Prospecto:Information for the User

Zoladex Trimestral 10.8 mg Preloaded Syringe Implant

Goserelin

Read this entire prospectus carefully beforestarting to use this medication, as it contains important information for you.

• Keep this prospectus, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you alone, and you should not give it to others who may 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 not listed in this prospectus. See section 4.

Zoladex Trimestral 10,8 mg belongs to a group of medicines called anti-hormones, which means it affects the levels of different hormones (natural chemical substances produced by the body). In males, it will reduce the levels of the male hormone, testosterone.

Zoladex Trimestral 10,8 mg is used in males to treat certain types of prostate cancer. Zoladex Trimestral 10,8 mg is not indicated for use in women.

Do not use Zoladex Trimestral 10,8 mg

• If you are allergic to goserelin or any of the other components of this medication (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 medication, inform your doctor if:

• You have experienced any difficulty urinating or have suffered discomfort in the lower back area,
• You have diabetes or,
• You have high blood pressure.

• Medications of this type may cause a loss of calcium from the bones (decrease in their thickness). If you have any disease that affects the strength of your bones or risk factors for osteoporosis [for example, chronic alcohol abuse, being a smoker, long-term treatment with anticonvulsants (medications for epilepsy or seizures) or corticosteroids (a type of anti-inflammatory medication), family history of osteoporosis], inform your doctor or nurse.
• Cases of depression have been reported in patients taking Zoladex Trimestral 10,8 mg that may be severe. 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 disease or are being treated for it, 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 hematoma or other symptoms of severe bleeding, such as difficulty breathing, dizziness, low blood pressure, and/or altered consciousness, which could be the result of vascular injuries at the injection site produced during the administration of Zoladex Trimestral 10,8 mg.
• Treatment with Zoladex Trimestral 10,8 mg may cause positive results in antidoping tests.

In case of hospital admission, inform the healthcare staff if 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 medications

Inform your doctor, pharmacist, or nurse if you are using, have used recently, or may need to use any other medication.

Zoladex Trimestral 10,8 mg may interact with some medications used to treat heart rhythm problems (for example: quinidine, procainamide, amiodarone, and sotalol) or may increase the risk of heart rhythm problems when used with other medications (for example: methadone (used for pain relief and detoxification of other medications), moxifloxacin (an antibiotic), antipsychotics (used to treat severe mental illnesses)).

Pregnancy and lactation

Zoladex Trimestral 10,8 mg is not indicated for use in women.

Driving and operating machines

There is no evidence that Zoladex Trimestral 10,8 mg affects the ability to drive or operate machines.

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

Remember to have your medication administered.

Your doctor will inform you of the duration of your treatment with Zoladex Trimestral 10,8 mg. Do not stop treatment before your doctor tells you to.

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 packaging for correct use.

Zoladex Trimestral 10,8 mg is normally administered as an injection under the skin, every 3 months.

It is essential that you continue treatment with Zoladex Trimestral 10,8 mg even if you feel well, unless your doctor decides to stop it.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

When administering Zoladex Trimestral 10.8 mg, the injection could cause a lesion in the area of administration, including damage to abdominal blood vessels.In very rare cases, this has caused severe bleeding. Seek immediate medical attention if you notice any of the following symptoms:Abdominal pain, abdominal swelling, difficulty breathing, dizziness, low blood pressure, and/or any alteration in level of consciousness. These could be symptoms of severe bleeding due to accidental damage to an abdominal blood vessel caused during the administration of Zoladex Trimestral 10.8 mg.

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

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

Rare side effects (may affect up to 1 in 100 people)

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

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

Side effects of unknown frequency (cannot be estimated from available data)

Reporting side effects.

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not store at a temperature above 25°C.

Store in the original packaging.

Do not use Zoladex Trimestral 10,8 mg after the expiration date that appears on the packaging and the overwrap after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of Zoladex Trimestral 10.8 mg

• The active ingredient 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 product and contents of the package

The medicine is presented in the form of a 10.8 mg implant in a preloaded syringe within a sealed pouch.

The implant is sterile, cream-colored, and releases the drug in a prolonged manner.

The pouch contains, in addition, a desiccant.

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

Marketing authorization holder and manufacturer responsible

Marketing authorization holder

AstraZeneca Farmacéutica Spain, S.A.

C/ Puerto de Somport 21-23

28050 Madrid

Spain

Manufacturer responsible

AstraZeneca AB

Gärtunavägen

SE-152 57 Södertälje

Sweden

Other presentations

Zoladex 3.6 mg: Package containing a 3.6 mg implant in a preloaded syringe within a sealed pouch, which also contains a desiccant in its interior. The preloaded syringe is equipped with a safety device (red clip) and a needle protection system.

Last review date of this prospectus: February 2020

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

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This information is intended solely for healthcare professionals:

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

1.Have the patient lie down in a comfortable position, with the upper body slightly elevated. Clean the abdominal injection area with a cotton swab soaked in a disinfectant agent (alcohol, etc.).

NOTE:Caution should be exercised when administering Zoladex Trimestral 10.8 mg in the anterior abdominal wall due to the proximity of the inferior epigastric artery and its branches. Thin patients may have a high risk of vascular injury.

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

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

Figure 1

3.Remove the blue plastic safety clip from the syringe and discard it.(Figure 2).

Remove the cap that protects the needle.As it is not a liquid injectable, there is no need to remove air bubbles, as the Zoladex Trimestral 10.8 mg implant may shift.

Figure 2

4.Hold the syringe around the needle protection system, using an aseptic technique. Take a fold of the patient's skin and insert the needle with a slight angle of inclination (30 to 45 degrees).

With the needle opening upwards,insert the needle into the subcutaneous tissueof the anterior abdominal wall below the navel line, until the needle protection 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 penetrates a large vessel, blood will be visible immediately in the syringe chamber. If a vessel is penetrated, remove the needle and immediately control any resulting bleeding, monitoring the patient for any signs or symptoms of abdominal hemorrhage. After ensuring the patient is hemodynamically stable, another Zoladex Trimestral 10.8 mg implant can be injected with a new syringe in another area. Extreme caution should be exercised when administering Zoladex Trimestral 10.8 mg in patients with low BMI and/or patients receiving full anticoagulant doses.

5.Do not penetrate the muscle or peritoneum.Figure 4, below, shows incorrect fixation and angle of exposure.

Figure 4

6.Press the plungercompletely,until it cannot be pressed further, in order to deposit the Zoladex Trimestral 10.8 mg implant and activate the needle protection system. You may hear a "click" and notice the needle protection system automatically sliding to cover the needle. If the plunger is not pressed completely, the needle protection systemWILL NOTactivate.

NOTE:The needle does not retract.

7.Continue holding the syringe as shown inFigure 5, remove the needle allowing the needle protection system to continue sliding and covering the needle.

Discard the syringe in accordance with local regulations.

Figure 5

NOTE: In the unlikely event of the need to surgically remove a Zoladex Trimestral 10.8 mg implant, it can be located by ultrasound.