Vepesid

PACKAGE LEAFLET

Package leaflet: information for the patient

VEPESID 50 mg soft capsules, 100 mg soft capsules

Etoposide
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist (see section 4).

Contents of this leaflet:

1. What VEPESID is and what it is used for
2. What you need to know before taking VEPESID
3. How to take VEPESID
4. Possible side effects
5. How to store VEPESID
6. Contents of the pack and other information

1. What VEPESID is and what it is used for

The name of this medicine is VEPESID. Each capsule contains 50 mg or 100 mg of etoposide as the active substance.
Etoposide belongs to a group of medicines called cytostatics, which are used in the treatment of tumors.
VEPESID is used in the treatment of certain types of tumors in adult patients:

• testicular cancer
• small cell lung carcinoma
• blood cancer (acute myeloid leukemia)
• tumors of the lymphatic system (Hodgkin lymphoma, non-Hodgkin lymphoma)
• ovarian cancer

The reason why VEPESID capsules have been prescribed for you should be discussed with your doctor.

2. What you need to know before taking VEPESID

Do not take VEPESID

• if you are allergic to etoposide, ethyl p-hydroxybenzoate sodium (E215), propyl p-hydroxybenzoate sodium (E217), or any of the other ingredients of this medicine (listed in section 6);
• if you have recently been administered a live vaccine, including the yellow fever vaccine;
• if you are breastfeeding or planning to breastfeed. If any of the above cases apply to you, or if you are unsure, consult your doctor for advice.

Warnings and precautions
Talk to your doctor or pharmacist before taking VEPESID:

• if you have any current infections;
• if you have recently undergone radiotherapy or chemotherapy;
• if you have low levels in the blood of a protein called albumin;
• if you have liver or kidney problems.

Effective cancer treatment can rapidly destroy large numbers of tumor cells. Very rarely, this may cause harmful amounts of substances derived from these tumor cells to be released into the bloodstream. In such cases, problems affecting the liver, kidneys, heart, or blood may occur, which could be fatal 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 certain blood cells, which could lead to infections or cause blood not to clot properly if you are cut. To ensure this does not happen, you will have blood tests before starting treatment and before each dose.
If you have impaired liver or kidney function, your doctor may decide to perform regular blood tests to monitor these functions.

Children and adolescents
The safety and efficacy of etoposide in pediatric patients have not been established.

Other medicines and VEPESID
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
This is particularly important:

• if you are taking a medicine called cyclosporine (a medicine used to reduce the activity of the immune system);
• if you are undergoing treatment with cisplatin (a medicine used to treat cancers);
• if you are taking phenytoin or other medicines for epilepsy;
• if you are taking warfarin (a medicine used to prevent blood clots);
• if you have recently received live vaccines;
• if you are taking phenylbutazone, sodium salicylate, or acetylsalicylic acid;
• if you are taking anthracyclines (a class of anticancer medicines);
• if you are taking any medicine with a mechanism of action similar to that of VEPESID.

Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
VEPESID must not be used during pregnancy unless clearly indicated by your doctor.
Breastfeeding is not allowed during treatment with VEPESID.
Male and female patients of reproductive age must use an effective contraceptive method (e.g., barrier method or condom) during treatment and for at least 6 months after the end of treatment with VEPESID.
Male patients receiving VEPESID are advised NOT to father a child during treatment and for 6 months after treatment ends. In addition, male patients are advised to seek counseling regarding sperm preservation before starting treatment.
Male and female patients who intend to have children after treatment with VEPESID should discuss this with their doctor or nursing staff.

Driving and using machines
No studies have been conducted on the effects of etoposide on the ability to drive vehicles or operate machinery. However, if you feel tired, nauseous, dizzy, or lightheaded, you should not drive or operate machinery until you have discussed this with your doctor.

VEPESID contains
VEPESID contains ethyl p-hydroxybenzoate sodium and propyl p-hydroxybenzoate sodium. These may cause allergic reactions (including delayed reactions).
This medicine contains less than 1 mmol (23 mg) of sodium per soft capsule, i.e., essentially “sodium-free”.

3. How to take VEPESID

Take this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Your dose will be individually adjusted and calculated by your doctor. The usual dose is 100 - 200
mg/m\² of body surface area per day for 5 consecutive days, or 200 mg/m\² administered on days 1, 3 and 5. The daily dose may sometimes be divided and taken in the morning and evening. The treatment cycle may be repeated based on blood test results, but at least 21 days should elapse from the start of the first cycle.
Sometimes an alternative dosage of 50 mg/m\² of body surface area is used, taken daily for 2 or 3 weeks. This treatment cycle may be repeated according to blood test results, but at least 7 days should elapse from the start of the first cycle.
Your doctor may sometimes prescribe a different dosage, particularly for patients with kidney problems.
The capsules must be taken with a glass of water on an empty stomach.
If you take more VEPESID than you should
If you take too many capsules, go immediately to the nearest emergency department or contact your doctor without delay. Take the empty container and any remaining capsules with you.
If you forget to take VEPESID
If you miss or forget to take a dose of this medicine, DO NOT WORRY. Take the next dose at the scheduled time. DO NOT take a double dose to make up for the missed dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Stop taking the medicine and inform your doctor immediately if you develop any of the following
symptoms: swelling of the tongue or throat, difficulty breathing, rapid heartbeat, skin redness or
skin irritation. These could be signs of a severe allergic reaction.
Sometimes serious liver, kidney or heart damage has occurred due to a condition called tumor lysis syndrome, caused by harmful amounts of substances released into the bloodstream from tumor cells, when patients have taken VEPESID together with other medicines to treat cancer.

Other side effects reported with VEPESID include:

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

• blood disorders (for this reason, blood tests will be performed between treatment cycles)
• loss of appetite
• changes in skin colour (pigmentation)
• constipation
• temporary hair loss
• feeling weak (asthenia)
• nausea and vomiting
• abdominal pain
• general malaise
• liver damage (hepatotoxicity)

Common side effects (may affect from 1 to 10 in 100 people)

• acute leukemia
• irregular heartbeat (arrhythmia) or heart attack (myocardial infarction)
• high blood pressure
• mouth, lip or throat ulcers
• dizziness
• diarrhoea
• skin problems such as itching or irritation

Uncommon side effects (may affect from 1 to 100 to 1 to 1,000 people)

• tingling or numbness in hands and feet

Rare side effects (may affect from 1 in 1,000 to 1 in 10,000 people)

• acid reflux
• temporary blindness
• redness
• severe skin and/or mucous membrane reactions
• difficulty swallowing, which may include painful blisters
• altered sense of taste
• severe skin reactions (Stevens-Johnson syndrome and toxic epidermal necrolysis)
• seizures
• fever
• drowsiness or fatigue
• breathing problems
• a sunburn-like irritation may occur on skin previously exposed to radiotherapy and may be severe (radiation recall dermatitis)

Not known (frequency cannot be estimated from available data)

• tumor lysis syndrome (complications due to substances released into the blood from tumor cells)
• bleeding
• infection (including infections observed in patients with weakened immune systems, for example, a lung infection called Pneumocystis jirovecii pneumonia)
• swelling of the face and tongue
• increased liver enzymes
• difficulty breathing
• infertility
• increased bilirubin
• allergic reactions (including delayed reactions; caused by parabens)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website:
Website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store VEPESID

Store below 25°C.
Keep in the original packaging.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and blister after EXP. The expiry date refers to the last day of that month.
Do not open any blister showing missing capsules.
As with any other antineoplastic medicine, care must be taken when handling VEPESID capsules. It is recommended to avoid direct contact with the capsules by wearing gloves and to wash hands thoroughly with soap and water after handling.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What VEPESID contains

• The active substance is etoposide. Each capsule contains 50 mg or 100 mg of etoposide.
• The other ingredients are: citric acid, anhydrous (E330), glycerol (85%) (E422), macrogol 400 (E1521) and water. The capsule shell contains gelatin (E441), glycerol (85%) (E422), iron oxide red (E172), ethyl p-hydroxybenzoate sodium (E215), propyl p-hydroxybenzoate sodium (E217) and titanium dioxide (E171).

Description of the appearance of VEPESID and contents of the pack
Opaque pink soft gelatin capsules.
50 mg capsules are supplied in 2 blisters of 10 soft gelatin capsules.
100 mg capsules are supplied in 1 blister of 10 soft gelatin capsules.
Not all pack sizes may be marketed.
MARKETING AUTHORISATION HOLDER AND
MANUFACTURER
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
This medicinal product is authorised in the European Economic Area Member States and in the United Kingdom (Northern Ireland) under the following names:
50 mg:

100 mg: