FULVESTRANT 250 mg Solution

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Fulvestrant Eugia, 250 mg, Solution for Injection in a Prefilled Syringe
   1. Read the package leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of Contents of the Package Leaflet:
3. What is Fulvestrant Eugia and what is it used for
4. Important information before taking Fulvestrant Eugia
   1. When not to take Fulvestrant Eugia:
   2. Warnings and precautions
   3. Children and adolescents
   4. Fulvestrant Eugia and other medicines
   5. Pregnancy and breastfeeding
   6. Driving and using machines
   7. Excipients:
   8. Etanol:
   9. Benzyl alcohol:
   10. Benzyl benzoate:
5. How to take Fulvestrant Eugia
6. Possible side effects
   1. If you experience any of the following side effects, contact your doctor immediately:
   2. Tell your doctor, pharmacist, or nurse if you notice any of the following side effects:
   3. All other side effects:
   4. Reporting side effects
7. How to store Fulvestrant Eugia
8. Contents of the pack and other information
   1. What Fulvestrant Eugia contains
   2. What Fulvestrant Eugia looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Marketing authorization holder:
   5. Manufacturer/Importer:
   6. This medicine is authorized in the Member States of the European Economic Area under the following names:
   7. Date of last revision of the package leaflet:
   8. Information intended for healthcare professionals only:

Package Leaflet: Information for the Patient

Fulvestrant Eugia, 250 mg, Solution for Injection in a Prefilled Syringe

Fulvestrant

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• 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 symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Package Leaflet:

• 1. What is Fulvestrant Eugia and what is it used for
• 2. Important information before taking Fulvestrant Eugia
• 3. How to take Fulvestrant Eugia
• 4. Possible side effects
• 5. How to store 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 a group of estrogen blockers.
Estrogens, a type of female sex hormone, may contribute to the growth of breast cancer in some cases.
Fulvestrant Eugia is used:

• as a single medicine, in the treatment of 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 in the treatment of women with a certain 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 yet reached menopause will also receive a medicine called a luteinizing hormone-releasing hormone (LHRH) agonist.

When Fulvestrant Eugia is given in combination with palbociclib, it is also important to read the patient information leaflet for palbociclib. If you have any questions about palbociclib, ask your doctor.

2. Important information before taking Fulvestrant Eugia

When not to take 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 impairment

Warnings and precautions

Before starting treatment with Fulvestrant Eugia, discuss with your doctor, pharmacist, or nurse if any of the following apply to you:

• if you have ever had kidney or liver problems
• if you have had a low platelet count (which helps blood to clot) or bleeding disorders
• if you have ever had blood clots
• if you have osteoporosis (loss of bone density)
• alcohol dependence

Children and adolescents

Fulvestrant Eugia is not recommended for use in children and adolescents under 18 years of age.

Fulvestrant Eugia and other medicines

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and about any medicines you plan to take.
In particular, inform your doctor if you are taking anticoagulant medicines (medicines that prevent blood clots).

Pregnancy and breastfeeding

Fulvestrant Eugia must not be used if you are pregnant. If you may become pregnant, you must use effective contraception during treatment with Fulvestrant Eugia and for 2 years after the last dose.
Do not breastfeed during treatment with Fulvestrant Eugia.

Driving and using machines

Fulvestrant Eugia has not been shown to affect the ability to drive or use machines. However, if you feel tired after taking the medicine, do not drive or use machines.

Excipients:

Etanol:

This medicine contains 10% v/v ethanol (alcohol), i.e. up to 500 mg per injection. The amount of alcohol in each injection (i.e. in two syringes) of this medicine is equivalent to 25 mL of beer or 10 mL of wine.
The amount of alcohol in this medicine is unlikely to have an effect in adults and adolescents. The alcohol in this medicine may affect the way other medicines work. If you are taking other medicines, consult your doctor or pharmacist.
If you are pregnant or breastfeeding, consult your doctor or pharmacist before taking this medicine.
If you are addicted to alcohol, consult your doctor or pharmacist before taking this medicine.

Benzyl alcohol:

This medicine contains 500 mg of benzyl alcohol per injection, which is equivalent to 100 mg/mL. Benzyl alcohol may cause allergic reactions.

Benzyl benzoate:

This medicine contains 750 mg of benzyl benzoate per injection, which is equivalent to 150 mg/mL.

3. How to take Fulvestrant Eugia

This medicine should always be taken exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
The usual dose is 500 mg of fulvestrant (two 250 mg/5 mL injections), given once a month, and an additional dose of 500 mg given 2 weeks after the first dose.
Fulvestrant Eugia is given by a doctor or nurse, as a slow intramuscular injection, one in each buttock.
If you have any further questions on 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.

If you experience any of the following side effects, contact your doctor immediately:

• Allergic reactions (hypersensitivity), including swelling of the face, lips, tongue, and/or throat, which may be signs of anaphylactic reactions
• Thromboembolic disease (increased risk of blood clots)*
• Hepatitis (inflammation of the liver)
• Liver failure

Tell your doctor, pharmacist, or nurse 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 enzyme levels (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 levels (a pigment produced by the liver)
• Thromboembolic disease (increased risk of blood clots)*
• Low platelet count (thrombocytopenia)
• Vaginal bleeding
• Lower back pain radiating to one leg (sciatica)
• Sudden weakness, numbness, tingling, or loss of mobility in one leg, especially on one side of the body, sudden difficulty walking or maintaining balance (peripheral neuropathy)

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

• Thick, white vaginal discharge and vaginal candidiasis (infection)
• Bruising and bleeding at the injection site
• Increased gamma-GT enzyme activity (in blood tests)
• Hepatitis (inflammation of the liver)
• Liver failure
• Numbness, tingling, and pain
• Anaphylactic reactions

* Includes side effects for which the role of Fulvestrant Eugia cannot be assessed due to the underlying disease.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help provide more information on the safety of this medicine.
Side effects can also be reported to the marketing authorization holder.

5. How to store Fulvestrant Eugia

Keep the medicine out of the sight and reach of children.
Store in a refrigerator (2°C – 8°C).
Do not use this medicine after the expiry date which is stated on the carton or syringe label after EXP. The expiry date refers to the last day of that month.
A healthcare professional will be responsible for the proper storage, administration, and disposal of this medicine. This medicine may pose a risk to aquatic environments.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Fulvestrant Eugia contains

• The active substance is fulvestrant. Each 5 mL prefilled syringe contains 250 mg of fulvestrant.
• The other ingredients (excipients) are: ethanol (96%), benzyl alcohol (E 1519), benzyl benzoate, and purified castor oil.

What Fulvestrant Eugia looks like and contents of the pack

Solution for injection in a prefilled syringe.
Clear, colorless to yellowish viscous solution essentially free from visible particles.
Fulvestrant Eugia, 250 mg, solution for injection is packaged in a 5 mL glass cylinder with a gray rubber stopper and a plastic needle shield. A safety needle for subcutaneous injection is also provided for connection to the cylinder for administration of the fulvestrant injection solution. The glass cylinder syringe with needle will be placed in a protective plastic tray with a clear plastic cover.
Fulvestrant Eugia is available in 6 pack sizes: a pack containing 1 glass prefilled syringe, 2 glass prefilled syringes, 4 glass prefilled syringes, 5 glass prefilled syringes, 6 glass prefilled syringes, and 10 glass prefilled syringes. The packs also contain needles for administration, with a safety system (BD Safety Glide).
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Eugia Pharma (Malta) Ltd.
Vault 14, level 2
Valletta Waterfront
Floriana, FRN 1914
Malta
e-mail: [email protected]

Manufacturer/Importer:

APL Swift Services (Malta) Ltd.
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
Generis Farmacêutica S.A.
Rua João de Deus 19, Venda Nova
2700-487 Amadora
Portugal
Arrow Génériques
26 Avenue Tony Garnier
69007 Lyon
France

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 pré-remplie
Germany:
Fulvestrant Eugia 250 mg Injektionslösung in einer Fertigspritze
Italy:
Fulvestrant Eugia
Netherlands:
Fulvestrant Eugia 250 mg, oplossing voor injectie in een voorgevulde spuit
Poland:
Fulvestrant Eugia
Portugal:
Fulvestrant Eugia
Romania:
Fulvestrant Eugia 250 mg soluție injectabilă în seringă preumplută
Spain:
Fulvestrant Eugia 250 mg solución inyectable en jeringa precargada EFG

Date of last revision of the package leaflet:

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Information intended for healthcare professionals only:

Fulvestrant Eugia, 500 mg (2 x 250 mg/5 mL, solution for injection) should be administered using two prefilled syringes, see section 3.
Administration instructions
Caution – Do notautoclave the needle with the safety system (BD Safety Glide Shielding Hypodermic Needle) before use.
Avoid hand contact with the needle during administration and disposal of the medicine.
For each of the two syringes:

• Remove the glass cylinder syringe from the container and check that it is not damaged.
• Remove the outer packaging of the needle with the safety system (Safety Glide).
• Parenteral solutions should be inspected visually for particulate matter and discoloration prior to administration.
• Hold the syringe upright in the striped area (C). With the other hand, grasp the plunger (A) and gently rock it back and forth until the plunger is released and can be removed, do not twist (see Figure 1).

Figure 1

• Remove the plunger (A) upwards. To maintain sterility, do not touch the tip of the syringe (B) (see Figure 2).

Figure 2

• Attach the needle with the safety system to the Luer-Lok and tighten to secure (see Figure 3).
• Check that the needle is locked in the Luer before moving to the upright position.
• Remove the needle shield to avoid damaging the needle point.
• Transport the filled syringe to the injection site.
• Remove the needle shield.
• Remove any air from the syringe.

Figure 3

• Administer the medicine intramuscularly, slowly (1-2 minutes/injection) into the buttock muscle (on the buttock). For the convenience of the person administering, the needle bevel is on the same surface as the arm of the safety system (see Figure 4).

Figure 4

• Immediately after administration, activate the needle safety system by pushing the arm forward (see Figure 5).
• CAUTION: Activate away from self and others. Listen for the click and visually confirm that the needle tip is fully covered.

Figure 5
Disposal of waste
The prefilled syringes are for single use only.
This medicine may pose a risk to aquatic environments. Any unused product or waste material should be disposed of in accordance with local requirements (see section 5.3 of the SmPC).