Label: information for the user

Faslodex250mg injectable solution

fulvestrant

Read this label carefully before starting to use this medication, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any doubts, consult your doctor,pharmacistornurse.
• This medication has been prescribed only for you, and you should not give it 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, pharmacist, or nurse, even if they are not listed in this label. See Section 4.

Faslodex contains the active ingredient fulvestrant, which belongs to the group of estrogen blockers. Estrogens, a type of female sex hormone, may be involved in the development of breast cancer in some cases.

Faslodex is used:

• alone, to treatpostmenopausal women with a type of breast cancer called estrogen receptor-positive breast cancer, which is locally advanced or has spread to other parts of the body (metastatic) or,
• in combination with palbociclib to treat women with a type of breast cancer called hormone receptor-positive breast cancer, human epidermal growth factor receptor 2-negative breast cancer, which is locally advanced or has spread to other parts of the body (metastatic). Women who have not yet reached menopause will also be treated with a medication called a luteinizing hormone-releasing hormone (LHRH) agonist.

Faslodex may be administered in combination with palbociclib. It is essential that you also read the prospectus for palbociclib. If you have any questions about palbociclib, consult your doctor

No use Faslodex:

• if you are allergic to fulvestrant or any of the other components of this medication (listed in section6)
• if you are pregnant or breastfeeding
• if you have severe liver problems

Advertencias and precautions

Consult your doctor, pharmacist, or nurse before starting to use Faslodex if any of the following apply:

• kidney or liver problems
• low platelet count (which helps blood clotting) or bleeding disorders
• previous history of blood clots
• osteoporosis (bone density loss)
• alcoholism

Children and adolescents

Faslodex is not indicated for children and adolescents under 18years.

Use of Faslodex with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Particularly, you must tell your doctor if you are using anticoagulants (medications to prevent blood clots).

Pregnancy and breastfeeding

You must not use Faslodex if you are pregnant. If you can become pregnant, you must use an effective contraceptive method while you are on treatment with Faslodex and for two years after your last dose.

You must not breastfeed while on treatment with Faslodex.

Driving and operating machinery

Faslodex is not expected to affect your ability to drive or operate machinery. However, if you feel tired after treatment, do not drive or operate machinery.

Faslodex contains10%by volume of ethanol (alcohol),that is, up to 500mg per injection, equivalent to 10ml of beer or 4ml of wine.

This medication is harmful to people with alcoholism.

The alcohol content should be taken into account in high-risk groups, such as patients with liver disease, or epilepsy.

Faslodex contains 500 mg of benzyl alcohol in each injection, equivalent to 100mg/ml.

Benzyl alcohol can cause allergic reactions.

Faslodex contains 750 mg of benzyl benzoate in each injection, equivalent to 150mg/ml

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

The recommended dose is 500 mg of fulvestrant (two injections of 250 mg/5 ml) administered once a month with an additional dose of 500 mg administered 2 weeks after the initial dose.

Your doctor or nurse will administer Faslodex via a slow intramuscular injection in each of your buttocks.

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

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

You may need urgent medical treatment if you experience any of the following side effects:

• Allergic reactions (hypersensitivity), including swelling of the face, lips, tongue, and/or throat, which may be symptoms of anaphylactic reactions
• Thromboembolism (increased risk of blood clots)*
• Liver inflammation (hepatitis)
• Liver failure

Inform your doctor, pharmacist, or nurse immediately if you notice any of the following side effects:

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

• Reactions at the injection site, such as pain and/or inflammation
• Abnormal liver enzyme levels (in blood tests)*
• Nausea (feeling of discomfort)
• Weakness, fatigue*
• Joint and musculoskeletal pain
• Hot flashes
• Skin rash
• Allergic reactions (hypersensitivity), including swelling of the face, lips, tongue, and/or throat

All other side effects:

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

• Headache
• Vomiting, diarrhea, or loss of appetite*
• Urinary tract infections
• Back pain*
• Increased bilirubin (a pigment produced by the liver)
• Thromboembolism (increased risk of blood clots)*
• Decreased platelet count (thrombocytopenia)
• Vaginal bleeding
• Lower back pain radiating to one leg (sciatica)
• Sudden weakness, numbness, tingling, or loss of movement in your leg, especially on one side of the body, sudden problems walking or balance (peripheral neuropathy)

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

• Thick, white vaginal discharge, and candidiasis (infection)
• Hematoma and bleeding at the injection site
• Increased gamma-GT, a liver enzyme identified in a blood test
• Liver inflammation (hepatitis)
• Liver failure
• Numbness, tingling, and pain
• Anaphylactic reactions

* Includes side effects for which the exact role of Faslodex cannot be evaluated due to underlying disease.

Reporting side effects

If you experienceany type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possibleside effect that does not appear in this prospectus.You can also report them directly through thenational notification system included in theAppendix V*. 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 use this medication after the expiration date that appears on the packaging or on the syringe labels after the CAD abbreviation. The expiration date is the last day of the month indicated.

Store and transport in a refrigerator (between 2°C and 8°C).

Temperature deviations outside the range of 2°C to 8°C must be controlled. This includes avoiding storage at temperatures above 30°C, and not exceeding a period of 28 days, during which the average storage temperature of the medication is below 25°C (but above 2°C and 8°C). After temperature deviations, the medication must be returned immediately to the recommended storage conditions (store and transport in a refrigerator between 2°C and 8°C). Temperature deviations have an accumulative effect on the quality of the medication, and should not exceed the 28-day period above the 4-year expiration date of Faslodex. Exposure to temperatures below 2°C will not damage the medication, as long as it is not stored below -20°C.

Store the pre-filled syringe in the original packaging to protect it from light.

Your healthcare professional will be responsible for the correct storage, use, and disposal of Faslodex.

This medication may pose a risk to aquatic environments. Medications should not be disposed of through drains or in the trash.Ask your pharmacist how to dispose ofthe packaging and medications that you no longerneed.This will help protect the environment.

Composition of Faslodex

-The active ingredient is fulvestrant. Each pre-filled syringe (5 ml) contains 250 mg of fulvestrant.

-The other components (excipients) are ethanol (96 percent), benzyl alcohol, benzyl benzoate, and refined ricin oil.

Appearance of the product and contents of the pack

Faslodex is a viscous, transparent, colourless to yellow solution in a pre-filled syringe equipped with a safety closure, containing 5 ml of injectable solution. Two syringes should be administered to receive the recommended monthly dose of 500 mg.

Faslodex is available in two formats, either a pack containing one pre-filled glass syringe or a pack containing two pre-filled glass syringes. In addition, safety needles (“BD SafetyGlide”) are provided for connection to the body of each syringe.

Only some pack sizes may be marketed.

Marketing Authorisation Holder

AstraZeneca AB

SE-151 85 Södertälje

Sweden

Responsible for manufacturing

AstraZeneca AB

Global External Sourcing (GES)

Astraallén

Gärtunaporten

SE‑151 85 Södertälje

Sweden

AstraZeneca UK Limited

Silk Road Business Park

Macclesfield

Cheshire

SK10 2NA

United Kingdom

For further information about this medicinal product, please consult the representative of the marketing authorisation holder in your country:

Last update of this leaflet:

Other sources of information

The detailed information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu.

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This information is intended for healthcare professionals only:

Faslodex500mg (2x250mg/5ml injectable solution) should be administered using two pre-filled syringes, see section3.

Administration instructions

Warning – Do not autoclave the safety needle (Hypodermic Needle Protector “BD SafetyGlide”) before use. Hands must remain behind the needle at all times during use and disposal.

For each of the two syringes:

Disposal

The pre-filled syringes areonlyfor single use.

This medicinal product may present a risk to the aquatic environment.The disposal of unused medicinal product and any waste materials should be in accordance with local requirements.