Package leaflet: Information for the patient

GONAPEPTYL Daily, 0.1 mg/1 ml, solution for injection
Triptorelini acetas
Please read all of this leaflet carefully before using this medicine, because it contains
important information for you.
Keep this leaflet, as you may need to read it again.
If you have any further questions, please ask your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm
another person, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See
section 4.
Leaflet contents:

What Gonapeptyl Daily is and what it is used for
Important information before using Gonapeptyl Daily
How to use Gonapeptyl Daily
Possible side effects
How to store Gonapeptyl Daily
Contents of the pack and other information

1. What Gonapeptyl Daily is and what it is used for

Gonapeptyl Daily is a liquid for injection supplied in a single-use pre-filled syringe. It is administered as a subcutaneous injection in the lower abdominal area.
Gonapeptyl Daily contains triptorelin, 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)]. Gonapeptyl Daily blocks the action of GnRH, thereby reducing the activity of LH and FSH (this is known as pituitary desensitization). This helps prevent premature ovulation (release of oocytes).
This medicine is used in the treatment of women undergoing assisted reproductive techniques (ART). In such procedures, ovulation may occur too early, significantly reducing the chances of achieving pregnancy. Gonapeptyl Daily is used to induce pituitary desensitization and prevent premature increases in LH activity, which could trigger premature oocyte release.

2. Important information before using Gonapeptyl Daily

When not to use Gonapeptyl Daily
if the patient has hypersensitivity to triptorelin acetate or to any of the other ingredients of this medicine
(listed in section 6),
if the patient has hypersensitivity to GnRH or to any other GnRH analogues (medicines similar to
Gonapeptyl Daily),
if the patient is pregnant or breastfeeding. See section "Pregnancy and breastfeeding".

Warnings and precautions
Before starting treatment with Gonapeptyl Daily, discuss this with your doctor.
Exercise caution, as there have been reports of depression in patients treated with Gonapeptyl Daily,
including cases of severe depression. If depressive moods occur during treatment with this medicine,
inform your doctor immediately.
Mood changes have been reported during treatment with this medicine. Your doctor will closely monitor
you if you develop depression.
Exercise caution, as treatment with this medicine may rarely cause cerebral haemorrhage (pituitary apoplexy).
If sudden headache, vomiting or visual disturbances occur, contact your doctor immediately.
Exercise caution, as treatment with this medicine may cause decreased bone density and increase the risk
of bone fractures.
If the patient has additional risk factors for reduced bone density (osteoporosis), this should be discussed
with the doctor before starting treatment. Risk factors include, among others:
if osteoporosis has been diagnosed in any close family member,
if the patient consumes excessive alcohol, follows a poor diet and/or is a chronic smoker,
if the patient is concurrently treated with medicines that may affect bone density.

If any of the warnings listed below apply or have applied in the past to the patient, inform the doctor.
If the patient has mild or severe liver disease.
If the patient has active allergies or a history of allergic reactions.
If the patient self-administers this medicine. The patient should be aware of possible allergic reactions,
such as skin itching, skin rash, fever (see section 4. "Possible side effects").

If any of the following reactions occur after injection of Gonapeptyl Daily, contact the doctor immediately.
If the patient experiences:
abdominal pain,
abdominal swelling,
nausea,
vomiting,
diarrhoea,
weight gain,
difficulty breathing,
decreased frequency or amount of urine.

The above symptoms should be reported to the doctor immediately, even if they appear several days after
the last dose of the medicine. These may be symptoms of ovarian hyperstimulation, which may be severe
(see also section 4. "Possible side effects"). If these symptoms worsen, infertility treatment should be discontinued
and appropriate treatment initiated in hospital.

During treatment with Gonapeptyl Daily, the doctor will usually arrange for ultrasound examinations (USG)
and sometimes blood tests to monitor the response to treatment.

Hormonal infertility treatment, such as with Gonapeptyl Daily, may increase the risk of:
ectopic pregnancy (tubal pregnancy) in women with a history of tubal disease,
miscarriage,
multiple pregnancy (twins, triplets, etc.),
congenital malformations (physical abnormalities present at birth).

Gonapeptyl Daily and other medicines
Inform your doctor or pharmacist about all medicines currently taken, recently taken or planned to be taken.

Pregnancy, breastfeeding and fertility
This medicine must not be used during pregnancy or while breastfeeding.
This medicine must not be used if there is any possibility that the patient may be pregnant. The doctor should
confirm before starting treatment that the patient is not pregnant. If pregnancy is detected during treatment,
Gonapeptyl Daily must be discontinued immediately.
During treatment with Gonapeptyl Daily, non-hormonal contraceptive methods should be used, such as
condoms or a contraceptive cap.

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

Gonapeptyl Daily contains sodium chloride
This medicine contains less than 1 mmol sodium (23 mg) per dose and is therefore essentially "sodium-free".

3. How to use Gonapeptyl Daily

This medicine should always be used exactly as your doctor has told you. If in doubt, consult your doctor.
The recommended dose is one subcutaneous injection per day into the lower abdominal area.
Treatment may be started on day 2 or 3 of the menstrual cycle, or on day 21 to 23 of the menstrual cycle (or 5–7 days before the expected start of menstruation). After 2 to 4 weeks, other hormones are usually administered to stimulate follicle growth (growth of the egg-containing follicles). Treatment with Gonapeptyl Daily is generally continued until the follicles have reached an appropriate size. This usually takes 4 to 7 weeks.
If a sufficient number of ovarian follicles are present, a single injection of a medicine called human chorionic gonadotropin (hCG) is given to trigger ovulation (release of the egg).
The patient remains under close medical supervision for at least 2 weeks after administration of hCG.

INSTRUCTIONS FOR USE
If your doctor has instructed you to self-inject this medicine, you must follow all instructions provided.
The first injection of this medicine should be given under the supervision of a doctor.
Remove the protective foil and take the syringe out of the blister. Hold the syringe vertically with the grey protective cap pointing upwards. Remove the grey protective cap. Gently press the plunger until the first drop appears at the needle tip.
Pinch a skin fold between your thumb and index finger. Insert the needle into the skin fold. Press the plunger and slowly inject the syringe's contents.

Use of a higher than recommended dose of Gonapeptyl Daily
If a higher than recommended dose of Gonapeptyl Daily has been used, inform your doctor or nurse immediately.

Missing a dose of Gonapeptyl Daily
If you miss a dose of Gonapeptyl Daily, inform your doctor or nurse.

Stopping treatment with Gonapeptyl Daily
Do not stop using Gonapeptyl Daily on your own. Follow your doctor's instructions exactly. Stopping treatment too early may reduce the chance of becoming pregnant.
If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although they do not occur in everyone.
Very common adverse effects (may affect more than 1 in 10 patients):
headache
abdominal pain
vaginal bleeding or spotting
nausea
inflammatory reaction at the injection site

Common adverse effects (may affect up to 1 in 10 patients):
common cold
influenza-like symptoms
sore throat
dizziness
abdominal distension
vomiting
miscarriage
back pain
pelvic pain
ovarian hyperstimulation (high level of activity) (see section 2. "When to take special care with Gonapeptyl Daily")
ovarian cysts (in the initial phase of treatment)
pain during menstruation
pain, reaction or redness at the injection site
feeling of fatigue

Uncommon adverse effects (may affect up to 1 in 100 patients):
allergic reactions (see section 2. "When to take special care with Gonapeptyl Daily")
breast pain
excessive sweating
hot flushes
mood changes, depression
rash

Rare adverse effects (may affect up to 1 in 1,000 patients):
blisters
anxiety
itching
shallow breathing
vaginal discharge

Not known: frequency cannot be estimated from the available data:
abdominal discomfort
sleep disturbances
weight gain
blurred vision
angioedema (subcutaneous swelling)
weakness
muscle cramps
enlargement of ovaries
intermenstrual spotting
decreased libido
visual disturbances
heavy, prolonged and (or) irregular menstruation
vaginal dryness
painful sexual intercourse
joint pain

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Aleje Jerozolimskie 181C, 02-222 Warsaw,
Tel: +48 22 49 21 301,
Fax: +48 22 49 21 309,
website: https://smz.ezdrowie.gov.pl.
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps provide more information on the safety of the medicine.

5. How to store Gonapeptyl Daily

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

6. Contents of the package and other information

What Gonapeptyl Daily contains

The active substance is triptorelin acetate. One pre-filled syringe containing 1 ml of solution for injection contains 100 micrograms of triptorelin acetate, equivalent to 95.6 micrograms of triptorelin.
The other ingredients are: sodium chloride, acetic acid (glacial), and water for injections.

What Gonapeptyl Daily looks like and contents of the pack
Gonapeptyl Daily is a clear, colourless 1 ml liquid in a glass syringe with a fixed needle.
The syringe is sealed with a rubber plunger stopper, and the needle is protected by a needle cap.
The carton contains 7 pre-filled syringes.
Marketing Authorisation Holder and Manufacturer:
Ferring GmbH
Wittland 11
D-24109 Kiel
Germany
This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Belgium Gonapeptyl Daily
Denmark Gonapeptyl
Finland Gonapeptyl
Netherlands Decapeptyl 0.1 mg/1 ml
Luxembourg Gonapeptyl Daily
Germany Decapeptyl IVF 0.1 mg/1 ml Injektionslösung
Norway Gonapeptyl
Poland Gonapeptyl Daily
Romania Gonapeptyl Zilnic
Slovenia Gonapeptyl 0,1 mg/ml raztopina za injiciranje
Sweden Gonapeptyl
Hungary Gonapeptyl Daily
Italy Fertipeptil
For more detailed information, please contact the representative of the Marketing Authorisation Holder:
Ferring Pharmaceuticals Poland Sp. z o.o.
ul. Szamocka 8
01-748 Warsaw
Tel.: +48 22 246 06 80