VEPESID 50 mg Soft Capsule

Зміст інструкції

1. VEPESID 50 mg soft capsules, 100 mg soft capsules
   1. What VEPESID is and what it is used for
   2. What you need to know before you take VEPESID
   3. How to take VEPESID
   4. Possible side effects
   5. How to store VEPESID
   6. Contents of the pack and other information

VEPESID 50 mg soft capsules, 100 mg soft capsules

Etoposide

Read this leaflet carefully before you start taking this medicine as it contains important
information for you.

• Keep this leaflet. 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 pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you get any side effects, even if not listed in this leaflet, tell 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 you take 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 that are used in the treatment of
tumours.
VEPESID is used in the treatment of some types of tumours in adult patients:

• testicular cancer
• small cell lung carcinoma
• blood cancer (acute myeloid leukaemia)
• tumours of the lymphatic system (Hodgkin's lymphoma, non-Hodgkin's lymphoma)
• ovarian cancer The reason why VEPESID capsules have been prescribed to you should be discussed with your doctor.

2. What you need to know before you take VEPESID

Do not take VEPESID

• if you are allergic to etoposide or any of the other ingredients of this medicine (listed in section 6);
• if you have recently been given a live vaccine, including the yellow fever vaccine;
• if you are breastfeeding or plan to breastfeed. If any of the above apply to you, or if you are not sure, talk to your doctor who will advise you.

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

• if you have ongoing infections;
• if you have recently undergone radiotherapy or chemotherapy;
• if you have low levels in your blood of a protein called albumin;
• if you have problems with your liver or kidneys.

Effective cancer treatment can destroy cancer cells quickly and in large numbers.
Very rarely, this can cause harmful amounts of substances released into the blood
from these cancer cells. In this case, problems with the liver, kidneys, heart or blood may occur,
which can be fatal if not treated.
To avoid this, your doctor will need to perform regular blood tests to monitor the level of these
substances during treatment with this medicine.
This medicine can cause a reduction in the level of some blood cells, which may lead to
infections, or cause the blood not to clot as it should if you cut yourself. To be sure this
does not happen, you will have blood tests before starting treatment and before taking
each dose.
If you have reduced liver or kidney function, your doctor may decide to perform regular blood tests to monitor these functions.

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

Other medicines and VEPESID
Tell 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 therapy based on cisplatin (a medicine used to treat tumors);
• 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 been given 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 are pregnant, are planning to become pregnant or are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
VEPESID should not be used during pregnancy unless clearly indicated by your doctor.
Breastfeeding is not permitted during the intake of VEPESID.
Male and female patients of childbearing potential must use effective contraception ( e.g.,barrier method or condom) during and for at least 6 months after the end of treatment with
VEPESID.
Male patients undergoing treatment with VEPESID are advised NOT to father children during the
treatment and for 6 months after the end of treatment. In addition, male patients are advised to
seek advice on 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 and operate
machinery. However, if you feel tired, nauseous, dizzy or lightheaded, do not
drive vehicles or operate machinery before talking to your doctor.

VEPESID contains
VEPESID contains ethyl p-hydroxybenzoate sodium and propyl p-hydroxybenzoate sodium. These may
cause allergic reactions (including delayed reactions).

3. How to take VEPESID

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, ask your doctor or pharmacist.
The dose you will receive is personalized and will be calculated by your doctor. The usual dose is 100 - 200 mg/m of
body surface area per day for 5 days in a row or 200 mg/m of body surface area to be
administered on days 1, 3 and 5. The daily dose can sometimes be divided to be taken in the morning and
in the evening. The treatment cycle can be repeated based on the results of blood tests, but at least 21 days must be waited from the first treatment cycle.
Sometimes an alternative dosage of 50 mg/m of body surface area is used, which is taken every
day for 2 or 3 weeks. This treatment cycle can be repeated based on the results of blood tests, but at least 7 days must be waited from the first treatment cycle.
Your doctor may sometimes prescribe a different dosage, especially for those 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 to the nearest emergency room or inform your doctor
immediately. Bring with you the empty container and any remaining capsules.

If you forget to take VEPESID
If you skip or forget to take a dose of this medicine, DO NOT WORRY. Take the next dose
at the right time. DO NOT take a double dose to make up for a missed dose.
If you have any doubts 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 everyone will experience them.

Stop taking the medicine and inform your doctor immediately if you develop any of these symptoms: swelling of the tongue or throat, difficulty breathing, rapid heartbeat, redness of the skin or skin irritation. These could be signs of a serious allergic reaction.
Serious liver, kidney, or heart damage has sometimes been reported due to a condition called tumor lysis syndrome, due to harmful substances released into the bloodstream from cancer cells, when the patient has taken VEPESID together with other medicines to treat cancer.

Other side effectsreported with VEPESID are;

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

• loss of appetite
• changes in skin color (pigmentation)
• constipation
• temporary hair loss - feeling of weakness (asthenia)
• nausea and vomiting - general malaise
• abdominal pain - liver damage (hepatotoxicity)

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

• blood disorders (for this reason, blood tests will be performed between treatment cycles)
• acute leukemia - diarrhea
• irregular heartbeat (arrhythmia) or heart attack (myocardial infarction)
• high blood pressure
• ulcers on the lips, mouth or throat
• dizziness - skin problems such as itching or irritation

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

• tingling or numbness in the hands and feet

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

• acid reflux - temporary blindness
• flushing
• difficulty swallowing
• altered sense of taste
• severe allergic reactions
• convulsions
• serious skin and/or mucous membrane reactions that may include painful blisters and fever, as well as extensive skin detachment (Stevens-Johnson syndrome and toxic epidermal necrolysis)
• 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 based on available data)

• tumor lysis syndrome (complications due to substances released into the blood from cancer cells)
• bleeding
• infection - difficulty breathing
• swelling of the face and tongue - increased liver enzymes
• infertility - increased bilirubin

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at http://www.agenziafarmaco.gov.it/content/come-segnalare-una-
sospetta-reazione-avversa .
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store VEPESID

Store at a temperature below 25°C.
Keep in the original package.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is reported on the package and on the blister after SCAD.
The expiry date refers to the last day of that month.
Do not open any blister that shows a leakage of capsules.
As with any other antineoplastic medicine, care must be taken when handling the
capsules of VEPESID. Avoid touching the capsules by wearing gloves and wash your hands with water
and soap after handling.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What VEPESID contains

• The active ingredient 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), red iron oxide (E172), ethyl p-hydroxybenzoate (E215), propyl p-hydroxybenzoate (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:
Corden Pharma Latina S.p.a.
Via del Murillo Km 2.800
04013 Sermoneta
Latina, Italy

This medicinal product is authorised in the Member States of the EEA under the following names:
50 mg:

100 mg: