Zoladex

Leaflet accompanying the packaging: patient information

Zoladex, 3.6 mg, subcutaneous implant

Goserelin

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

• 1. What is Zoladex and what is it used for
• 2. Important information before using Zoladex
• 3. How to use Zoladex
• 4. Possible side effects
• 5. How to store Zoladex
• 6. Contents of the pack and other information

Most of the information in this leaflet refers to both men and women.

• If the information applies only to men, it will be marked with the heading "Information for men".
• If the information applies only to women, it will be marked with the heading "Information for women".

1. What is Zoladex and what is it used for

Zoladex contains the active substance: goserelin. It belongs to a group of medicines called LHRH analogues.

Use of Zoladex in men

In men, Zoladex is used to treat prostate cancer. It works by reducing the amount of testosterone (a hormone) produced by the patient's body.

Use of Zoladex in women

In women, Zoladex is used to treat:

• breast cancer,
• a condition called endometriosis, a disease in which clusters of uterine lining cells spread to other parts of the body (usually in organs near the uterus),
• benign changes in the uterus, i.e. uterine fibroids,
• thinning of the uterine lining (endometrium) before its surgical removal,
• infertility (in combination with other medicines). It helps control the release of egg cells from the ovaries.

In women, Zoladex works by reducing the amount of estrogens (hormones) produced by the patient's body.

2. Important information before using Zoladex

When not to use Zoladex

• if the patient is allergic to goserelin or any of the other ingredients of this medicine (listed in section 6)
• if the patient is pregnant or breastfeeding (see also the section "Pregnancy and breastfeeding").

If any of these situations apply to you, do not use Zoladex. If you are in doubt, consult your doctor or pharmacist before using Zoladex.

Warnings and precautions

In case of hospitalization, inform the staff about the treatment with Zoladex. Inform your doctor if you have any heart or blood vessel diseases, including rhythm disorders (arrhythmia) or if you are taking medicines for these disorders. During treatment with Zoladex, the risk of rhythm disorders may be increased.

Information for men

Before starting treatment, inform your doctor about all health problems:

• problems with urination or back pain,
• diabetes,
• depression,
• high blood pressure,
• any diseases that may weaken bones. Medicines in this group may cause bone loss.

Information for women

Before starting treatment, inform your doctor about all health problems:

• any diseases that may weaken bones,
• depression,
• high blood pressure. Medicines in this group may cause bone loss. This may improve after stopping treatment.

If you are using Zoladex for endometriosis, your doctor may recommend using other medicines that reduce the effect of Zoladex on bones. Women of childbearing age should use non-hormonal methods of contraception during treatment with Zoladex and until menstruation resumes after stopping Zoladex.

Children

Zoladex should not be used in children.

Zoladex and other medicines

Tell your doctor about all medicines you are taking now or have taken recently, as well as medicines you plan to take. This also applies to medicines available without a prescription. Zoladex may affect the action of some medicines used to treat rhythm disorders (e.g. quinidine, procainamide, amiodarone, and sotalol) or may increase the risk of rhythm disorders when used with certain other medicines [e.g. methadone used to relieve pain and in detoxification therapy for addiction, moxifloxacin (an antibiotic), and antipsychotic medicines used to treat serious mental illnesses].

Pregnancy and breastfeeding

• Zoladex should not be used during pregnancy and breastfeeding.
• Zoladex should not be used if you are trying to become pregnant (unless the use of Zoladex is part of infertility treatment).
• During treatment with Zoladex, do not take oral hormonal contraceptives (so-called birth control pills). Use mechanical methods, such as condoms or diaphragms.

The decision to stop treatment with Zoladex should be made by the doctor who prescribed it.

Driving and using machines

It is unlikely that Zoladex will affect your ability to drive or use machines.

3. How to use Zoladex

This medicine should always be used exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

Recommended dose

• Zoladex 3.6 mg, in the form of an implant, is injected subcutaneously into the abdominal wall, by a doctor or nurse, every four weeks (28 days).
• It is essential not to interrupt treatment with Zoladex, even if the patient's condition improves.
• The decision to stop treatment with Zoladex should be made by the doctor who prescribed it.

Next visit

• Zoladex should be injected regularly, every 28 days.
• Always schedule the next injection with your doctor or nurse.
• If the scheduled date for the next injection falls within a shorter or longer period than 28 days, inform your doctor or nurse.
• If more than 28 days have passed since the last injection, contact your doctor or nurse to have the next dose administered as soon as possible.

Information for women

• If you are using Zoladex for uterine fibroids and blood tests show anemia (low red blood cell and hemoglobin levels), your doctor may recommend taking iron supplements.
• The duration of treatment depends on the reason for using Zoladex:
• if you have uterine fibroids, treatment with Zoladex may last only up to 3 months,
• if you have endometriosis, treatment with Zoladex may last only up to 6 months,
• if you are receiving Zoladex to thin the uterine lining before surgery, you should receive two doses of Zoladex, i.e. one injection of 3.6 mg goserelin every 4 weeks. The surgical procedure should be performed within 2 weeks of the second injection of Zoladex.

4. Possible side effects

Like all medicines, Zoladex can cause side effects, although not everybody gets them.

The following side effects may occur in men and women

Allergic reactions

These effects occur rarely. The symptoms may occur suddenly:

• rash, itching, or hives,
• swelling of the face, lips, or tongue, or other parts of the body,
• feeling of shortness of breath, wheezing, or difficulty breathing. If any of these symptoms occur, contact your doctor immediately.

Other possible side effects

• hot flashes and sweating. Sometimes these side effects may persist for a longer period (even several months) after stopping treatment with Zoladex.
• decreased libido,
• bone loss,
• tingling in the fingers and toes,
• skin rashes,
• joint pain,
• abnormal blood pressure,
• reactions at the injection site of Zoladex
• injuries at the injection site of Zoladex (including damage to abdominal blood vessels) have been reported. Very rarely, this has caused serious bleeding. Contact your doctor immediately if you experience any of the following symptoms: abdominal pain, abdominal swelling, shortness of breath, dizziness, low blood pressure, and/or any disturbance of consciousness,
• mood changes (including depression),
• psychiatric disorders,
• pituitary tumor,
• if you have a pituitary tumor, Zoladex may cause bleeding from the tumor or collapse. This occurs very rarely. In such cases, severe headaches, nausea, or vomiting, loss of vision, and loss of consciousness may occur.
• hair loss (alopecia),
• weight gain,
• changes in the ECG recording (prolongation of the QT interval).

Information for men

The following side effects may occur in men:

• back pain and difficulty urinating. If these occur, inform your doctor immediately.
• bone pain, especially at the beginning of treatment. If these occur, inform your doctor immediately.
• erectile dysfunction,
• breast swelling and tenderness,
• impaired glucose tolerance,
• heart failure, myocardial infarction.

Information for women

The following side effects may occur in women:

• changes in blood calcium levels. Symptoms include nausea, vomiting, or increased thirst. If you experience these symptoms, inform your doctor. Your doctor may recommend blood tests.
• vaginal bleeding. This usually occurs during the first month of treatment and resolves on its own. If the symptoms persist or bother you, tell your doctor.
• headaches,
• vaginal dryness,
• breast enlargement,
• development of small ovarian cysts, which can cause pain in some women. These usually resolve without additional treatment,
• in women who enter menopause during treatment with Zoladex, permanent cessation of menstruation may occur,
• a flare-up effect (temporary increase in estrogen levels during the first days or weeks of treatment). The tumor may grow, which can worsen symptoms, but this is a temporary effect.
• acne (mainly during the first month of treatment) has been reported very frequently.

If Zoladex is used to treat breast cancer,the following side effects may occur:

• worsening of cancer symptoms at the beginning of treatment. This may lead to increased pain and/or growth of cancerous changes. These symptoms are usually short-term and resolve during treatment with Zoladex. If the symptoms persist or bother you, tell your doctor.

If Zoladex is used to treat uterine fibroids,the following side effects may occur:

• mild worsening of symptoms related to the disease, such as pain. These symptoms are usually short-term and resolve during treatment. However, if they persist, contact your doctor.

If Zoladex is used to treat infertility,the following side effects may occur:

• excessive effect on the ovaries. This may cause abdominal pain, bloating, nausea, and vomiting. If these occur, tell your doctor.

The list of side effects should not cause undue concern. It is possible that none of the above side effects will occur.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, 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. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Zoladex

• Zoladex will be prescribed to you by your doctor. Have the prescription filled at a pharmacy and bring the medicine with you to your next visit.
• Store the medicine in its original packaging, do not open the foil packaging.
• Store at a temperature not exceeding 25°C.
• Keep the medicine out of the sight and reach 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 month stated.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Zoladex contains

• The active substance is goserelin. Zoladex implant contains 3.6 mg of goserelin.
• The other ingredient (excipient) is: lactic-glycolic acid copolymer.

What Zoladex looks like and contents of the pack

Zoladex, 3.6 mg, contains a syringe implant (a small particle) that is ready to use by a doctor or nurse. Zoladex 3.6 mg is available in packs containing one implant.

Marketing authorization holder

AstraZeneca AB, SE-151 85 Södertälje, Sweden

Manufacturer

AstraZeneca AB, Gärtunavägen, SE-152 57 Södertälje, Sweden. For more detailed information, please contact the local representative of the marketing authorization holder: AstraZeneca Pharma Poland Sp. z o.o., ul. Postępu 14, 02-676 Warsaw, tel: +48 22 245 73 00, fax: +48 22 485 30 07. Date of last revision of the leaflet:January 2024.