3.75 mg powder and solvent for injection, suspension
triptorelin<\/p>\n\n\n\n
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.<\/p>\n\n\n\n
It is used for:<\/p>\n\n\n\n
In men:<\/em><\/p>\n\n\n\n Treatment of hormone-dependent locally advanced or metastatic prostate cancer.<\/p>\n\n\n\n In women:<\/em><\/p>\n\n\n\n To reduce the level of ovarian hormones too:<\/p>\n\n\n\n In children:<\/em><\/p>\n\n\n\n Treatment of premature puberty (puberty that occurs prematurely but with physical and hormonal changes as in normal puberty).<\/p>\n\n\n\n Women:<\/em><\/p>\n\n\n\n Men and women<\/p>\n\n\n\n Men:<\/em><\/p>\n\n\n\n Tell your doctor:<\/p>\n\n\n\n During treatment:<\/p>\n\n\n\n During treatment with Gonapeptyl Depot, you may experience a worsening of your condition.<\/p>\n\n\n\n Contact your doctor if your symptoms worsen.<\/p>\n\n\n\n Women:<\/em><\/p>\n\n\n\n Tell your doctor:<\/p>\n\n\n\n During treatment:<\/p>\n\n\n\n Children:<\/em><\/p>\n\n\n\n During treatment:<\/p>\n\n\n\n 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.<\/p>\n\n\n\n For information on possible side effects, see section 4.<\/p>\n\n\n\n Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.<\/p>\n\n\n\n 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).<\/p>\n\n\n\n Gonapeptyl Depot should not be used during pregnancy or breastfeeding.<\/p>\n\n\n\n See also section \u201cDo not use Gonapeptyl depot\u201d. 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.<\/p>\n\n\n\n Fertile women should use an effective non-hormonal contraceptive (such as a condom or diaphragm ) during treatment with Gonapeptyl Depot until menstruation returns.<\/p>\n\n\n\n Gonapeptyl Depot has no known effect on the ability to drive and use machines.<\/p>\n\n\n\n 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.<\/p>\n\n\n\n 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.<\/p>\n\n\n\n Gonepeptyl Depot is usually prepared and given to you by a healthcare professional.<\/p>\n\n\n\n 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).<\/p>\n\n\n\n Men:<\/em><\/p>\n\n\n\n Women:<\/em><\/p>\n\n\n\n Children:<\/em><\/p>\n\n\n\n The length of treatment is checked by your doctor.<\/p>\n\n\n\n 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.<\/p>\n\n\n\n Gonapeptyl Depot treatment should only be stopped after a decision by your doctor.<\/p>\n\n\n\n If you have any further questions on the use of this product, ask your doctor or pharmacist.<\/p>\n\n\n\n Like all medicines, Gonapeptyl Depot can cause side effects, although not everybody gets them.<\/p>\n\n\n\n General (all patients):<\/p>\n\n\n\n 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.<\/p>\n\n\n\n Cases of enlargement of existing pituitary tumors have been reported during treatment with LH -RH- agonists, it has not been observed at triporelinterapi.<\/p>\n\n\n\n Men:<\/em><\/p>\n\n\n\n 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.<\/p>\n\n\n\n Very common affects more than 1 user in 10:<\/em><\/p>\n\n\n\n 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.<\/p>\n\n\n\n Common, affects 1 to 10 users in 100:<\/em><\/p>\n\n\n\n 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.<\/p>\n\n\n\n Uncommon affects 1 to 10 users in 1,000:<\/em><\/p>\n\n\n\n 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<\/p>\n\n\n\n No known frequency, can not be determined from the available data:<\/em><\/p>\n\n\n\n Women:<\/em><\/p>\n\n\n\n Very common affects more than 10 users:<\/em><\/p>\n\n\n\n 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.<\/p>\n\n\n\n Common, affects 1 to 10 users in 100:<\/em><\/p>\n\n\n\n Allergic reactions, low mood, depression, nausea, pain in muscles and joints, fatigue, pain and reactions at the injection site, irritation.<\/p>\n\n\n\n Uncommon affects 1 to 10 users in 1,000:<\/em><\/p>\n\n\n\n Anaphylactic reaction, impaired vision, stinging, tingling, numbness, back pain, increased blood cholesterol, increased levels of certain liver enzymes.<\/p>\n\n\n\n No known frequency, can not be determined from the available data:<\/em><\/p>\n\n\n\n Children:<\/em><\/p>\n\n\n\n Common, affects 1 to 10 users in 100:<\/em><\/p>\n\n\n\n Mood swings, depression.<\/p>\n\n\n\n Uncommon affects 1 to 10 users in 1,000:<\/em><\/p>\n\n\n\n In girls, bleeding and discharge may occur. Nausea, vomiting, and anaphylactic reaction have occurred.<\/p>\n\n\n\n No known frequency, can not be determined from the available data:<\/em><\/p>\n\n\n\n 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.<\/p>\n\n\n\nBEFORE YOU USE GONAPEPTYL DEPOT<\/h2>\n\n\n\n
Do not use Gonapeptyl Depot<\/h2>\n\n\n\n
Take special care with Gonapeptyl Depot<\/h2>\n\n\n\n
Use of other medicines<\/h2>\n\n\n\n
Pregnancy and breastfeeding<\/h2>\n\n\n\n
Driving and using machines<\/h2>\n\n\n\n
3. HOW TO USE GONAPEPTYL DEPOT<\/h2>\n\n\n\n
If you use more Gonapeptyl Depot than you should <\/h2>\n\n\n\n
If you stop using Gonapeptyl Depot<\/h2>\n\n\n\n
4. POSSIBLE SIDE EFFECTS<\/h2>\n\n\n\n
\u2022 common cold<\/td> \u2022 diabetes mellitus<\/td><\/tr> \u2022 gout<\/td> \u2022 tensions in the abdomen<\/td><\/tr> \u2022 fraud<\/td> \u2022 constipation<\/td><\/tr> \u2022 diarrhea<\/td> \u2022 shortness of breath<\/td><\/tr> \u2022 redness at the injection site<\/td> \u2022 flu-like symptoms<\/td><\/tr> \u2022 drowsiness<\/td> \u2022 dimsyn<\/td><\/tr> \u2022 stinging, tingling, numb feeling<\/td> \u2022 impaired memory<\/td><\/tr> \u2022 taste disorders<\/td> \u2022 impaired vision<\/td><\/tr> \u2022 abnormal sensation in the eye<\/td> \u2022 tinnitus<\/td><\/tr> \u2022 increased appetite<\/td> \u2022 general discomfort<\/td><\/tr> \u2022 oro<\/td> \u2022 decreased sexual desire<\/td><\/tr> \u2022 dizziness<\/td> \u2022 insomnia<\/td><\/tr> \u2022 chest pain<\/td> \u2022 state of confusion<\/td><\/tr> \u2022 chills<\/td> \u2022 decreased activity<\/td><\/tr> \u2022 chest pain<\/td> \u2022 fever<\/td><\/tr> \u2022 testicular pain<\/td> \u2022 weakness<\/td><\/tr> \u2022 joint swelling<\/td> \u2022 impaired ejaculation<\/td><\/tr> \u2022 muscle stiffness<\/td> \u2022 osteoarthritis<\/td><\/tr> \u2022 back pain<\/td> \u2022 shortness of breath when lying down<\/td><\/tr> \u2022 purple skin<\/td> \u2022 joint stiffness<\/td><\/tr> \u2022 pain in muscles and bones<\/td> \u2022 pain in arms and legs<\/td><\/tr> \u2022 weather stresses<\/td> \u2022 muscle weakness<\/td><\/tr> \u2022 blisters<\/td> \u2022 hives<\/td><\/tr> \u2022 angioedema (swelling under the skin)<\/td> \u2022 muscle cramps<\/td><\/tr> \u2022 vomiting<\/td> \u2022 itching<\/td><\/tr> \u2022 abdominal pain<\/td> \u2022 acne<\/td><\/tr> \u2022 low blood pressure<\/td> \u2022 skin rash<\/td><\/tr> \u2022 euphoria<\/td> \u2022 nosebleeds<\/td><\/tr> \u2022 elevated body temperature<\/td> \u2022 difficulty standing<\/td><\/tr> \u2022 edema<\/td> \u2022 increased levels of certain liver and kidney enzymes<\/td><\/tr> \u2022 high blood pressure<\/td> \u2022 inflammation at the injection site<\/td><\/tr> \u2022 ECG changes ( QT prolongation)<\/td> \u2022 pain<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n \u2022 feeling of discomfort in the abdomen<\/td> \u2022 fever<\/td><\/tr> \u2022 heavy, prolonged, or irregular menstruation<\/td> \u2022 dizziness<\/td><\/tr> \u2022 angioedema (swelling under the skin)<\/td> \u2022 high blood pressure<\/td><\/tr> \u2022 missed periods<\/td> \u2022 chest pain<\/td><\/tr> \u2022 reduced bone density leading to increased osteoporosis<\/td> \u2022 redness at the injection site<\/td><\/tr> \u2022 itching<\/td> \u2022 skin rash<\/td><\/tr> \u2022 oro<\/td> \u2022 general discomfort<\/td><\/tr> \u2022 diarrhea<\/td> \u2022 vomiting<\/td><\/tr> \u2022 fraud<\/td> \u2022 muscle weakness<\/td><\/tr> \u2022 dimsyn<\/td> \u2022 hives<\/td><\/tr> \u2022 state of confusion<\/td> \u2022 shortness of breath<\/td><\/tr> \u2022 weight changes<\/td> \u2022 muscle cramps<\/td><\/tr> \u2022 inflammation at the injection site<\/td> <\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n \u2022 allergic reactions<\/td> \u2022 pain<\/td><\/tr> \u2022 nervousness<\/td> \u2022 headache<\/td><\/tr> \u2022 abdominal pain<\/td> \u2022 dimsyn<\/td><\/tr> \u2022 impaired vision<\/td> \u2022 feeling of discomfort in the abdomen<\/td><\/tr> \u2022 nosebleeds<\/td> \u2022 genital bleeding<\/td><\/tr> \u2022 hot flashes<\/td> \u2022 high blood pressure<\/td><\/tr> \u2022 skin rash<\/td> \u2022 weight gain<\/td><\/tr> \u2022 hives<\/td> \u2022 pain, inflammation, and redness at the injection site<\/td><\/tr> \u2022 hair loss<\/td> \u2022 general discomfort<\/td><\/tr> \u2022 growth changes in bones<\/td> \u2022 muscle pain<\/td><\/tr> \u2022 angioedema (swelling under the skin)<\/td> \u2022 emotional insecurity<\/td><\/tr> \u2022 redness<\/td> <\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n