Vepesid Soft Capsules 50mg
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VEPESID™ SOFT CAPSULES 50 MG AND 100 MG
(Etoposide)
Please read this leaflet carefully before you take your medicine.
This leaflet provides a summary of the information available on your medicine. This medicine is for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
If you want to know more or are not sure, ask your doctor or pharmacist.
In this leaflet:
1. What Vepesid is and what it is used for
2. Before taking your medicine
3. Taking your medicine
4. Possible side effects
5. How to store your medicine
6. Further information
1. WHAT VEPESID IS AND WHAT IT IS USED FOR
The name of this medicine is Vepesid. Each capsule contains etoposide (either 50 or 100mg) as the active ingredient.
Etoposide belongs to the group of medicines called anti-neoplastic agents which are used in the treatment of cancer.
Vepesid is used in the treatment of certain types of cancer, in particular small cell lung cancer and testicular cancer.
The exact reason why you have been prescribed Vepesid Capsules is best discussed with your doctor.
2. BEFORE TAKING YOUR MEDICINE DO NOT take Vepesid if:
• you suffer from severe liver problems
• you have had an allergic reaction to a similar medicine or any of the ingredients in this medicine
• you are pregnant or planning to become pregnant or there is any possibility that you could become pregnant
• you are breast feeding
• you have any infections in any area of your body that your doctor does not know about
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.
Important Information
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 product contains propyl parahydroxybenzoate which may cause allergic reactions (possibly delayed).
Taking Vepesid with other medicines
Always tell your doctor about other medicines you are taking, or have recently taken, including those obtained without a prescription.
This is especially important if you are taking;
• A medicine called ciclosporin, as it may affect your treatment with etoposide.
Pregnancy and breastfeeding
If you are pregnant, planning to become pregnant or are breast feeding, you should speak to your doctor before using this product.
Driving or operating machinery
Vepesid capsules should not affect your ability to drive or operate machinery, however, if you feel dizzy or light-headed you should not do so until you have discussed it with your doctor.
Taking with food or drink
Vespid is not known to react with alcohol, however, you should speak to your doctor to find out if it is advisable for you to drink alcohol.
3. TAKING YOUR MEDICINE
Take Vepesid as your doctor has instructed. Your pharmacist may also help if you are not sure.
The dose you receive will be specific to you, which the doctor will calculate. The usual dose is 120-240mg/m2 body surface area, daily for 5 days in a row.
The doctor may sometimes prescribe a different dose.
The capsules should be taken with a glass of water on an empty stomach.
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.
If you take more Vepesid than you should
If you take too many tablets, 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 product, ask your Doctor or Pharmacist.
4. POSSIBLE SIDE EFFECTS
As with all medicines, Vepesid can cause unwanted side effects, although not everybody gets them.
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.
Possible side effects experienced with Vepesid are;
• blood disorders (this is why you will be having blood tests between courses of treatment)
• temporary hair loss
• nausea and vomiting
• abdominal pain
• loss of appetite
• diarrhoea
• acid reflux
• difficulty swallowing
• high or low blood pressure
• skin problems such as itching, rash and pigmentation
• flushing
• sore mouth
• after taste
• fever
• sleepiness or tiredness
• tingling or numbness in hands and feet
• breathing problems
• temporary blindness
Rare Side Effects
Leukaemia has been reported in patients treated with Vepesid together with other antineoplastic drugs.
Very Rare Side Effects
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.
If you notice any of these or any other side effects, during or after your treatment has finished, tell your doctor or pharmacist.
5. HOW TO STORE YOUR MEDICINE
Keep your medicines out of the reach and sight of children.
Do not store Vepesid capsules above 25°C
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.
Please check the expiry date of the product, shown on the blister strip and the outer packaging after EXP. The expiry date refers to the last day of that month. Do not use after the month stated.
Do not open any blister in which there is evidence of capsule leakage.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION What Vepesid contains
Each soft capsule contains etoposide (either 50mg or 100mg) as the active ingredient. In addition, Vepesid capsules contain the following ingredients: citric acid, glycerol, macrogol 400 and water; capsules containing gelatin, glycerol, iron oxide (E172), sodium hydroxybenzoic acid ethyl ester, sodium propyl parahydroxybenzoate (E217), titanium dioxide (E171) and water.
What Vepesid looks like and contents of the pack
Vepesid capsules are opaque pink, soft gelatin capsules.
The 50mg capsules are packed in cartons of 20 capsules and the 100mg capsules are packed in cartons of 10 capsules.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
UK.
Bristol-Myers Squibb Holdings Limited t/a Bristol-Myers Pharmaceuticals Uxbridge Business Park, Sanderson Road,
Uxbridge, Middlesex UB8 1DH, England.
Tel: 0800 7311736
Ireland
Bristol-Myers Squibb Holdings Limited t/a Bristol-Myers Pharmaceuticals Swords,
County Dublin,
Ireland.
Tel: 1 800 749 749 Manufacturer
Corden Pharma Latina S.p.A.
Via del Murillo Km 2.800 04013 Sermoneta Latina, Italy