Prospect: information for the user

Fulvestrant Eugia 250 mg injectable solution in pre-filled syringe EFG

Read this prospect carefully before starting to use this medicine, because it contains important information for you.

-Keep this prospect, 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 must not give it to other people 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 prospect. See section 4.

1.What is Fulvestrant Eugia and what is it used for

2.What you need to know before starting to use Fulvestrant Eugia

3.How to use Fulvestrant Eugia

4.Possible side effects

5.Storage of Fulvestrant Eugia

6.Contents of the package and additional information

FulvestrantEugiacontains 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.

Fulvestrant is used:

• alone, 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 will 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 also read the prospectus for palbociclib. If you have any questions about palbociclib, consult your doctor.

No use Fulvestrant Eugia

-if you are allergic to fulvestrant or any of the 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 if any of the following apply:

- kidney or liver problems

- low platelet count (which helps blood clotting) or bleeding disorders

- previous blood clotting problems

- osteoporosis (bone density loss)

- alcoholism

Niños y adolescentes

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

Otros medicamentos y Fulvestrant Eugia

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 (medicines to prevent blood clots).

Embarazo y lactancia

Do not use fulvestrant if you are pregnant. If you can become pregnant, use an effective contraceptive method while you are receiving treatment with fulvestrant and for two years after your last dose.

Do not breastfeed while receiving 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.

Use in athletes

This medication contains fulvestrant, which may produce a positive result in doping control tests.

Excipientes:

Etanol:

This medication contains 10% v/v of ethanol (alcohol), that is, up to 500 mg per injection.

The amount in a treatment dose (i.e., two syringes) of this medication is equivalent to 25 ml of beer or 10 ml of wine.

It is unlikely that the amount of alcohol contained in this medication will have any noticeable effect in adults or adolescents. The amount of alcohol contained in this medication may affect the action of other medications. Consult your doctor or pharmacist if you are taking other medications.

If you are pregnant or breastfeeding, consult your doctor or pharmacist before taking this medication.

If you have an alcohol addiction, consult your doctor or pharmacist before taking this medication.

Alcohol bencílico:

This medication contains 500 mg of benzyl alcohol in each injection, equivalent to 100 mg/ml. Benzyl alcohol may cause allergic reactions.

Benzoato de bencilo:

This medication contains 750 mg of benzyl benzoate in each injection, equivalent to 150 mg/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 fulvestrant via a slow intramuscular injection in each of your buttocks.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

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, which may be symptoms 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:

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

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

All other side effects:

Frequent 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 of bile produced by the liver).
• Thromboembolism (increased risk of blood clots)*.
• Decreased platelet levels (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).

Rare 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 or pharmacist, 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: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.

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

Do not use this medication after the expiration date that appears on the packaging or on the syringe labels after the abbreviation CAD. The expiration date is the last day of the month indicated.

Your healthcare professional will be responsible for the correct storage, 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 your pharmacy. Ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Fulvestrant Eugia

-The active ingredient is fulvestrant. Each pre-filled syringe 5 ml (50 mg/ml) contains 250 mg of fulvestrant.

-The other components (excipients) are ethanol (96%), benzyl alcohol (E1519), benzyl benzoate, and refined ricin oil.

Appearance of the product and contents of the pack

Injectable solution in pre-filled syringe.

Viscous, transparent, colourless to yellow solution, practically free of visible particles.

Fulvestrant Eugia 250 mg injectable solution in pre-filled syringe EFG is presented in a transparent type I glass syringe of 5 ml with a tip cap, equipped with a tamper-evident closure and sealed with a grey plunger with a bromobutyl rubber stopper and a plunger.

In addition, a hypodermic needle with a safety system is provided for connection with the syringe body to administer the fulvestrant injection solution.The glass syringe body with the needle will be placed in a plastic protective container with a transparent lid.

Fulvestrant Eugia 250 mg injectable solution in pre-filled syringe EFG is available in 6 presentations, a pack containing 1 glass syringe, a pack containing 2 glass syringes, a pack containing 4 glass syringes, a pack containing 5 glass syringes, a pack containing 6 glass syringes, and a pack containing 10 glass syringes.In addition, safety needles (“BD SafetyGlide”) are provided for connection to the body of each syringe.

Only some sizes of packs may be commercially available.

Marketing Authorisation Holder and Responsible Person for Manufacturing

Marketing Authorisation Holder

Eugia Pharma (Malta) Limited

Vault 14, Level 2, Valletta Waterfront

Floriana, FRN 1914

Malta

Responsible Person for Manufacturing:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

O

Generis Farmacêutica, S.A.

Rua João de Deus, nº 19, Venda Nova

2700-487 Amadora

Portugal

O

Arrow Génériques

26 Avenue Tony Garnier

69007 Lyon

France

You can request more information about this medicine by contacting the local representative of the marketing authorisation holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

This medicine is authorised in the member states of the European Economic Area with the following names:

Belgium:Fulvestrant Eugia 250 mg solution for injection in pre-filled syringe / solution injectable en seringue préremplie / Injektionslösung in einer Fertigspritze

France:Fulvestrant Arrow 250 mg, solution injectable en seringue préremplie

Germany:Fulvestrant PUREN 250 mg Injektionslösung in einer Fertigspritze

Italy:FulvestrantAurobindo

Netherlands:FulvestrantEugia250 mg, oplossing voor injectie in een voorgevulde spuit

Poland:FulvestrantEugia

Portugal:Fulvestrant Generis

Romania:Fulvestrant Eugia 250 mg solu?ie injectabila în seringa preumpluta

Spain:Fulvestrant Eugia 250 mg injectable solution in pre-filled syringe EFG

Last update of this leaflet:February 2023

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

This information is intended solely for healthcare professionals:

Fulvestrant Eugia 500 mg (2 x 250 mg/5 ml injectable solution) should be administered using two pre-filled syringes, see section 3.

Administration instructions

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

To administer each of the two syringes:

• Remove the glass syringe body from the tray and check that it is not damaged.
• Open the outer packaging of the safety needle (“SafetyGlide”).
• Before administration, visually inspect the parenteral solutions for content in particles and discoloration.
• Hold the syringe in a vertical position, gripping it by the fluted part (C). With the other hand, hold the stopper (A) and incline it carefully back and forth until the cap comes off and can be removed, do not turn it (see Figure 1).

Figure 1

• Remove the stopper (A) by pulling it upwards. To maintain sterility, avoid touching the tip of the syringe (B) (see Figure 2).

Figure 2

• Attach the safety needle to the “Luer-Lok” and screw it in until it is securely attached (see Figure 3).
• Check that the needle is attached to the Luer connector before releasing it from the vertical position.
• Pull the protective cap of the needle straight off to avoid damaging the tip of the needle.
• Carry the loaded syringe to the administration site.
• Remove the protective cap of the needle.
• Remove excess gas from the syringe.

Figure 3

• Administer slowly by intramuscular injection in the buttock (gluteal region) (1-2 minutes/injection). For greater comfort, the orientation of the needle with the bevel up is the same as the arm of the plunger raised (see Figure 4).

Figure 4

• After injection, immediately give a single tap on the plunger arm to activate the protection mechanism (see Figure 5).

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

Figure 5

Disposal

The pre-filled syringes areonlyfor single use.

This medicine may pose a risk to aquatic environments. The disposal of unused medicine and all materials that have come into contact with it will be carried out in accordance with local regulations (see section 5).