Zoladex 10.8 mg implant in pre-filled syringe for intramuscular injection

Patient Information Leaflet

Introduction

Patient Information Leaflet

Zoladex Trimestral 10.8 mg implant in pre-filled syringe

goserelin

Please read all of this leaflet carefully before you start 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of this leaflet:

1. What Zoladex Trimestral 10.8 mg is and what it is used for.
2. What you need to know before using Zoladex Trimestral 10.8 mg.
3. How to use Zoladex Trimestral 10.8 mg.
4. Possible side effects.
5. How to store Zoladex Trimestral 10.8 mg.
6. Contents of the pack and other information.

1. What Zoladex Trimestral 10.8 is and what it is used for

Zoladex Trimestral 10.8 mg belongs to a group of medicines called anti-hormonal agents, meaning that it affects the levels of various hormones (natural chemicals produced by the body). In men, it will reduce the levels of the male hormone, testosterone.

Zoladex Trimestral 10.8 mg is used in men to treat certain types of prostate cancer. Zoladex Trimestral 10.8 mg is not indicated for use in women.

2. What you need to know before using Zoladex Trimestral 10.8 mg

Do not use Zoladex Trimestral 10.8 mg

• If you are allergic to goserelin or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

• Consult your doctor or pharmacist before starting to use Zoladex Trimestral 10.8 mg.

• Before starting treatment with this medicine, inform your doctor if:

• you have previously experienced difficulty urinating or have had back pain in the lower back area,

• you have diabetes, or

• you have high blood pressure (hypertension).

• Medicines of this type may cause loss of calcium from the bones (reduction in bone thickness). If you have a condition affecting bone strength or risk factors for osteoporosis [for example, chronic alcohol abuse, smoking, long-term treatment with anticonvulsants (medicines for epilepsy or seizures) or corticosteroids (a type of anti-inflammatory medicine), family history of osteoporosis], inform your doctor or nurse.

• Cases of depression, which may be severe, have been reported in patients taking Zoladex Trimestral 10.8 mg. If you are taking Zoladex Trimestral 10.8 mg and experience depression, inform your doctor.

• Inform your doctor if you have any heart or blood vessel condition or are being treated for such conditions, including medications to control heart rhythm (arrhythmias). The risk of heart rhythm problems may increase when using Zoladex Trimestral 10.8 mg.

• Inform your doctor immediately if you experience abdominal pain and bruising or other symptoms of severe bleeding, such as difficulty breathing, dizziness, low blood pressure, and/or altered level of consciousness, which could result from vascular injury at the injection site during administration of Zoladex Trimestral 10.8 mg.

• Treatment with Zoladex Trimestral 10.8 mg may lead to positive results in anti-doping tests.

If you are admitted to hospital, inform healthcare staff that you are being treated with Zoladex Trimestral 10.8 mg.

Children and adolescents

Zoladex Trimestral 10.8 mg is not indicated for use in children.

Use of Zoladex Trimestral 10.8 mg with other medicines

Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might need to take any other medicines.

Zoladex Trimestral 10.8 mg may interfere with certain medicines used to treat heart rhythm disorders (e.g., quinidine, procainamide, amiodarone, and sotalol), or may increase the risk of heart rhythm problems when used together with other medicines (e.g., methadone (used for pain relief and detoxification from other medicines), moxifloxacin (an antibiotic), antipsychotics (used to treat serious mental illnesses)).

Pregnancy and breastfeeding

Zoladex Trimestral 10.8 mg is not indicated for use in women.

Driving and using machines

There is no evidence that Zoladex Trimestral 10.8 mg impairs the ability to drive or operate machinery.

3. How to use Zoladex Trimestral 10.8 mg

Follow exactly the instructions for administration of this medicine as given by your doctor. If in doubt, consult your doctor, pharmacist, or nurse again.

Remember to have your medicine administered.

Your doctor will tell you how long to continue treatment with Zoladex Trimestral 10.8 mg. Do not stop treatment before your doctor tells you to do so.

Zoladex Trimestral 10.8 mg will be administered to you as an injection by your doctor or nurse, who will follow the instructions on the package label for proper use.

Zoladex Trimestral 10.8 mg is normally administered by injection under the skin every 3 months.

It is important to continue treatment with Zoladex Trimestral 10.8 mg even if you feel well, unless your doctor decides to discontinue it.

If you have any further questions about the use of this product, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

When Zoladex Trimestral 10.8 mg is administered, the injection may cause injury at the site of administration, including injury to abdominal blood vessels. In very rare cases, this has led to severe bleeding. Seek immediate medical attention if you experience any of the following symptoms: abdominal pain, swelling of the abdomen, difficulty breathing, dizziness, low blood pressure, and/or any change in level of consciousness. These could be symptoms of severe bleeding due to accidental injury of an abdominal blood vessel during administration of Zoladex Trimestral 10.8 mg.

Very common adverse effects (may affect more than 1 in 10 people)

• Hot flushes, sweating. These adverse effects may continue after stopping treatment with Zoladex Trimestral 10.8 mg.
• Decreased libido and impotence.

Common adverse effects (may affect up to 1 in 10 people)

• Increased blood sugar levels.
• Tingling or numbness in the fingers or toes.
• Skin rash, usually mild and resolving without discontinuation of treatment.
• Reduced cardiac function, myocardial infarction. The risk of developing these is higher when Zoladex is used together with other medications (antiandrogens) to treat prostate cancer.
• Changes in blood pressure (increase or decrease).
• Bone pain, usually at the beginning of treatment with Zoladex Trimestral 10.8 mg. If this occurs, inform your doctor, as they may need to prescribe a medication to relieve the pain.
• Weight gain.
• Breast swelling.
• Injection site reactions such as pain, bruising, bleeding, redness, or swelling at the site, or other reactions.
• Loss of bone mineral density (decreased bone thickness).
• Mood changes and depression (with long-term treatment).
• Spinal cord compression.

Uncommon adverse effects (may affect up to 1 in 100 people)

• Hypersensitivity reactions to the medicine.
• Joint pain.
• Breast discomfort.
• Mood changes and depression (with short-term treatment).
• Obstruction of the ureters (tubes that carry urine from the kidneys to the bladder), which may cause difficulty urinating or discomfort in the lower back.

Rare adverse effects (may affect up to 1 in 1,000 people)

• Anaphylactic reaction (severe allergic reaction).

Very rare adverse effects (may affect up to 1 in 10,000 people)

• Psychotic disorders that may cause hallucinations, thought disturbances, and personality changes.
• Development of a tumour in the pituitary gland (an endocrine gland located in the head). If you have a pituitary tumour, Zoladex Trimestral 10.8 mg may cause bleeding from the tumour. Pituitary tumours can cause headache, malaise, loss of vision, and may even lead to loss of consciousness.

Adverse effects with unknown frequency (cannot be estimated from available data)

• Hair loss, especially loss of body hair.
• Changes in the electrocardiogram (prolongation of the QT interval).
• Changes in blood cell counts (observed in blood tests).
• Blood clots in the lungs (causing chest pain and difficulty breathing) and inflammation of the tissue surrounding the lung structures (alveoli) where oxygen is absorbed (interstitial pneumonia) (causing symptoms such as cough and difficulty breathing).
• Liver dysfunction.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Zoladex Trimestral 10.8 mg

Keep this medicine out of the sight and reach of children.

Do not store above 25°C.

Keep in the original packaging.

Do not use Zoladex Trimestral 10.8 mg after the expiry date stated on the carton and pouch following EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of Zoladex Trimestral 10.8 mg

• The active substance is goserelin (as acetate). Each implant contains 10.8 mg of goserelin.
• The other components are a mixture of high and low molecular weight lactide-glycolide copolymers.

Appearance of the medicinal product and contents of the pack

The medicine is supplied as a 10.8 mg implant in a pre-filled syringe contained within a sealed pouch.

The implant is sterile, cream-colored, and provides prolonged release of the drug.

The pouch also contains a desiccant inside.

The pre-filled syringe is equipped with a safety device (blue clip) and a needle protection system.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

AstraZeneca Farmacéutica Spain, S.A.
C/ Puerto de Somport 21-23
28050 Madrid
Spain

Manufacturer

AstraZeneca AB
Gärtunavägen
SE-152 57 Södertälje
Sweden

Other presentations

Zoladex 3.6 mg: Pack containing one 3.6 mg implant in a pre-filled syringe within a sealed pouch, which also contains a desiccant inside. The pre-filled syringe is equipped with a safety device (red clip) and a needle protection system.

Date of latest revision of this product information: February 2020

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

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This information is intended for healthcare professionals only:

Zoladex Trimestral 10.8 mg must be administered by subcutaneous injection – read and fully understand all instructions before administration.

1. Position the patient comfortably lying down, with the upper body slightly elevated. Clean the abdominal injection site with a cotton swab soaked in a disinfectant agent (alcohol, etc.).

NOTE: Exercise caution when administering Zoladex Trimestral 10.8 mg by subcutaneous injection into the anterior abdominal wall due to the proximity of the underlying inferior epigastric artery and its branches. Patients who are very thin may be at higher risk of vascular injury.

2. Examine the pouch and syringe for any damage. Remove the syringe from the opened pouch and hold it at an angle towards the light.

Ensure that at least part of the Zoladex Trimestral 10.8 mg implant is visible. (Figure 1).

Figure 1

3. Gently remove the blue plastic safety tab from the syringe and discard it. (Figure 2).

Remove the cap protecting the needle. Since this is not a liquid injection, there is no need to expel air bubbles, as attempting to do so may displace the Zoladex Trimestral 10.8 mg implant.

Figure 2

4. Hold the syringe around the protective system using an aseptic technique. Grasp a skin fold of the patient and insert the needle at a shallow angle (30 to 45 degrees).

With the needle bevel facing upward, insert the needle into the subcutaneous tissue of the anterior abdominal wall below the umbilical line, until the protective system touches the patient's skin. (Figure 3).

Figure 3

NOTE: The Zoladex Trimestral 10.8 mg syringe cannot be used for aspiration. If the hypodermic needle enters a large vessel, blood will be immediately visible in the syringe chamber. If a vessel is punctured, withdraw the needle immediately and promptly control any resulting bleeding, monitoring the patient for signs or symptoms of intra-abdominal hemorrhage. After confirming the patient is hemodynamically stable, another Zoladex Trimestral 10.8 mg implant may be administered using a new syringe at a different site. Exercise extreme caution when administering Zoladex Trimestral 10.8 mg to patients with a low BMI and/or those receiving full-dose anticoagulants.

5. Do not penetrate the muscle or peritoneum. Figure 4 below illustrates incorrect syringe grip and angle of insertion.

Figure 4

6. Press the plunger fully until it cannot be pushed further, in order to deposit the Zoladex Trimestral 10.8 mg implant and activate the protective system. You may hear a "click" and feel the protective system activate, automatically sliding forward to cover the needle. If the plunger is not fully depressed, the protective system will NOT activate.

NOTE: The needle does not retract.

7. While continuing to hold the syringe as shown in Figure 5, withdraw the needle, allowing the protective system to continue sliding forward and covering the needle.

Dispose of the syringe in a sharps container according to local regulations.

Figure 5

NOTE: In the unlikely event that surgical removal of a Zoladex Trimestral 10.8 mg implant is required, it can be localized using ultrasound.