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VEPESID SOFT CAPSULES 50MG

Active substance(s): ETOPOSIDE

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Package leaflet: Information for the patient

VEPESID™ 50 mg and 100 mg capsules, soft
Etoposide
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same
as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in 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

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1. What VEPESID is and what it is used for
The name of this medicine is VEPESID. Each capsule contains etoposide 50 mg or 100 mg as the active ingredient.
Etoposide belongs to the group of medicines called cytostatic which are used in the treatment of cancer.
VEPESID is used in the treatment of certain types of cancers in adults:
- testicular cancer
- small cell lung cancer
- cancer of the blood (acute myeloid leukaemia)
- tumour in the lymphatic system (Hodgkin’s lymphoma, non-Hodgkin’s lymphoma)
- ovarian cancer
The exact reason why you have been prescribed VEPESID capsules is best 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 Yellow fever vaccine.
• If you are breast-feeding or planning to breast-feed.
If any of the above affects you, or if you are unsure if they do, tell your doctor who will be able to advise you.
Warnings and precautions
Talk to your doctor or pharmacist before taking VEPESID
- if you have any infections.
- if you have had radiotherapy or chemotherapy recently.
- if you have low levels of a protein called albumin in your blood.
- if you have liver or kidney problems.
Effective anti-cancer treatment can destroy cancer cells rapidly in large numbers. On very rare occasions this may cause harmful amounts of
substances from these cancer cells to be released into the blood. If this happens it can cause problems with the liver, kidney, heart or blood,
which may result in death if not treated.
In order to prevent this, your doctor will need to do 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 could cause you to suffer from infections, or may mean that your
blood doesn’t clot as well as it should if you cut yourself. Blood tests will be taken at the start of your treatment, and before each dose you
take, to make sure that this isn’t happening.
If you have reduced liver or kidney function, your doctor may also want you to take regular blood tests to monitor these levels.
Children and adolescents
The safety and effectiveness in paediatric patients has 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 especially important:
• If you are taking a medicine called ciclosporin (a drug used to reduce the activity of the immune system).
• If you are being treated with cisplatin (a medicine used to treat cancer)
• If you are taking phenytoin or any other medicines used to treat epilepsy
• If you are taking warfarin (a medicine used to prevent blood clots from forming)
• If you have recently been given any live vaccines
• If you are taking phenylbutazone, sodium salicylate, or aspirin
• If you are taking any anthracyclines (a group of medicines used to treat cancer)
• If you are taking any drugs with a similar mechanism of action as VEPESID
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice
before taking this medicine.
VEPESID must not be used during pregnancy unless clearly indicated by your doctor.
You must not breastfeed while you are taking VEPESID.
Both male patients and female patients of child-bearing age should use an effective contraceptive method (e.g., the barrier method or condoms) 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. In addition, men
are advised to seek counselling on sperm preservation before starting treatment.
Both male and female patients who are considering having a child after having 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, sick to your stomach, dizzy
or light-headed you should not do so until you have discussed it with your doctor.

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3. How to take VEPESID
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The dose you receive will be specific to you, which the doctor will calculate. The usual dose is 100 to 200 mg/m2 body surface area, daily for 5
days in a row or 200 mg/m2 body surface area on days 1, 3 and 5. The daily dose may sometimes be split to be taken morning and evening.
This course of treatment may then be repeated, depending on the results of blood tests, but this will not be for at least 21 days after the first
course of treatment.
An alternative dosing of 50 mg/m2 body surface area taken each day for 2 to 3 weeks is sometimes used. This course of treatment may then
be repeated, depending on the results of blood tests, but this will not be for at least 7 days after the first course of treatment.
The doctor may sometimes prescribe a different dose particularly if you have kidney problems.
The capsules should 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 your nearest hospital emergency department or tell your doctor immediately. 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 – just 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 further questions on 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.

ARTWORK
PRODUCT CODE:

1241565A2

PRODUCT NAME:
INS Vepesid cap. 50/100mg

SEPARATIONS:

 BLACK

COUNTRY:
Gran Bretagna
ISSUE DATE

OPERATOR

25/10/17

RI001

DRAFT

02

BARCODE TYPE: 2/5
MEASURES (mm): 140x330 (140 x 165)
FONT TYPE: Arial WGL

PDF 1.5

CORDEN
PHARMA
Ra lized b y:

PACKAGING DE VE LOPMENT CENTER

premedia@eurpack.it

Stop taking the medicine and tell your doctor immediately if you get any of the following symptoms: swelling of your tongue or
throat, breathing difficulties, fast heartbeat, flushing of the skin or a rash. These may be signs of an allergic reaction.
Severe liver, kidney or heart damage from a condition called Tumour Lysis Syndrome, caused by harmful amounts of substances from the
cancer cells getting into the blood stream, has been seen sometimes when VEPESID is taken along with other drugs used to treat cancer.
Other side effects experienced with VEPESID that are;
Very common side effects (affecting more than 1 in 10 people)

• blood disorders (this is why you will be having blood
tests between courses of treatment)

• loss of appetite
• changes in skin colour (pigmentation)
• constipation
• feeling weak (asthenia)
• generally feeling unwell (malaise)
• damage to the liver (hepatotoxicity)

• temporary hair loss
• nausea and vomiting
• abdominal pain
Common side effects (affecting between 1 in 10 and 1 in 100 people)

• acute leukaemia
• irregular heart beat (arrhythmia), or a heart attack
(myocardial infarction)
• dizziness

• diarrhoea
• high blood pressure
• sore lips, mouth or throat ulcers
• skin problems such as itching or rash

Uncommon side effects (affecting between 1 in 100 and 1 in 1000 people)

• tingling or numbness in hands and feet
Rare side effects (affecting between 1 in 1,000 and 1 in 10,000 people)

• acid reflux
• flushing
• difficulty swallowing
• a change in the way things taste
• severe allergic reactions
• convulsions (seizure)
• fever
• sleepiness or tiredness
• breathing problems

• temporary blindness
• serious reactions of the skin and/or mucous
membranes which may include painful blisters and
fever, including extensive detachment of the skin
(Stevens-Johnson syndrome and toxic epidermal
necrolysis)
• a sunburn-like rash that may occur on skin that
has previously been exposed to radiotherapy and
can be severe (radiation recall dermatitis)

Not known (frequency cannot be estimated from the available data)

• tumour lysis syndrome (complications of substances released from
treated cancer cells entering the blood)
• infection
• face and tongue swelling
• infertility

• bleeding
• difficulty breathing
• increased liver enzymes
• increased bilirubin

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system (see details below). By reporting side effects you can help provide more information
on the safety of this medicine.
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
5. How to store VEPESID
Keep your medicines 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 refers to the last day of that
month.
Do not store above 25°C.
Store in the original package.
VEPESID capsules should not get too hot or damp; so do not leave your capsules near a radiator, on a window sill or in the bathroom.
Do not open any blister in which there is evidence of capsule leakage.
As with all medicines used to treat cancer, care must be taken when handling VEPESID capsules. You should avoid touching the capsules by
wearing gloves and wash your hands with soap and water after handling the medicine.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use.
These measures will help protect the environment.
6. Contents of the pack and other information
What VEPESID contains
- The active substance is etoposide. Each capsule contains 50 mg or 100 mg etoposide.
The other ingredients are: citric acid, anhydrous (E330), glycerol (85 per cent) (E422), macrogol 400 (E1521) and water. The capsule shell
contain gelatin (E441), glycerol (85 per cent) (E422), red iron oxide (E172), sodium ethyl parahydroxybenzoate (E215), sodium propyl parahydroxybenzoate (E217) and titanium dioxide (E171).
What VEPESID looks like and contents of the pack
Opaque, pink capsules, softgels.
The 50 mg capsules are supplied in blister packs of 20, 50 Capsules, softgels.
The 100 mg capsules are supplied in blister packs of 10, 60 Capsules, softgels.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Bristol-Myers Squibb Holdings Limited
t/a Bristol-Myers Pharmaceuticals
Uxbridge Business Park, Sanderson Road,
Uxbridge, Middlesex UB8 1DH, England.
Tel: 0800 7311736

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:
Denmark
Finland
Germany
Ireland
Italy
Netherlands
Norway
Romania
Spain
Sweden
United Kingdom

VEPESID
VEPESID
VEPESID K
VEPESID
VEPESID
VEPESID
VEPESID
VEPESID
VEPESID
VEPESID
VEPESID

Austria
Belgium
Croatia
Estonia
Germany
Ireland
Italy
Luxembourg
Netherlands
Romania
Slovenia
Spain
United Kingdom

VEPESID
VEPESID
VEPESID
VEPESID
VEPESID K
VEPESID
VEPESID
VEPESID
VEPESID
VEPESID
VEPESID
VEPESID
VEPESID

This leaflet was last revised in October 2017

1241565A2

ARTWORK
PRODUCT CODE:

1241565A2

PRODUCT NAME:
INS Vepesid cap. 50/100mg

SEPARATIONS:

 BLACK

COUNTRY:
Gran Bretagna
ISSUE DATE

OPERATOR

25/10/17

RI001

DRAFT

02

BARCODE TYPE: 2/5
MEASURES (mm): 140x330 (140 x 165)
FONT TYPE: Arial WGL

PDF 1.5

CORDEN
PHARMA
Ra lized b y:

PACKAGING DE VE LOPMENT CENTER

premedia@eurpack.it

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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