Product Details

What you need to know before you use Decapeptyl SR 3 mg

MEN Do not use Decapeptyl SR 3 mg • If you are allergic to triptorelin or similar types of drugs (other GnRH agonists) or any of the other ingredients of this medicine (listed in section 6). Warnings and precautions Talk to your doctor or pharmacist before taking Decapeptyl SR 3 mg. • There have been reports of depression in patients taking Decapeptyl SR 3 mg which may be severe. If you are taking Decapeptyl SR 3 mg and develop depressed mood, inform your doctor. Your doctor may want to monitor your depression during treatment. • If you are using medicines for preventing your blood clotting, you may experience bruising at the site of the intramuscular injection. • In adults, triptorelin may cause thinning of the bones (osteoporosis) with an increased risk of bone fractures. You should therefore tell your doctor if you have any of the below risk factors as he/she might give you bisphosphonate (drugs used to treat wark bones) to treat bone loss. Risk factors may include: o If you or any of your close family have thinning of the bones. o If you drink excessive amounts of alcohol, and/or smoke heavily. o If you take medicines over a long period of time that may cause thinning of the bones, for example medicines for epilepsy or steroids (such as hydrocortisone or prednisolone). • When you first start treatment with Decapeptyl SR 3 mg it actually increases the level of your hormones for a short time. This means that you may feel worse to begin with (see section 4 ‘Possible side effects’ for more information). The doctor may give you some medicine (an anti-androgen) to prevent your symptoms from getting worse. After a short time, the amount of hormone will drop and your symptoms will get better. • If you suffer from urinary obstruction or spinal cord (nerves in your backbone) compression due to your prostate cancer spreading, your doctor will supervise you closely for the first few weeks of treatment. If you experience difficulty passing urine, bone pain, weakness of lower limbs or pins and needles sensation, contact your doctor immediately, who will assess and treat you appropriately. • Tell your doctor if you have diabetes. • Tell your doctor if you have any heart or blood vessel conditions, including heart rhythm problems (arrhythmia), or are being treated with medicines for these conditions. The risk of heart rhythm problems may be increased when using Decapeptyl SR 3 mg. • If you have an enlargement (benign tumour) of the pituitary gland that you were unaware of, this may be discovered during treatment with Decapeptyl SR 3 mg. Symptoms include sudden headache, problems with eyesight and paralysis of the eye muscles. • After surgical castration triptorelin does not induce any further decrease in serum testosterone levels. • Diagnostic tests of pituitary gonadal function or sex organs conducted during treatment or after discontinuation of therapy with Decapeptyl SR 3 mg may be misleading. • Testosterone decreasing agents may cause changes in ECG associated with heart rhythm abnormalities (QT prolongation). • Tell your doctor if you have back pain, weakness, numbness or tingling in your legs. Page 3 of 11 Your doctor may give you another drug to help you feel better during this time. Other medicines and Decapeptyl SR 3 mg Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Decapeptyl SR 3 mg might interfere with some medicines used to treat heart rhythm problems (e.g. quinidine, procainamide, amiodarone and sotalol) or might increase the risk of heart rhythm problems when used with some other drugs (e.g. methadone (used for pain relief and part of drug addiction detoxification), moxifloxacin (an antibiotic), antipsychotics used for serious mental illnesses). Drugs which increase the level of a hormone called prolactin may react with Decapeptyl SR 3 mg. Many different kinds of drugs may increase prolactin levels. Driving and using machines You may feel dizzy, tired or have problems with your sight such as blurred vision. These are possible side effects of treatment or from the underlying disease. If you experience any of these side effects, you should not drive or use machines. Decapeptyl SR 3 mg contains sodium This medicine contains less than 1 mmol (23 mg) sodium per dose, i.e., essentially ‘sodium-free‘. WOMEN Do not use Decapeptyl SR 3 mg • If you are allergic to triptorelin or similar types of drugs (other GnRH agonists) or any of the other ingredients of this medicine (listed in section 6). • If you are pregnant or breast-feeding. • If you are using Decapeptyl SR 3 mg for breast cancer, do not use an ‘aromatase inhibitor’ medicine (such as exemestane) with Decapeptyl SR 3 mg until you have been treated with Decapeptyl SR 3 mg for at least 6 to 8 weeks. Warnings and precautions Talk to your doctor or pharmacist before taking Decapeptyl SR 3 mg. • Due to lack of clinical experience in women under 18 years of age, triptorelin is not recommended in adolescent and young women as it might cause thinning of bone. • There have been reports of depression in patients taking Decapeptyl SR 3 mg which may be severe. If you are taking Decapeptyl SR 3 mg and develop depressed mood, inform your doctor. Your doctor may want to monitor your depression during treatment. • If you are using medicines for preventing your blood clotting, you may experience bruising at the site of the intramuscular injection. • In adults, triptorelin may cause thinning of the bones (osteoporosis) with an increased risk of bone fractures. You should therefore tell your doctor if you have any of the below risk factors as he/she might give you bisphosphonate (drugs used to treat wark bones) to treat bone loss. Risk factors may include: o If you or any of your close family have thinning of the bones. o If you drink excessive amounts of alcohol, and/or smoke heavily. o If you take medicines over a long period of time that may cause thinning of the bones, for example medicines for epilepsy or steroids (such as hydrocortisone or prednisolone). • You may have some vaginal bleeding in the first month of treatment. After that your periods normally stop. • Tell your doctor if you have bleeding after the first month of treatment. • Your periods should start approximately 2 months after the last injection. Page 4 of 11 • You must use some form of contraception other than the ‘pill’ while you are having treatment and until you start your next period. Your doctor may suggest using a barrier method of contraception such as a condom or diaphragm (cap). • If you are a woman with submucous fibroids (benign tumours in the muscle underneath the lining of the womb), Triptorelin can cause bleeding when the fibroids break-down within the first 6-10 weeks after starting treatment. Contact your doctor immediately if you experience severe or unusual bleeding or pain. • If you have an enlargement (benign tumour) of the pituitary gland that you were unaware of, this may be discovered during treatment. Symptoms include sudden headache, problems with eyesight and paralysis of the eye muscles. If you are using Decapeptyl SR 3mg for Breast cancer: If you have anything wrong with you that affects your bones, such as osteoporosis, inform your doctor. This may affect the way you doctor decides to treat you. Your doctor will do a bone scan before treatment starts if you are at risk of osteoporosis and monitor you during treatment. If you have diabetes or high blood pressure, inform your doctor. Your doctor will check your blood sugar levels and blood pressure during treatment. Tell your doctor if you suffer from heart problems. If you suffer from depression, inform your doctor. Your doctor may want to monitor your depression during treatment. If you discontinue triptorelin treatment, you must discontinue at the same time aromatase inhibitor (such as exemestane) treatment. Other medicines and Decapeptyl SR 3 mg Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Drugs which increase the level of a hormone called prolactin may react with Decapeptyl SR 3 mg. Many different kinds of drugs may increase prolactin levels. Pregnancy and breast-feeding Do not take Decapeptyl SR 3 mg if you are pregnant or breast-feeding. Driving and using machines You may feel dizzy, tired or have problems with your sight such as blurred vision. These are possible side effects of treatment or from the underlying disease. If you experience any of these side effects, you should not drive or use machines. Decapeptyl SR 3 mg contains sodium This medicine contains less than 1 mmol (23 mg) sodium per dose, i.e., essentially ‘sodium-free‘