FERTIPEPTIL 0.1 mg Injectable solution

Зміст інструкції

1. Fertipeptil 0,1 mg/1 ml, injectable solution
   1. What Fertipeptil is and what it is used for
   2. What you need to know before using Fertipeptil
   3. How to use Fertipeptil
   4. Possible side effects
   5. How to store Fertipeptil
   6. Contents of the pack and other information

Fertipeptil 0,1 mg/1 ml, injectable solution

Triptorelin acetate

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, pharmacist or nurse.
• 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, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What Fertipeptil is and what it is used for

This medicine is supplied as an injectable solution in a single-use syringe. It is
administered as a subcutaneous injection in the lower part of the abdomen.
This medicine contains triptorelin, which is a synthetic analogue of the natural
gonadotropin-releasing hormone (GnRH). GnRH regulates the release of gonadotropins (sex
hormones: luteinizing hormone (LH) and follicle-stimulating hormone (FSH)). Fertipeptil blocks
the action of GnRH, thus reducing the levels of LH and FSH (downregulation). This leads to
a prevention of premature ovulation (release of eggs).
This drug is used for the treatment of women undergoing assisted reproductive technology (ART). In ART, ovulation can occasionally occur in
advance, causing a significant decrease in the chances of becoming pregnant.
Fertipeptil is used for downregulation and for the prevention of premature LH surges that
could therefore cause a premature release of the eggs.

2. What you need to know before using Fertipeptil

Do not use Fertipeptil:

• If you are allergicto triptorelin acetateor to any of the other ingredients of this medicine (listed in section 6)
• If you are allergicto GnRH or other GnRH analogues (medicines similar to Fertipeptil)
• If you are pregnant or breastfeeding. Read the “Pregnancy and breastfeeding” section.

Warnings and precautions

• Talk to your doctor or nurse before taking Fertipeptil.
• Cases of depression have been reported in patients taking Fertipeptil, which can be severe. If you are taking this medicine and develop a depressed mood, tell your doctor.
• Mood changes have been reported during the use of this medicine. Your doctor will monitor you if you have depression.
• Treatment with this medicine, in rare cases, can cause cerebral hemorrhage (pituitary apoplexy). Contact your doctor immediately if you experience sudden headache, vomiting, or visual disturbances.
• Treatment with this medicine can cause thinning of the bones, which increases the risk of fractures.
• If you are at additional risk of bone thinning (osteoporosis), tell your doctor before using this medicine. Risk factors include:
• if a family member suffers from bone thinning
• if you drink an excessive amount of alcohol, have a poor diet and/or smoke heavily
• if you are being treated with medicines that can alter bone strength.

Tell your doctor if any of the following warnings apply to you or have applied to you in

the past.

• If you have a mild or severe liver disorder.
• If you have an ongoing allergic reaction or if you have often suffered from allergic reactions in the past.
• If you administer this medicine to yourself, you must be informed of the possible allergic reactions that may occur (itching, skin rashes, fever) (see section 4 “Possible side effects”).

Contact your doctor immediately if any of these reactions occur after the injection of

Fertipeptil.
If you suffer from:

• Abdominal pain
• Abdominal bloating
• Nausea
• Vomiting
• Diarrhea
• Weight gain
• Difficulty breathing
• Decreased urine production. Tell your doctor immediately, even if the symptoms appear several days after theadministration of the last injection.These may be signs of high ovarian activity that can become serious (see also section 4 “Possible side effects”). If the symptoms become severe, infertility treatment must be discontinued and you should go to hospital.

During treatment with this medicine, your doctor will perform an ultrasoundand,
sometimes, blood teststo monitor your response to treatment.
Treatment for infertility with hormones like this medicine can increase the risk of:

• Ectopic pregnancy (pregnancy outside the uterus) if you have a history of problems with your fallopian tubes
• Miscarriage
• Multiple pregnancy (twins, triplets, etc.)
• Congenital malformations (birth defects present at birth).

Other medicines and Fertipeptil
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including medicines you bought without a prescription.

Pregnancy, breastfeeding and fertility
Do not use this medicine if you are pregnant or while breastfeeding.
Do not use this medicine if you suspect you are pregnant. Pregnancy must first be
excluded by your doctor.
Do not continue to use Fertipeptil if you discover you are pregnant during treatment.
During treatment with Fertipeptil, you should use non-hormonal contraception,
such as a condom or diaphragm.

Driving and operating machinery
It is unlikely that the medicine will affect your ability to drive vehicles and operate
machinery.

For athletes
The use of the medicine without a therapeutic need constitutes doping and may still
result in a positive doping test.

Fertipeptil contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, which is
essentially “sodium-free”.

3. How to use Fertipeptil

Take this medicine following the instructions of your doctor exactly. If you have any doubts
consult your doctor.
The recommended dose is a subcutaneous injection in the lower part of the abdomen, once a
day. Treatment may be started on the 2nd or 3rd day or from the 21st to the 23rd day of the
menstrual cycle (or 5-7 days before the hypothetical start day of the menstrual cycle). After 2-4
weeks, other hormones will be administered to promote follicle growth (growth of the sac
containing the egg). Normally, treatment with Fertipeptil continues until
the follicle has reached the right size, generally from 4 to 7 weeks.
If a sufficient number of follicles are obtained, you will be administered a
medicine called human chorionic gonadotropin (hCG) in a single injection, to
induce ovulation (release of an egg).
The doctor will monitor your progress for at least 2 weeks after
the hCG injection.
INSTRUCTIONS FOR ADMINISTRATION

If you have been asked to administer this medicine yourself, carefully follow

all the instructions that have been provided to you.
The first injection of this medicine must be performed under the supervision of a
doctor.

• Remove the protective film and remove the syringe from the package. Hold the syringe with the needle pointing upwards, keeping the gray protective cap on. Remove the gray protective cap. Gently push the plunger until the first drop of liquid comes out.
• Lift the skin between thumb and index finger. Push the syringe plunger and inject the contents of the syringe slowly.

If you take more Fertipeptil than you should
Inform your doctor or nurse.

If you forget to take Fertipeptil
Inform your doctor or nurse.

If you stop taking Fertipeptil
Do not stop therapy with Fertipeptil on your own, but strictly follow
the doctor's instructions. If you stop treatment too early, the probability of
becoming pregnant will decrease. If you have any doubts about the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

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

• headache • abdominal pain
• vaginal bleeding/spotting • nausea
• inflammation at the injection site

Common side effects(may affect less than 1 in 10 people):

• cold • flu-like symptoms
• sore throat • dizziness
• abdominal bloating • vomiting
• abortion • back pain
• ovarian hyperstimulation (hyperactivity), (see section 2 “Warnings and precautions”)
• pelvic pain
• Pain during menstruation • ovarian cysts (at the beginning of treatment)
• fatigue • pain, reactions or redness at the injection site

Uncommon side effects(may affect less than 1 in 100 people):

• allergic reactions (see section 2 “Warnings and Precautions”)
• hot flushes
• breast pain • mood changes, depression
• excessive sweating • skin rash

Rare side effects(may affect less than 1 in 1000 people):

• blisters • shortness of breath
• fear • vaginal discharge
• itching

Not known(frequency cannot be estimated based on available data):

• abdominal discomfort • spotting between periods
• sleep disturbances • decreased sexual desire
• weight gain • vision disorders
• blurred vision • heavy, prolonged and/or irregular menstruation
• angioedema (swelling immediately under • vulvo-vaginal dryness

the skin)

• weakness • pain during sexual intercourse
• muscle spasms • joint pain
• enlargement of the ovaries

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please tell your doctor or pharmacist. 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 Fertipeptil

Store in a refrigerator (2  C – 8  C). Do not freeze. Store in the original package
to protect from light. Keep this medicine out of the sight and reach of
children.
Do not use this medicine after the expiry date indicated on the package. The expiry date
refers to the last day of that month.
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 Fertipeptil contains

• The active ingredient is triptorelin acetate. Each pre-filled syringe of 1 ml of injectable solution contains 100 micrograms of triptorelin acetate equivalent to 95.6 micrograms of triptorelin free base.
• The other components are sodium chloride, glacial acetic acid and water for injectable preparations.

Description of the appearance of Fertipeptil and contents of the pack
This medicine is a clear, colorless solution in a 1 ml glass syringe to which an
needle is attached. The syringe and needle are closed with a rubber stopper and a cap
for the needle. The package contains 7 pre-filled syringes.

Marketing authorisation holder and manufacturer
Marketing authorisation holder
Ferring S.p.A. - via C. Imbonati, 18 - 20159 Milano
Manufacturer
Ferring GmbH – Postbus 2145 - 24109 Kiel – Germany

with the following denominations:
Belgium Gonapeptyl Daily
Denmark Gonapeptyl
Finland Gonapeptyl
Germany Decapeptyl IVF 0.1 mg/1 ml Injection solution
Hungary Gonapeptyl Daily
Italy Fertipeptil
Luxembourg Gonapeptyl Daily
Netherlands Decapeptyl 0.1 mg/1 ml
Norway Gonapeptyl
Poland Gonapeptyl Daily
Romania Gonapeptyl Zilnic
Slovenia Gonapeptyl 0.1 mg/ml injection solution
Sweden Gonapeptyl>