Zoladex La 10.8mg Implant
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S. Gonzalez, s. I.
artes gisificds
Mercurio 13 - Pol. Ind. "Coherman" 28970 Humanes (Madrid) T. 91 697 65 02 - F. 91 697 18 03 artesgraficas@s-gonzalezsl.com
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Prueba N.°: 2
Fecha: 10.5.2012
Cliente: BOTICALIA Codigo: ZOL10.8P Edicion: 09.05.2012 Prospecto:
ZOLADEX LA 10.8 MG IMPLANT
Tamano: 150 x 440 mm
Plegado: 150 x 27,5 mm
N° de Colores: 1/1
Color: Negro
Cod. Barras: ---
Papel: Offset blanco 50 g/m2
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, nurse 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 10.8mg Implant is and what it is used for
2. Before you are given Zoladex LA 10.8mg Implant
3. How Zoladex LA 10.8mg Implant will be given
4. Possible side effects
5. How to store Zoladex LA 10.8mg Implant
6. Further information
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MEDIDA FINAL PLEGADO
Tipografia
Helvetica Condensed Tamano: 9,5 pt.
Zoladex LA 10.8mg Implant contains a medicine called goserelin. This belongs to a group of medicines called ‘LHRH analogues'.
Zoladex LA 10.8mg Implant is used to treat prostate cancer. It works by reducing the amount of ‘testosterone’ (a hormone) that is produced by your body. Zoladex LA 10.8mg Implant is a long-acting form of Zoladex and it is given every 12 weeks.
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Do not have Zoladex LA 10.8mg Implant if:
• 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 10.8mg Implant if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before having Zoladex LA 10.8mg Implant.
Zoladex LA 10.8mg Implant should not be given to children.
Take special care with Zoladex LA 10.8mg Implant
Check with your doctor or nurse before you have Zoladex LA 10.8mg Implant if:
• You have problems passing urine (water) or problems with your back
• You have diabetes
• You have high blood pressure
• 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).
Medicines of this type can cause a reduction in bone calcium (thinning of bones).
There have been reports of depression in patients taking Zoladex LA 10.8mg Implant which may be severe. If you are taking Zoladex LA 10.8mg Implant and develop depressed mood, inform your doctor.
If you go into hospital, tell the medical staff that you are having Zoladex LA 10.8mg Implant. 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 10.8mg Implant is not likely to affect you being able to drive or use any tools or machines.
• The Zoladex LA 10.8mg Implant will be injected under the skin on your stomach every twelve weeks. This will be done by your doctor or nurse.
• It is important that you keep having Zoladex LA 10.8mg Implant treatment, even if you are feeling well.
• Keep having this treatment until your doctor decides that it is time for you to stop.
Your next appointment
• You should be given a Zoladex LA 10.8mg Implant 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.
Like all medicines, Zoladex LA 10.8mg Implant can cause side effects, although not everybody gets them.
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.
• Thinning of your bones.
• Rises in blood sugar levels.
• Tingling in your Angers or toes.
• Skin rashes.
• Hair loss.
• Weight gain.
• Pain, bruising, bleeding, redness or swelling where Zoladex LA 10.8mg Implant is injected.
• Pain in the joints.
• Reduced heart function or heart attack.
• Changes in blood pressure.
• Swelling and tenderness of your breasts.
• Mood changes, depression
• In Long term use: Common
• In Shortterm use: Uncommon co • Changes in your blood.
? • Liver problems.
S • A blood clot in your lungs causing chest pain or shortness of breath.
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Prueba N.°: 2 Fecha: 10.5.2012
Cliente: BOTICALIA Codigo: ZOL10.8P Edicion: 09.05.2012 Prospecto:
ZOLADEX LA 10.8 MG IMPLANT
Tamano: 150 x 440 mm
Plegado: 150 x 27,5 mm
N° de Colores: 1/1
Color: Negro
Cod. Barras: ---
Papel: Offset blanco 50 g/m2
• 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 10.8mg Implant 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.
Tipografia
• Your doctor may give you a prescription so that you can get your medicine from the pharmacy and give it to your doctor when you see him or her again.
• Keep it in its original package and do not break the seal.
• Do not store above 25°C.
• Do not use this medicine after the expiry date shown on the carton label.
• If your medicine is not used, take it back to your pharmacist.
• Keep out of the reach and sight of children.
• If the injection shows any signs of deterioration, you should seek the advice of your pharmacist.
Helvetica Condensed Tamano: 9,5 pt.
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Correcciones □ |
Aprobado |
Fecha y Firma
REVERSO / BACK
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What Zoladex LA 10.8mg Implant contains
Each implant contains goserelin acetate, equivalent to 10.8 mg goserelin.
Also includes lactide-glycolide copolymer which is an inactive substance.
What Zoladex LA 10.8mg Implant looks like and the contents of the pack
It is a single dose SafeSystem™ syringe applicator containing a white opaque solid cylindrical implant with a blue protective sleeve in a sealed pouch.
Zoladex LA 10.8mg Implant is available in packs of one implant (injection).
Who manufactured your medicine
Zoladex LA 10.8mg Implant is manufactured by AstraZeneca UK Limited, Silk Road Business Park, Macclesfield, Cheshire SK10 5NA UK and is procured from within the EU and repackaged by Product Licence holder Boticalia Ltd, 27 Acton Park, The Vale, London W3 7QE.
PL 23038/0187
POM
Leaflet referenceand revision date: 09.05.2012
Zoladex is a trademark of the AstraZeneca group of companies
ZOL10.8P