3.75 mg powder and solvent for injection, suspension
triptorelin
1. WHAT GONAPEPTYL DEPOT IS AND WHAT IT IS USED FOR
Gonapeptyl Depot contains triptorelin (as triptorelin acetate). Triptorelin belongs to a group of drugs called GnRH – analogue you. One of its functions is to reduce the production of sex hormones in the body.
It is used for:
In men:
Treatment of hormone-dependent locally advanced or metastatic prostate cancer.
In women:
To reduce the level of ovarian hormones too:
- Reduce the size of uterine fibroids, which are benign tumors that occur in the myometrium (uterine muscle wall)
- Treat endometriosis (formation of uterine lining outside the uterus).
In children:
Treatment of premature puberty (puberty that occurs prematurely but with physical and hormonal changes as in normal puberty).
BEFORE YOU USE GONAPEPTYL DEPOT
Do not use Gonapeptyl Depot
- If you are allergic (hypersensitive) to triptorelin or any of the other ingredients of Gonapeptyl Depot .
- If you are allergic to gonatropinfrisättande hormone ( GnRH ) or any other GnRH – analogue .
Women:
- If you are pregnant or breastfeeding
Take special care with Gonapeptyl Depot
Men and women
- Depression (possibly severe) has been reported in patients taking Gonapeptyl Depot . Tell your doctor if you are taking Gonapeptyl Depot and develop a lowered mood.
- Because Gonapeptyl Depot can lead to mood swings.
- As treatment with Gonapeptyl Depoti in some cases can lead to cerebral haemorrhage (pituitary apoplexy) Contact your doctor immediately if you experience sudden headache, vomiting or visual disturbances.
- Because treatment with Gonapeptyl Depot can lead to a reduction in bone density with the risk of bone damage.
- If you are at increased risk of bone density (osteoporosis), tell your doctor before taking Gonapeptyl Depot . Risk factors can be:
- If someone in the immediate family has a reduction in bone density.
- If you drink large amounts of alcohol, have an unhealthy diet and / or are a heavy smoker
- If you are being treated with other medicines that may affect your bone density.
Men:
Tell your doctor:
- If you have skeletal pain, or difficulty throwing water
- If you have metastases in the spine or tumor in the urinary tract.
- If you are neutered
- If you have been diagnosed with diabetes
- If you have a high risk of heart disease, such as being diagnosed with high blood pressure or having a heart rhythm problem ( arrhythmia ).
- If you have cardiovascular disease including cardiac arrhythmias ( arrhythmia ), or if you are taking medication for this. The risk of heart rhythm disorders may be increased when Gonapeptyl Depot is used
During treatment:
During treatment with Gonapeptyl Depot, you may experience a worsening of your condition.
Contact your doctor if your symptoms worsen.
Women:
Tell your doctor:
- If you experience intermittent bleeding during treatment (except during the first month)
During treatment:
- After the first injection , use a non-hormonal method of contraception (such as a condom or diaphragm ) for the first month. This also applies from the 4th week after the last injection until menstruation begins again.
- Menstruation usually stops during treatment and returns 7-12 weeks after the last injection .
- Contact your doctor if your period persists during treatment.
Children:
- Treatment should only be started in girls under 9 years of age and in boys under 10 years of age.
During treatment:
During the first months of treatment, mild vaginal bleeding may occur. After completion of treatment, the pubertal features develop. In most girls, menstruation starts about a year after the end of treatment and is in most cases regular.
For information on possible side effects, see section 4.
Use of other medicines
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Gonapeptyl Depot may affect some other medicines used to treat heart rhythm disorders (eg quinidine, procainamide, amiodarone, and sotalol) or may increase the risk of heart rhythm disorders when used with other medicines (eg methadone (used for pain and in the treatment of drug addiction), moxifloxacin (an antibiotic ), antipsychotics (used for severe mental illness).
Pregnancy and breastfeeding
Gonapeptyl Depot should not be used during pregnancy or breastfeeding.
See also section “Do not use Gonapeptyl depot”. If there is a possibility that you are pregnant, this should first be investigated and ruled out by your doctor before starting treatment with Gonapeptyl Depot.
Fertile women should use an effective non-hormonal contraceptive (such as a condom or diaphragm ) during treatment with Gonapeptyl Depot until menstruation returns.
Driving and using machines
Gonapeptyl Depot has no known effect on the ability to drive and use machines.
However, it can not be ruled out that the ability to drive and use machines may be affected during treatment by some of the side effects (dizziness, drowsiness/difficulty sleeping, and impaired vision). Take special care if you experience these side effects.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
3. HOW TO USE GONAPEPTYL DEPOT
Gonepeptyl Depot is usually prepared and given to you by a healthcare professional.
Depending on what you are being treated for, one dose is tailored to you and is given by intramuscular injection (into a muscle) or subcutaneous injection (under the skin).
Men:
- An injection of Gonpeptyl Depot is usually given every 4 weeks as a long-term treatment.
Women:
- An injection of Gonapeptyl Depot is usually given every 4 weeks for up to 6 months.
- Treatment should be started during the first 5 days of the menstrual cycle.
Children:
- At the beginning of treatment, an injection should be given on days 0, 14 and 28.
- Dose one should be based on body weight. Children weighing less than 20 kg are given 1.875 mg (1/2 dose ); children weighing 20-30 kg are given 2.5 mg (2/3 dose ); children weighing more than 30 kg are given 3.75 mg.
- Thereafter, injections are given every 3-4 weeks, depending on the effect.
The length of treatment is checked by your doctor.
If you use more Gonapeptyl Depot than you should
It is unlikely that you have received too much Gonapeptyl Depot. If you have been given too much Gonapeptyl Depot, talk to a doctor or pharmacist immediately.
If you stop using Gonapeptyl Depot
Gonapeptyl Depot treatment should only be stopped after a decision by your doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Gonapeptyl Depot can cause side effects, although not everybody gets them.
General (all patients):
If you notice swelling of the face, lips, mouth, or throat, which may make it difficult for you to swallow or breathe, talk to your doctor immediately or contact the emergency department.
Cases of enlargement of existing pituitary tumors have been reported during treatment with LH -RH- agonists, it has not been observed at triporelinterapi.
Men:
The symptoms you are being treated for (eg urinary tract blockage, skeletal pain, compression of the spinal cord, muscle fatigue and edema in the legs, weakness, and tingling in the feet and hands) may initially worsen. This is due to increased levels of testosterone at the start of treatment.
Very common affects more than 1 user in 10:
Most side effects of Gonapeptyl Depot in men are due to the lower levels of testosterone. Impotence, decreased sexual desire, hot flashes, skeletal pain and difficult and painful emptying of the bladder can occur.
Common, affects 1 to 10 users in 100:
Allergic reactions, mood swings, mood swings, depression, sleep disturbances, nausea, muscle and joint pain, fatigue, pain and reactions at the injection site, irritation, heavy sweating, headache, and enlargement of the mammary gland in men.
Uncommon affects 1 to 10 users in 1,000:
Elevated levels of certain liver enzymes, anaphylactic reaction, decreased testicular size, high blood pressure, decreased appetite, dry mouth, upper abdominal pain, worsening asthma, weight changes, blood clots, hair loss and decreased hair growth
No known frequency, can not be determined from the available data:
| • common cold | • diabetes mellitus |
| • gout | • tensions in the abdomen |
| • fraud | • constipation |
| • diarrhea | • shortness of breath |
| • redness at the injection site | • flu-like symptoms |
| • drowsiness | • dimsyn |
| • stinging, tingling, numb feeling | • impaired memory |
| • taste disorders | • impaired vision |
| • abnormal sensation in the eye | • tinnitus |
| • increased appetite | • general discomfort |
| • oro | • decreased sexual desire |
| • dizziness | • insomnia |
| • chest pain | • state of confusion |
| • chills | • decreased activity |
| • chest pain | • fever |
| • testicular pain | • weakness |
| • joint swelling | • impaired ejaculation |
| • muscle stiffness | • osteoarthritis |
| • back pain | • shortness of breath when lying down |
| • purple skin | • joint stiffness |
| • pain in muscles and bones | • pain in arms and legs |
| • weather stresses | • muscle weakness |
| • blisters | • hives |
| • angioedema (swelling under the skin) | • muscle cramps |
| • vomiting | • itching |
| • abdominal pain | • acne |
| • low blood pressure | • skin rash |
| • euphoria | • nosebleeds |
| • elevated body temperature | • difficulty standing |
| • edema | • increased levels of certain liver and kidney enzymes |
| • high blood pressure | • inflammation at the injection site |
| • ECG changes ( QT prolongation) | • pain |
Women:
Very common affects more than 10 users:
Decreased sexual desire, mood swings, sleep disorders, hot flashes, abdominal pain, skeletal pain, heavy sweating, bleeding / intermittent bleeding, dryness in the abdomen, pain during intercourse, painful menstruation, enlarged ovaries, pelvic pain, weakness, and headache.
Common, affects 1 to 10 users in 100:
Allergic reactions, low mood, depression, nausea, pain in muscles and joints, fatigue, pain and reactions at the injection site, irritation.
Uncommon affects 1 to 10 users in 1,000:
Anaphylactic reaction, impaired vision, stinging, tingling, numbness, back pain, increased blood cholesterol, increased levels of certain liver enzymes.
No known frequency, can not be determined from the available data:
| • feeling of discomfort in the abdomen | • fever |
| • heavy, prolonged, or irregular menstruation | • dizziness |
| • angioedema (swelling under the skin) | • high blood pressure |
| • missed periods | • chest pain |
| • reduced bone density leading to increased osteoporosis | • redness at the injection site |
| • itching | • skin rash |
| • oro | • general discomfort |
| • diarrhea | • vomiting |
| • fraud | • muscle weakness |
| • dimsyn | • hives |
| • state of confusion | • shortness of breath |
| • weight changes | • muscle cramps |
| • inflammation at the injection site |
Children:
Common, affects 1 to 10 users in 100:
Mood swings, depression.
Uncommon affects 1 to 10 users in 1,000:
In girls, bleeding and discharge may occur. Nausea, vomiting, and anaphylactic reaction have occurred.
No known frequency, can not be determined from the available data:
| • allergic reactions | • pain |
| • nervousness | • headache |
| • abdominal pain | • dimsyn |
| • impaired vision | • feeling of discomfort in the abdomen |
| • nosebleeds | • genital bleeding |
| • hot flashes | • high blood pressure |
| • skin rash | • weight gain |
| • hives | • pain, inflammation, and redness at the injection site |
| • hair loss | • general discomfort |
| • growth changes in bones | • muscle pain |
| • angioedema (swelling under the skin) | • emotional insecurity |
| • redness |
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency, By reporting side effects, you can help increase drug safety information.
5. HOW TO STORE GONAPEPTYL DEPOT
Keep out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton. The expiration date is the last day of the specified month.
Store at 2ºC-8ºC (in a refrigerator). Store the syringes in the outer carton.
The medicine 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 to protect the environment.
6. FURTHER INFORMATION
Content declaration
A pre-filled syringe (powder) contains 4.12 mg of triptorelin acetate corresponding to 3.75 mg of the active substance triptorelin.
The other ingredients are poly- (d, l-lactide coglycolide), propylene glycol dicaprylocaprate.
The diluent contains
Dextran 70, polysorbate 80, sodium chloride, sodium dihydrogen phosphate dihydrate, sodium hydroxide, water for injections
This medicine contains less than 1 mmol sodium (3.69 mg / ml or 0.160 mmol / ml) per dose , ie essentially ‘sodium-free’.
What the medicine looks like and the contents of the pack
One pack contains 1 set of the following: 1 or 3 pairs of pre-filled syringes (powder and diluent )
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Ferring Läkemedel AB
Box 4041
203 11 Malmö
Manufacturer
Ferring GmbH
Wittland 11
D-24109 Kiel
Germany
This medicinal product is authorized under the European Economic Area under the names:
GONAPEPTYL Depot (Belgium, Greece, Italy, Luxembourg, the Netherlands, Sweden, Spain, Portugal, UK), GONAPEPTYL 3.75 mg (France), GONAPEPTYL Depot 3.75 mg (Ireland), DECAPEPTYL Depot (Czech Republic, Denmark, Iceland, Estonia, Germany, Latvia, Lithuania, Norway, Poland, Slovakia), Decapeptyl Depot 3.75 (Finland), Decapeptyl N (Germany), UROPEPTYL Depot (Germany), Decapeptyl GYN (Germany), GYNOPEPTYL (Germany), Decapeptyl CR 3.75 (Netherlands), Decapeptyl Depot Retardant microcapsules and suspending agents for single syringes (Austria), DECAPEPTYL Depot injection (Hungary), DECAPEPTYL Retard injection in / sc (Switzerland).