Package Insert: Information for the User

Fostipur 75 UI Powder and Solvent for Injectable Solution

Urofolitropin

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

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you alone, 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 package insert. See section 4.

• Fostipur is used to stimulate ovulation in women who do not ovulate and who do not respond to other treatments (clomiphene citrate).
• For the induction of multifollicular development (and, consequently, of several oocytes) in women undergoing fertility treatments.

Urofolitropin is a highly purified human follicle-stimulating hormone, which belongs to a group of medications called gonadotropins.

This medication must be used under the control of your doctor.

Before starting treatment, the couple's fertility should be evaluated.

Do not use Fostipur

• If you are allergic to urofolitropin or any of the other components of this medication (listed in section 6).
• Increased size of ovaries or ovarian cysts not caused by a hormonal disorder (polycystic ovary syndrome).

trastorno hormonal (síndrome del ovario poliquístico).

• Unknown origin bleeding.
• Ovarian, uterine, or breast cancer.
• Abnormal swelling (tumor) of the pituitary gland or hypothalamus (in the brain).

This medication should not be used if you have conditions such as premature menopause, organ malformation, or tumors in the uterus that prevent a normal pregnancy.

Warnings and precautions

Although there is no information on allergic reactions with Fostipur, inform your doctor if you have any allergic reactions to similar medications.

This treatment increases the risk of developing a condition known as ovarian hyperstimulation syndrome (OHSS) (see Possible side effects).If OHSS occurs, you should stop treatment and avoid becoming pregnant. The first signs of OHSS are lower abdominal pain, nausea (discomfort), vomiting, and weight gain. If these symptoms appear, you should be examined by your doctor as soon as possible. In severe cases, but rare, the ovaries may become enlarged and fluid may accumulate in the abdomen or chest.

The medication used to achieve the final release of mature eggs (containing human chorionic gonadotropin, hCG) may increase the likelihood of OHSS.Therefore, it is not recommended to use hCG in cases where OHSS is developing, and you should not have sex, even with barrier contraceptive methods, for at least 4 days.

It should be noted that women with fertility problems have a higher rate of spontaneous abortions than the general population.

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.

There is a slight increase in the risk of ectopic pregnancy (ectopic pregnancy) in women with damaged fallopian tubes.

Multiple pregnancies and characteristics of parents undergoing fertility treatments (e.g., mother's age, sperm characteristics) may be associated with a higher risk of birth defects.

Treatment with Fostipur, like pregnancy itself, may increase the risk of developing thrombosis. Thrombosis is the formation of a blood clot in a blood vessel, most often in the veins of the legs or lungs.

Consult your doctor before starting treatment, especially:

• if you already know you have a higher risk of developing thrombosis.
• if you or a close relative have had thrombosis in the past,
• if you have excessive weight.

This medication is prepared from human urine. The risk of transmission of infection or disease to the body cannot be completely eliminated. However, this risk is limited by the virus elimination phases in the manufacturing process, particularly HIV, Herpes virus, and Papillomavirus.

No cases of viral contamination have been reported.

Use of Fostipur with other medications

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

Pregnancy and breastfeeding

Fostipur should not be used if you are pregnant or breastfeeding.

Fostipur contains sodium

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

Dosage and duration of treatment:

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

Women who do not ovulate and have irregular or incomplete menstruation:

If you have your period, the treatment should start within 7 days of the onset of menstruation (the first 7 days of the menstrual cycle).

The dosage consists of 1 injection per day, subcutaneously or intramuscularly.

The initial common dose is 75 UI to 150 UI of FSH (Fostipur) per day. This dose may be increased, if necessary, from 37.5 to 75 UI at intervals of 7 days or, preferably, 14 days, to obtain an adequate response.

The maximum daily dose of FSH should not generally exceed 225 UI.

If your doctor does not find an adequate response after 4 weeks of treatment, this treatment cycle should be interrupted. For the next cycle, your doctor will indicate a treatment with a higher initial dose.

When a good response (satisfactory follicular growth) is obtained, only one injection of another medication (hCG) will be administered, used to induce final follicular maturation and ovulation release. This will take place 24-48 hours after the last Fostipur injection. It is recommended to have sexual intercourse on the same day of hCG administration and the next day.

If an excessive ovarian response is obtained, treatment should be interrupted and hCG should not be administered (see Possible Adverse Effects). For the next cycle, your doctor will indicate a lower initial dose.

Women undergoing ovarian stimulation for multiple follicular development prior to in vitro fertilization or other assisted reproduction techniques:

Situation 1– If you have your period.

The treatment should start 2 or 3 days after the onset of menstruation (the first 2 or 3 days of the menstrual cycle).

The dosage consists of 1 injection per day, subcutaneously or intramuscularly.

A common dose for superovulation is the administration of 150 to 225 UI of Fostipur per day. Treatment continues, with dose adjustment according to your response, until adequate follicular development is achieved. This is usually achieved by the 10th day of treatment (an average of 5 to 20 days) and is evaluated by blood sampling and/or ultrasound examinations.

The maximum dose is generally 450 UI/day.

Once adequate follicular development is achieved, a single injection of a medication used to induce final follicular maturation will be administered; this medication contains up to 10,000 UI of human chorionic gonadotropin (hCG). It will be administered between 24-48 hours after the last Fostipur injection.

Oocyte puncture will take place approximately 35 hours later.

Situation 2- When a GnRH agonist is used

Fostipur should be administered approximately 2 weeks after the start of this treatment. Both treatments will continue until adequate follicular development is achieved. One injection of Fostipur per day will be administered, subcutaneously or intramuscularly. For example, after 2 weeks of treatment with a GnRH agonist, 150 to 225 UI of Fostipur will be administered for the first 7 days. The dose will then be adjusted according to ovarian response.

Administration instructions:

Fostipur is administered by injection, both subcutaneously and intramuscularly.

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

After advising and practicing conveniently, your doctor may ask you to administer the Fostipur injection yourself.

Firstly, your doctor must:

• Leave you to practice administering the injection to yourself subcutaneously.
• Indicate which areas are possible for you to administer the injection.
• Indicate how to prepare the solution for the injection carefully.
• Explain how to prepare the correct dose to be administered.

Other types of presentations, different from ampoules, are intended for self-administration by patients.

Before you administer the Fostipur injection, read the following instructions carefully:

How to prepare and inject Fostipur, using 1 vial of powder

The solution must be prepared just before administering the injection. Each vial is for single use. The medication must be reconstituted under aseptic conditions.

Fostipur must be reconstituted only with the solvent provided in the package.

Prepare a clean surface and wash your hands before reconstituting the solution. It is essential that both your hands and the utensils you will use are as clean as possible.

Extend the following materials on a clean surface:

• 2 pieces of alcohol-soaked cotton (not included in the package)
• 1 vial containing the Fostipur powder
• 1 ampoule of solvent
• 1 syringe (not included in the package)
• 1 needle for preparing the injection (not included in the package)
• 1 fine needle for subcutaneous injection (not included in the package)

Reconstitution of the injection solution, using 1 vial of powder

Preparing the injection solution:

Preparing higher doses, using more than 1 vial of powder.

If your doctor has recommended higher doses, you can obtain them by using more than 1 vial of powder with a solvent ampoule.

When reconstituting more than 1 vial of Fostipur, at the end of phase 4 described above, introduce the reconstituted content of the first vial back into the syringe, and inject it slowly into a second vial. Repeat phases 2 to 4 for the second vial and subsequent ones, until the content of the required number of vials is dissolved (within the limit of the maximum total dose of 450 UI, corresponding to a maximum of 6 vials of Fostipur 75 UI or 3 vials of Fostipur 150 UI).

Your doctor may increase your dose by 37.5 UI, which represents half of a vial of Fostipur 75 UI.

To do this, you must reconstitute the content of the 75 UI vial according to phases 2 to 3 described above, and introduce half of this reconstituted solution (0.5 ml) into the syringe according to phase 4.

In this situation, you will have two preparations to inject: the first reconstituted preparation in 1 ml and the second containing 37.5 UI in 0.5 ml.

Both preparations should be injected with their own syringes according to the following

phases.

The solution must be transparent and colorless.

Inject the medication subcutaneously:

The injection site:

•Your doctor ornurse will haveindicated which part ofyour body you can inject themedication.Common areas include the thigh or the lower abdominal wall below the navel.

• Clean theinjection site withan alcohol-soaked cotton swab.

Insertion of the needle:

Injecting the solution:

•Inject itunder the skinas you were taught.Do not inject it directly into a vein.Push theplunger slowly and steadily,so thatthe solution isinjected correctlyand the skinis not damaged.

Take all the timeyou needto inject the prescribed volume of solution.Depending on the dose prescribed by your doctor, you may not need to use the total volume of the solution.

Removing the needle:

• Pull the syringe quickly and press a cotton swab with disinfectant on the injection site. A gentle massage on the site, while still maintaining pressure, helps to disperse the Fostipur solution and relieves discomfort.

Disposal of all used utensils:

Any unused product or waste material must be disposed of according to local requirements(once the injection is complete, all needles and empty syringes must be disposed of in an appropriate container).

If you use more Fostipur than you should

The effects of a Fostipur overdose are unknown, although it is assumed that a hyperstimulation syndrome could occur (see Possible Adverse Effects). If more Fostipur than prescribed is administered, contact your doctor or pharmacist.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or the Toxicology Information Service, phone: 915 620 420, indicating the medication and the amount ingested.

If you forget to use Fostipur

Administer the next injection at the scheduled time. Do not use a double dose to compensate for the missed doses.

If you interrupt treatment with Fostipur

Do not interrupt treatment on your own initiative. Consult your doctor if you are considering stopping using this medication. If you have any other doubts about the use of this medication, consult your doctor or pharmacist.

Like all medications, Fostipurmay cause adverse effects, although not everyone will experience them.

The following adverse effects are important and will require immediate action if you experience them. You must discontinue Fostipur administration and seek immediate medical attention if you experience the following:

Frequent, may affect up to 1 in 10 people:

• Ovarian Hyperstimulation Syndrome (see section 2 for additional information).

The following adverse effects have also been reported:

Frequent, may affect up to 1 in 10 people:

• headache,
• abdominal bloating sensation,
• constipation,
• pain at the injection site.

Rare, may affect up to 1 in 100 people:

• increased thyroid gland activity,
• mood changes,
• fatigue,
• dizziness,
• difficulty breathing (dyspnea),
• nasal bleeding,
• nausea, indigestion, abdominal pain,
• skin rash, itching,
• seizures,
• cystitis,
• breast enlargement, breast pain,
• difficulty stopping bleeding.

Redness, pain, and hematomas may occur at the injection site (frequency not established).

See section 2 for additional information on the risk of blood clots, ectopic pregnancy, multiple pregnancies, and miscarriage.

If you consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting Adverse Effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es.

By reporting adverse effects, you can contribute to providing more information

about the safety of this medication.

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

Do not store at a temperature above 25°C. Store the vial and the solvent ampoule in the outer packaging, to protect it from light.

Do not use Fostipur after the expiration date that appears on the case and on the vial.

Use immediately after reconstitution.

Do not use Fostipur if it warns that the solution is not transparent. After reconstitution, the solution must be transparent and colorless.

Medicines should not be thrown down the drains or in the trash. Dispose of the containers and medicines that you do not need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines that you do not need. In this way, you will help to protect the environment.

Composition of Fostipur

The active principle is urofolitropina.Cada vial contains 75 UI of urofolitropina (hormona foliculostimulante: FSH): 1 ml of reconstituted solution may contain 75 UI, 150 UI, 225 UI, 300 UI, 375 UI or 450 UI of urofolitropina, when reconstituting 1, 2, 3, 4, 5 or 6 vials, respectively, in 1 ml of solvent.

The specific activityin vivois equal to or greater than 5,000 UI of FSH per mg of protein.

The other components are:

Powder: lactose monohydrate.

Solvent: sodium chloride and water for injectable preparations.

Appearance of the product and contents of the package

Fostipur is presented in powder and solvent for injectable solution.

Box with 1, 5 or 10 cartons. Each carton contains: 1 vial with powder containing 75 UI of urofolitropina and 1 ampoule of solvent (1 ml).

The appearance of the powder is a hardened white to off-white mass and the solvent is transparent and colorless,

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

IBSA Farmaceutici Italia srl

Via Martiri di Cefalonia 2

26900 Lodi (Italy)

Responsible for manufacturing

IBSA Farmaceutici Italia S.r.L, Via Martiri di Cefalonia - 26900 Lodi (Italy)

You can request more information about this medication by contacting the local representative of the holder of the marketing authorization:

Instituto Bioquimico Iberico IBSA S.L.

Avenida Diagonal 605,

8th floor, Local 1,

08028 Barcelona (Spain)

This medication is authorized in the member states of the European Economic Area with the following names (the concentrations and pharmaceutical forms are identical in all countries, only the commercial names change)

Austria:Fostimon

Belgium:Fostimon

Cyprus:Fostimon

Denmark:Fostimon

Finland:Fostimon

France:Fostimon

Luxembourg:Fostimon

Ireland:Fostimon

Netherlands:Fostimon

Norway:Fostimon

Spain:Fostipur

Sweden:Fostimon

United Kingdom:Fostimon

Date of the last review of this prospectus:February 2024

The detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/