ZOLADEX LA 10.8MG INJECTION
Active substance: GOSERELIN ACETATE
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Assessed against UK PIL dated April 2012
By Aneela Mahmood at 2:43 pm, Aug 01, 2012
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Zoladex LA 10.8mg Injection
(goserelin acetate) Your medicine is known by the above name, but will be referred to as Zoladex LA throughout this: Patient Information Leaflet Read all of this leaflet carefully before you start using this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1) What Zoladex LA is and what it is used for 2) Before you are given Zoladex LA 3) How Zoladex LA will be given 4) Possible side effects 5) How to store Zoladex LA 6) Further information You suffer from depression. You have any condition that affects the strength of your bones, especially if you are a heavy drinker, a smoker, have a family history of osteoporosis (a condition that affects the strength of your bones) or take anticonvulsants (medicines for epilepsy or fits) or corticosteroids (steroids).
There have been reports of depression in patients taking Zoladex LA which may be severe. If you are taking Zoladex LA and develop depressed mood, inform your doctor. Medicines of this type can cause a reduction in bone calcium (thinning of bones). If you go into hospital, tell the medical staff that you are having Zoladex LA. Taking other medicines Please tell your doctor or nurse if you are taking or have recently taken any other medicines. This includes medicines that you buy without a prescription and herbal medicines. Driving and using machines Zoladex LA is not likely to affect you being able to drive or use any tools or machines.
1) What Zoladex LA is and what it is used for
Zoladex LA contains a medicine called goserelin. This belongs to a group of medicines called LHRH analogues. Zoladex LA is used to treat prostate cancer. It works by reducing the amount of testosterone (a hormone) that is produced by your body. Zoladex LA is a long-acting form of Zoladex and it is given every 12 weeks.
3) How Zoladex LA will be given
The Zoladex LA 10.8 mg Implant will be injected under the skin on your stomach every 12 weeks. This will be done by your doctor or nurse. It is important that you keep having Zoladex LA treatment, even if you are feeling well. Keep having this treatment until your doctor decides that it is time for you to stop.
2) Before you are given Zoladex LA
Do not have Zoladex LA: You are allergic (hypersensitive) to goserelin or any of the other ingredients of this medicine (listed in Section 6: Further information). You are a woman. Do not have Zoladex LA if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before having Zoladex LA. Zoladex LA should not be given to children. Take special care with Zoladex LA: Check with your doctor or nurse before you have Zoladex LA if: You have problems passing urine (water) or problems with your back. You have diabetes. You have high blood pressure.
Your next appointment You should be given a Zoladex LA injection every 12 weeks. Always remind the doctor or nurse to set up an appointment for your next injection. If you are given an appointment for your next injection which is earlier or later than 12 weeks from your last injection, tell your doctor or nurse. If it has been more than 12 weeks since your last injection, contact your doctor or nurse so that you can receive your injection as soon as possible.
4) Possible side effects
Like all medicines, Zoladex LA can cause side effects, although not everybody gets them. Mood changes, depression In Long term use: Common In Short term use: Uncommon Allergic reactions: These are rare. The symptoms can include sudden onset of: Rash, itching or hives on the skin. Swelling of the face, lips or tongue or other parts of the body. Shortness of breath, wheezing or trouble breathing. If this happens to you, see a doctor straight away. Other possible side effects: Pain in your lower back or problems passing urine. If this happens, talk to your doctor. Bone pain at the beginning of treatment. If this happens, talk to your doctor. Hot flushes and sweating. A reduced sex drive and impotence. Thinning of your bones. Rises in blood sugar levels. Tingling in your fingers or toes. Skin rashes. Hair loss Weight gain Pain, bruising, bleeding, redness or swelling where Zoladex LA is injected. Pain in the joints. Reduced heart function or heart attack Changes in blood pressure. Swelling and tenderness of your breasts. Changes in your mood (including depression). Changes in your blood. Liver problems. A blood clot in your lungs causing chest pain or shortness of breath. Inflammation of the lungs. The symptoms may be like pneumonia (such as feeling short of breath and coughing). Psychiatric problems called psychotic disorders which may include hallucinations (seeing, feeling or hearing things that are not there), disordered thoughts and personality changes. This is very rare. The development of a tumour of the pituitary gland in your head or, if you already have a tumour in your pituitary gland, Zoladex LA may make the tumour bleed or collapse. These effects are very rare.
Pituitary tumours can cause severe headaches, feeling or being sick, loss of eyesight and becoming unconscious. Do not be concerned by this list of possible side effects. You may not get any of them. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist.
5) How to store Zoladex LA
Keep all medicines out of the reach and sight of children. You may be given a prescription and asked to collect your injection from the pharmacy and keep it until you see your doctor. Keep it in the original package, do not break the seal. Do not use after the expiry date printed on the carton or labelled pack. Do not store above 25C. If your medicine is not used, take t back to your pharmacist. If your medicine shows any signs of deterioration, you should seek the advice of your pharmacist.
6) Further information
What Zoladex LA 10.8mg Injection contains: Your medicine is called Zoladex LA 10.8mg Injection and contains the active ingredient, goserelin acetate equivalent to 10.8mg goserelin in a sustained release formulation. Your medicine also contains lactide glycolide co-polymer which is an inactive substance. What Zoladex LA 10.8mg Injection looks like and contents of the pack Zoladex LA 10.8mg Injection is available as an implant in a pre-filled single dose syringe applicator. PL 10383/0568 POM
Who makes and repackages your medicine? Your medicine is manufactured by AstraZeneca UK Ltd Silk Road Business Park Macclesfield, Cheshire SK10 2NA. Procured from within the EU and repackaged by the Product Licence Holder: Primecrown Ltd, 4/5 Northolt Trading Estate, Belvue Road, Northolt, Middlesex, UB5 5QS. Leaflet date: 15.05.2012 Zoladex is a trade mark of the AstraZeneca group of companies.
By Aneela Mahmood at 2:43 pm, Aug 01, 2012
MockUp
Zoladex LA 10.8mg Injection
(goserelin acetate) Your medicine is known by the above name, but will be referred to as Zoladex LA throughout this: Patient Information Leaflet Read all of this leaflet carefully before you start using this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1) What Zoladex LA is and what it is used for 2) Before you are given Zoladex LA 3) How Zoladex LA will be given 4) Possible side effects 5) How to store Zoladex LA 6) Further information You suffer from depression. You have any condition that affects the strength of your bones, especially if you are a heavy drinker, a smoker, have a family history of osteoporosis (a condition that affects the strength of your bones) or take anticonvulsants (medicines for epilepsy or fits) or corticosteroids (steroids).
There have been reports of depression in patients taking Zoladex LA which may be severe. If you are taking Zoladex LA and develop depressed mood, inform your doctor. Medicines of this type can cause a reduction in bone calcium (thinning of bones). If you go into hospital, tell the medical staff that you are having Zoladex LA. Taking other medicines Please tell your doctor or nurse if you are taking or have recently taken any other medicines. This includes medicines that you buy without a prescription and herbal medicines. Driving and using machines Zoladex LA is not likely to affect you being able to drive or use any tools or machines.
1) What Zoladex LA is and what it is used for
Zoladex LA contains a medicine called goserelin. This belongs to a group of medicines called LHRH analogues. Zoladex LA is used to treat prostate cancer. It works by reducing the amount of testosterone (a hormone) that is produced by your body. Zoladex LA is a long-acting form of Zoladex and it is given every 12 weeks.
3) How Zoladex LA will be given
The Zoladex LA 10.8 mg Implant will be injected under the skin on your stomach every 12 weeks. This will be done by your doctor or nurse. It is important that you keep having Zoladex LA treatment, even if you are feeling well. Keep having this treatment until your doctor decides that it is time for you to stop.
2) Before you are given Zoladex LA
Do not have Zoladex LA: You are allergic (hypersensitive) to goserelin or any of the other ingredients of this medicine (listed in Section 6: Further information). You are a woman. Do not have Zoladex LA if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before having Zoladex LA. Zoladex LA should not be given to children. Take special care with Zoladex LA: Check with your doctor or nurse before you have Zoladex LA if: You have problems passing urine (water) or problems with your back. You have diabetes. You have high blood pressure.
Your next appointment You should be given a Zoladex LA injection every 12 weeks. Always remind the doctor or nurse to set up an appointment for your next injection. If you are given an appointment for your next injection which is earlier or later than 12 weeks from your last injection, tell your doctor or nurse. If it has been more than 12 weeks since your last injection, contact your doctor or nurse so that you can receive your injection as soon as possible.
4) Possible side effects
Like all medicines, Zoladex LA can cause side effects, although not everybody gets them. Mood changes, depression In Long term use: Common In Short term use: Uncommon Allergic reactions: These are rare. The symptoms can include sudden onset of: Rash, itching or hives on the skin. Swelling of the face, lips or tongue or other parts of the body. Shortness of breath, wheezing or trouble breathing. If this happens to you, see a doctor straight away. Other possible side effects: Pain in your lower back or problems passing urine. If this happens, talk to your doctor. Bone pain at the beginning of treatment. If this happens, talk to your doctor. Hot flushes and sweating. A reduced sex drive and impotence. Thinning of your bones. Rises in blood sugar levels. Tingling in your fingers or toes. Skin rashes. Hair loss Weight gain Pain, bruising, bleeding, redness or swelling where Zoladex LA is injected. Pain in the joints. Reduced heart function or heart attack Changes in blood pressure. Swelling and tenderness of your breasts. Changes in your mood (including depression). Changes in your blood. Liver problems. A blood clot in your lungs causing chest pain or shortness of breath. Inflammation of the lungs. The symptoms may be like pneumonia (such as feeling short of breath and coughing). Psychiatric problems called psychotic disorders which may include hallucinations (seeing, feeling or hearing things that are not there), disordered thoughts and personality changes. This is very rare. The development of a tumour of the pituitary gland in your head or, if you already have a tumour in your pituitary gland, Zoladex LA may make the tumour bleed or collapse. These effects are very rare.
Pituitary tumours can cause severe headaches, feeling or being sick, loss of eyesight and becoming unconscious. Do not be concerned by this list of possible side effects. You may not get any of them. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist.
5) How to store Zoladex LA
Keep all medicines out of the reach and sight of children. You may be given a prescription and asked to collect your injection from the pharmacy and keep it until you see your doctor. Keep it in the original package, do not break the seal. Do not use after the expiry date printed on the carton or labelled pack. Do not store above 25C. If your medicine is not used, take t back to your pharmacist. If your medicine shows any signs of deterioration, you should seek the advice of your pharmacist.
6) Further information
What Zoladex LA 10.8mg Injection contains: Your medicine is called Zoladex LA 10.8mg Injection and contains the active ingredient, goserelin acetate equivalent to 10.8mg goserelin in a sustained release formulation. Your medicine also contains lactide glycolide co-polymer which is an inactive substance. What Zoladex LA 10.8mg Injection looks like and contents of the pack Zoladex LA 10.8mg Injection is available as an implant in a pre-filled single dose syringe applicator. PL 10383/0568 POM
Who makes and repackages your medicine? Your medicine is manufactured by AstraZeneca UK Ltd Silk Road Business Park Macclesfield, Cheshire SK10 2NA. Procured from within the EU and repackaged by the Product Licence Holder: Primecrown Ltd, 4/5 Northolt Trading Estate, Belvue Road, Northolt, Middlesex, UB5 5QS. Leaflet date: 15.05.2012 Zoladex is a trade mark of the AstraZeneca group of companies.
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
