VEPESID 100 mg SOFT CAPSULES

2. What you need to know before you take Vepesid

Do not take Vepesid

• - if you are allergic to the active ingredient, sodium ethyl hydroxybenzoate (E-215), sodium propyl hydroxybenzoate (E-217), or any of the other ingredients of this medicine (listed in section 6).
• - if you have recently received a live vaccine, including the yellow fever vaccine.
• - if you are breastfeeding or plan to breastfeed.

If any of the above applies to you, or if you are not sure, consult your doctor, who will be able to advise you.

Warnings and precautions

Consult your doctor or pharmacist before starting treatment with Vepesid

• if you have any infection.
• if you have recently received radiotherapy or chemotherapy.
• if you have low levels of a protein called albumin in your blood.
• if you have liver or kidney problems.

Effective anticancer treatment can destroy cancer cells quickly and in large quantities. In very rare cases, this can lead to 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 life-threatening if not treated.

To prevent this, your doctor will need to perform regular blood tests to monitor the levels of these substances during treatment with this medicine.

This medicine may cause a reduction in the level of some blood cells, which could make you more likely to get infections or make it harder for your blood to clot if you cut yourself. To check that this is not happening, you will have blood tests at the start of treatment and before each dose you take.

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

Children and Adolescents

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

Other medicines and Vepesid

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

This is especially important

• if you are taking a medicine called ciclosporin (which is used to reduce the activity of the immune system).
• if you are receiving treatment with cisplatin (a medicine used to treat cancer).
• if you are taking phenytoin or any other medicine used for epilepsy.
• if you are taking warfarin (a medicine used to prevent blood clots).
• if you have recently received a live vaccine.
• if you are taking phenylbutazone, sodium salicylate, or acetylsalicylic acid.
• if you are taking any anthracycline (a group of medicines used to treat cancer).
• if you are taking any medicine with a similar mechanism of action to Vepesid.

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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

You should not breastfeed while taking Vepesid.

Patients of both sexes, men and women, of childbearing potential must use an effective method of contraception (e.g., barrier method or condom) during treatment and for at least 6 months after the end of treatment with Vepesid.

Male patients treated with Vepesid are advised not to father a child during treatment and for up to 6 months after treatment. Additionally, male patients are advised to seek advice on sperm preservation before starting treatment.

Patients of both sexes who plan to have a child after treatment with Vepesid should discuss this with their doctor or nurse.

Driving and Using Machines

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

Vepesid Contains

Vepesid may cause allergic reactions (possibly delayed) because it contains sodium ethyl hydroxybenzoate (E-215) and sodium propyl hydroxybenzoate (E-217).

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

3. How to Take Vepesid

Follow exactly the instructions for administration of this medicine given by your doctor or pharmacist. If you are unsure, 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, 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 evening. This treatment cycle may be repeated later based on the results of blood tests, but not within at least 21 days after the first treatment cycle.

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

In some cases, your doctor may prescribe a different dose, especially if you have kidney problems.

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

If you take more Vepesid than you should

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

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

If you forget to take Vepesid

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

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

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets 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 flushing, or rash. These could be signs of a severe allergic reaction.

Occasionally, severe liver, kidney, or heart damagehas been observed due to a disorder called tumor lysis syndrome, which is caused by the entry of harmful amounts of substances from cancer cells into the bloodstream when Vepesid is taken with other drugs used to treat cancer.

Other side effectsexperienced with Vepesid

Very common side effects(affecting more than 1 in 10 people)

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

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

• tingling or numbness in hands and feet

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

Frequency not known(cannot be estimated from the available data)

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet (see section 4). You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Vepesid

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

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date is the last day of the month stated.

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

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

As with all medicines used to treat cancer, it is necessary to handle Vepesid capsules and associated names with caution. You should avoid touching the capsules using gloves and wash your hands with water and soap after handling the medicine.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the SIGRE collection point at the pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the Pack and Other Information

Composition of Vepesid

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

Appearance of Vepesid and Contents of the Pack

Opaque pink soft capsules.

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

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

CHEPLAPHARM Arzneimittel GmbH

Ziegelhof 24

17489 Greifswald

Germany

Manufacturer

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) under the following names:

Germany: Vepesid K

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

United Kingdom (Northern Ireland): Etoposide

Date of the last revision of this leaflet: January 2024.

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