GONAPEPTYL 0.1 mg/ml Solution

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. GONAPEPTYL Daily, 0.1 mg/1 ml, Solution for Injection
   1. Read the package leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of Contents of the Package Leaflet:
3. What is Gonapeptyl Daily and what is it used for
4. Important information before using Gonapeptyl Daily
   1. When not to use Gonapeptyl Daily
   2. Warnings and precautions
   3. Gonapeptyl Daily and other medicines
   4. Pregnancy, breastfeeding, and fertility
   5. Driving and using machines
   6. Gonapeptyl Daily contains sodium chloride
5. How to use Gonapeptyl Daily
   1. Overdose of Gonapeptyl Daily
   2. Missed dose of Gonapeptyl Daily
   3. Stopping treatment with Gonapeptyl Daily
6. Possible side effects
   1. Reporting side effects
7. How to store Gonapeptyl Daily
8. Contents of the pack and other information
   1. What Gonapeptyl Daily contains
   2. What Gonapeptyl Daily looks like and contents of the pack
   3. Marketing authorization holder and manufacturer:
   4. This medicinal product is authorized in the Member States of the European Economic Area under the following names:
   5. Date of last revision of the package leaflet: 03/2021

Package Leaflet: Information for the Patient

GONAPEPTYL Daily, 0.1 mg/1 ml, Solution for Injection

Triptorelin acetate

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

Keep this package leaflet, you may need to read it again.
In case of any doubts, consult a doctor, pharmacist, or nurse.
This medicine has been prescribed to you by a doctor and should not be given to others. It may harm them, even if their symptoms are the same as yours.
If you experience any side effects, including those not listed in this package leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Package Leaflet:

• 1. What is Gonapeptyl Daily and what is it used for
• 2. Important information before using Gonapeptyl Daily
• 3. How to use Gonapeptyl Daily
• 4. Possible side effects
• 5. How to store Gonapeptyl Daily
• 6. Contents of the pack and other information

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

Gonapeptyl Daily is a solution for injection in a pre-filled syringe. It is administered as a subcutaneous injection in the lower abdomen.
Gonapeptyl Daily contains triptorelin, which is a synthetic equivalent 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 called pituitary desensitization). This leads to the prevention of premature ovulation (release of egg cells).
This medicine is used to treat women as part of assisted reproduction techniques (ART). Sometimes, in these techniques, ovulation may occur too early, significantly reducing the chances of pregnancy. Gonapeptyl Daily is used to induce pituitary desensitization and prevent premature increase in LH activity, which may cause such premature release of egg cells.

2. Important information before using Gonapeptyl Daily

When not to use Gonapeptyl Daily

if you are allergicto triptorelin acetateor any of the other ingredients of this medicine (listed in section 6),
if you are allergicto GnRH or any other GnRH analogues (medicines similar to Gonapeptyl Daily),
if you are pregnant or breastfeeding. See section "Pregnancy and breastfeeding".

Warnings and precautions

Before starting treatment with Gonapeptyl Daily, discuss it with your doctor.
Be cautious, as there have been reports of depression in patients taking Gonapeptyl Daily, including severe depression. If you experience depressive moods while taking this medicine, inform your doctor.
Mood changes have been reported during treatment with this medicine. Your doctor will closely monitor you if you experience depression.
Be cautious, as treatment with this medicine may rarely cause pituitary apoplexy (a condition characterized by bleeding in the pituitary gland). If you experience sudden severe headache, vomiting, or vision disturbances, contact your doctor immediately.
Be cautious, as treatment with this medicine may cause a decrease in bone density and increase the risk of bone fractures.
If you have additional risk factors for decreased bone density (osteoporosis), inform your doctor before using this medicine. Risk factors include:
if someone in your immediate family has been diagnosed with osteoporosis,
if you consume excessive amounts of alcohol, follow a low-calorie diet, and/or are a heavy smoker,
if you are being treated with medicines that may affect bone density.
If any of the following warnings apply or have applied to you in the past, inform your doctor.
If you have a mild or severe liver disease.
If you have a history of hypersensitivity or have experienced allergic reactions in the past.
If you are self-administering this medicine. You should be aware of possible allergic reactions, such as skin itching, skin rash, or fever (see section 4. "Possible side effects").
If the following reactions occur after injecting Gonapeptyl Daily, contact your doctor immediately.
If you experience:
abdominal pain,
abdominal swelling,
nausea,
vomiting,
diarrhea,
weight gain,
breathing difficulties,
decreased urine output.
Inform your doctor immediately about these symptoms, even if they occur several days after the last dose of the medicine.These may be symptoms of ovarian hyperstimulation syndrome (OHSS), which can be severe (see also section 4. "Possible side effects"). If these symptoms worsen, fertility treatment should be discontinued and appropriate hospital treatment should be initiated.
During treatment with Gonapeptyl Daily, your doctor will usually refer you for ultrasound scansand sometimes blood teststo monitor your response to treatment.
Fertility treatment with hormones like Gonapeptyl Daily may increase the risk of:
ectopic pregnancy (pregnancy outside the uterus) in women with a history of tubal disease,
miscarriage,
multiple pregnancy (twins, triplets, etc.),
congenital malformations (physical defects present at birth).

Gonapeptyl Daily and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.

Pregnancy, breastfeeding, and fertility

This medicine should not be used during pregnancy and breastfeeding.
This medicine should not be used if there is a possibility that you are pregnant. Your doctor should ensure that you are not pregnant before starting treatment. If you discover that you are pregnant during treatment, stop using Gonapeptyl Daily.
During treatment with Gonapeptyl Daily, use non-hormonal methods of contraception, such as condoms or a diaphragm.

Driving and using machines

It is unlikely that this medicine will affect your ability to drive or use machines.

Gonapeptyl Daily contains sodium chloride

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

3. How to use Gonapeptyl Daily

Always use this medicine exactly as your doctor has told you. If you are unsure, consult your doctor.
The recommended dose is one injection per day under the skin of the lower abdomen.
Treatment can be started on the 2nd or 3rd day of the menstrual cycle or on the 21st to 23rd day of the menstrual cycle (or 5-7 days before the expected start of menstruation). After 2-4 weeks, other hormones are administered to stimulate follicular growth. Usually, treatment with Gonapeptyl Daily is continued until the follicles have reached the appropriate size. This usually takes 4-7 weeks.
If there are enough follicles, a single injection of human chorionic gonadotropin (hCG) is administered to induce ovulation (release of the egg cell).
You will remain under close supervision of your doctor for at least 2 weeks after hCG administration.
INSTRUCTIONS FOR USE
If your doctor has recommended self-administration of this medicine, follow the instructions provided.
The first injection of this medicine should be performed under the supervision of a doctor.
Remove the protective foil and take the syringe out of the blister pack. Hold the syringe vertically with the gray protective cap facing upwards. Remove the gray protective cap. Gently press the plunger until the first drop appears on the needle.
Lift the skin fold between your thumb and index finger. Insert the needle into the skin fold. Press the plunger and slowly inject the contents of the syringe.

Overdose of Gonapeptyl Daily

In case of overdose, inform your doctor or nurse.

Missed dose of Gonapeptyl Daily

In case of a missed dose, inform your doctor or nurse.

Stopping treatment with Gonapeptyl Daily

Do not stop treatment with Gonapeptyl Daily on your own, but follow your doctor's instructions. If treatment is stopped too early, it may reduce the chances of pregnancy.
In case of any further doubts about the use of this medicine, consult 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 or spotting
nausea
injection site reaction
Common side effects(may affect up to 1 in 10 people):
common cold
flu-like symptoms
pharyngitis
dizziness
hot flashes
vomiting
abdominal distension
back pain
miscarriage
pelvic pain
ovarian hyperstimulation syndrome (OHSS) (high activity level) (see section 2. "Important information before using Gonapeptyl Daily")
ovarian cysts (in the initial phase of treatment)
dysmenorrhea (painful menstruation)
pain or reaction at the injection site
fatigue
Uncommon side effects(may affect up to 1 in 100 people):
mood changes
depression
Unknown: frequency cannot be estimated from the available data:
abdominal complaints
ovarian enlargement
excessive sweating
intermenstrual bleeding
allergic reactions (see section 2. "Important information before using Gonapeptyl Daily")
sleep disorders
decreased libido
shortness of breath
blurred vision
visual disturbances
pruritus
prolonged, heavy, or irregular menstrual bleeding
rash
vaginal dryness
angioedema (swelling under the skin)
painful intercourse
weakness
breast pain
muscle spasms
redness at the injection site
arthralgia (joint pain)
weight gain

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, inform your doctor. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje Jerozolimskie 181C, 02-222 Warsaw,
Phone: +48 22 49 21 301,
Fax: +48 22 49 21 309,
website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this 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. Store in the original package to protect from light.
Do not use this medicine after the expiry date stated on the carton after the words "EXP". The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Gonapeptyl Daily contains

• The active substance is triptorelin acetate. One pre-filled syringe with 1 ml solution for injection contains 100 micrograms of triptorelin acetate, which corresponds to 95.6 micrograms of triptorelin.
• The other ingredients are: sodium chloride, glacial acetic acid, and water for injection.

What Gonapeptyl Daily looks like and contents of the pack

Gonapeptyl Daily is a 1 ml clear, colorless solution in a glass syringe with a fixed needle. The syringe is closed with a rubber plunger stopper, and the needle is protected with a needle shield.
The carton contains 7 pre-filled syringes.

Marketing authorization holder and manufacturer:

Ferring GmbH
Wittland 11
D-24109 Kiel
Germany

This medicinal product is authorized 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 Injektionslösnung
Norway
Gonapeptyl
Poland
Gonapeptyl Daily
Romania
Gonapeptyl Zilnic
Slovenia
Gonapeptyl 0.1 mg/ml raztopina za injiciranje
Sweden
Gonapeptyl
Hungary
Gonapeptyl Daily
Italy
Fertipeptil

Date of last revision of the package leaflet: 03/2021

For more detailed information, contact the representative of the marketing authorization holder:
Ferring Pharmaceuticals Poland Sp. z o.o.
Szamocka 8
01-748 Warsaw
Phone: + 22 246 06 80