Package leaflet: Information for the patient

DECAPEPTYL 0,1 mg, 0,1 mg/ml, solution for injection
Triptorelinum
Please read carefully all the information in this leaflet before using this medicine, because it contains
important information for the patient.
Keep this leaflet so that you can read it again if necessary.
If you have any further questions, please consult your doctor.
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 any adverse reactions occur in the patient, including any adverse reactions not listed in this leaflet,
please inform your doctor. See section 4.
Table of contents of the leaflet:

What Decapeptyl 0,1 mg is and what it is used for
Important information before using Decapeptyl 0,1 mg
How to use Decapeptyl 0,1 mg
Possible side effects
How to store Decapeptyl 0,1 mg
Contents of the pack and other information

1. What Decapeptyl 0,1 mg is and what it is used for

Decapeptyl 0,1 mg contains triptorelin (as triptorelin acetate). One of its actions is to reduce
the body's production of sex hormones.
Decapeptyl 0,1 mg is used:
In men:
for the treatment of hormone-dependent locally advanced or metastatic prostate cancer.
In women:
for the treatment of endometriosis (growth of uterine tissue outside the uterus).

2. Important information before using Decapeptyl 0.1 mg

When not to use Decapeptyl 0.1 mg
if the patient is allergic to triptorelin or any of the other ingredients of this medicine
(listed in section 6),
if the patient is allergic to gonadotropin-releasing hormone (GnRH) or any other GnRH analogue.
In women:
if the patient is pregnant,
if the patient is breastfeeding.

Warnings and precautions
Before starting treatment with Decapeptyl 0.1 mg, discuss this with your doctor.
In men and women
There have been reports of depression in patients receiving Decapeptyl 0.1 mg, including cases of severe depression. If depressive mood occurs during treatment with Decapeptyl 0.1 mg, inform your doctor.
pl-en Pg. 1
In men
Exercise caution:
if the patient experiences difficulty urinating, bone pain, muscle pain, or lymphedema of the lower limbs,
if the patient has metastatic tumors in the spine or urinary tract,
if the patient has any cardiovascular disorders, including heart rhythm disorders (arrhythmia), or is taking medications for these conditions; the risk of heart rhythm disorders may be increased during treatment with Decapeptyl 0.1 mg.
Inform your doctor if any symptoms of the disease worsen.

In women
Exercise caution:
if bleeding occurs between menstrual periods during treatment (except during the first month),
if the patient has an increased risk of reduced bone density.
Treatment with Decapeptyl 0.1 mg for several months may lead to a reduction in bone mass. For this reason, treatment duration should not exceed 6 months. After discontinuation of treatment, bone mass usually recovers within 6 to 9 months. Particular caution is required in patients with additional risk factors for osteoporosis.
A non-hormonal method of contraception should be used during the first month of treatment. This should also be continued from 4 weeks after the last injection until the return of menstrual bleeding or until another contraceptive method is initiated.
During treatment with Decapeptyl 0.1 mg, menstrual bleeding ceases. If regular menstrual periods persist during treatment, inform your doctor.

Decapeptyl 0.1 mg and other medicines
Tell your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Decapeptyl 0.1 mg may interact with certain medicines used to treat heart rhythm disorders (e.g. quinidine, procainamide, amiodarone, and sotalol) or may increase the risk of heart rhythm disorders when used concomitantly with certain other medicines [e.g. methadone (used for pain relief and as part of opioid detoxification), moxifloxacin (an antibiotic), antipsychotic medicines used to treat severe psychiatric disorders].
Exercise caution when triptorelin is administered concomitantly with medicines affecting pituitary gonadotropin secretion.

Pregnancy and breastfeeding
Decapeptyl 0.1 mg must not be used during pregnancy or breastfeeding.
Women of childbearing potential should use effective, non-hormonal contraceptive methods.

Driving and operating machinery
There is no known effect on the ability to drive vehicles or operate machinery.

3. How to use Decapeptyl 0.1 mg

This medicine should always be used as prescribed by the doctor. In case of any doubts, consult your
physician.
Decapeptyl 0.1 mg is intended for subcutaneous injection.
pl-pl Pg. 2
The usual initial dose is 0.5 mg once daily for 7 days, followed by a maintenance dose of 0.1 mg once daily.
Use of a higher than recommended dose of Decapeptyl 0.1 mg
If a higher than recommended dose of Decapeptyl 0.1 mg has been administered, inform the
physician.
Missed dose of Decapeptyl 0.1 mg
If a dose of Decapeptyl 0.1 mg has been missed, inform the physician.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.

In men

The following very common adverse reactions occur in more than 1 in 10 patients:

Loss of libido
Hot flushes
Excessive sweating
Erectile dysfunction

The following common adverse reactions occur in 1 to 10 in 100 patients:

Dizziness
Increased blood pressure
Bone pain
Feeling of fatigue
Pain at injection site

The following uncommon adverse reactions occur in 1 to 10 in 1000 patients:

Decreased appetite
Insomnia
Paresthesia (tingling, pricking, or numbness)
Nausea
Constipation
Dry mouth
Hair loss
Back pain
Gynaecomastia

Frequency unknown: cannot be estimated based on available data:

Nasopharyngitis (common cold)
Memory disorders
Anaphylactic reactions
Taste disturbances
Hypersensitivity
Somnolence
Increased appetite
Difficulty standing
Gout
Abnormal sensation in the eye
Diabetes
Visual disturbances
Depression
Blurred vision
Mood changes
Tinnitus
Confusion
Balance disorders
Reduced activity
Decreased blood pressure
Euphoric mood
Dyspnea (shortness of breath)
Anxiety
Dyspnea (shortness of breath) when lying down
Apathy
Epistaxis (nosebleed)
Headache
Abdominal pain
Diarrhea
Testicular pain
Vomiting
Absence of ejaculation
Abdominal distension
Weakness
Flatulence
Changes in ECG (prolongation of QT interval)
Acne
Erythema at injection site
Skin itching
Inflammatory reaction at injection site
Rash
Swelling
Angioedema (swelling under the skin)
Chills
Urticaria
Chest pain
Purpura (purple spots on the skin)
Influenza-like symptoms
Musculoskeletal pain
Fever
Limb pain
Irritability
Muscle spasms
Increased activity of certain liver enzymes
Muscle weakness
Increased blood creatinine levels
Increased blood urea levels
Increased blood pressure
Increased body temperature
Increased body weight
Decreased body weight
Breast pain
Testicular atrophy

In women

The following very common adverse reactions occur in more than 1 in 10 patients:

Decreased libido
Sleep disturbances
Headache
Hot flushes
Excessive sweating
Vaginal bleeding or spotting
Vaginal and vulvar dryness

The following common adverse reactions occur in 1 to 10 in 100 patients:

Hyperandrogenism
Mood changes
Anxiety
Insomnia
Depression
Low mood
Dizziness
Palpitations
Upper respiratory tract symptoms
Nausea
Dyspepsia
Gastrointestinal disorders
Abdominal pain
Hair loss
Joint pain
Painful sexual intercourse
Breast disorders
Withdrawal bleeding
Feeling of fatigue
Weakness
Irritability
Increased body weight
Abnormal body weight

The following uncommon adverse reactions occur in 1 to 10 in 1000 patients:

Paresthesia (tingling, pricking, or numbness)
Balance disorders
Back pain
Bone pain
Muscle cramps
Swelling
Pain at injection site
Reaction at injection site
Increased blood pressure

The following rare adverse reactions occur in 1 to 10 in 10,000 patients:

Vomiting
Muscle pain
Heavy menstrual bleeding
Pelvic pain

Frequency unknown: cannot be estimated based on available data:

Hypersensitivity
Anaphylactic reactions
Confusion
Blurred vision
Visual disturbances
Dyspnea (shortness of breath)
Abdominal discomfort
Diarrhea
Skin itching
Rash
Angioedema (swelling under the skin)
Urticaria
Muscle weakness
Painful menstruation
Breast pain
Bleeding between normal menstrual periods
Absence of menstruation
Erythema at injection site
Inflammation at injection site
Fever
Malaise

Reporting of adverse reactions

If any adverse reactions occur, including any not listed in this leaflet, inform your doctor. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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. Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Decapeptyl 0.1 mg

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the container after EXP.
The expiry date refers to the last day of the stated month.
Store in a refrigerator (2°C – 8°C).
For a period of one month, it may be stored at temperatures below 25°C.
Store in the original packaging to protect from light.
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 Decapeptyl 0.1 mg contains
The active substance is triptorelin. 1 ml of solution contains 0.1 mg of triptorelin.
Other ingredients: sodium chloride, glacial acetic acid, water for injections.

What Decapeptyl 0.1 mg looks like and contents of the pack
Decapeptyl 0.1 mg is a clear, colourless solution for injection in pre-filled syringes with a volume of 1 ml.
The carton pack contains 7 pre-filled syringes.

Marketing Authorisation Holder and Manufacturer:
Ferring GmbH
Wittland 11
D-24109 Kiel
Germany

For further information, please contact the local representative of the Marketing Authorisation Holder:
Ferring Pharmaceuticals Poland Sp. z o.o.
Szamocka 8 Street
01-748 Warsaw
Poland
Tel.: +48 22 246 06 80
Fax: +48 22 246 06 81
pl-pl Pg. 6