FULVESTRANT EUGIA 250 mg SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE

Introduction

Package Leaflet: Information for the User

Fulvestrant Eugia 250 mg solution for injection in pre-filled syringe EFG

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Fulvestrant Eugia and what is it used for
2. What you need to know before you use Fulvestrant Eugia
3. How to use Fulvestrant Eugia
4. Possible side effects
5. Storage of Fulvestrant Eugia
6. Contents of the pack and other information

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

Fulvestrant Eugia contains the active substance 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 hormone 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, HER2-negative breast cancer, which is locally advanced or has spread to other parts of the body (metastatic). Women who have not reached menopause will also be treated with a medicine called a luteinizing hormone-releasing hormone (LHRH) agonist.

Fulvestrant may be administered in combination with palbociclib. It is important that you also read the package leaflet of palbociclib. If you have any questions about palbociclib, ask your doctor.

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

Do not use Fulvestrant Eugia

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

Warnings and precautions

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

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

Children and adolescents

Fulvestrant is not indicated in children and adolescents under 18 years of age.

Other medicines and Fulvestrant Eugia

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

In particular, you should tell your doctor if you are using anticoagulants (medicines to prevent blood clots).

Pregnancy and breastfeeding

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

You must not breastfeed while being treated with fulvestrant.

Driving and using machines

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 medicine contains fulvestrant, which may produce a positive result in doping tests.

Excipients

Ethanol

This medicine contains 10% v/v ethanol (alcohol), i.e., up to 500 mg per injection.

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

It is unlikely that the amount of alcohol in this medicine will have a noticeable effect on adults or adolescents. The amount of alcohol in this medicine may alter the effect of other medicines. Consult your doctor or pharmacist if you are taking other medicines.

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

If you have a history of alcoholism, consult your doctor or pharmacist before taking this medicine.

Benzyl alcohol

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

Benzyl benzoate

This medicine contains 750 mg of benzyl benzoate in each injection, equivalent to 150 mg/ml.

3. How to use Fulvestrant Eugia

Follow exactly the instructions of administration of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is 500 mg of fulvestrant (two 250 mg/5 ml injections) 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 by slow intramuscular injection into 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 medicine and the amount ingested.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets 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 can be symptoms of anaphylactic reactions.
• Thromboembolism (increased risk of blood clots)*.
• Hepatitis (inflammation of the liver).
• Liver failure.

Tell 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)

• Injection site reactions, such as pain and/or inflammation.
• Abnormal liver enzymes (in blood tests)*.
• Nausea (feeling sick).
• Weakness, fatigue*.
• Joint and musculoskeletal pain.
• Hot flushes.
• 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 bile pigment produced by the liver).
• Thromboembolism (increased risk of blood clots)*.
• Decreased platelet count (thrombocytopenia).
• Vaginal bleeding.
• Lumbar 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 with 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.
• Hepatitis (inflammation of the liver).
• Liver failure.
• Numbness, tingling, and pain.
• Anaphylactic reactions.

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

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Agency's website (www.notificaram.es). By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Fulvestrant Eugia

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

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

Do not use this medicine after the expiry date which is stated on the carton or on the labels of the syringes after the abbreviation EXP. The expiry date is the last day of the month shown.

Your healthcare professional will be responsible for the proper storage, use, and disposal of fulvestrant. This medicine may pose a risk to the aquatic environment.

Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to a pharmacy. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Fulvestrant Eugia

• The active substance is fulvestrant. Each pre-filled syringe 5 ml (50 mg/ml) contains 250 mg of fulvestrant.
• The other ingredients (excipients) are ethanol (96%), benzyl alcohol (E1519), benzyl benzoate, and refined castor oil.

Appearance and packaging

Solution for injection in pre-filled syringe.

Viscous, clear, colorless to yellow solution, practically free from visible particles.

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

A hypodermic needle with a safety system for connection to the syringe body is also provided to administer the fulvestrant solution for injection. The glass syringe body along with the needle will be placed in a protective plastic container with a transparent cap.

Fulvestrant Eugia 250 mg solution for injection in pre-filled syringe EFG has 6 presentations, a pack containing 1 glass pre-filled syringe, a pack containing 2 glass pre-filled syringes, a pack containing 4 glass pre-filled syringes, a pack containing 5 glass pre-filled syringes, a pack containing 6 glass pre-filled syringes, and a pack containing 10 glass pre-filled syringes. Safety needles ("BD SafetyGlide") for connection to the syringe body are also provided.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Eugia Pharma (Malta) Limited

Vault 14, Level 2, Valletta Waterfront

Floriana, FRN 1914

Malta

Manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Or

Generis Farmacêutica, S.A.

Rua João de Deus, nº 19, Venda Nova

2700-487 Amadora

Portugal

Or

Arrow Génériques

26 Avenue Tony Garnier

69007 Lyon

France

You can obtain further information on this medicine by contacting the local representative of the marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Belgium: Fulvestrant Eugia 250 mg oplossing voor injectie in voorgevulde spuit / 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: Fulvestrant Aurobindo

Netherlands: Fulvestrant Eugia 250 mg, oplossing voor injectie in een voorgevulde spuit

Poland: Fulvestrant Eugia

Portugal: Fulvestrant Generis

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

Spain: Fulvestrant Eugia 250 mg solución inyectable en jeringa precargada EFG

Date of last revision of this leaflet:February 2023

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).

This information is intended only for healthcare professionals:

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

Administration instructions

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

For each of the two syringes:

• Remove the glass syringe body from the tray and check that it is not damaged.
• Open the outer package of the safety needle ("SafetyGlide").
• Before administration, parenteral solutions should be inspected visually for particulate matter and discoloration.
• Hold the syringe in an upright position, grasping the ribbed part (C). With the other hand, grasp the cap (A) and carefully tilt it back and forth until it comes off and can be removed, do not twist it (see Figure 1).

Figure 1

• Remove the cap (A) by pulling 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 on until it is firmly attached (see Figure 3).
• Check that the needle is attached to the Luer connector before releasing the upright position.
• Pull the protective cap straight off the needle to avoid damaging the tip.
• Take the loaded syringe to the injection site.
• Remove the protective cap from the needle.
• Eliminate excess gas from the syringe.

Figure 3

• Administer slowly by intramuscular injection into the buttock (gluteal area) (1-2 minutes/injection). For greater comfort, the position of the needle with the bevel up has the same orientation as the lever raised (see Figure 4).

Figure 4

• After injection, immediately touch the lever with your finger 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 needle tip is fully protected.

Figure 5

Disposal

The pre-filled syringes are for single use only.

This medicine may pose a risk to the aquatic environment. Disposal of unused medicine and all materials that have been in contact with it will be carried out in accordance with local regulations (see section 5).