Zoladex La

Package Leaflet: Information for the Patient

Zoladex LA, 10.8 mg, Subcutaneous Implant

Goserelin

Read All of This Leaflet Carefully Before Using This Medicine Because It Contains Important Information for You.

• 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. 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, Tell Your Doctor, Pharmacist, or Nurse. This Includes Any Possible Side Effects Not Listed in This Leaflet. See Section 4.

Contents of the Pack:

• 1. What Zoladex LA Is and What It Is Used For
• 2. Important Information Before Using Zoladex LA
• 3. How to Use Zoladex LA
• 4. Possible Side Effects
• 5. How to Store Zoladex LA
• 6. Contents of the Pack and Other Information

1. What Zoladex LA Is and What It Is Used For

Zoladex LA: A Subcutaneous Implant, White to Off-White in Color, Cylindrical in Shape, Containing 10.8 mg of Goserelin.
Goserelin, the Active Substance of Zoladex LA, Is a Synthetic Equivalent of the Naturally Occurring Hormone - Gonadorelin (LHRH - Luteinizing Hormone-Releasing Hormone).
It Belongs to a Group of Medicines Called Gonadorelin Analogues. The Prolonged Action of Goserelin Leads to a Decrease in Testosterone Levels (Male Sex Hormone) in Men. This Effect Is Reversible After Treatment Is Stopped.
Zoladex LA Is Used to Treat Prostate Cancer That Responds to Hormonal Treatment.

2. Important Information Before Using Zoladex LA

When Not to Use Zoladex LA

• In Women,
• In Children,
• If You Are Allergic to Goserelin or Any of the Other Ingredients of This Medicine (Listed in Section 6).

Tell Your Doctor If You Have Ever Had Any Problems Before When Using a Medicine Containing Goserelin, Any of the Ingredients Listed in Section 6, or Any Other Medicine in the Same Group as Zoladex LA (LHRH Analogues).
Also, Tell Your Doctor If You Have Ever Had Any Problems with Other Medicines.

Warnings and Precautions

Before Starting Treatment, Tell Your Doctor About All Your Health Problems, Especially Bone Diseases and Pain, Urination Problems, Diabetes, Depression, and High Blood Pressure.
Tell Your Doctor If You Have Ever Had Any Heart or Blood Vessel Problems, Including Heart Rhythm Problems (Arrhythmia), or If You Are Taking Medicines for These Problems. The Risk of Heart Rhythm Problems May Be Increased When Using Zoladex LA.
Consult Your Doctor Even If the Above Warnings Apply to Past Situations.
The Decision to Stop Treatment with Zoladex LA Should Be Made by the Doctor Who Prescribed It for You.
If You Are Admitted to Hospital, Tell the Medical Staff That You Are Using Zoladex LA.
Medicines in This Group Can Cause Loss of Bone Density and Decreased Glucose Tolerance.

Children

Zoladex LA Should Not Be Used in Children.

Zoladex LA and Other Medicines

Tell Your Doctor About All Medicines You Are Taking Now or Have Recently Taken, Including Those You Have Bought Without a Prescription and Herbal Medicines.
Zoladex LA May Affect the Action of Some Medicines Used to Treat Heart Rhythm Problems (Such as Quinidine, Procainamide, Amiodarone, and Sotalol) or May Increase the Risk of Heart Rhythm Problems When Used with Certain Other Medicines [Such as Methadone Used for Pain Relief and in Drug Detoxification, Moxifloxacin (an Antibiotic), and Antipsychotic Medicines Used to Treat Serious Mental Illnesses].

Using Zoladex LA with Food and Drink

Not Applicable.

Pregnancy and Breast-Feeding

Zoladex LA Is Not Intended for Use in Women.

Driving and Using Machines

There Is No Data on the Effects of Zoladex LA on the Ability to Drive and Use Machines.

3. How to Use Zoladex LA

This Medicine Should Always Be Used Exactly as Your Doctor or Pharmacist Has Told You. If You Are Not Sure, Check with Your Doctor or Pharmacist.

Recommended Dose

One Implant, Containing 10.8 mg of Goserelin, Is Injected Under the Skin, into the Front Wall of the Abdomen, by a Doctor or Nurse, Every 12 Weeks.
If You Feel That the Effect of Zoladex LA Is Too Strong or Too Weak, Talk to Your Doctor.

Using More Zoladex LA Than You Should

Zoladex LA Is Given by a Doctor or Nurse in a Clinic or Hospital Setting. It Is Unlikely That You Will Be Given Too Much Goserelin. However, If You Are Given Too Much, Tell Your Doctor as Soon as Possible.

Forgetting to Use Zoladex LA

Zoladex LA Should Be Injected Regularly Every 12 Weeks. Always Make an Appointment with Your Doctor or Nurse for the Next Injection. Remember, the Interval Between Injections Should Not Be Too Long or Too Short. If the Interval Is Longer Than 12 Weeks, Tell Your Doctor as Soon as Possible.

Stopping Zoladex LA

Do Not Stop Using Zoladex LA Without Talking to Your Doctor. This Includes If You Feel Better.

4. Possible Side Effects

Like All Medicines, This Medicine Can Cause Side Effects, Although Not Everybody Gets Them.
The Following Side Effects May Happen with Zoladex LA:

• Hot Flushes, Sweating, These Side Effects May Sometimes Last for a Long Time (Even Several Months) After Stopping Zoladex LA,
• Decreased Sex Drive/Erectile Dysfunction,
• Bone Density Loss,
• Numbness or Tingling in Fingers and Toes,
• Skin Rashes,
• Allergic Reactions,
• Joint Pain,
• Abnormal Blood Pressure,
• Reactions at the Injection Site of Zoladex LA,
• Injection Site Injuries (Including Damage to Abdominal Blood Vessels) Have Been Reported with Zoladex LA. These Have Very Rarely Resulted in Serious Bleeding. You Should Contact Your Doctor Immediately If You Experience Any of the Following Symptoms: Abdominal Pain, Abdominal Distension, Shortness of Breath, Dizziness, Low Blood Pressure, and/or Any Change in Consciousness.
• Pituitary Tumor,
• If You Have a Tumor in the Pituitary Gland, Zoladex LA May Cause Bleeding from the Tumor or Pituitary Apoplexy. This Happens Very Rarely. Symptoms Include Severe Headache, Nausea, Vomiting, Loss of Vision, and Loss of Consciousness. If You Experience Any of These Side Effects, Contact Your Doctor or Go to the Nearest Hospital as Soon as Possible.
• Hair Loss (Loss of Body Hair),
• Weight Gain,
• Bone Pain, Lower Back Pain, and Difficulty Passing Urine. Tell Your Doctor, as They May Prescribe Medicines to Reduce These Symptoms.
• Breast Enlargement, Breast Swelling, and Breast Pain,
• Heart Failure, Heart Attack,
• Mood Changes (Including Depression),
• Psychiatric Disorders,
• Decreased Glucose Tolerance,
• Changes in the ECG (Prolonged QT Interval).

The List of Side Effects Is Not Exhaustive. You Might Not Experience Any of Them.

Reporting Side Effects

If You Experience Any Side Effects, Including Those Not Listed in This Leaflet, Tell Your Doctor, Pharmacist, or Nurse. You Can Also Report Side Effects Directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products,
Jerozolimskie Avenue 181C,
02-222 Warsaw,
Phone: +48 22 49 21 301,
Fax: +48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl.
You Can Also Report Side Effects to the Marketing Authorization Holder.
Reporting Side Effects Will Help to Gather More Information on the Safety of This Medicine.

5. How to Store Zoladex LA

Keep This Medicine Out of the Sight and Reach of Children.
Do Not Use This Medicine After the Expiry Date Which Is Stated on the Packaging. The Expiry Date Refers to the Last Day of the Month.
Store in a Temperature Not Exceeding 25°C.
Medicines Should Not Be Disposed of via Wastewater or Household Waste. Ask Your Pharmacist How to Dispose of Medicines No Longer Required. These Measures Will Help to Protect the Environment.

6. Contents of the Pack and Other Information

What Zoladex LA Contains

• The Active Substance Is Goserelin.
• The Other Ingredient (Excipient) Is Lactide-Glycolide Copolymer.

What Zoladex LA Looks Like and Contents of the Pack

A Sterile, Pre-Filled Syringe with an Automatically Triggered Safety Needle Guard (Safe System), in a Foil Pouch, in a Carton.

Marketing Authorization Holder

AstraZeneca AB,
SE-151 85 Södertälje,
Sweden.

Manufacturer

AstraZeneca AB,
Gärtunavägen,
SE-152 57 Södertälje,
Sweden.
For Further Information, Contact Your Local Representative of the Marketing Authorization Holder:
AstraZeneca Pharma Poland Sp. z o.o.,
Postępu Street 14,
02-676 Warsaw,
Phone: +48 22 245 73 00,
Fax: +48 22 485 30 07.
Date of Last Revision of the Leaflet:January 2024.