Zoladex la
Poland
Table of Contents
Patient Information Leaflet
Zoladex LA, 10.8 mg, subcutaneous implant
Goserelin
Please read this leaflet carefully before using this medicine, as it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any further questions, please consult your doctor, pharmacist, or nurse.
- This medicine has been prescribed for a specific individual only. Do not pass it on to others. It may harm them even if their symptoms are the same.
- If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
Leaflet Contents:
- What Zoladex LA is and what it is used for
- Important information before using Zoladex LA
- How to use Zoladex LA
- Possible side effects
- How to store Zoladex LA
- Contents of the pack and other information
1. What Zoladex LA is and what it is used for
Zoladex LA is a white-cream colored, cylindrical implant for subcutaneous administration, containing 10.8 mg of goserelin.
Goserelin, the active substance in Zoladex LA, is a synthetic analogue of the naturally occurring hormone gonadotropin-releasing hormone (GnRH, also known as LHRH – luteinizing hormone-releasing hormone). It belongs to a group of medicines called gonadotropin-releasing hormone analogues. Prolonged action of goserelin leads to a reduction in testosterone levels (male sex hormone) in men. This effect reverses after treatment is discontinued.
Zoladex LA is used in the treatment of hormone-responsive prostate cancer.
2. Important information before using Zoladex LA
When not to use Zoladex LA
- in women,
- in children,
- if the patient is allergic to goserelin or any of the other ingredients of this medicine (listed in section 6).
You should inform your doctor about any troubling symptoms previously experienced
after taking a medicine containing goserelin, any ingredient listed in section 6,
or another product belonging to the group of medicines called LHRH analogues.
You should also inform your doctor about any troubling symptoms that occurred after taking
other medicines.
Warnings and precautions
Before starting treatment, you must inform your doctor about any health problems,
especially bone diseases and bone pain, urinary problems, as well as diabetes, depression, and hypertension.
Inform your doctor if the patient has any heart or blood vessel disorders, including heart rhythm disorders (arrhythmia), or if the patient is taking medicines for these conditions.
The use of Zoladex LA may increase the risk of heart rhythm disturbances.
Consult your doctor, even if the above warnings refer to conditions that occurred in the past.
The decision to discontinue treatment with Zoladex LA should be made by the doctor who prescribed it.
If hospitalization occurs, inform the medical staff that Zoladex LA is being used.
Medicines in this group may cause loss of bone mass and reduced glucose tolerance.
Children
Zoladex LA must not be used in children.
Zoladex LA and other medicines
Tell your doctor about all medicines the patient is currently taking or has recently taken, including medicines obtained without a prescription and herbal medicines.
Zoladex LA may affect the action of certain medicines used to treat heart rhythm disorders (e.g. quinidine, procainamide, amiodarone, and sotalol) or may increase the risk of heart rhythm disturbances when used together with certain other medicines [e.g. methadone used for pain relief and in detoxification therapy for addiction, moxifloxacin (an antibiotic), and antipsychotic medicines used to treat serious mental illnesses].
Taking Zoladex LA with food and drink
Not applicable.
Pregnancy and breastfeeding
Zoladex LA is not intended for use in women.
Driving and using machines
There is no data available on the effect of Zoladex LA on the ability to drive or operate machinery.
3. How to use Zoladex LA
This medicine should always be used exactly as recommended by your doctor or pharmacist. If you have any doubts,
please consult your doctor or pharmacist.
Recommended dose
One implant containing 10.8 mg of goserelin is administered subcutaneously into the anterior abdominal wall every 12 weeks by a doctor or nurse.
If you feel that the effect of Zoladex LA is too strong or too weak, you should contact your doctor.
Use of a higher than recommended dose of Zoladex LA
Zoladex LA is administered by a doctor or nurse at a clinic or hospital ward. Therefore, overdose of goserelin is unlikely. However, if a dose higher than recommended is accidentally administered or the next dose is given before the end of the 12-week interval, you should contact your treating doctor as soon as possible.
Missed dose of Zoladex LA
Zoladex LA should be administered regularly every 12 weeks. You should always schedule the date of the next visit for the subsequent dose with your doctor or nurse, ensuring that the interval between doses of Zoladex LA is neither too long nor too short. If the interval between injections exceeds 12 weeks, you should contact your treating doctor as soon as possible.
Stopping treatment with Zoladex LA
Do not discontinue treatment with Zoladex LA without consulting your treating doctor, even if your health condition improves.
4. Possible adverse reactions
Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Possible adverse reactions with Zoladex LA may include:
- hot flushes, sweating; these adverse reactions may sometimes persist for a prolonged period (even several months) after discontinuation of Zoladex LA treatment,
- decreased libido/erectile dysfunction,
- loss of bone mass,
- tingling in the fingers and toes,
- skin rashes,
- allergic reactions,
- joint pain,
- abnormal blood pressure,
- reactions at the injection site of Zoladex LA,
- injuries at the injection site of Zoladex LA have been reported (including damage to abdominal blood vessels). Very rarely, this has led to serious bleeding. Immediate medical advice should be sought if any of the following symptoms occur: abdominal pain, abdominal distension, shortness of breath, dizziness, low blood pressure, and/or any disturbance of consciousness.
- pituitary tumour,
- if the patient has a pituitary tumour, Zoladex LA may cause bleeding from the tumour or apoplexy. This is very rare. In such cases, severe headaches, nausea or vomiting, visual loss, and loss of consciousness may occur. If any of these adverse reactions occur, contact a doctor immediately or go to the nearest hospital without delay.
- alopecia (loss of body hair),
- weight gain,
- bone pain, lower back pain, and difficulty urinating. These should be reported to the doctor, as the doctor may prescribe medications to alleviate these symptoms.
- breast enlargement, swelling and tenderness of the breasts,
- heart failure, myocardial infarction,
- mood changes (including depression),
- psychiatric disorders,
- impaired glucose tolerance,
- changes in ECG findings (prolongation of the QT interval).
The list of mentioned adverse reactions should not cause undue concern. It is possible that none of the above effects will occur in the patient.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
PL-02 222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions may also be reported to the marketing authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.
5. How to store Zoladex LA
The medicine should be stored in a place inaccessible and out of sight of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Store at a temperature not exceeding 25°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.
6. Contents of the package and other information
What Zoladex LA contains
- The active substance is goserelin.
- The other component (excipient) is polylactide-co-glycolide copolymer.
What Zoladex LA looks like and contents of the pack
Sterile, ready-to-use single-dose pre-filled syringe with an automatic needle shield that covers the needle after injection (in English: Safe System), in an aluminium foil pouch within a cardboard box.
Marketing Authorisation Holder
AstraZeneca AB
SE-151 85 Södertälje
Sweden
Manufacturer
AstraZeneca AB
Gärtunavägen
SE-152 57 Södertälje
Sweden
For further information, please contact the local representative of the Marketing Authorisation Holder:
AstraZeneca Pharma Poland Sp. z o.o.
ul. Postępu 14
02-676 Warszawa
tel.: +48 22 245 73 00
fax: +48 22 485 30 07