<!DOCTYPE DOCUMENT SYSTEM "icon.dtd" []>

<DOCUMENT author="perl program" datec=020199 title="leaflet" book="ABPI" edition="1996-97" section="company">
<DIV type=0>

<HEAD>
Tomudex
</HEAD>

<DIV type=1>

<HEAD weight="bold" >
What you should know about Tomudex
</HEAD>


<BLOCK>
The information in this leaflet applies only to your medicine, Tomudex, please read it carefully. It gives you important information but it can't tell you everything. If you have any questions, or are not sure about anything, ask your doctor or pharmacist.
</BLOCK>


</DIV>
<DIV type=1>

<HEAD weight="bold" >
What is your medicine7
</HEAD>


<BLOCK>
Tomudex comes as a powder containing 2 milligrams of raltitrexed which is then made into a solution for injection into a vein.
</BLOCK>


<BLOCK>
Each injection vial also contains a number of other ingredientswhichallowittobemadeup.Theirnames are mannitol, dibasic sodium phosphate and sodium hydroxide.
</BLOCK>


<BLOCK>
Tomudex comes in containers of single vials.
</BLOCK>


<BLOCK>
Tomudex belongs to a group of medicines used for the treatment of cancer. This means that it can kill cells within your body which cause certain types of cancer. Your doctor will probably explain this to you in more detail.
</BLOCK>


</DIV>
<DIV type=1>

<HEAD weight="bold" >
Who has made your medicine7
</HEAD>


<BLOCK>
The product licence holder of Tomudex is: 
<EMPH weight="bold">
ZENECA Limited, 
</EMPH>
Macclesfield, Cheshire.
</BLOCK>


<BLOCK>
The manufacturer of Tomudex is: Ben Venue Limited, 300 Northfield Road, PO Box 46568, Bedford, Ohio, USA.
</BLOCK>


</DIV>
<DIV type=1>

<HEAD weight="bold" >
What is your medicine for7
</HEAD>


<BLOCK>
Tomudex is used to treat cancer which affects the colon and rectum (parts of your bowel).
</BLOCK>


</DIV>
<DIV type=1>

<HEAD weight="bold" >
When should Tomudex not be used7
</HEAD>


<BLOCK>
Before receiving your medicine, you should tell your doctor if you are, or suspect you are pregnant, or you are breast feeding, as Tomudex should not be given to pregnant women or mothers breast feeding their babies.
</BLOCK>


<BLOCK>
Tomudex should not be given to children.
</BLOCK>


<BLOCK>
Tomudex should not be given to patients with severe kidney disease.
</BLOCK>


</DIV>
<DIV type=1>

<HEAD weight="bold" >
What precautions should be taken with Tomudex7
</HEAD>


<BLOCK>
Before you receive your medicine tell your doctor if:
</BLOCK>


<BLOCK>
- you and your partner are hoping to start a family; it is recommended that pregnancy should be avoided during treatment and for at ieast 6 months after completion of treatment if either partner is receiving Tomudex - you have or have had any problems with your blood kidneys or liver; - you have or have had any stomach or bowel (intestinal) problems; -you have previously had radiotherapy (treatment with high dose X-rays); - you are taking any other medicines including those which you have bought. In particular, if you are taking folinic or folic acid vitamins or vitamin supplements, or you are taking an anticoagulant (a medicine to prevent blood clotting).
</BLOCK>


<BLOCK>
Contact your doctor if you have been given Tomudex and have then suffered from soreness or ulcers inside your mouth, or diarrhoea.
</BLOCK>


<BLOCK>
Your doctor will need to take regular samples of your blood while you are receiving Tomudex. He/she will use the results from these to decide your dose of Tomudex.
</BLOCK>


<BLOCK>
Your medicine is unlikely to affect your ability to drive a car or to operate machinery. However, some patiets may experienceflu-like symptoms, or a general feeling of being unwell, for a short time after receiving Tomudex. If you do experience these effects you shouid not drive or operate machinery.
</BLOCK>


<BLOCK>
If you receive any other treatment for other medical 8/lE/UK/1015417 conditions or illnesses, let the medical staff know you are 
<EMPH weight="bold">
receving Tomudex.
</EMPH>

</BLOCK>


</DIV>
<DIV type=1>

<HEAD weight="bold" >
How will I receive my Tomudex7
</HEAD>


<BLOCK>
Your Tomudex injection will be given to you under the supervision of a doctor who is a specialist in the use of this type of drug.
</BLOCK>


<BLOCK>
You should follow any instructions that your doctor gives you about your treatment.
</BLOCK>


<BLOCK>
If you are not sure about anything ask your doctor.
</BLOCK>


<BLOCK>
The exact dose you are given will be decided by your doctor. It will vary dependent on your size and how you react to your treatment. The result of your blood tests will also help the doctor to decide what dose you will receive.
</BLOCK>


<BLOCK>
The usual dose is 3 milligrams for each square metre of your body surface area, which your doctor will calculate from your height and weight.
</BLOCK>


<BLOCK>
The dose you receive may well vary from treatment to treatment.
</BLOCK>


<BLOCK>
Tomudex will be slowly injected into one of your veins. The injectionwill usuallytake 15 minutes.
</BLOCK>


<BLOCK>
Tomudex is usuallygiven ever3weeks, but depend ing on the results of your blood tests, it could be less often .
</BLOCK>


<BLOCK>

<EMPH weight="bold">
What undesirableevents may be ~en with Tomudex7 
</EMPH>
As with all medicines, undesirable events are sometimes seen. It is useful for you to know about them so that you can do something about them. In particular you can tell your doctor, who can take the necessary steps to lessen the harm. But do not be alarmed by this list of possible events. Although it is quite common to have some of these events such as 
<EMPH weight="bold">
nausea, vomiting and 
</EMPH>
diarrhoea, you may not actually 
<EMPH weight="bold">
have any one 
</EMPH>
of them.
</BLOCK>


<BLOCK>
Here is a list of the undesirable events: anorexia (loss of appetite) mouth ulceration of stomatitis (sore mouth) mucostitis (inflammation of the mouth and intes tines resulting in soreness or ulceration of the 
<EMPH weight="bold">
mouth or diarrhoea) nausea (feeling sick) vomiting
</EMPH>
 abdominal pain diarrhoea constipation weight loss dehydration (feeling thirsty and/or dry skin) painful joints muscle cramps fever infections weakness (sometimes like influenza) headache swollen hands, ankles or feet effects on skin (red skin or an itchy rash) cellulitis (tenderness and swelling under the skin) sweating hair loss or thinning altered taste conjunctivitis (red and/or itchy eyes)
</BLOCK>


<BLOCK>
In, addition, Tomudex may cause changes to your blood. These occur because of effects on yoLlr bol1e marrow and your liver. Your doctor will check your blood regularly.
</BLOCK>


<BLOCK>
Tell your doctor if you think you have any of these or any other problems with your treatment Diarrhoea may be particularly severe and could reqviire urgent medical attention.
</BLOCK>


<BLOCK>

<EMPH weight="bold">
How should I store Tomudex7
</EMPH>
 The injection will normally be stored for vou by the hospital. the staff are responsible for the correct storage, use and disposl of Tomudex Date of preparation of leaflet: 31 Jlaly 1995 Tomudex is a trade mark P2137008
</BLOCK>

</DIV>

</DIV>

</DOCUMENT>
