BEMFOLA 75 IU/0.125 ML Roztwór do wstrzykiwań

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1. Bemfola 75 IU/0.125 ml injectable solution in pre-filled pen, 150 IU/0.25 ml injectable solution in pre-filled pen, 225 IU/0.375 ml injectable solution in pre-filled pen, 300 IU/0.50 ml injectable solution in pre-filled pen, 450 IU/0.75 ml injectable solution in pre-filled pen
   1. What is Bemfola and what is it used for
   2. What you need to know before using Bemfola
   3. How to use Bemfola
   4. Possible side effects
   5. How to store Bemfola
   6. Contents of the pack and other information
2. Bemfola pre-filled pen 75 IU /0.125 ml, pre-filled pen 150 IU /0.25 ml, pre-filled pen 225 IU /0.375 ml, pre-filled pen 300 IU /0.50 ml, pre-filled pen 450 IU /0.75 ml
   1. How to use the Bemfola pre-filled pen
   2. Choose a clean work surface
   3. How to prepare a prefilled pen for injection
   4. How to set the dose prescribed by the doctor
   5. How to inject the dose
   6. After the injection

Bemfola 75 IU/0.125 ml injectable solution in pre-filled pen, 150 IU/0.25 ml injectable solution in pre-filled pen, 225 IU/0.375 ml injectable solution in pre-filled pen, 300 IU/0.50 ml injectable solution in pre-filled pen, 450 IU/0.75 ml injectable solution in pre-filled pen

follitropin alfa

Read this leaflet carefully before you start to use this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Bemfola is and what it is used for
• 2. What you need to know before you use Bemfola
• 3. How to use Bemfola
• 4. Possible side effects
• 5. How to store Bemfola
• 6. Contents of the pack and other information

1. What is Bemfola and what is it used for

What is Bemfola
Bemfola contains an active substance called “follitropin alfa”. Follitropin alfa is a “follicle-stimulating hormone” (FSH), belonging to the family of hormones called “gonadotropins”. Gonadotropins are involved in reproduction and fertility.

What is Bemfola used for
In adult women, Bemfola is used:

• to promote the release of an egg from the ovary (ovulation) in women who do not have ovulation and who have not responded to treatment with a medicine called “clomifene citrate”;
• together with another medicine called “lutropin alfa” (“luteinizing hormone” or LH) to promote the release of an egg from the ovary (ovulation) in women whose body produces very few gonadotropins (FSH and LH);
• to promote the development of several follicles (each containing an egg) in women undergoing assisted reproductive procedures (procedures that can help start a pregnancy), such as “in vitro fertilization”, “gamete intrafallopian transfer” or “zygote intrafallopian transfer”;

In adult men, Bemfola is used:

• together with another medicine called “human chorionic gonadotropin” (hCG) to promote sperm production in infertile men due to low levels of certain hormones.

2. What you need to know before using Bemfola

Before starting treatment, the couple's fertility must be adequately assessed by a physician experienced in the treatment of fertility disorders.

Do not use Bemfola

• if you are allergic to follicle-stimulating hormone or any of the other ingredients of this medicine (listed in section 6);
• if you have a tumor of the hypothalamus or pituitary gland (both parts of the brain);
• if you are a woman
• with large ovaries or fluid-filled sacs in the ovary (ovarian cysts) of unknown origin
• with vaginal bleeding of unknown origin
• with cancer of the ovary, uterus or breast
• with a condition that usually makes normal pregnancy impossible, such as ovarian insufficiency (premature menopause) or malformations of the reproductive system;
• if you are a man
• with irreversible damage to the testicles.

Do not use Bemfola if you suffer from any of these conditions. If you have doubts, consult your doctor before using this medicine.

Warnings and precautions
Consult your doctor or pharmacist before using Bemfola
Porphyria
Tell your doctor before starting treatment if you or a family member suffers from porphyria (inability to break down porphyrins, which can be passed on from parents to children).
Immediately inform your doctor if:

• the skin becomes fragile and easily blisters, especially in areas frequently exposed to the sun, and/or
• you have pain in the stomach, arms or legs.

In these cases, your doctor may recommend that you stop treatment.
Ovarian Hyperstimulation Syndrome (Ovarian Hyperstimulation Syndrome, OHSS)
If you are a woman, this medicine increases the risk of OHSS. In this case, the follicles develop excessively and turn into large cysts. Immediately inform your doctor if you experience lower abdominal pain, rapid weight gain, nausea or vomiting, or difficulty breathing; your doctor may ask you to stop taking the medicine (see section 4).
If you are anovulatory patients and if the recommended dosage and administration schedule are followed correctly, the risk of OHSS is less likely. Treatment with Bemfola rarely causes severe OHSS if a medicine (containing human chorionic gonadotropin – hCG) is not administered to induce ovulation. If you are developing OHSS, your doctor may not administer hCG in this treatment cycle and recommend that you avoid sexual intercourse or use a barrier contraceptive for at least four days.
Multiple pregnancy
While using Bemfola, you have a higher risk of establishing a multiple pregnancy, in most cases twins, compared to natural conception. Multiple pregnancy can cause complications for you and your babies. You can reduce the risk of a multiple pregnancy by using the correct dose of Bemfola at the correct times. In assisted reproductive procedures, the risk of a multiple pregnancy is related to age, the quality and number of eggs fertilized or embryos transferred to you.
Abortion
If you undergo assisted reproductive procedures or ovarian stimulation for egg production, you are more likely to have an abortion compared to other women.
Blood coagulation disorders (thromboembolic events)
If you have had blood clots in your legs or lungs, a heart attack or stroke in the past or recently, or if these events have occurred in your family, you may increase the risk that these problems occur or worsen during treatment with Bemfola.
Men with excessive levels of FSH in the blood
If you are a man, excessive levels of FSH in the blood may be a sign of testicular damage. In this case, Bemfola generally does not work. If the doctor decides to attempt treatment with Bemfola, they may ask you to provide semen samples for control analyses 4-6 months after starting treatment.

Children and adolescents
The use of Bemfola is not indicated in children and adolescents under 18 years of age.

Other medicines and Bemfola
Tell your doctor if you are taking, have recently taken or might take any other medicines.

• If you use Bemfola with other medicines that promote ovulation (such as hCG or clomifene citrate), this may enhance the response of the follicles.
• If you use Bemfola simultaneously with a gonadotropin-releasing hormone (GnRH) agonist or antagonist (these medicines reduce the levels of sex hormones and block ovulation), you may need a higher dose of Bemfola to produce follicles.

Pregnancy and breastfeeding
Do not use Bemfola during pregnancy or breastfeeding.

Driving and operating machinery
This medicine is not expected to impair the ability to drive and operate machinery.

Bemfola contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, that is to say essentially “sodium-free”.

3. How to use Bemfola

Use this medicine following the doctor's instructions exactly. If you have any doubts, consult your
doctor or pharmacist.
How to use the medicine

• Bemfola must be administered with an injection just under the skin (subcutaneously). Use each pre-filled pen only once and then dispose of these safely. Do not administer the solution if it contains particles or if it is not clear.
• The first injection of Bemfola must be performed under the supervision of the doctor.
• The doctor or nurse will show you how to use the pre-filled Bemfola pen to inject the medicine yourself.
• If you administer Bemfola yourself, read the "Instructions for Use" carefully and follow them.

Which dose to use
The doctor will decide how much medicine you need to take and how often. The doses reported below
are expressed in International Units (IU) and in milliliters (mL).

Women
If you do not ovulate and have irregular or absent menstrual cycles

• Bemfola is generally administered every day.
• If you have irregular menstrual cycles, start using Bemfola within the first 7 days of your cycle. If you do not have menstrual cycles, you can start using the medicine any day.
• The initial dose of Bemfola is generally personalized and can be gradually adjusted.
• The daily dose of Bemfola should not exceed 225 IU (0.375 mL).
• When you obtain the desired response, you will be given a single injection of 250 micrograms of “recombinant hCG” (r-hCG, an hCG produced in the laboratory with a particular DNA technique) or 5,000-10,000 IU of hCG, 24-48 hours after the last injection of Bemfola. The most suitable days for sexual intercourse are the day of the hCG injection and the following day.

If the doctor does not observe the desired response, continuation of that treatment cycle with
Bemfola must be evaluated and managed according to standard clinical practice.
If your body responds excessively, treatment will be discontinued and you will not be
administered hCG (see paragraph 2, “Ovarian Hyperstimulation Syndrome (OHSS)”). In the next
cycle, the doctor will administer a lower dose of Bemfola.

If you have been diagnosed with very low levels of the hormones FSH and LH

• The usual initial dose of Bemfola is between 75 and 150 IU (0.12-0.25 mL) together with 75 IU (0.12 mL) of lutropin alfa.
• You will need to use these two medicines every day for a maximum of five weeks.
• The dose of Bemfola may be increased by 37.5-75 IU every 7 days or every 14 days until the desired response is obtained.
• When you obtain the desired response, you will be given a single injection of 250 micrograms of “recombinant hCG” (r-hCG, an hCG produced in the laboratory with a particular DNA technique) or 5,000-10,000 IU of hCG, 24-48 hours after the last injection of Bemfola and lutropin alfa. The most suitable days for sexual intercourse are the day of the hCG injection and the following day. Alternatively, intrauterine insemination or another medically assisted reproductive procedure may be performed, at the doctor's discretion.

If the doctor does not observe any response after 5 weeks, that treatment cycle with Bemfola must
be interrupted. In the next treatment cycle, the doctor will administer a higher initial
dose of Bemfola.
If your body responds excessively, treatment with Bemfola will be discontinued and you will not be
administered hCG (see paragraph 2, “Ovarian Hyperstimulation Syndrome (OHSS)”). In the next
cycle, the doctor will administer a lower dose of Bemfola.
If you need to develop several eggs to be collected for assisted reproductive techniques

• The initial dose of Bemfola is generally personalized and can be gradually adjusted up to a maximum of 450 IU per day (0.75 mL)
• Treatment continues until the eggs have reached a certain degree of development. The doctor will determine the right time with blood tests and/or ultrasound.
• When the eggs have developed, you will be given a single injection of 250 micrograms of “recombinant hCG” (r-hCG, an hCG produced in the laboratory with a particular recombinant DNA technique) or 5,000-10,000 IU of hCG, 24-48 hours after the last injection of Bemfola. This prepares the eggs for collection. Men
• The usual dose of Bemfola is 150 IU (0.25 mL) together with hCG.
• You will need to use these two medicines three times a week for at least 4 months.
• If, after 4 months, you have not responded to treatment, the doctor may suggest continuing the use of the two medicines for at least 18 months

If you use more Bemfola than you should
Effects due to the use of an excessive amount of Bemfola have not been described. However,
ovarian hyperstimulation syndrome (OHSS) may occur as described in paragraph 4. However,
OHSS may only occur if hCG has also been administered (see paragraph 2, “Ovarian
Hyperstimulation Syndrome (OHSS)”).

If you forget to use Bemfola
If you forget to use Bemfola, do not take a double dose to make up for the missed dose. Inform the doctor as soon as you realize you have forgotten a dose.
If you have any doubts about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Serious side effects in women

• Pelvic pain in combination with nausea or vomiting may be symptoms of ovarian hyperstimulation syndrome (OHSS). This may indicate that the ovaries are reacting excessively to the treatment and that large ovarian cysts have developed (see also section 2, “Ovarian hyperstimulation syndrome (OHSS)”). This side effect is common (may affect up to 1 in 10 people).
• OHSS can become severe, with markedly enlarged ovaries, reduced urine production, weight gain, difficulty breathing and/or possible accumulation of fluid in the abdomen or chest. This side effect is uncommon (may affect up to 1 in 100 people).
• Rarely, complications of OHSS may occur, such as ovarian torsion or blood clotting (may affect up to 1 in 1000 people).
• Very rarely, serious complications of blood clotting (thromboembolic events) may occur, sometimes independently of OHSS (may affect up to 1 in
• 10,000). This can cause chest pain, shortness of breath, stroke or heart attack (see also section 2, “Blood clotting disorders (thromboembolic events)”).

Serious side effects in men and women

• Sometimes, allergic reactions such as skin reaction, redness, itching, swelling of the face with difficulty breathing, may be severe. This side effect is very rare (may affect up to 1 in 10,000 people).

If you notice any of the side effects described, contact your doctor immediately, who may
ask you to stop using Bemfola.

Other side effects in women
Very common (may affect more than 1 in 10 people):

• Fluid-filled sacs in the ovary (ovarian cysts)
• Headache
• Local reactions at the injection site such as pain, redness, bruising, swelling and/or irritation

Common (may affect up to 1 in 10 people):

• Abdominal pain
• Nausea, vomiting, diarrhea, abdominal cramps and flatulence

Very rare (may affect up to 1 in 10,000 people):

• Allergic reactions such as skin reaction, redness, itching, swelling of the face with difficulty breathing may occur. These reactions can be severe.
• Asthma may worsen.

Other side effects in men
Very common (may affect more than 1 in 10 people):

• Local reactions at the injection site such as pain, redness, bruising, swelling and/or irritation

Common (may affect up to 1 in 10 people):

• Swelling of the veins located above and behind the testicles (varicocele)
• Enlargement of the breast gland, acne or weight gain

Very rare (may affect up to 1 in 10,000 people):

• Allergic reactions such as skin reaction, redness, itching, swelling of the face with difficulty breathing may occur. These reactions can be severe.
• Asthma may worsen.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through
the national reporting system at https://www.aifa.gov.it/content/segnalazioni-
reazioni-avverse . By reporting side effects you can help provide more information
on the safety of this medicine.

5. How to store Bemfola

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date that is stated on the pen label or on the
pack after Exp. The expiry date refers to the last day of that month.
Store in a refrigerator (2°C-8°C). Do not freeze.
Store in the original package to protect the medicine from light.
Within the period of validity, the intact pen can be stored at a temperature not exceeding 25°C for
a maximum period of 3 months without being refrigerated again and must be discarded if,
after 3 months, it has not been used.
Do not use this medicine if you notice visible signs of deterioration, if the liquid contains particles or if
it is not clear.
Once opened, the medicine must be injected immediately.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Bemfola contains

• The active substance is follitropin alfa.
• Bemfola 75 IU/0.125 ml: each cartridge contains 75 IU (equivalent to 5.5 micrograms) of follitropin alfa in 0.125 ml of solution.
• Bemfola 150 IU/0.25 ml: each cartridge contains 150 IU (equivalent to 11 micrograms) of follitropin alfa in 0.25 ml of solution.
• Bemfola 225 IU/0.375 ml: each cartridge contains 225 IU (equivalent to 16.5 micrograms) of follitropin alfa in 0.375 ml of solution.
• Bemfola 300 IU/0.50 ml: each cartridge contains 300 IU (equivalent to 22 micrograms) of follitropin alfa in 0.50 ml of solution.
• Bemfola 450 IU/0.75 ml: each cartridge contains 450 IU (equivalent to 33 micrograms) of follitropin alfa in 0.75 ml of solution.
• Each mL of the solution contains 600 IU of follitropin alfa (equivalent to 44 micrograms).
• The other components are poloxamer 188, sucrose, methionine, disodium phosphate dihydrate, monosodium phosphate dihydrate, phosphoric acid and water for injections.

Description of the appearance of Bemfola and contents of the pack

• Bemfola is presented as a clear and colourless injectable liquid in a pre-filled pen (injection).
• Bemfola is supplied in packs containing 1, 5 or 10 pre-filled pens, 1, 5 or 10 single-use needles and 1, 5 or 10 alcohol swabs. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Gedeon Richter Plc.
Gyömrői út 19-21.
1103 Budapest
Hungary
Further detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.

Bemfola pre-filled pen 75 IU /0.125 ml, pre-filled pen 150 IU /0.25 ml, pre-filled pen 225 IU /0.375 ml, pre-filled pen 300 IU /0.50 ml, pre-filled pen 450 IU /0.75 ml

Instructions for use
SUMMARY

1. How to use the Bemfola pre-filled pen

2. Before starting to use the pre-filled pen

3. How to prepare a pre-filled pen for injection

4. How to set the dose prescribed by the doctor

5. How to inject the dose

6. After the injection

Warning: please read and follow these Instructions for use of the Bemfola pre-filled pens.
Do not follow instructions from sources other than those described in these Instructions for use
or provided by healthcare professionals because this may compromise the correct use of the
pre-filled pen and its treatment.

1. How to use the Bemfola pre-filled pen

• Before starting to use the pre-filled pens, read the Instructions for Use carefully and in their entirety.
• Each pre-filled pen is single-use- do not allow anyone else to use it.
• The numbers shown on the dose window of the pre-filled pens are expressed in International Units or IU. Your doctor will have told you how many IU you need to inject each day.
• Your doctor/pharmacist will tell you how many single-use Bemfola pre-filled pens you will needfor the complete treatment cycle.
• Give the injection every day at approximately the same time.

2. Before starting to use the pre-filled pen

2.1. Remove the pen from the refrigerator

• Remove one of the pens from the refrigerator 5 to 10 minutes before using it.
• If the medicine is frozen, do not use it.
• 2.2. Wash your hands
• Wash your hands with soap and lukewarm water and dry them.
• It is important that your hands and the objects you use to prepare the pen are as clean as possible.

2.3. Choose a clean work surface

• A clean table or surface is suitable.

3. How to prepare a prefilled pen for injection

The different parts of your prefilled pen

Practice the injection every day at approximately the
same time. Remove the pen from the refrigerator 5-10
minutes before using it.

Note: check that the medicine is not

frozen.

Prepare the injection needle
Take a new needle – use only the single-use needles
supplied in the package. Hold
the outer needle cap firmly.
In all cases, check that the detachable
seal on the outer needle cap is not
damaged or loosened.
Remove the detachable seal from the needle
for injection.

Caution: if the detachable seal is

damaged or loosened, do not use the needle.

Dispose of it in a sharps container. Take a new needle.

Insert the needle.
Hold the pen on the sides, keeping the needle in line
with it; apply the needle. Screw the needle on
clockwise onto the tip of the pen until
it is firmly attached. Make sure the needle
is correctly attached in a linear position
on the pen.

Caution: Do not overtighten the needle.

Do not press the dose setting button during needle application.

Remove the outer needle cap (G).

Keep it aside. You will need it after
the injection to dispose of the pen.
Remove the inner needle cap (F).
Make sure the needle is in the correct
position.

Correct needle position Incorrect needle position

4. How to set the dose prescribed by the doctor

First, hold the pen in such a way that
the needle is pointing upwards. To remove air
bubbles from the system, gently tap the side of
the pen to allow any air bubbles present to rise
to the top.

Keeping the pen always pointing upwards,
press the dose setting button until the activation
bar, marked by a small arrow, disappears. You
should hear a click and some liquid should come
out (this is normal). Now the pen is ready to
set the dose.

Caution: if no liquid comes out or if a liquid

leak is detected at the needle connection, the pen

must not be used. Inform your doctor or

pharmacist if you notice any problems.
Gently rotate the dose setting button until the dose
bar is in line with the center of the dash on the
pen.

Note: for the prefilled Bemfola 75

IU/0.125 mL pen, the dose setting button cannot

make a full rotation, but it can still be rotated

backwards. Now the pen is ready for injection.

Caution: at this point, do not press the

dose setting button again.

5. How to inject the dose

Now you can proceed to immediately administer the injection in the injection site (e.g.,
abdomen, front of the thigh) indicated by the doctor or nurse. To minimize
skin irritation, choose a different injection site each day.
With a circular
motion, clean the
injection site with the
cotton ball soaked in
alcohol provided in the
package.
Before administering
the injection, wait a
few seconds for the
alcohol to evaporate
completely. The skin must
be dry.
Double-check that the
correct dose is
displayed on the pen.
Between two fingers, gently
pinch the skin of the
area where you will
administer the injection.
Hold the pen
at approximately a right
angle (90° angle) and insert
the needle completely
into the skin with one
decisive movement.

Caution: during

needle insertion,

do not press the

dose setting button and do not change the

needle direction.
Once the needle is
completely inserted
into the injection site,
press the dose setting
button slowly and
continuously until it
stops and the dose
bar is no longer
visible.

e n z i a

Do not remove the needle
immediately; wait at least 5
secondsbefore removing it
to ensure that you have
injected the entire dose.
After removing
the needle: clean the skin with
a cotton ball soaked in
alcohol with a circular
motion on the
injection site.

Caution: if

liquid leaks at the

connection of the needle or

pen during

injection, inform your

doctor or pharmacist.

6. After the injection

Carefully reposition the outer cap
onto the needle.

Use the prefilled injection pen only
once and discard the pen even if there is
liquid remaining in the pen after the injection. Discard the
box, the inner needle cap, the
tab, the alcohol swab, and the
instructions for use, in normal household
waste. Do not dispose of any medicine in the
sink, toilet, or household waste. Used
pens must be disposed of in a
sharps container or needle disposal and
must be taken to a pharmacy for proper
disposal. Ask the pharmacist how to
dispose of unused medicines.