Sibudel 250 mg solucion inyectable en jeringa precargada efg

Prospecto:Information for the User

Sibudel 250 mg injectable solution in pre-filled syringe EFG

Fulvestrant

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

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult yourdoctor,pharmacistor nurse.

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

• If you experience any adverse effects,consult your doctor, pharmacist or nurse,evenif they do not appear in this prospectus. See section 4.

1.What is Sibudel and what is it used for

2.What you need to know before starting to use Sibudel

3.How to use Sibudel

4.Possible adverse effects

5.Storage of Sibudel

6.Contents of the package and additional information

Sibudelcontains 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.

Sibudelis used:

• alone, to treat 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 estrogen receptor-positive breast cancer, 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.

Fulvestrant may 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 useSibudel:

• 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 (see section “Pregnancy and breastfeeding”)
• if you have severe liver problems

Warnings and precautions

Consult your doctor,pharmacist or nurse before starting to useSibudelif 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 (see section “Sibudelcontains ethanol 96% (alcohol)”).

Fulvestrant (as monotherapy or in combination with palbociclib) has not been studied for efficacy and safety in patients with critical visceral disease.

Children and adolescents

Sibudelis not indicated for children and adolescents under 18 years.

Use of Sibudelwithother medications

Inform your doctor or pharmacist if you aretaking, havetakenrecentlyor may need to take any other medication.

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

Pregnancy andlactation

Do not useSibudelif you are pregnant. If you can become pregnant, use an effective contraceptive method while you are being treated withSibudeland for 2 years after your last dose.

Do not breastfeed while being treated withSibudel.

Driving and operating machinery

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

Sibudelcontains ethanol 96% (alcohol)

This medication contains 474 mg of alcohol (ethanol) in each pre-filled syringe of 5 ml, which corresponds to 94.8 mg/ml. The amount in a 10 ml dose of this medication is equivalent to less than 24 ml of beer or 10 ml of wine.

The small amount of alcohol in this medication will have no notable effect.

Sibudelcontains benzyl alcohol

This medication contains 500 mg of benzyl alcohol in each pre-filled syringe of 5 ml, equivalent to 100 mg per ml.

Benzyl alcohol may cause allergic reactions.

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

Sibudelcontains benzyl benzoate

This medication contains 750 mg of benzyl benzoate in each pre-filled syringe of 5 ml, equivalent to 150 mg per 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 administerSibudelvia 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.

Like all medicines, this medicine can 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 signs of anaphylactic reactions
• thromboembolism (increased risk of blood clots)*
• inflammation of the liver (hepatitis)
• liver failure.

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

Side effects reported in patients treated with fulvestrant monotherapy:

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

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).
• thromboembolism (increased risk of blood clots)*
• 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)

Uncommon: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
• inflammation of the liver (hepatitis)
• liver failure
• numbness, tingling, and pain
• anaphylactic reactions

*Includes side effects for which the exact role ofSibudelcannot be evaluated due to underlying disease.

Side effects reported in patients treated with fulvestrant in combination with palbociclib:

Very common:may affect more than 1 in 10 people

• decreased neutrophil count (neutropenia)
• decreased white blood cell count (leucopenia)
• infections
• fatigue
• nausea
• reduced red blood cell count (anemia)
• inflammation or ulceration of the mouth
• diarrhea
• decreased platelet count (thrombocytopenia)
• vomiting
• hair loss
• skin rash
• loss of appetite
• fever

Common:may affect up to 1 in 10 people

• feeling of weakness
• increased levels of liver enzymes
• loss of taste
• nasal bleeding
• excessively watery eyes
• dry skin
• blurred vision
• dry eyes

Uncommon:may affect up to 1 in 100 people

fever with other signs of infection (neutropenic fever).

Reporting of 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 leaflet. You can also report them directly through theSpanish System for the Pharmacovigilance of Medicines for Human Use: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 onthecontainer or on the labels of the syringesafter CAD. The expiration date is the last day of the month indicated.

Do not usethis medicationif you observe particles or discoloration before administration.

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

Temperature deviations outside the range of between 2°C and 8°C must be controlled. This includes avoiding storage at temperatures above 25°C, and not exceeding a period of 28 days, during which the average storage temperature of the medication is below 25°C (but above between 2°C and 8°C). After temperature deviations, the medication must be returned immediately to the recommended storage conditions (store and transport in a refrigerator 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 beyond the duration of the expiration date of 2 years ofSibudel. 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 conservation, use, and disposal ofSibudel.

This medication may pose a risk to aquatic environments. Medications should not be disposed of through drains or in the trash.Deposit the containers and medications that you no longer need at the SIGRE point of your pharmacy.In case of doubt,please ask your pharmacisthow to dispose ofthecontainers and medications that you no longerneed. By doing so, you will help protect the environment.

Composition of Sibudel

• The active ingredient is fulvestrant. Each pre-filled syringe 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 of the product and contents of the pack

Sibudel is a viscous, clear, colourless to yellow solution in a pre-filled syringe equipped with a Luer-Lock connector containing 5 ml of injectable solution. Two syringes should be administered to receive the recommended monthly dose of 500 mg.

Sibudel presents 2 formats:

• 1 pack containing 1 pre-filled glass syringe and 1 safety needle for connection with the syringe body.

• 1 pack containing 2 pre-filled glass syringes and 2 safety needles for connection with the syringe body are also provided.

Only some pack sizes may be marketed.

Marketing authorisation holder and manufacturer responsible

Marketing authorisation holder

Teva Pharma, S.L.U.

C/ Anabel Segura, 11. Edificio Albatros B, 1st floor

28108 Alcobendas, Madrid

Spain

Manufacturer responsible

Pliva Croatia Ltd.

Prilaz baruna Filipovica 25

10000 Zagreb

Croatia

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

Germany:Fulvestrant AbZ 250 mg Injection Solution in a Pre-filled Syringe

Spain:Sibudel 250 mg injectable solution in pre-filled syringe EFG

Date of the last review of thisleaflet: January 2021

The detailed information on 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:

Sibudel 500 mg (2 x 250 mg/5 ml injectable solution) should be administered using two pre-filled syringes(see section 3).

Administration instructions

Administer the injection according to local guidelines for the intramuscular injection of large volumes.

NOTE: Due to the proximity of the sciatic nerve, caution should be exercised if Sibudel is injected in the dorsogluteal area (see section 4.4).

Warning- DO NOT sterilize the safety needle in an autoclave before use. Hands should remain behind the needle at all times during use and disposal.

For each of the two syringes:

Disposal

The pre-filled syringes areonlyfor single use.

This medicinal product may pose a risk to aquatic environments. The disposal of unused medicinal product and all materials that have come into contact with it will be carried out in accordance with local regulations.