Patient Information Leaflet

Vepesid100mg Soft Capsules

Etoposide

Read this leaflet carefully before you start taking 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 or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet (see section 4)

The name of this medication is Vepesid. Each capsule contains 100mg of etoposide as the active ingredient.

Etoposide belongs to a group of medications called cytostatics that are used in the treatment of cancer.

Vepesid is used in the treatment of certain types of cancer in adults:

-testicular cancer

-small cell lung cancer

-blood cancer (acute myeloid leukemia)

-lymphatic system tumor (Hodgkin's lymphoma, non-Hodgkin's lymphoma)

-ovarian cancer

It is advisable to discuss with your doctor the exact reason why you have been prescribed Vepesid in capsules.

Do not take Vepesid

• -If you are allergic to the active ingredient, etil parahidroxibenzoato sódico (E-215), propil parahidroxibenzoato sódico (E-217), or any of the other components of this medication (listed in section 6).
• -If you have recently received a live virus vaccine, including the yellow fever vaccine.
• -If you are breastfeeding or plan to do so.

If any of the above applies to you, or if you are unsure, consult your doctor, who will be able to advise you.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Vepesid

-If you have anyinfection.

-If you have recently receivedradioterapia o quimioterapia.

-If you have low levels of a protein calledalbúminain your blood.

-If you have liver or kidney problems.

The effective anticancer treatment can destroy cancer cells quickly in large quantities. In very rare cases, this can cause the release of harmful amounts of these cancer cells into the blood. In this case, it can cause problems in the liver, kidney, heart, or blood, which could be fatal if not treated.

To prevent this, your doctor must perform regular blood tests to control the level of these substances during treatment with this medication.

This medication can cause a reduction in the level of some blood cells that could make you suffer from infections or prevent your blood from clotting as well as it should if you suffer any cuts. To check that this does not occur, you will have blood tests at the beginning of treatment and before each dose you take.

If you have reduced liver or kidney function, your doctor may also want to have regular blood tests to control these levels.

Children and adolescents

The safety and efficacy have not been established in pediatric patients.

Other medications and Vepesid

Inform your doctor if you are using, have used recently, or may use any other medication.

This is especially important

-If you are taking a medication called ciclosporina (which is used to reduce the activity of the immune system).

-If you are receiving treatment with cisplatino (a medication used to treat cancer).

-If you are taking phenytoin or any other medication used for epilepsy.

-If you are taking warfarin (a medication used to prevent blood clotting).

-If you have recently received any live virus vaccine.

-If you are taking phenylbutazone, sodium salicylate, or acetylsalicylic acid.

-If you are taking any anthracycline (a group of medications used to treat cancer).

-If you are taking any medication with a similar mechanism of action to Vepesid

Pregnancy, breastfeeding, and fertility

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

You should not use Vepesid during pregnancy unless your doctor clearly indicates it.

You should not breastfeed while taking Vepesid.

Both male and female patients of childbearing age should use an effective contraceptive method (e.g., barrier method or condom) during treatment and at least 6months after completing treatment with Vepesid.

Male patients treated with Vepesid are advised not to conceive any children during treatment and for at least 6months after treatment. Additionally, men are advised to seek advice on sperm conservation before starting treatment.

Both male and female patients who plan to have a child after treatment with Vepesid should discuss it with their doctor or nurse.

Driving and operating machinery:

No studies have been conducted on the effects on the ability to drive and operate machinery. However, if you are tired, have an upset stomach, feel dizzy or disoriented, do not do it until you have discussed it with your doctor.

Vepesid contains

Vepesid can cause allergic reactions (possibly delayed) because it contains etil parahidroxibenzoato sódico (E-215) and propil parahidroxibenzoato sódico (E-217).

This medication contains less than 1 mmol of sodium (23 mg) per soft capsule; it is essentially “sodium-free”.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The dose you receive will be specific to you and will be calculated by your doctor. The usual dose is between 100 and 200 mg/m² of body surface area, taken daily for 5 consecutive days, or 200 mg/m² of body surface area on days 1, 3, and 5. The daily dose may sometimes be divided to be taken in the morning and at night. This treatment cycle may be repeated as needed based on blood test results, but not within at least 21 days after the first treatment cycle.

Occasionally, an alternative administration of 50 mg/m² of body surface area is used, taken daily for 2 or 3 weeks. This treatment cycle may be repeated as needed based on blood test results, but not within at least 7 days after the first treatment cycle.

Your doctor may prescribe a different dose, especially if you have kidney problems.

The capsules should be taken with a glass of water and an empty stomach.

If you take more Vepesid than you should

If you take too many capsules, go to the nearest hospital emergency department or speak with your doctor immediately. Bring the empty packaging and any remaining capsules with you.

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone 91 562 04 20.

If you forget to take Vepesid

If you miss or forget a dose of this medication, DO NOT WORRY and take the next dose when it is due. DO NOT take a double dose to make up for the missed dose.

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

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

Stop taking the medicine and inform your doctor immediately if you experience any of the following symptoms: swelling of the tongue or throat, difficulty breathing, rapid heartbeat, skin redness, or rash. They could be signs of a severe allergic reaction.

On occasion, damage to the liver, kidneys, or heart has been observeddue to a condition called tumor lysis syndrome caused by the entry of harmful amounts of substances from cancer cells into the bloodstream when Vepesid is taken with other medications used to treat cancer.due to a condition called tumor lysis syndrome caused by the entry of harmful amounts of substances from cancer cells into the bloodstream when Vepesid is taken with other medications used to treat cancer.

Other side effectsexperienced with Vepesid

Frequent side effects(affecting more than 1 in 10 people)

Frequent side effects(affecting between 1 in 10 and 1 in 100 people)

Rare side effects(affecting between 1 in 100 and 1 in 1,000 people)

• tingling or numbness in the hands and feet

Very rare side effects(affecting between 1 in 1,000 and 1 in 10,000 people)

Unknown frequency(cannot be estimated from available data)

Reporting side effects

Ifyouexperience side effects, consult your doctor or pharmacist, even if they are possible side effects that do not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: htpps://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the box and the blister after CAD. The expiration date is the last day of the month indicated.

Do not store above 25 °C.Store in the original packaging.

Do not open any blister or bottle that shows signs of leakage of the capsule contents.

As with all medications used to treat cancer, it is necessary to exercise caution when handling Vepesid capsules and associated designations. You should avoid touching the capsules using gloves and wash your hands with water and soap after handling the medication.

Medications should not be disposed of through drains or trash. Deposit the containers and medications you do not need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you do not need. In this way, you will help protect the environment.

Composition of Vepesid

• The active ingredient is etoposide. Each capsule contains 100 mg of etoposide.
• The other components are: anhydrous citric acid (E330),glycerol (85 percent) (E422),macrogol 400(E1521)and water. The capsule body contains gelatin (E441), glycerol(85 percent) (E422), iron oxide red (E172),sodium p-hydroxybenzoate (E215), propyl p-hydroxybenzoate (E217) andtitanium dioxide (E171).

Appearance of Vepesid and content of the container

Opaque pink capsules, soft gelatin.

The 100mg capsules are presented in PVC/aluminum blisters, in containers of 10 soft gelatin capsules.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

CHEPLAPHARM Arzneimittel GmbH

Ziegelhof 24

17489 Greifswald

Germany

Responsible for manufacturing

Latina Pharma S.p.A.

Via del Murillo No. 7

04013 Sermoneta

Latina, Italy

Or

CHEPLAPHARM Arzneimittel GmbH

Ziegelhof 23-24

17489 Greifswald

Germany

Local representative

Laboratorios Rubió, S.A.

C/ Industria, 29 - Pol. Ind. Comte de Sert

08755 Castellbisbal (Barcelona)

Spain

This medicine is authorized in the member states of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names:

Germany: Vepesid K

Austria, Belgium, Estonia, Ireland, Italy, Netherlands, Luxembourg, Romania, Spain: Vepesid

United Kingdom (Northern Ireland): Etoposide

Last review date of this leaflet: January 2024.

“Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/”