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

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the Patient

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

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.

• If you have any questions, ask your doctor, pharmacist, or nurse.

• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.

  • If you experience any adverse reactions, consult your doctor, pharmacist, or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Fulvestrant Viso Farmacéutica is and what it is used for
2. What you need to know before using Fulvestrant Viso Farmacéutica
3. How to use Fulvestrant Viso Farmacéutica
4. Possible adverse effects
5. How to store Fulvestrant Viso Farmacéutica
6. Contents of the pack and other information

1. What Fulvestrant Viso Farmacéutica is and what it is used for

This medicine contains the active substance fulvestrant, which belongs to the group of estrogen receptor blockers.

Estrogens, a type of female sex hormones, may in some cases be involved in the development of breast cancer.

Fulvestrant is used:

• as monotherapy, for the treatment of 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 and 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 medicine called a luteinizing hormone-releasing hormone (LHRH) agonist.

When fulvestrant is administered in combination with palbociclib, it is important that you also read the palbociclib package leaflet. If you have any questions about palbociclib, consult your doctor.

2. What you need to know before starting to use Fulvestrant Viso Farmacéutica

Do not use Fulvestrant Viso Farmacéutica:

• if you are allergic to fulvestrant or to 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

Talk to your doctor, pharmacist or nurse before using Fulvestrant Viso Farmacéutica if any of the following apply to you:

• kidney or liver problems,
• low platelet count (platelets help blood to clot) or bleeding disorders,
• previous history of blood clots,
• osteoporosis (loss of bone density),
• alcoholism.

Children and adolescents

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

Other medicines and Fulvestrant Viso Farmacéutica

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

In particular, you must inform your doctor if you are using anticoagulants (medicines used to prevent blood clots).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

You must not use this medicine if you are pregnant. If you could become pregnant, you must use an effective method of contraception during treatment with this medicine and for two years after the last dose.

You must not breastfeed while being treated with Fulvestrant Viso Farmacéutica.

Driving and using machines

This medicine is not expected to affect your ability to drive or operate machinery. 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 control tests.

Fulvestrant Viso Farmacéutica contains ethanol

This medicine contains 500 mg of alcohol (ethanol) per pre-filled syringe, equivalent to 100 mg/ml (10% m/v). The amount in each syringe is equivalent to less than 13 ml of beer or 5 ml of wine.

The amount of alcohol in this medicine is unlikely to have any noticeable effect in adults or adolescents. It could have some effects in young children, such as drowsiness.

The amount of alcohol contained 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 using this medicine.

If you have alcohol addiction, consult your doctor or pharmacist before using this medicine.

Fulvestrant Viso Farmacéutica contains benzyl alcohol

This medicine contains 500 mg of benzyl alcohol per pre-filled syringe, equivalent to 100 mg/ml (10% m/v). Benzyl alcohol may cause allergic reactions.

Consult your doctor or pharmacist if you are pregnant or breastfeeding. This is because large amounts of benzyl alcohol may accumulate in your body and cause adverse effects (metabolic acidosis).

Consult your doctor or pharmacist if you have liver or kidney disease. This is because large amounts of benzyl alcohol may accumulate in your body and cause adverse effects (metabolic acidosis).

Fulvestrant Viso Farmacéutica contains benzyl benzoate

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

3. How to use Fulvestrant Viso Farmacéutica

Follow exactly the administration instructions for this medicine provided 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 500 mg dose given 2 weeks after the initial dose.

Your doctor or nurse will administer Fulvestrant Viso Farmacéutica to you as a slow intramuscular injection into each of your buttocks.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

You may require urgent medical treatment if you experience any of the following adverse 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.

Immediately inform your doctor, pharmacist, or nurse if you notice any of the following adverse effects:

Very common adverse effects (may affect more than 1 in 10 patients)

• reactions at the injection site, such as pain and/or swelling,
• abnormal levels of liver enzymes (in blood tests)*,
• nausea (feeling unwell),
• weakness, fatigue*,
• joint and musculoskeletal pain,
• hot flushes,
• skin rash,
• allergic reactions (hypersensitivity), including swelling of the face, lips, tongue, and/or throat.

All remaining adverse effects:

Common adverse effects (may affect up to 1 in 10 patients)

• 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 levels (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 with walking or balance (peripheral neuropathy).

Uncommon adverse effects (may affect up to 1 in 100 patients)

• thick, whitish vaginal discharge and candidiasis (infection),

• bruising and bleeding at the injection site,

• increased gamma-GT, a liver enzyme detected in blood tests,

• inflammation of the liver (hepatitis),

• liver failure,

• numbness, tingling, and pain,

• anaphylactic reactions.

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Fulvestrant Viso Farmacéutica

This medicinal product does not require special storage conditions.

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

Your healthcare professional is responsible for the proper storage, use, and disposal of Fulvestrant Viso Farmacéutica.

This medicinal product may pose a risk to the aquatic environment. Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point in your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Fulvestrant Viso Farmacéutica

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

Appearance of the product and contents of the pack

Fulvestrant Viso Farmacéutica is a viscous, transparent, colourless to yellowish solution in a pre-filled syringe containing 5 ml of injectable solution. Two syringes must be administered to receive the recommended monthly dose of 500 mg.

Fulvestrant Viso Farmacéutica is available in three pack sizes: one pack containing 1 glass pre-filled syringe, one pack containing 2 glass pre-filled syringes, and one pack containing 6 glass pre-filled syringes. Additionally, one, two or six safety needles (BD SafetyGlide) are provided for attachment to the barrel of each syringe.

Only some pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Glenmark Arzneimittel GmbH

Industriestr. 31

82194 Gröbenzell

Germany

Manufacturer:

Laboratorios Farmalán, S.A.

C/ La Vallina s/n, Edificio 2

Polígono Industrial Navatejera

24193, Villaquilambre, León

Spain

For more information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Glenmark Farmacéutica, S.L.U.

C/ Retama 7, 7th floor

28045 Madrid

Spain

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

Netherlands: Fulvestrant Glenmark 250 mg oplossing voor injectie in een voorgevulde spuit
Germany: Fulvestrant Glenmark 250 mg Injektionslösung in einer Fertigspritze
Denmark: Fulvestrant Glenmark
Spain: Fulvestrant Viso Farmacéutica 250 mg solución inyectable en jeringa precargada EFG
Norway: Fulvestrant Glenmark
Sweden: Fulvestrant Glenmark

Date of the most recent review of this leaflet: April 2025

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

This information is intended for healthcare professionals only:

Fulvestrant Viso Farmacéutica 500 mg (2 x 250 mg/5 ml solution for injection) must be administered using two pre-filled syringes. See section 3.

Administration instructions

Warning – Do not sterilize the safety needle (BD SafetyGlideTM hypodermic safety needle) in an autoclave 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 barrel from the tray and check that it is undamaged.

• Peel off the outer packaging of the safety needle (SafetyGlide).

• Parenteral solutions should be inspected visually for particles and discoloration prior to administration.

• Hold the syringe vertically by the flange (C). With the other hand, grasp the cap (A) and carefully turn the rigid plastic tip cap counterclockwise to remove it. (see Figure 1):

Figure 1

• Remove the rigid plastic tip cap (A) straight upwards. To maintain sterility, do not touch the syringe tip (B) (see Figure 2).

Figure 2

Attach the safety needle to the Luer-Lok and rotate it until firmly seated (see Figure 3).

• Ensure that the needle is securely locked into the Luer connector before moving out of the vertical plane.
• Remove the needle protector to avoid damaging the needle tip.
• Transport the filled syringe to the administration site.
• Remove the needle cover.
• Expel excess air from the syringe.

Figure 3

• Administer slowly by intramuscular injection (1-2 minutes per injection) into the buttock (gluteal region). For user comfort, the needle bevel orientation is directed toward the lever arm (see Figure 4).

Figure 4

After injection, immediately press a finger against the lever arm to activate the safety mechanism (see Figure 5).

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

Figure 5

Disposal

Pre-filled syringes are for single use only.

This medicinal product may pose a risk to the aquatic environment. Any unused medicine or waste material must be disposed of in accordance with local requirements.