Fertipeptil

Package leaflet: Information for the patient

Fertipeptil 0.1 mg/1 ml, solution for injection

Triptorelin acetate
Please read all of this leaflet carefully before you start using this medicine because 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including 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 using 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 medicinal product is supplied as an injectable solution in a single-use pre-filled syringe.
It is administered as a subcutaneous injection in the lower 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, thereby reducing levels of LH and FSH (downregulation). This leads to the prevention of premature ovulation (release of eggs).
This medicine is used in the treatment of women undergoing assisted reproductive techniques (ART). In ART, ovulation may occasionally occur prematurely, significantly reducing the chances of becoming pregnant.
Fertipeptil is used for downregulation and to prevent premature LH surges, which could otherwise cause premature release of eggs.

2. What you need to know before using Fertipeptil

Do not use Fertipeptil:

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

Warnings and precautions

• Talk to your doctor or nurse before taking Fertipeptil.
• Cases of depression, which may be severe, have been reported in patients taking Fertipeptil. If you are taking this medicine and develop depressive mood, inform your doctor.
• Mood changes have been reported during treatment with this medicine. Your doctor will monitor you if you have depression.
• Treatment with this medicine may rarely cause cerebral haemorrhage (pituitary apoplexy). Contact your doctor immediately if you experience sudden headache, vomiting or visual disturbances.
• Treatment with this medicine may cause thinning of the bones, increasing the risk of fractures.
• If you are at additional risk of bone thinning (osteoporosis), inform your doctor before using this medicine. Risk factors include:
• if a family member has bone thinning
• if you drink excessive amounts of alcohol, have a poor diet, and/or smoke heavily
• if you are being treated with medicines that may affect bone strength.

Inform your doctor if any of the following warnings apply to you or have applied in the past.

• If you have a mild or severe liver disorder.
• If you are currently experiencing an allergic reaction or have frequently suffered from allergic reactions in the past.
• If you self-administer this medicine, you must be informed about 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 injection of Fertipeptil.
If you experience:

• Abdominal pain
• Abdominal swelling
• Nausea
• Vomiting
• Diarrhoea
• Weight gain
• Difficulty breathing
• Reduced urine production. Inform your doctor immediately, even if symptoms appear several days after the last injection.
  These may be signs of ovarian hyperstimulation, which can become severe (see also section 4 “Possible side effects”). If symptoms become severe, infertility treatment must be stopped and you should go to hospital.

During treatment with this medicine, your doctor will perform ultrasound scans and,
sometimes, blood tests to monitor your response to treatment.
Hormonal treatment for infertility, such as with this medicine, may increase the risk of:

• Ectopic pregnancy (pregnancy outside the uterus), especially if you have had previous problems with the Fallopian tubes
• Spontaneous abortion
• Multiple pregnancy (twins, triplets, etc.)
• Congenital malformations (physical birth defects).

Other medicines and Fertipeptil
Inform your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicines, including medicines obtained without a prescription.
Pregnancy, breastfeeding and fertility
Do not use this medicine if you are pregnant or breastfeeding.
Do not use this medicine if you suspect you are pregnant. Pregnancy must first be
excluded by your doctor.
Do not continue using Fertipeptil if you find out you are pregnant during treatment.
During treatment with Fertipeptil, you must use a non-hormonal contraceptive method,
such as condoms or diaphragm.
Driving and using machines
It is unlikely that this medicine will affect your ability to drive or operate machinery.
For those engaged in sports
Using this medicine without therapeutic need constitutes doping and may lead to a positive anti-doping test.
Fertipeptil contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, therefore it is
essentially “sodium-free”.

3. How to use Fertipeptil

Take this medicine exactly as your doctor has told you. If you have any doubts, consult your doctor.
The recommended dose is one subcutaneous injection in the lower abdominal area, once daily. Treatment may be started on day 2 or 3, or between day 21 and day 23 of the menstrual cycle (or 5-7 days before the expected start of the menstrual cycle). After 2-4 weeks, additional hormones will be administered to promote follicular growth (growth of the sac containing the egg). Normally, treatment with Fertipeptil continues until the follicle has reached the appropriate size, usually for 4 to 7 weeks.
If a sufficient number of follicles has developed, you will be given a single injection of a medicine called human chorionic gonadotropin (hCG) to trigger ovulation (release of an egg).
Your doctor will monitor your progress for at least 2 weeks following the hCG injection.

INSTRUCTIONS FOR ADMINISTRATION
If you have been instructed to self-administer this medicine, carefully follow all instructions provided to you.
The first injection of this medicine must be given under the supervision of a doctor.

• Remove the protective film and take the syringe out of the packaging. Hold the syringe with the needle pointing upwards, keeping the grey protective cap in place. Remove the grey protective cap. Gently push the plunger until the first drop of liquid appears.
• Lift the skin with your thumb and index finger. Push the syringe plunger and slowly inject the contents of the syringe.

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 using Fertipeptil
Do not stop treatment with Fertipeptil on your own; follow your doctor's instructions carefully. Stopping treatment too early may reduce your chances of becoming pregnant. If you have any questions about how to use this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

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

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

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

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

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

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

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

Rare side effects (may affect less than 1 in 1,000 people):

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

Not known (frequency cannot be estimated from the available data):

• abdominal discomfort • intermenstrual spotting
• sleep disorders • 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
• ovarian enlargement

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

5. How to store Fertipeptil

Store in the refrigerator (2 °C – 8 °C). Do not freeze. Keep in the original packaging to protect from light. Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Fertipeptil contains

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

Description of the appearance of Fertipeptil and contents of the pack
This medicine is a clear, colourless solution in a 1 ml glass syringe with an attached needle. The syringe and needle are sealed with a rubber stopper and a needle cap. The carton contains 7 pre-filled syringes.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Ferring S.p.A. - via C. Imbonati, 18 - 20159 Milan, Italy
Manufacturer
Ferring GmbH – Postbus 2145 - 24109 Kiel – Germany

With the following trade names:
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 solution for injection
Sweden Gonapeptyl