Product Information for the User

Fulvestrant Dr. Reddys 250 mg Injectable Solutionin Pre-filled Syringe EFG

Read this entire product information carefully before starting to use this medicine, as it contains important information for you.

• Keep this product information, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine 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 side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this product information. See Section 4.

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

Fulvestrant is used:

• As monotherapy, to treat postmenopausal 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 may also be treated with a medication called a luteinizing hormone-releasing hormone (LHRH) agonist.

Fulvestrant may be administered in combination with palbociclib. It is essential that you read the prospectus of palbociclib as well. If you have any questions about palbociclib, consult your doctor.

No use Fulvestrant Dr. Reddys:

• If you are allergic to fulvestrant or any of the other components of this medication (listed in section 6)
• If you are pregnant or breastfeeding
• If you have severe liver problems

Advertencias y precauciones

Consult your doctor, pharmacist, or nurse before starting to use Fulvestrant Dr. Reddys 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

Niños y adolescentes

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

Uso de Fulvestrant Dr. Reddys con otros medicamentos

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

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

Embarazo y lactancia

You should not use fulvestrant if you are pregnant. If you can become pregnant, you must use an effective contraceptive method while you are on treatment with fulvestrant and for 2 years after your last dose.

You should not breastfeed while on treatment with fulvestrant.

Conducción y uso de máquinas

Fulvestrant is not expected to affect your ability to drive or use machines. However, if you feel tired after treatment, do not drive or use machines.

Etanol

This medication contains 500 mg of alcohol (ethanol) in 5 ml of solution. The amount in a dose (two 5 ml syringes) of this medication is equivalent to less than 25 ml of beer or 10 ml of wine. It is unlikely that the amount of alcohol in this medication will have an effect on adults and adolescents. The alcohol in this medication may interact with other medications. Talk to your doctor or pharmacist if you are taking other medications. If you are addicted to alcohol, consult your doctor or pharmacist before taking this medication.

Alcohol de bencilo

This medication contains 500 mg of benzyl alcohol in each 5 ml vial. Benzyl alcohol may cause allergic reactions.

Ask your doctor or pharmacist for advice if you have liver or kidney disease. This is because large amounts of benzyl alcohol may accumulate in your body and cause side effects (known as "metabolic acidosis").

Benzoato de bencilo

This medication contains 750 mg of benzyl benzoate in each 5 ml vial.

Aceite de ricino

It may cause severe allergic reactions.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.

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

Your doctor or nurse will administer fulvestrant 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, this medicine can 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 that may be signs of anaphylactic reactions
• Thromboembolism (increased risk of blood clots)*
• Inflammation of the liver (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 1 in 10 people)

• Reactions at the injection site, such as pain and/or inflammation
• Abnormal levels of liver enzymes (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 1 in 10 people)

• 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 that radiates 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)

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

• 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
• Inflammation of the liver (hepatitis)

• Liver failure
• Numbness, tingling, and pain
• Anaphylactic reactions

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

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 the Spanish System for Pharmacovigilance of Medicines for Human Use:http://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 use this medication after the expiration date that appears on the packaging or on the syringe label after CAD.

The expiration date is the last day of the month indicated.

This medication does not require special temperature storage conditions.

Store the preloaded syringe in the original packaging to protect it from light.

Your healthcare professional will be responsible for the proper conservation, use, and disposal of fulvestrant.

This medication may pose a risk to aquatic environments. Medications should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Fulvestrant Dr. Reddys

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

Each ml contains 50 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 package

Fulvestrant Dr. Reddys is a viscous, transparent, colorless to yellow solution in a pre-filled syringe equipped with a tamper-evident closure, containing 5 ml of injectable solution. Two syringes should be administered to receive the recommended monthly dose of 500 mg.

Fulvestrant Dr. Reddys is available in 4 formats, either a package containing 1 glass pre-filled syringe, or a package containing 2 glass pre-filled syringes, or a package containing 4 glass pre-filled syringes, or a package containing 6 glass pre-filled syringes. In addition, safety needles (Terumo^® SurGuard^® 3) are provided for connection to the body and a handle is provided on each syringe.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder:

Reddy Pharma Iberia, S.A.U.

Avenida Josep Tarradellas, nº 38

08029 Barcelona (Spain)

Tel: +34 93 355 49 16

Fax: +34 93 355 49 61

Manufacturer responsible:

Betapharm Arzneimittel GmbH

Kobelweg 95-Augsburg

86156

Germany

Fax: +004982174881-420

Phone: +004982174881-0

Or

S.C. Rual Laboratories S.R.L.,

313, Splaiul Unirii, Building H, 1st floor,

sector 3, Bucharest,

030138, Romania

This medicinal product is authorized in the Member States of the European Economic Area with the following names: :

Last revision date of this leaflet: August 2023

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This information is intended solely for healthcare professionals:

Fulvestrant Dr. Reddys 500 mg (2 injections of 250 mg) should be administered using two pre-filled syringes, see section 3.

Administration instructions

Warning – Do not sterilize the safety needle (Terumo^® SurGuard^® 3) in an autoclave before use. Hands must remain behind the needle at all times during use and disposal.

For each of the two syringes:

Figure 1

• Remove the glass barrel from the syringe from the tray and check that it is not damaged.

• Break the plastic transparent connector Luer-Lock protector seal on the syringe to remove this protector with the rubber cap from the tip (see Figure 1).

Figure 2

• Open by removing the outer packaging from the safety needle. Attach the safety needle to the Luer-Lock (see Figure 2).

• Turn until it locks firmly onto the connector Luer.

• Carry the loaded syringe to the administration site.

Figure 3

• Before removing the needle cap, remove the safety cover, towards the syringe cylinder at the angle shown.

• Before administration, visually inspect parenteral solutions for particulate matter and discoloration.

• Remove excess gas from the syringe.

• Administer slowly intramuscularly in the gluteus (1-2 minutes/injection). For greater comfort, the needle position with the bevel up has the same orientation as the arm of the lever raised (see Figure 3).

• Use the handle if necessary

Figure 4

• After injection, to activate the safety mechanism, perform the technique with one hand using any of the three methods illustrated above (activation is verified by an audible or tactile click and can be visually confirmed) (see Figure 4).

NOTE: Activate away from your body and others. Listen for the click and visually confirm that the needle tip is fully protected.

Disposal

The pre-filled syringes are only for single use.

This medicinal product may present a risk to aquatic environments. The disposal of unused medicinal product and all materials that have been in contact with it will be in accordance with local regulations.