Package Leaflet: Information for the User

Zoladex 3,6 mg Pre-filled Syringe Implant

Goserelin

Read this package leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this package 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 side effects, talk to your doctor or pharmacist. See section 4.

Contents of the pack and additional information.

Zoladex 3,6 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 men, it will reduce the levels of the male hormone, testosterone, and in women, those of the female hormone, estrogen.

Zoladex 3,6 mg is used:

• In men, to treat certain types of prostate cancer.
• In women, to:
• • Treat certain types of breast cancer.
  • Treat endometriosis, a benign disease in which the tissue that normally grows inside the uterus also forms outside the uterus.
  • Treat uterine fibroids, which are benign growths that form in the uterus.
  • Reduce the thickness of the lining of the uterus (endometrium) before undergoing a surgical procedure called endometrial ablation, which involves the removal of the lining of the uterus.

Control the release of eggs from the ovary as part of a treatment for infertility.

No use Zoladex 3,6 mg

• If you are allergic to goserelin or any of the other components of this medication (listed in section 6).
• • Before receiving your injection, inform your doctor if you are pregnant, think you may be, or are breastfeeding.Zoladex 3,6 mg should not be used if you are pregnant or trying to become pregnant, except if this medication is used as part of a treatment for infertility. Zoladex 3,6 mg should not be used during lactation (see the section “Fertility, Pregnancy and Breastfeeding” later).

Warnings and Precautions

• Consult your doctor or pharmacist before starting to use Zoladex 3,6 mg.

• Cases of depression have been reported in patients taking Zoladex 3,6 mg, which can be severe. If you are taking Zoladex 3,6 mg and experience depression, inform your doctor.
• Inform your doctor if you have any heart or blood vessel conditions or are being treated for them, including medications to control heart rhythm (arrhythmias). The risk of heart rhythm problems may increase when using Zoladex 3,6 mg.
• Inform your doctor if you have hypertension (high blood pressure).
• 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 3,6 mg (see section 4).
• The treatment with Zoladex 3,6 mg may cause positive results in antidoping tests.

In case of hospital admission, inform the healthcare staff that you are being treated with Zoladex 3,6 mg.

Males:

• 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 of the spine, or
  • You have diabetes.
• 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.

Females:

• Medications of this type may cause a loss of calcium from the bones.Part of this loss could be recovered after completing your treatment. 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, family history of osteoporosis, and malnutrition, such as anorexia nervosa],inform your doctor or nurse, as the reduction in bone density is likely to be more detrimental. If you are using Zoladex 3,6 mg for the treatment of endometriosis, your doctor may put you on additional treatment to counteract this reduction in bone thickness.
• Inform your doctor if you experience vaginal bleeding that does not stop after the first month of treatment with Zoladex 3,6 mg.
• If you are using Zoladex 3,6 mg for the treatment of endometriosis or uterine fibroids, the maximum duration of your treatment with this medication should not exceed a period of 6 months.
• During treatment with Zoladex 3,6 mg and until menstruation is restored once treatment is interrupted, contraceptive methods should be used, such as condoms or diaphragms, and never oral contraceptives (“the pill”). This warning does not apply when receiving Zoladex 3,6 mg as treatment for infertility.

Children and Adolescents

Zoladex 3,6 mg is not indicated for use in children.

Use of Zoladex 3,6 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 3,6 mg may interfere 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), moxifloxacino (an antibiotic), antipsychotics (used to treat severe mental illnesses)).

Pregnancy and Lactation

If you are pregnant or breastfeeding, or think you may be, consult your doctor, pharmacist, or nurse before using this medication.

Zoladex 3,6 mg should not be used if you are pregnant or trying to become pregnant, except if this medication is used as part of a treatment for infertility. Zoladex 3,6 mg should not be used during lactation.

Driving and Operating Machines

There is no evidence that Zoladex 3,6 mg affects the ability to drive or operate machines.

Follow exactly the administration instructions for this medication as indicated by your doctor.

If you are unsure, consult your doctor, pharmacist, or nurse again.

Remember that your medication will be administered.

Your doctor will inform you of the duration of your treatment with Zoladex 3,6 mg. Do not discontinue treatment before your doctor tells you to.

Zoladex 3,6 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 3,6 mg is normally administered as an injection under the skin, every 28 days.

It is essential that you continue treatment with Zoladex 3,6 mg even if you feel well, unless your doctor decides to interrupt it.

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

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

• When administering Zoladex 3.6 mg, the injection could cause a lesion in the area of administration, including abdominal blood vessel injury. 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 consciousness. These could be symptoms of severe bleeding due to accidental injury to an abdominal blood vessel produced during the administration of Zoladex 3.6 mg.

• Side effects reported in women:

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

Common (may affect up to 1 in 10 people)

Rare (may affect up to 1 in 100 people)

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

Overstimulation of the ovaries when Zoladex 3.6 mg is used as part of a treatment for infertility. If you notice abdominal pain, abdominal swelling, nausea, or vomiting after treatment with these medications, inform your doctor immediately.

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

Frequency not known (cannot be estimated from available data)

• Side effects reported in men:

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

Common (may affect up to 1 in 10 people)

Rare (may affect up to 1 in 100 people)

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

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

Frequency not known (cannot be estimated from available data)

Reporting of 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 the 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 medication.

Keepthis medicationout of sight andout of reach of children.

Do not store at a temperature above 25°C.

Store in the original packaging.

Do not use Zoladex 3,6 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.Deposit the containers and unused medicines at the SIGRE collection pointat the pharmacy. If in doubtask your pharmacist how to dispose of unused containers and medicines. By doing so, you will help protect the environment.

Composition of Zoladex 3,6 mg

- The active ingredient is goserelin (as acetate). Each implant contains 3.6 mg of goserelin.

- The other component is lactide-glycolide copolymer.

Appearance of the product and contents of the package

The medicine is presented in the form of a 3.6 mg implant in a pre-loaded syringe within a sealed pouch.

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

The pouch contains, inside, a desiccant in addition.

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

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

AstraZeneca Farmacéutica Spain, S.A.

C/ Puerto de Somport 21-23

28050 Madrid

Spain

Responsible for manufacturing

AstraZeneca AB

Gärtunavägen

SE-152 57 Södertälje

Sweden

Other presentations

Zoladex Trimestral 10.8 mg: Package containing a 10.8 mg implant in a pre-loaded syringe within a sealed pouch, which also contains a desiccant inside. The pre-loaded syringe is equipped with a safety device (blue 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 3.6 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 injection site on the abdomen with a cotton swab soaked in a disinfectant agent (alcohol, etc.).

NOTE: Caution should be exercised when administering Zoladex 3.6 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.

1. 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 3.6 mg implant is visible.(Figure 1).

Figure 1

1. Remove the 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 3.6 mg implant could be displaced.

Figure 2

1. Hold the syringe around the needle protection system using an aseptic technique. Take a fold of the patient's skin and insert the needle at an angle of 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 3.6 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 3.6 mg implant can be administered with a new syringe in another area. Extreme caution should be exercised when administering Zoladex 3.6 mg to patients with low BMI and/or patients receiving full anticoagulant doses.

1. Do not penetrate the muscle or peritoneum.Figure 4 below shows incorrect grip and angle of exposure.

Figure 4

1. Press the plungercompletely,until it cannot be pressed further, in order to deposit the Zoladex 3.6 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 NOTbe activated.

NOTE:The needle does not retract.

1. Continue holding the syringe as shown inFigure 5, remove the needle allowing

the needle protection system to continue sliding and cover the needle.

Dispose of the syringe in accordance with local regulations.

Figure 5

NOTE: In the unlikely event of the need to surgically remove a Zoladex 3.6 mg implant, it can be located by ultrasound.