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TOMUDEX 2MG/VIAL INJECTION

Active substance(s): RALTITREXED

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Tomudex® 2mg Injection
raltitrexed
Read all of this leaflet carefully before you start having this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, nurse or pharmacist.
• If any of the side effects get serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor, nurse or pharmacist.
In this leaflet:
1. What Tomudex is and what it is used for
2. Before you are given Tomudex
3. How Tomudex will be given
4. Possible side effects
5. How to store Tomudex
6. Further information

1. What Tomudex is and what it is used for
Tomudex contains a medicine called raltitrexed. This belongs to a group of medicines known as
chemotherapy. These are used to treat cancer.
Tomudex is used to treat cancer which affects the colon and rectum (parts of your ‘bowel’ or
gut).
It works by killing cells within your body which cause certain types of cancer. Your doctor will
probably explain this to you in more detail.

2. Before you are given Tomudex
Do not have Tomudex if:
• You have severe kidney disease.
• You are pregnant, think you might be pregnant, are trying for a baby or you are breastfeeding (see the section on ‘Pregnancy and breast-feeding’).
• You are taking leucovorin or folic acid or any vitamins containing these.
Do not have Tomudex if any of the above apply to you. If you are not sure, talk to your doctor
or nurse before having Tomudex.
Tomudex should not be given to children.
Take special care with Tomudex
Check with your doctor or nurse before having Tomudex if you have ever had:
• Any problems with your blood, kidneys or liver.
• Radiotherapy (treatment with high dose X-rays).
Please tell your doctor or nurse if there is a change in your stomach or bowel (gut) problems
whilst taking Tomudex.
If you are elderly, your doctor or nurse will monitor you more closely for side effects. Elderly
people can be more affected by the side effects of this kind of medicine.
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If you have any other treatment for other problems or illnesses, tell your doctor, nurse or
pharmacist that you are having Tomudex.
If you are not sure if any of the above apply to you, talk to your doctor, nurse or pharmacist
before having Tomudex.
Taking other medicines
Please tell your doctor, nurse or pharmacist if you are taking, or have recently taken, any
other medicines. This includes medicines that you buy without a prescription and herbal
medicines. This is because Tomudex can affect the way some medicines work and some
medicines can have an effect on Tomudex.
In particular, tell your doctor, nurse or pharmacist if you are taking any of the following:
• Vitamins or vitamin supplements.
• Medicines to thin your blood and stop it clotting (anti-coagulants).
Pregnancy and breast-feeding
• Do not have Tomudex if you are pregnant, think you may be pregnant or might become
pregnant. This is because it may affect your baby.
• You should not try for a baby when either partner is having Tomudex, during the
treatment or for at least 6 months after stopping treatment. This is because it may affect
the baby.
• Do not have Tomudex if you are breast-feeding.
Driving and using machines
You may feel generally unwell or have flu-like symptoms for a short time after having
Tomudex. If this happens, do not drive or use any tools or machines.
3. How Tomudex will be given
• You will be given Tomudex by a doctor or nurse who is a specialist in the use of this
type of medicine.
• Tomudex will be injected slowly into one of your veins. The injection will usually take 15
minutes.
• The exact dose you are given will be decided by your doctor. It will depend on your size
and how you react to your treatment.
• The usual dose is 3 milligrams for each square metre of your body surface area. Your
doctor will calculate this from your height and weight.
• Your doctor will need to take regular samples of your blood while you are having
Tomudex. The results of your blood tests will also help the doctor to decide what dose
you will receive. The dose you are given may be different each time.
• Tomudex is usually given every 3 weeks, but it could be less often, depending on the
results of your blood tests.
You should follow any instructions that your doctor gives you about your treatment.
If you are not sure about anything ask your doctor or nurse.

4. Possible side effects
Like all medicines, Tomudex can cause side effects, although not everybody gets them. The
following side effects may happen with this medicine.
Tell your doctor or the hospital straight away if you notice any of the following side
effects – you may need urgent medical treatment:

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Very common (affects more than 1 user in 10)
• Diarrhoea.
• Being sick (vomiting).
• High temperature (fever) or chills.
• Mucositis (inflammation of the mouth and gut lining).
Common (affects 1 to 10 users in 100)
• Sore throat.
• Any infections.
• Soreness or ulcers inside your mouth.
Not known (frequency cannot be estimated from available data)
• Bleeding from the gut.
Other possible side effects are:
Very common (affects more than 1 user in 10):
• Loss of appetite.
• Indigestion.
• Feeling sick (nausea).
• Stomach pain.
• Constipation.
• Weight loss.
• Itchy rash.
• Tomudex may cause changes to your blood. These occur because of effects on your bone
marrow and your liver. Your doctor will take regular blood samples to check your blood.
Common (affects 1 to 10 users in 100):
• Painful joints.
• Muscle cramps.
• Swollen hands, ankles or feet.
• Yellow skin and eyes (jaundice).
• Tenderness and swelling under the skin (cellulitis).
• Sweating.
• Hair loss or thinning.
• Feeling thirsty or dry skin (signs of dehydration).
• Headache.
• Altered taste.
• Red or itchy eyes (conjunctivitis).
• Weakness (sometimes flu-like symptoms).
Uncommon (affects 1 to 10 users in 1000):
• Red or peeling skin.
Do not be concerned by this list of possible side effects. You may not get any of them. If any
of the side effects get serious, or if you notice any side effects not listed in this leaflet, please
tell your doctor, nurse or pharmacist.

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5. How to store Tomudex
This medicine will normally be stored for you by the hospital. The doctor and hospital
pharmacist are responsible for storing, using and disposing of Tomudex correctly.
• Keep out of the reach and sight of children.
• Keep unopened vials in the outer carton to protect them from light.
• Do not store above 25°C.
• Do not use Tomudex after the expiry date which is stated on the vial. The expiry date
refers to the last day of that month.

6. Further information
What Tomudex contains
The active substance is raltitrexed. Each vial contains 2mg of raltitrexed.
The other ingredients are mannitol, dibasic sodium phosphate heptahydrate or dodecahydrate
and sodium hydroxide.
What Tomudex looks like and the contents of the pack
Tomudex comes in containers of single glass vials containing a powder which is then made
into a solution for injection into a vein. The vials are packed in cartons.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation for Tomudex is held by Hospira UK Limited, Queensway,
Royal Leamington Spa, Warwickshire, CV31 3RW, United Kingdom.
Tomudex is manufactured by AstraZeneca UK Limited, Silk Road Business Park,
Macclesfield, Cheshire, SK10 2NA, UK or Hospira UK Limited, Queensway, Royal
Leamington Spa, Warwickshire, CV31 3RW, UK.
Leaflet updated: October 2011
Tomudex® is a registered trade mark of the Hospira group of companies.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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