Prospecto:information for the patient

Fulvestrant STADAFARMA 250 mg injectable solutionin pre-filled syringe EFG

Read this prospectus carefully before receiving this medication, as it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only to you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they do not appear in this prospectus. See Section 4.

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

2.What you need to know before receiving Fulvestrant Stadafarma

3.How to administer Fulvestrant Stadafarma

4.Possible adverse effects

5Storage of Fulvestrant Stadafarma

6.Contents of the package and additional information

Fulvestrant Stadafarmacontains the active ingredient fulvestrant, which belongs to the group of estrogen receptor blockers. Estrogens, a type of female sex hormone, may be involved in the development of breast cancer in some cases.

Fulvestrantis used:

Fulvestrantmay 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.

Do not receiveFulvestrant Stadafarma:

• if you are allergic to fulvestrant or any of the other components 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 receivingfulvestrantif you have any of the following problems:
• kidney or liver problems
• low platelet count (which helps blood clotting) or bleeding disorders
• previous history of blood clots
• osteoporosis (bone density loss)
• alcoholism

Children and adolescents

Fulvestrantis not indicated for children and adolescents under 18 years.

Other medications andFulvestrant Stadafarma

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

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

Pregnancy and lactation

You must not usefulvestrantif you are pregnant. If you can become pregnant, you must use an effective contraceptive method while you are on treatment withfulvestrantand for two years after your last dose.

You must not breastfeed while on treatment withfulvestrant.

Driving and operating machinery

Fulvestrantis 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.

This medication contains 1000mg of alcohol (ethanol)in each dose of 2 x 5ml of injectable solution. The amount present in 2 x 5ml of this medication is equivalent to less than 20ml of beer or 8ml of wine.

The small amount of alcohol present in this medication has no appreciable effect.

This medication is harmful to people with alcoholism.

The alcohol content should be taken into account in high-risk groups, such as patients with liver disease, or epilepsy.

This medicationcontains 500mg of benzyl alcoholin each 5ml injection, which is equivalent to 100mg/ml. Benzyl alcohol may cause allergic reactions. Consult your doctor or pharmacist if you have any liver or kidney problems. You should do this because, if you receive large amounts of benzyl alcohol, these may accumulate in your body and cause adverse effects (known as «metabolic acidosis»).

This medication contains 750mg of benzoate of benzylin each 5ml injection, which is equivalent to 150mg/ml.

The recommended dose is 500mg of fulvestrant (two injections of 250mg/5ml) administered once a month, with an additional dose of 500mg two weeks after the initial dose.

Your doctor or nurse will administerfulvestrantvia a slow intramuscular injection in each of your buttocks.

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

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.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Inform your doctor immediately if you experience any of the following side effects, as you may need immediate medical treatment

:

• 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)*
• Liver inflammation (hepatitis)
• Liver failure

Inform your doctor, pharmacist, or nurse immediately if you notice any of the following side effects:

• Very common(may affect more than 1 in 10 people)

• 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
• Hot flashes
• Skin rash

All remaining side effects:

• Common(may affect up to 1 in 10 people)

• Headache
• Vomiting, diarrhea, or loss of appetite*
• Urinary tract infections
• Back pain*
• Increased bilirubin (a pigment produced by the liver)
• Decreased platelet count (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 walking or balance (peripheral neuropathy)

Rare(may affect up to 1 in 100 people)

• Thick, whitish vaginal discharge, and candidiasis (infection)
• Hematoma and bleeding at the injection site
• Increased gamma-GT, a liver enzyme identified in a blood test
• 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 that does not appear in this prospectus. You can also report them directly through the national notification system included in the Spanish System of 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.

Maintain this medication out of the sight and reach of children.

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.

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

Temperature deviations between 2 °C and 8 °C should be limited. This includes avoiding storage at temperatures above 25 °C, and not exceeding a period of 28 days in which the average storage temperature of the medication is below 25 °C (but above between 2 °C and 8 °C). After a temperature deviation occurs, the medication should be returned immediately to the recommended storage conditions (refrigerated storage and transport between 2 °C and 8 °C). Temperature deviations have an accumulative effect on the quality of the medication and should not exceed the period of 28 days during the 36-month validity period of fulvestrant injectable. Exposure to temperatures below 2 °C will not damage the medication 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 storage, use, and disposal of Fulvestrant Stadafarma 250 mg injectable solution in pre-filled syringe EFG.

This medication may pose a risk to aquatic environments. Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. Deposit the packaging and medications that you no longer need in the SIGRE collection point at the pharmacy. In this way, you will be helping to protect the environment.

Composition ofFulvestrantStadafarma

• The active ingredient is fulvestrant. Each pre-filled syringe (5 ml) contains 250 mg of fulvestrant. Each ml of solution contains 50 mg of fulvestrant.
• The other components (excipients) are ethanol (96 %), benzyl alcohol, benzyl benzoate, and refined ricin oil.

Appearance ofFulvestrantStadafarmaand contents of the package

Fulvestrant Stadafarma is a viscous, transparent, colorless to yellowish solution in a pre-filled syringe with a bromobutyl stopper, polystyrene plunger, and polypropylene cap containing 5 ml of injectable solution. To complete the recommended monthly dose of 500 mg, two syringes must be administered.

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

Only some sizes of packages may be commercially available.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer responsible

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

or

KeVaRo GROUP Ltd.

9 Tzaritza Elenora Str., office 23

Sofia 1618

Bulgaria

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

GermanyFulvestrant AL 250 mg Injektionslösung in einer Fertigspritze

ItalyFulvestrant EG STADA

HungaryFulmerak 250 mg oldatos injekcióeloretöltött fecskendoben

PortugalFulvestrant ELC

SpainFulvestrant STADAFARMA 250 mg solución inyectable en jeringa precargada EFG

Date of the last review of this leaflet:December 2023

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

This information is intended solely for healthcare professionals:

Fulvestrant500 mg (2 x 250 mg/5 ml injectable solution) must 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 barrel from the syringe 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 particles and discoloration.
• Hold the syringe in a vertical position by the ridged part (C). With the other hand,holdthe stopper (A) and turn it carefully in a counterclockwise direction until it comes loose and can be removed (see Figure1).

Figure 1

• Remove the stopper (A) by pulling it straight up. To maintain sterility, do not touch the tip of the syringe (B) (see Figure2).

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.

Figure 3

• Pull the protective cap of the needle straight up to avoid damaging the tip of the needle.
• Take the loaded syringe to the administration site.
• Remove the protective cap of the needle.
• Remove any excess gas from the syringe.
• Administer the solution intramuscularly slowly (1-2 minutes per injection) in the buttock (gluteal region). For greater user comfort, the orientation of the needle with the bevel up has the same orientation as the arm of the plunger (see Figure4).

Figure 4

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

NOTE: Activate the protection mechanism 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 medicinal product may pose a risk to aquatic environments. Any unused medicinal product or waste must be disposed of in accordance with local regulations.