044BP1627B

Package leaflet: Information for the user

Carboplatin 10 mg/ml concentrate for solution for infusion

Carboplatin

What is in this leaflet

1.    What Carboplatin is and what it is used for

2.    What you need to know before you are given Carboplatin

3.    How to use Carboplatin

4.    Possible side effects

5.    How to store Carboplatin

6.    Contents of the pack and other information

1.    What Carboplatin is and what it is used for

Carboplatin contains carboplatin, which belongs to a group of medicines known as platinum coordination compounds, which are used to treat cancer.

Carboplatin is used against advanced cancer of the ovary and small cell cancer of the lung.

2.    What you need to know before you are given Carboplatin Do not use Carboplatin

-    if you are allergic to carboplatin or to any of the other ingredients of this medicine (listed in section 6)

-    if you are allergic to another drug that belongs to the group of platinum containing compound

-    if you have severe problems with your kidneys (creatinine clearance at or below 20 ml/min)

-    if you have an imbalance of your blood cells (severe myelosuppression)

-    if you have a tumour that bleeds

-    if you are pregnant or breast feeding

1.    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 infusion.

2.    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.

Warnings and precautions

Talk to your doctor before you are given Carboplatin:

If you are pregnant or if there is a chance you may be pregnant

If you are breastfeeding

If you are likely to drink alcohol whilst being treated 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.

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.

Carboplatin must be diluted with another solution before it is administered. You should discuss this with your doctor and make sure that it is suitable for you.

Other medicines and Carboplatin

Tell your doctor or nurse if you are taking, have recently taken or might take 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 various types of convulsions and seizures)

-    warfarin (used to prevent the formation of blood clots).

Carboplatin with food, drink and alcohol

There is no known interaction between carboplatin and alcohol. However you should check with your doctor as carboplatin may affect the liver's ability to cope with alcohol.

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 for advice before taking this medicine.

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 unsure of yourself.

3. How to use Carboplatin

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 who will or who has administered Carboplatin. Your dose will be dependent on your height and weight, function of your blood (haematopoietic) system and your kidney function. Your doctor will choose the best dose for you. Carboplatin will normally be diluted before use.

Adult

The recommended dose is 400 mg/m²of your body surface area (calculated from your height and weight).

Elderly

The recommended adult doses may be used although the doctor may choose to use a different dose.

Renal impairment

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. Carboplatin will be given by a doctor experienced in the use of cancer treatment.

Use in children and adolescents

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.

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 administering your medicine.

If you miss a dose of Carboplatin

It is very unlikely that you will miss a dose of your medicines, as yours doctor will have instructions on when to give you your medicine. If you think you have missed dose please talk to your doctor.

Carboplatin 10 mg/ml concentrate for solution for infusion

Carboplatin

The following information is intended for healthcare professionals only: Instructions for use

Carboplatin 10 mg/ml concentrate for solution for infusion

Incompatibilities

Needles, syringes, catheters or intravenous sets containing aluminum parts that may come into contact with carboplatin should not be used for preparation or administration of carboplatin.

Shelf life

Do not store above 25 °C. Do not refrigerate or freeze.

Keep container in the outer carton in order to protect from light.

Unopened product: 2 years Diluted product: 8 hours at room temperature (15-25°C), or 24 hours under refrigeration (2-8°C).

From a microbiological point of view, the product should be used immediately. If not used immediately, in use storage times and conditions are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless reconstitution / dilution has taken place under controlled and validated aseptic conditions.

Instructions for handling, use and disposal

The medicinal product is for single use only. Any unused infusion solution should be discarded.

Instructions for dilution

| The product must be diluted prior to infusion, with 5% i Glucose for Injection or 0.9% Sodium Chloride for Injection, i to concentrations as low as 0.5 mg/ml (500 micrograms/ml). When diluted as directed, carboplatin is chemically and physically stable for 8 hours at room temperature (15-25°C) and for 24 hours at 2-8°C.

From a microbiological point of view, the infusion | preparation should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally | not be longer than 24 hours at 2-8°C, unless dilution has taken place under controlled and validated conditions.

The solution is to be inspected visually for particulate matter and discoloration prior to administration

The solution should only be used if the solution is clear and

free from particles.

Guidelines for the safe handling of anti-neoplastic

agents:

1    Carboplatin should be prepared for administration only by professionals who have been trained in the safe use of chemotherapeutic agents

2    This should be performed in a designated area.

3    Adequate protective gloves should be worn.

4    Precautions should be taken to avoid the drug accidentally coming into contact with the eyes. In the event of contact with the eyes, wash with water and/or saline.

5    The cytotoxic preparation should not be handled by pregnant staff.

6    Adequate care and precautions should be taken in the disposal of items (syringes, needles, etc.) used to reconstitute cytotoxic drugs. Excess material and body waste may be disposed of by placing in double sealed polythene bags and incinerating at a temperature of 1,000 °C. Liquid waste may be flushed with copious amounts of water.

7    The work surface should be covered with disposable plastic-backed absorbent paper.

8    Use Luer-Lock fittings on all syringes and sets. Large bore needles are recommended to minimise pressure and the possible formation of aerosols. The latter may also be reduced by the use of a venting needle.

Disposal

Any unused medicinal product or waste material should

be disposed of in accordance with local requirements.

If you stop using Carboplatin

If you have any further questions on the use of this medicine ask your doctor or nurse.

! 4. Possible side effects

i

Like all medicines, this medicine can cause side effects, although not everybody gets them.

i

i

i 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).

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

-    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 (may affect up to 1 in 10 people)

-    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

i - 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 (may affect up to 1 in to 100 people)

-    secondary malignancies

-    central nervous symptoms often associated with medicine you may be taking to stop you from feeling or being sick

-    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 (may affect up to 1 in 1,000 people)

-    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. Your doctor 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.

Very rare side effects (may affect up to 1 in 10,000 people)

-    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).

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine.

5.    How to store Carboplatin

Keep this medicine out of the sight and reach of children.

You will not be asked to store this medicine. It will be brought to you ready to be administered straight away.

Your doctor or pharmacist will ensure that you do not receive this medicine after the expiry date which is stated on the label and on the outer carton after EXP The expiry date refers to the last day of that month.

Medicines should not be disposed of via waste water or household waste.

When the infusion has finished, any remaining carboplatin will be disposed of carefully by the doctor or nurse. These measures will help to protect the environment.

6.    Contents of the pack and other information What Carboplatin contains

-    The active substance is carboplatin.

-    a    vial    of    5 ml of concentrate contains 50 mg carboplatin

-    a    vial    of    15    ml of concentrate    contains 150    mg    carboplatin

-    a    vial    of    45    ml of concentrate    contains 450    mg    carboplatin

-    a    vial    of    60    ml of concentrate    contains 600    mg    carboplatin.

-    The other ingredient is water for injections.

What Carboplatin looks like and contents of the pack

Carboplatin 10 mg/ml is a clear colourless solution in a vial, which requires further dilution before use.

It is available in: vials of 5 ml, 15 ml, 45 ml, and 60 ml and boxes of 1, 5 and 10 vials.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87 2132 JH Hoofddorp The Netherlands

This medicinal product is authorised in the Member

States of the EEA under the following names

Germany    Carboplatin SUN 10 mg/ml Konzentrat

zur Herstellung einer Infusionslosung

Spain    Carboplatino SUN 10 mg/ml

concentrado para solucion para perfusion

France    CARBOPLATINE SUN 10 mg/ml

solution a diluer pour perfusion

Italy    Carboplatino SUN 10 mg/ml

concentrato per soluzione per infusione

Netherlands    Carboplatin SUN 10 mg/ml concentraat

voor oplossing voor intraveneuze infusie

United Kingdom Carboplatin 10 mg/ml Concentrate for Solution for Infusion

This leaflet was last revised in 12/2013.

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