DECAPEPTYL 0.1 mg/ml Solution

Contents of the leaflet

1. Package Leaflet: Information for the Patient
   1. Read the package leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet:
2. What is Decapeptyl 0.1 mg and what is it used for
3. Important information before using Decapeptyl 0.1 mg
   1. When not to use Decapeptyl 0.1 mg
   2. Warnings and precautions
   3. Decapeptyl 0.1 mg and other medicines
   4. Pregnancy and breast-feeding
   5. Driving and using machines
4. How to use Decapeptyl 0.1 mg
   1. Using a higher dose of Decapeptyl 0.1 mg than recommended
   2. Missing a dose of Decapeptyl 0.1 mg
5. Possible side effects
   1. Reporting side effects
6. How to store Decapeptyl 0.1 mg
7. Contents of the pack and other information
   1. What Decapeptyl 0.1 mg contains
   2. What Decapeptyl 0.1 mg looks like and contents of the pack
   3. Marketing Authorisation Holder and Manufacturer:
   4. Date of last revision of the leaflet: 03/2021

Package Leaflet: Information for the Patient

DECAPEPTYL 0.1 mg, 0.1 mg/ml, solution for injection
Triptorelin

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

Keep this leaflet, you may need to read it again.
In case of any doubts, consult your doctor.
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 leaflet, tell your doctor. See section 4.

Table of Contents of the Leaflet:

• 1. What is Decapeptyl 0.1 mg and what is it used for
• 2. Important information before using Decapeptyl 0.1 mg
• 3. How to use Decapeptyl 0.1 mg
• 4. Possible side effects
• 5. How to store Decapeptyl 0.1 mg
• 6. Contents of the pack and other information

1. What is Decapeptyl 0.1 mg and what is it used for

Decapeptyl 0.1 mg contains triptorelin (as triptorelin acetate). One of its actions is to reduce the production of sex hormones by the body.
Decapeptyl 0.1 mg is used:
In men:
to treat hormone-dependent prostate cancer that is locally advanced or has spread.
In women:
to treat endometriosis (the growth of womb tissue outside the womb).

2. Important information before using Decapeptyl 0.1 mg

When not to use Decapeptyl 0.1 mg

if you are allergic to triptorelin or any of the other ingredients of this medicine (listed in section 6),
if you are allergic to gonadotropin-releasing hormone (GnRH) or any other GnRH analogue.
In women:
if you are pregnant,
if you are breast-feeding.

Warnings and precautions

Before starting treatment with Decapeptyl 0.1 mg, discuss it with your doctor.
In men and women
There have been reports of depression in patients taking Decapeptyl 0.1 mg, including severe depression. If you experience depressive symptoms while taking Decapeptyl 0.1 mg, tell your doctor.
In men
Be cautious:
if you have difficulty urinating, bone pain, muscle pain, lymphedema of the lower limbs,
if you have metastases in the spine or urinary tract,
if you have any cardiovascular disorders, including arrhythmia, or are taking medications to treat these disorders; the risk of arrhythmia may be increased during treatment with Decapeptyl 0.1 mg.
Tell your doctor if any of your disease symptoms worsen.
In women
Be cautious:
if you experience bleeding between menstrual periods (except for the first month),
if you have an increased risk of decreased bone density.
Treatment with Decapeptyl 0.1 mg for several months may lead to a decrease in bone mass.
Therefore, the treatment period should not exceed 6 months. After stopping treatment, bone mass usually recovers within 6 to 9 months. Special attention should be paid to patients with additional risk factors for osteoporosis.
During the first month of treatment, use a non-hormonal method of contraception. It should also be used from the 4th week after the last injection until menstrual bleeding resumes or another method of contraception is used.
During treatment with Decapeptyl 0.1 mg, menstrual bleeding stops. If regular menstrual periods persist during treatment, tell your doctor.

Decapeptyl 0.1 mg and other medicines

Tell your doctor about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Decapeptyl 0.1 mg may interact with certain medicines used to treat arrhythmias (e.g. quinidine, procainamide, amiodarone, and sotalol) or may increase the risk of arrhythmias when used with certain other medicines [e.g. methadone (used to reduce pain and as part of drug detoxification), moxifloxacin (an antibiotic), antipsychotic medicines used to treat severe mental disorders].
Be cautious when triptorelin is administered with medicines that affect gonadotropin secretion by the pituitary gland.

Pregnancy and breast-feeding

Decapeptyl 0.1 mg should not be used during pregnancy and breast-feeding.
Women of childbearing age should use effective, non-hormonal methods of contraception.

Driving and using machines

There is no known effect on the ability to drive and use machines.

3. How to use Decapeptyl 0.1 mg

This medicine should always be used as directed by your doctor. If you are unsure, consult your doctor.
Decapeptyl 0.1 mg is intended for subcutaneous injection.
Usually, an initial dose of 0.5 mg is given once a day for 7 days, followed by a maintenance dose of 0.1 mg once a day.

Using a higher dose of Decapeptyl 0.1 mg than recommended

If you use a higher dose of Decapeptyl 0.1 mg than recommended, tell your doctor.

Missing a dose of Decapeptyl 0.1 mg

If you miss a dose of Decapeptyl 0.1 mg, tell your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
In men
The following very common side effectsoccur in more than 1 in 10 patients:
loss of sexual desire
hot flashes
excessive sweating
erectile dysfunction
The following common side effectsoccur in 1 to 10 in 100 patients:
dizziness
increased blood pressure
bone pain
fatigue
pain at the injection site
The following uncommon side effectsoccur in 1 to 10 in 1,000 patients:
decreased appetite
insomnia
paresthesia (tingling, prickling, or numbness)
nausea
constipation
dry mouth
hair loss
back pain
gynecomastia
Frequency not known: cannot be estimated from the available data:
nasopharyngitis (common cold)
anaphylactic reactions
hypersensitivity
increased appetite
gout
diabetes
depression
mood changes
confusion
decreased activity
euphoric mood
anxiety
apathy
headache
memory disorders
taste disorders
sleepiness
difficulty standing
abnormal sensation in the eye
visual disturbances
blurred vision
tinnitus
balance disorders
decreased blood pressure
shortness of breath (dyspnea)
shortness of breath (dyspnea) when lying down
nasal bleeding
abdominal pain
diarrhea
vomiting
abdominal distension
bloating
acne
skin itching
rash
vesicles on the skin
angioedema (swelling that occurs under the skin)
testicular pain
absence of ejaculation
weakness
changes in ECG (QT interval prolongation)
redness at the injection site
inflammation at the injection site
reaction at the injection site
swelling
pain
chills
chest pain
flu-like symptoms
fever
malaise
irritability
increased activity of certain enzymes
under the skin)
hives
purpura (purple spots on the skin)
musculoskeletal pain
limb pain
joint pain
muscle spasms
muscle weakness
muscle pain
joint stiffness
joint swelling
musculoskeletal stiffness
arthritis
breast pain
testicular atrophy
increased liver enzymes in the blood
increased creatinine levels in the blood
increased urea levels in the blood
increased blood pressure
increased body temperature
increased body weight
decreased body weight
In women
The following very common side effectsoccur in more than 1 in 10 patients:
decreased sexual desire
sleep disorders
headache
hot flashes
excessive sweating
vaginal bleeding or spotting
vaginal dryness and vulvar dryness
The following common side effectsoccur in 1 to 10 in 100 patients:
hyperandrogenism
mood changes
anxiety
insomnia
depression
low mood
dizziness
palpitations
respiratory tract symptoms
nausea
gastrointestinal disorders
abdominal pain
hair loss
joint pain
painful sexual intercourse
breast disorders
withdrawal bleeding
fatigue
weakness
irritability
increased body weight
abnormal body weight
The following uncommon side effectsoccur in 1 to 10 in 1,000 patients:
paresthesia (tingling, prickling, or numbness)
balance disorders
back pain
bone pain
muscle spasms
swelling
pain at the injection site
reaction at the injection site
increased blood pressure
The following rare side effectsoccur in 1 to 10 in 10,000 patients:
vomiting
muscle pain
excessive menstrual bleeding
pelvic pain
Frequency not known: cannot be estimated from the available data:
hypersensitivity
anaphylactic reactions
confusion
blurred vision
visual disturbances
shortness of breath (dyspnea)
abdominal symptoms
diarrhea
skin itching
rash
angioedema (swelling that occurs under the skin)
hives
muscle weakness
painful menstruation
breast pain
intermenstrual bleeding
amenorrhea
redness at the injection site
inflammation at the injection site
fever
malaise

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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. By reporting side effects, you can help provide more information on the safety of this 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 packaging after the EXP label.
The expiry date refers to the last day of the month.
Store in a refrigerator (2°C – 8°C).
For a period of one month, it can be stored at a temperature 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.
The other ingredients are: 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, colorless solution for injection in pre-filled syringes with a capacity of 1 ml.
The carton box contains 7 pre-filled syringes.

Marketing Authorisation Holder and Manufacturer:

Ferring GmbH
Wittland 11
D-24109 Kiel
Germany
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
Fax: +48 22 246 06 81

Date of last revision of the leaflet: 03/2021

pl-pl
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