Prospect: information for the patient

Fulvestrant Viso Pharmaceutical 250 mg injectable solution in preloaded syringe EFG

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

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.

-This medication has been prescribedonlyto you, and you must not give it to other people even iftheyhave the same symptomsas you,as it may harm them.

• If you experience adverse effects,consult your doctor, pharmacist, or nurse, evenifthey do not appear in this prospect. See section 4.

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

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

3. How to use Fulvestrant Viso Pharmaceutical

4. Possible adverse effects

5. Storage of Fulvestrant Viso Pharmaceutical

6. Contents of the package and additional information

This medicationcontains 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.

Fulvestrantis used:

• in 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 breast cancer 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 medication called a luteinizing hormone-releasing hormone (LHRH) agonist.

WhenFulvestrantis administered in combination with palbociclib, it is essential that you also read the prospectus for palbociclib. If you have any doubts about palbociclib, consult your doctor.

Do not useFulvestrant Viso Farmacéutica:

• if you are allergic to fulvestrant or any of the other ingredients of this medication (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 Viso Farmacéutica if any of the following apply:

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

Children and adolescents

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

Other medicines and Fulvestrant Viso Farmacéutica

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

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

Pregnancy and breastfeeding

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

You must not use this medication if you are pregnant.You must use an effective contraceptive method while you are being treated with this medication and for two years after the last dose.

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

Driving and operating machinery

This medication is not expected to affect your ability to drive or operate machinery. However, if you feel tired after treatment, do not drive or operate machinery.

Use in athletes

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

Fulvestrant Viso Farmacéutica contains ethanol

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

It is unlikely that the amount of alcohol contained in this medication will have any noticeable effect on adults or adolescents. It may have some effect on young children, such as drowsiness.

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 using this medication.

If you have a history of alcohol addiction, consult your doctor or pharmacist before using this medication.

Fulvestrant Viso Farmacéutica contains benzyl alcohol

This medication contains 500 mg of benzyl alcohol in each 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 medication contains 750 mg of benzyl benzoate per 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/5ml) administered once a month with an additional dose of 500 mg administered 2 weeks after the initial dose.

Your doctor or nurse will administerFulvestrant Viso Pharmaceuticalvia 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 may 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:

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

• 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,
• headaches,
• skin rash,
• allergic reactions (hypersensitivity), including swelling of the face, lips, tongue, and/or throat.

All remaining side effects:

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

• headaches,
• 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 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).

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

• 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 not listed in this prospectus. You can also report them directly through theSistema Español de Farmacovigilancia de Medicamentos de Uso Humano:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears onthe packaging or the syringe labelafter CAD. The expiration date is the last day of the month indicated.

Store and transport refrigerated (between 2°C and 8°C).

Temperature variations outside of 2°C - 8°C must be limited. This includes avoiding storage at temperatures above 30°C and not exceeding a period of 28 days in which the average storage temperature of the product is below 25°C (but above 2°C - 8°C). After temperature variations, the product must be returned immediately to the recommended storage conditions (store and transport in a refrigerator between 2°C and 8 °C). Temperature variations have an accumulative effect on product quality and should not exceed the 28-day period during the 2-year validity period of Fulvestrant Viso Pharmaceutical. Exposure to temperatures below 2°C will not damage the product as long as it is not stored below -20°C.

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

Your healthcare professional will be responsible for the correct conservation, use, and disposal of Fulvestrant Viso Pharmaceutical.

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

Composition of Fulvestrant Viso Pharmaceutical

• The active ingredient 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 ricin oil.

Appearance of the product and contents of the package

Fulvestrant Viso pharmaceutical is a viscous, transparent, colorless to yellow solution in a pre-filled syringe containing 5 ml of injectable solution. Two syringes should be administered to receive the recommended monthly dose of 500 mg.

Fulvestrant Viso pharmaceutical is available in three packaging formats, a package containing one pre-filled syringe of glass, a package containing two pre-filled syringes of glass, and a package containing six pre-filled syringes of glass. In addition, one, two, or six safety needles (BD SafetyGlide) are provided for connection to the body of each syringe.

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Glenmark Arzneimittel GmbH

Industriestr. 31,

82194 Gröbenzell,

Germany

Responsible manufacturer

Laboratorios Farmalán, S.A.

C/ La Vallina s/n, Edificio 2,

Polígono Industrial Navatejera,

24193, Villaquilambre, León

Spain

Further information about this medicinal product can be obtained from the local representative of the marketing authorization holder:

VisoPharmaceutical, S.L.U.

c/ Retama 7, 7ª Planta,

28045 Madrid,

Spain

This medicinal product is authorized in the member states of the European Economic Area with the following names:

Netherlands:Fulvestrant Glenmark 250 mg solution for injection in a pre-filled syringe

Germany:Fulvestrant Glenmark 250 mg injection solution in a pre-filled syringe

Denmark:Fulvestrant Glenmark

Spain:Fulvestrant Viso Pharmaceutical 250 mg injectable solution in a pre-filled syringe EFG

Norway:Fulvestrant Glenmark

Sweden:Fulvestrant Glenmark

Poland:Fulvestrant Glenmark

Last review date of this leaflet: September 2020

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

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This information is intended solely for healthcare professionals:

Fulvestrant Viso Pharmaceutical 500 mg (2 x 250 mg/5 mlinjectable solution) should be administered using two pre-filled syringes. See section 3.

Administration instructions

Warning – Do not sterilize the safety needle (BD SafetyglideTM) in an autoclave before use. Hands should remain behind the needle at all times during use and disposal.

To administer each of the two syringes:

-Remove the glass cylinder from the syringe from the tray and check that it is not damaged.

-Remove the outer packaging of the safety needle (SafetyGlide).

-Parenteral solutions should be visually inspected for particles and discoloration before administration.

-Hold the syringe in a vertical position over the bevel (C). With the other hand, grasp the stopper (A) and turn the rigid plastic tip stopper clockwise. (see figure 1):

Figure 1

-Remove the cap from the rigid plastic tip (A) in a straight upward direction. To maintain sterility, do not touch the tip of the syringe (B) (see figure 2)

Figure 2

Connect the safety needle to the Luer-Lok and turn it until it is firmly seated (see figure 3).

-Check that the needle is blocked in the Luer connector before leaving the vertical plane.

-Remove the needle protector to avoid damaging the needle tip.

-Draw the syringe full to the administration point.

-Remove the needle cover.

-Expel excess gas from the syringe.

Figure 3

-Administer intramuscularly slowly (1-2 minutes/injection) in the buttock (gluteal area). For user comfort, the bevel of the needle is oriented towards the handle (see figure 4).

Figure 4

After injection, immediately give a tap on the handle to activate the safety mechanism (see Figure 5).

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

Figure 5

Disposal

The pre-filled syringes are forsingle use.

This medicinal product may pose a risk to aquatic environments. Any unused medicinal product or waste should be disposed of in accordance with local requirements.