Carboplatin 10 Mg/Ml Concentrate For Solution For Infusion
PACKAGE LEAFLET: INFORMATION FOR THE USER Carboplatin 10 mg/ml Concentrate for Solution for Infusion
Carboplatin
Read all of this leaflet carefully before you start taking this medicine.
• 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Carboplatin is and what it is used for.
2. Before you are given Carboplatin.
3. How Carboplatin will be used.
4. Possible side effects.
5. How to store Carboplatin.
6. Further information.
1. WHAT CARBOPLATIN IS AND WHAT IT IS USED FOR
Carboplatin belongs to a group of medicines known as platinum compounds, which are used to treat cancer. Carboplatin is used against advanced cancer of the ovary and small cell cancer of the lung.
2. BEFORE YOU ARE GIVEN CARBOPLATIN
Do not use Carboplatin
- if you are allergic (hypersensitive) to carboplatin
- if you are allergic to another drug that belongs to the group of platinum containing compound
- if you have severe problems with your kidneys
- if you have an imbalance of your blood cells (severe myelosuppression)
- if you have a tumour that bleeds
- if you are pregnant, trying to get pregnant or breast feeding
If any of these apply to you and you have not already discussed this with your doctor or nurse, you should do so as soon as possible and before receiving an infusion.
Carboplatin is usually given to patients in hospital. Normally you should not handle this medicine. Your doctor or nurse will administer the medicine and will carefully and frequently monitor you during and after treatment. You will normally have blood tests before each administration.
Take special care with Carboplatin
• If your kidneys are not working properly the effects of carboplatin on the blood (haematopoietic system) are increased and prolonged compared to patients with normal kidney function. Your doctor will want to monitor you more regularly if your kidneys are not working properly.
• Carboplatin can cause serious allergic reactions (difficulty in breathing and dizziness), especially if you had previously received a platinum medicine.
• Carboplatin may cause severe depression of your bone marrow and a decrease of blood cells. This is more pronounced if you are also receiving other myelosuppressive medicines or your kidneys are not working properly.
• Carboplatin may cause severe sickness and you may receive premedication with anti-emetics to reduce this side effect.
• Carboplatin may cause abnormalities in your nervous system, such as pins and needles or hearing problems, especially if you have received platinum treatments in the past. Your doctor may regularly assess you.
If any of these apply to you and you have not already discussed this with your doctor or nurse, you should do as soon as possible and before receiving Carboplatin.
Using other medicines
You should tell your doctor or nurse if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
You should tell your doctor if you are taking any of the following medicines as they may interact with Carboplatin.
- other medicines that are known to affect blood cell formation in the bone marrow
- other medicines that are known to be toxic to your kidneys (e.g. aminoglycosides antibiotics)
- other medicines that are known to damage the hearing or balance functions of the ear (e.g. aminoglycosides antibiotics; furosemide [used to treat heart failure and oedema])
- chelating agents (substances binding to carboplatin thereby decreasing the effect of carboplatin)
- phenytoin ( used to treat epilepsy)
- warfarin (used to prevent the formation of blood clots).
Pregnancy and breast-feeding
Tell your doctor if you are trying to become pregnant, are already pregnant, or are breast-feeding before being treated with Carboplatin. If any of these apply to you and you have not already discussed this with your doctor or nurse, you should do as soon as possible and before receiving Carboplatin.
Pregnancy
You must not be treated with Carboplatin during pregnancy unless clearly indicated by your doctor. Animal studies have shown a possible risk of abnormalities in the developing foetus. If you are being treated with carboplatin whilst pregnant, you should discuss with your doctor the possible risk of effects on your unborn child. Women of child bearing potential must use an effective method of contraception both before and during treatment with carboplatin. Since carboplatin can cause genetic damage, if pregnancy occurs during treatment with carboplatin, genetic counselling is recommended.
Genetic counselling is also recommended for patients wishing to have children after treatment with Carboplatin.
Breast-feeding
It is not known whether carboplatin is excreted into the breast milk. Therefore, during treatment with Carboplatin you should discontinue breast-feeding.
Fertility
Carboplatin can cause genetic damage. Women of childbearing potential should be advised to avoid becoming pregnant by using effective contraception before and during treatment. For women who are pregnant or become pregnant during therapy, genetic counselling should be provided.
Men treated with carboplatin are advised not to father a child during, and up to 6 months after treatment. Advice on conservation of sperm should be sought prior to treatment because of the possibility of irreversible infertility.
Ask your doctor or nurse for advice before using any medicine.
Driving and using machines
Carboplatin does not affect your ability to drive and use machines. However you should take extra care when you are first given carboplatin, especially if you feel dizzy or unwell.
3. HOW CARBOPLATIN WILL BE USED
Carboplatin will always be administered by nurse or doctor.
It is usually given in a drip by slow injection into a vein and will usually take between 15 and 60 minutes to be administered. If you require any further information, ask your doctor or nurse. Carboplatin will be given by a doctor experienced in the use of cancer treatment.
Your dose will be dependent on your height and weight, function of your blood system and your kidney function.
Your doctor will choose the best dose for you. Carboplatin will be diluted before use.
Adult
The usual dose is 400 mg/m2 of your body surface area (calculated from your height and weight).
Elderly
The usual adult doses may be used although the doctor may choose to use a different dose.
Kidney problems
The amount given may vary, according to how well your kidneys are working. If you suffer from kidney problems your doctor may reduce the dose and may perform frequent blood tests as well as monitoring your kidney function.
Children
There has not been enough usage of carboplatin in children to allow the recommendation of specific dose.
You may feel sick while you are being treated with Carboplatin. Your doctor may give you another medicine to reduce these effects before you are treated with Carboplatin.
There will be usual gap of 4 weeks between each dose of Carboplatin. Your doctor will want to perform some blood tests each week after giving you Carboplatin. So he/she can decide on the correct next dosage for you. You may receive Carboplatin in combination with other medicines and your dose may be adjusted.
If you receive more Carboplatin than you should
It is unlikely that you will be given too much carboplatin. However in the event that this occurs you may have some problems with your kidneys. If you are worried that too much has been administered or you have any questions about the dose being given you should talk to the doctor.
If you miss a dose of Carboplatin
It is very unlikely that you will miss a dose of your medicine, as your doctor will have instructions on when to give it to you. If you think you have missed a dose please talk to your doctor.
If you stop using Carboplatin
Do not stop treatment before talking to your doctor. If you have any further question on the use of this product ask your doctor or nurse.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Carboplatin can have side effects, although not everybody gets them.
Tell your doctor immediately if you notice any of the following:
- abnormal bruising, bleeding, or signs of infection such as a sore throat and high temperature
- severe itching of the skin (with raised lumps) or swelling of the face, lips, tongue and/or throat, which may cause difficulty in swallowing or breathing (angio-oedema)
- stomatitis/mucositis (e.g. sore lips or mouth ulcers).
Other side effects:
If any of the following side effects gets serious, please tell your doctor or nurse.
Very common side effects (affects more than 1 user in 10)
- changes in your red and white blood cells and platelets (myelosuppression). Your doctor may want to monitor you.
- anaemia (a condition in which there is a decreased number of red blood cells which lead to tiredness)
- increase in the level of the creatinine and urea in your blood. Your doctor may want to monitor you.
- slight loss of hearing
- abnormal liver enzymes levels. Your doctor may want to monitor you.
- increased uric acid levels in your blood which may lead to gout
- feeling or being sick
- abdominal pain and cramp
- unusual feelings of tiredness or weakness
- decrease in the level of salts in your blood. Your doctor may want to monitor you.
- damage to the kidneys (renal toxicity)
Common side effects (affects 1 to 10 users in 100)
- unusual bruising or bleeding (haemorrhagic complications)
- reduced function of your kidneys
- diarrhoea, constipation, sore lips or mouth ulcers (mucositis)
- allergic reactions including rash, urticaria, skin reddening, itching, high temperature
- ringing in the ears (tinnitus), hearing impairment and hearing loss
- pins and needles (peripheral neuropathy)
- hair loss
- feeling unwell
- decreased serum levels of calcium
- flu-like syndrome
- loss or lack of body strength
- fever
Uncommon side effects (affects 1 to 10 users in 1,000)
- secondary malignancies
- central nervous symptoms
- fever and chills without evidence of infection
- redness, swelling and pain or dead skin around the injection site (injection site reaction)
- infection
Rare side effects (affects 1 to 10 users in 10,000)
- feeling unwell with a high temperature due to low levels of white blood cells (febrile neutropenia)
- life threatening infections and bleeding
- taste alteration
- loss of appetite (anorexia)
- severely impaired liver function, damage or death of liver cells. Yourdoctor may want to monitor you.
- temporary visual disturbances including temporary sight loss
- inflammation of the optic nerve that may cause a complete or partial loss of vision (optic neuritis)
- haemolytic-uraemic syndrome (a disease characterised by acute renal failure, decreased number of red blood cells (microangiopathic haemolytic anaemia) and a low platelet count)
- severe allergic reactions (anaphylaxis/anaphylactic reactions)
- symptoms of a severe allergic reaction include sudden wheeziness or tightness of chest, swelling of the eyelids, face or lips, facial flushing, hypotension, tachycardia, urticaria, dyspnoea, dizziness and anaphylactic shock
- low sodium levels in your blood leading to confusion, fits and coma
Very rare side effects (affects less than 1 user in 10,000)
- heart failure, blockage in blood vessels of your heart, high blood pressure
- bleeding in the brain, which may result in a stroke or loss of consciousness
- scarring of the lungs which causes shortness of breath and/or cough (pulmonary fibrosis).
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse.
5. HOW TO STORE CARBOPLATIN
Keep out of the reach and sight of children.
Do not store above 25 °C. Do not store in a refrigerator. Keep the vial in the outer carton in order to protect from light. Do not use this medicinal product after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
The product should be diluted and used immediately after opening.
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 Carboplatin 10 mg/ml Concentrate for Solution for Infusion contains
The vials contain:
• The active substance Carboplatin.
• Each ml of concentrate for solution for infusion contains 10mg of carboplatin. Each 5ml vial contains 50mg of carboplatin, each 15ml vial contains 150mg of carboplatin and each 45ml vial contains 450mg of carboplatin.
• The other ingredient is water for injections
What Carboplatin 10 mg/ml Concentrate for Solution for Infusion looks like and contents of the pack
Carboplatin 10 mg/ml Concentrate for Solution for Infusion is a clear, colourless or almost colourless solution. It is presented in clear vials of hydrolytic Type I glass, packed in a carton.
Vials are closed with a fluororesin coated bromobutyl rubber stopper with an aluminium crimp cap with a polypropylene flip-off lid.
Packs of 1 vial containing 50 mg/5ml of carboplatin.
Packs of 1 vial containing 150 mg/15ml of carboplatin.
Packs of 1 vial containing 450 mg/45ml of carboplatin.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation Holder is Cipla (EU) Limited, Hillbrow House, Hillbrow Road, Esher, Surrey, KT10 9NW, United Kingdom.
The manufacturer responsible for batch release is
Cipla (EU) Limited, 20 Balderton Street, London W1K 6TL, United Kingdom Cipla Europe NV, Uitbreidingstraat 80, 2600 Antwerp, Belgium.
This information is available in alternative formats upon request.
This leaflet was last revised in 03/2016.
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