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 medications.

Children and Adolescents

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

Use of HMG-lepori with Other Medications

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

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

Pregnancy, Lactation, and Fertility

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

Driving and Operating Machines

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

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

Important Information about Some Components of HMG-lepori

This medication contains less than 23 mg (1 mmol) of sodium per dose, making it essentially "sodium-free".

Use in Athletes

Inform male athletes that this medication contains chorionic gonadotropin, which may produce a positive result in doping control tests.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor again.

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

I. Women who do not ovulate (do not produce eggs):

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

The initial dose is usually 75-150 IU per day (1-2 vials), which may be adjusted according to the individual response of the patient (up to a maximum of 225 IU, 3 vials of powder). This individual dose must be administered for at least 7 days before adjusting the dose. The recommended dose increase is 37.5 IU per adjustment, and it should not exceed 75 IU. The treatment cycle should be discontinued if it does not respond adequately after 4 weeks.

When an optimal response is obtained, a single injection of another hormone called human chorionic gonadotropin (hCG: 5,000 to 10,000 IU, or hCG-r: 250 mcg) will be administered one day after the last injection of HMG-lepori. It is recommended that the patient have intercourse on the same day and the day after administration of hCG. Insemination may 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 sex until the next period begins.

II. Women in assisted reproduction programs:

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

In patients not receiving GnRH agonists, HMG-lepori treatment 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 IU (2-3 vials of powder).

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

If there are sufficient egg sacs (follicles), a single injection of human chorionic gonadotropin (hCG: 5,000 IU to 10,000 IU or hCG-r: 250 mcg) 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, 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 sex until the next period begins.

III. Women who do not ovulate because their body produces very small amounts of FSH and LH hormones:

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

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

When an optimal response is obtained, a single injection of human chorionic gonadotropin (hCG: 5,000 IU to 10,000 IU or hCG-r: 250 mcg) should be administered 24-48 hours after the last injection of hMG. It is recommended that the patient have intercourse on the same day of hCG administration, 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 FSH dose than the previous cycle.

IV. Male infertility:

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

HMG-lepori is administered slowly in the muscle through an injection in the same.

Each vial is for single use only, 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-lepori are unknown, although it is assumed that a hyperstimulation syndrome (see section 2) could 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 medication and the amount used or ingested.

If you forgot to use HMG-lepori:

Do not administer a double dose to compensate for the missed 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 medication, ask your doctor.

Like all medications, this medicationcan produce adverse effects, although not all people will experience them.

Reported adverse effects are:

Frequent, may affect up to 1 in 10 people:

• headache,
• feeling of swelling,
• diarrhea,
• polycystic ovary syndrome,
• pain at the injection site.

Less frequent, may affect up to 1 in 100 people:

• nausea,
• abdominal pain,
• slow digestion,
• fatigue,
• difficulty breathing (dyspnea),
• redness and itching after injection,
• enlargement of the breast,
• breast pain,
• migraines,
• dizziness,
• sensation of lack of energy (lethargy),
• changes in mood,
• drowsiness,
• increased activity of the thyroid gland,
• nasal bleeding,
• 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
• formation of blood clots (thromboembolism).

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medicationout of the sight and reach of children.

Do not store above 25°C.

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

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

Use immediately after reconstitution. The solution must be transparent and colorless.

Medicines should not be disposed of through drains or in the trash. Dispose of containers and unused medicines at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and unused medicines. By doing so, you will help protect the environment.

Composition of HMG-lepori

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

For the powder: lactose.

For the solvent: sterile physiological solution.

Appearance of the product and contents of the packaging

HMG-leporiis presented in 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 colorless transparent solution.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

ANGELINI PHARMA ESPAÑA, S.L.

c/ Antonio Machado, 78-80

3rd floor, module A-Edificio Australia

08840 Viladecans, Barcelona (Spain)

Responsible for manufacturing:

Labiana Pharmaceuticals, S.L.

C. Casanova 27-31

08757 Corbera de Llobregat

Barcelona

Date of the last review of this leaflet:March 2015

The detailed and updated information on this medication is available on the website

of the Spanish Agency for Medicines and Medical Devices (AEMPS)

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