What Vepesid is and what it is used for
The name of this medicine is Vepesid. Each capsule contains the active substance etoposide 50 mg.
Etoposide belongs to a group of medicines called cytostatics, which are used to treat cancer.
Vepesid is used in the treatment of certain types of cancer in adults:
– testicular cancer
– small cell lung cancer
– cancer of the blood ( acute myeloid leukemia )
– tumor of 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.
Etoposide contained in Vepesid may also be approved to treat other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before taking Vepesid
Do not take Vepesid:
- If you are allergic to etoposide, sodium ethyl parahydroxybenzoate (E215), sodium propyl parahydroxybenzoate (E217), or any of the other ingredients of this medicine (listed in section 6)
- If you have recently been vaccinated with 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 if it applies to you, consult your doctor.
Warnings and precautions
Talk to your doctor or pharmacist before using Vepesid
- if you have any infection you.
- if you have received 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 treatment against cancer can rapidly destroy cancer cells on a large scale. In very rare cases, this can cause harmful amounts of substances from these cancer cells to be released into the blood. If this occurs, it can cause liver, kidney, heart, or blood problems and lead to death if left untreated.
To prevent this, your doctor needs to take regular blood tests to monitor the level of these substances during treatment with this medicine.
This medicine can cause a decrease in certain blood cells which can lead to you getting an infection or it could mean that your blood doesn’t clot as well if you were to cut yourself. Blood samples will be taken at the start of your treatment and before each dose you take to check that this does not happen.
If you have impaired liver or kidney function, your doctor may also want to take regular blood tests to monitor your liver and kidney function.
Children and young people
Safety and efficacy in children 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 ciclosporin (a medicine 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 other medicines used to treat epilepsy.
- if you are taking warfarin (a medicine that prevents blood clots from forming).
- if you have recently been vaccinated with any live vaccines.
- if you are taking phenylbutazone, sodium salicylate, or acetylsalicylic acid.
- if you are taking any anthracyclines (a group of medicines used to treat cancer).
- if you are taking any medicines that have 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 using this medicine.
Vepesid must not be used during pregnancy unless your doctor considers it necessary.
You must not breastfeed while taking Vepesid.
Both male patients and female patients of childbearing potential must use effective contraception (eg, a barrier method or condom) during treatment and up to 6 months after stopping treatment with Vepesid.
Men treated with Vepesid are advised not to make a woman pregnant during treatment and for up to 6 months after treatment. Men are also advised to obtain information about the possibility of conserving sperm before the treatment.
Both male and female patients who are considering having children after treatment with Vepesid should discuss this with a doctor or nurse.
Driving ability and use of machinery
Effects on the ability to drive or use machines have not been studied. If you feel tired, unwell, dizzy, or faint, do not drive or use machines until you have discussed this with your doctor.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.
Vepesid contains
Vepesid contains sodium ethyl parahydroxybenzoate and sodium propyl parahydroxybenzoate. These substances can cause allergic reactions (possibly delayed).
This medicine contains less than 1 mmol (23 mg) of sodium per soft capsule, i.e. it is almost “sodium-free”.
How to take Vepesid
Always use this medicine as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
The dose you receive will be tailored to you and calculated by your doctor. The usual dose is 100 to 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 of one can sometimes be divided to be taken in the morning and the evening. This course of treatment can then be repeated depending on the results of the blood tests, but this will not happen until at least 21 days after the first course of treatment.
An alternative dosage of 50 mg/m 2 body surface area taken daily for 2 to 3 weeks is sometimes used. This course of treatment can then be repeated depending on the results of the blood tests, but this will not happen until at least 7 days after the first course of treatment.
The doctor can sometimes prescribe a different dose, especially if you have kidney problems.
The capsules should be taken with a glass of water on an empty stomach.
If you have taken too much Vepesid
If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice. Take the packaging and any remaining capsules with you.
If you forget to take Vepesid
If you miss or forget to take a dose of this medicine, DON’T WORRY – just take the next dose when it is due. DO NOT take a double dose to make up for a missed dose.
If you have any further questions about this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking the medicine and contact your doctor immediately if you experience any of the following symptoms: swollen tongue or throat, difficulty breathing, fast heart rate, flushing, or rash. These can be signs of a serious allergic reaction.
Serious liver, kidney, or heart damage from a condition called tumor lysis syndrome, which is caused by harmful amounts of substances from the cancer cells entering the bloodstream, has sometimes been seen when Vepesid is taken with other medicines to treat cancer.
Other side effects that can be experienced with Vepesid are;
Very common side effects ( affects more than 1 in 10 users)
| blood effects (this is why you will have blood samples taken between treatment courses)temporary hair loss nausea and vomiting abdominal pain | loss of appetite change in skin color ( pigmentation )constipationweakness ( asthenia )general malaiseliver damage (hepatotoxicity) |
Common side effects ( affects up to 1 in 10 users)
| acute leukemiairregular heart rhythm ( arrhythmia ) or a heart attack (myocardial infarction)dizziness | diarrhea high blood pressure sore lips, sores in the mouth, or throat skin problems such as itching or rashes |
Uncommon side effects ( affects up to 1 in 100 users)
| tingling or loss of feeling in the hands and feet |
Rare side effects ( affects up to 1 in 1,000 users)
| acid refluxrednessdifficulty swallowing change in how things taste severe allergic reactionsconvulsionsfeversleepiness or tirednessbreathing problems | temporary blindnessserious skin and/or mucous membrane reactions which may include painful blisters and fever, including widespread skin shedding (Steven-Johnson syndrome and toxic epidermal necrolysis )a rash that resembles a sunburn and that can appear on the skin where you have previously received radiation treatment (“radiation recall” dermatitis ), this can be serious |
Has been reported (occurring in an unknown number of users)
| tumor lysis syndrome (complications of substances released from cancer cells entering the bloodstream)infection swelling of the face and tongueinfertilityallergic reactions (possibly delayed; caused by parabens) | bleeding breathing difficulties elevated liver enzymes elevated bilirubin |
How Vepesid should be stored
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the carton and blister card after “EXP”. The expiration date is the last day of the specified month.
Store at a maximum of 25 °C. Store in the original packaging.
Do not open any blister card where 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 washing your hands with soap and water after handling the medicine.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is etoposide.
- Other ingredients are anhydrous citric acid (E330), glycerol (85%) (E422), macrogol 400 (E1521), and purified water. The capsule shell contains gelatin (E441), glycerol (85%) (E422), red iron oxide (E172), sodium ethyl parahydroxybenzoate (E215), sodium propyl parahydroxybenzoate (E217) and titanium dioxide (E171).
Appearance and package sizes of the medicine
Capsules with Vepesid are pale pink, soft gelatin capsules.
Vepesid capsules are supplied in blister cards in an outer carton. Package size: 20 tablets.
Marketing Authorisation Holder
CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 24
17489 Greifswald
Germany
Manufacturer
Corden Pharma Latina SpA
Via del Murillo No. 7
04013 Sermoneta
Latina, Italy
CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 23-24
17489 Greifswald
Germany
This medicine is approved in the European Economic Area under the names:
50mg:
| Finland | VEPESID |
| Germany | VEPESID K |
| Ireland | VEPESID |
| Italy | VEPESID |
| Netherlands | VEPESID |
| Norway | VEPESID |
| Romania | VEPESID |
| Spain | VEPESID |
| Sweden | VEPESID |
| UK | VEPESID |