3.6 mg implant, prefilled syringe
goserelin
What Zoladex is and what it is used for
The active substance is goserelin. Zoladex belongs to a group of medicines that reduce the hormonal effects in the body by affecting the levels of certain hormones (= natural substances produced by the body). In men, Zoladex lowers the level of the male sex hormone, testosterone. In women, the preparation lowers the level of the female sex hormone, estrogen.
In men, Zoladex is given to treat prostate cancer.
For women, Zoladex is prescribed for
- treatment of endometriosis (endometrium outside the uterus)
- treatment of breast cancer
- preoperative reduction of bleeding and pain in patients with uterine fibroids
- pretreatment before endometrial resection
What you need to know before you are given Zoladex
You should not be given Zoladex
- if you are allergic to goserelin or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Medicines of this type can reduce the amount of calcium in the bones (which cause osteoporosis). If you have any disease that affects the strength of the bone structure, tell the doctor about this.
Tell the doctor if you have severely impaired kidney function.
If you are admitted to the hospital, tell the healthcare staff that you are being treated with Zoladex.
Depression, which can be severe, has been reported in patients taking Zoladex. Inform your doctor if you become moody/depressed while taking Zoladex.
Talk to your doctor if you have any of the following: Cardiovascular disease including heart rhythm disturbances ( arrhythmia ), or if you are taking medication for this. The risk of suffering from heart rhythm disorders may be increased when using Zoladex.
Men
Talk to your doctor before starting treatment with Zoladex:
- if you have had difficulty urinating or problems in the lower back
- if you have diabetes
- if you are being treated with antiandrogens. The risk of heart failure and myocardial infarction may increase when Zoladex is combined with an antiandrogen
Women
If you are being treated for endometriosis, your doctor may prescribe additional treatment to reduce the osteoporosis caused by Zoladex. The osteoporosis can to a certain extent be corrected by itself when the treatment ends.
Children and young people
Zoladex should not be given to children and adolescents under the age of 18.
Other medicines and Zoladex
Tell the doctor or hospital staff if you are using, have recently used, or might use any other medicines.
Zoladex may affect certain 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 together with other medicines eg methadone (used for pain and in the treatment of drug addiction), moxifloxacin (an antibiotic ), antipsychotics (used for serious mental illness).
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, do not use this medicine.
Use a condom or spiral as contraception when you are treated with Zoladex. Birth control pills should not be used during treatment with Zoladex. If you should nevertheless become pregnant during treatment, tell the doctor immediately.
Driving ability and use of machinery
Zoladex is not known to affect the ability to drive or use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. 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. A description of these
effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with a doctor or pharmacist if you are unsure.
How Zoladex is given
Your doctor or a nurse injects the Zoladex implant under the skin of the abdomen. The treatment is repeated every 28 days. You must continue treatment with Zoladex even if you feel well unless your doctor decides to stop treatment. If you have further questions regarding treatment with Zoladex, contact your doctor or nurse.
Women
- If you receive Zoladex for the treatment of endometriosis, the treatment may continue for a maximum of six months
- If you receive Zoladex as pre-treatment before endometrial resection, two Zoladex implants are given 28 days apart
- If you receive Zoladex for the treatment of fibroids, treatment may continue for a maximum of three months
If you are given too much Zoladex
If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice.
If you have any further questions about this medicine, ask your doctor, pharmacist, or nurse.
If you stop using Zoladex
Do not stop treatment with Zoladex unless your doctor tells you to do so.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Men
Very common (affects more than 1 in 10 users)
- Decreased sex drive
- Impotence
- Hot flashes and profuse sweating. These side effects may persist (sometimes for months) after stopping treatment with Zoladex
Common (affects more than 1 in 100 users)
- Reduction of sugar balance in the blood
- Abnormal sensations (eg crawling, tingling)
- Spinal cord compression
- Heart failure, heart attack
- Blood pressure changes
- Rash
- Skeletal pain
- Breast enlargement in men
- Injection site reactions (eg redness, pain, swelling, bleeding). Injury (eg damage to the blood vessels of the stomach) may occur at the injection site after administration of Zoladex. In very rare cases, it has led to severe bleeding. Contact a doctor immediately if you experience any of the following symptoms: stomach pain, swelling of the stomach, shortness of breath, dizziness, and loss of consciousness
- Decrease in bone density
- Weight gain
- Mood changes, depression
Uncommon (affects less than 1 in 100 users)
- Hypersensitivity reaction
- Joint pain
- Urinary tract narrowing
- Tenderness in the breasts
Rare (affects less than 1 in 1,000 users)
- Rapid and severe allergic reaction ( anaphylactic reaction )
Very rare (affects less than 1 in 10,000 users)
- Tumor/growth in pituitary gland a. If you have a growth in the pituitary gland, Zoladex can cause bleeding from it or collapse (sudden feeling of weakness). This is very rare and causes severe headaches, nausea, loss of vision, and unconsciousness
- Psychotic disorders
Frequency not known (cannot be estimated from available data)
- Hair loss
- Changes ( QT prolongation) in the ECG ( electrocardiogram )
Women
Very common (affects more than 1 in 10 users)
- Decreased sex drive
- Hot flashes and profuse sweating. These side effects may persist (sometimes for months) after stopping treatment with Zoladex
- Vaginal dryness
- Enlarged breasts
- Injection site reactions (eg redness, pain, swelling, bleeding). Injury (eg damage to the blood vessels of the stomach) may occur at the injection site after administration of Zoladex. In very rare cases, it has led to severe bleeding. Contact a doctor immediately if you experience any of the following symptoms: stomach pain, swelling of the stomach, shortness of breath, dizziness, and loss of consciousness
- Acne
Common (affects more than 1 in 100 users)
- Mood changes, depression
- Abnormal sensations (eg crawling, tingling)
- Headache
- Blood pressure changes
- Rash
- Joint pain
- “Tumour flare”, pain from a tumor
- Decrease in bone density
- Hair loss
- Weight gain
Uncommon (affects less than 1 in 100 users)
- Hypersensitivity reaction
- Too high calcium content in the blood
Rare (affects less than 1 in 1,000 users)
- Rapid and severe allergic reaction ( anaphylactic reaction )
- Ovarian cyst
- Overstimulated ovaries
Very rare (affects less than 1 in 10,000 users)
- Tumor/growth in pituitary gland a. If you have a growth in the pituitary gland, Zoladex can cause bleeding from it or collapse (sudden feeling of weakness). This is very rare and causes severe headaches, nausea, loss of vision, and unconsciousness
- Psychotic disorders
Frequency not known (cannot be estimated from available data)
- Withdrawal bleeding
- Degeneration of fibroids in women who have them
How to store Zoladex
Keep this medicine out of the sight and reach of children.
Store at a maximum of 25 °C.
Store in the original packaging. Do not open the inner packaging. The inner packaging is sterile on the inside and may only be opened by the healthcare professional who gives you the injection under the skin.
Use before the expiry date which is stated on the carton and inner packaging after EXP. The expiration date is the last day of the specified month.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
The active substance is goserelin. One implant contains 3.6 mg of goserelin.
Other ingredients are lactide-glycolide copolymers.