<!DOCTYPE DOCUMENT SYSTEM "icon.dtd" []>
<DOCUMENT author="perl program" datec=3/11./98 title="leaflet" book="ABPI" edition="1996-97" section="company">
<PB n=1>
<CB n=1>
<DIV>

<HEAD weight="bold"  justified="center" >
‘NOLVADEX’  
</HEAD>


<PB n=2>


<CB n=2>


<BLOCK justified=center>

<EMPH weight="bold">
Please read this leaflet carefully before you take
</EMPH>
 
<EMPH weight="bold">
your medicine. This leaflet only gives a summary of 
<EMPH weight="bold">
the information available on your medicine.
</BLOCK>


<BLOCK justified=center>

<EMPH weight="bold">
If you have any questions or are not sure about 
<EMPH weight="bold">
anything, ask your doctor or pharmacist.
</EMPH>

</BLOCK>


<BLOCK justified=center>

<EMPH weight="bold">
WHAT YOU SHOULD KNOW ABOUT
</EMPH>
 YOUR MEDICINE The name of your medicine is 'Nolvadex'. The active ingredient is tamoxifen. Your medicine also contains the following inactive ingredients: croscarmellose sodium, gelatin, lactose, macrogol, magnesium stearate, maize starch, methylhydroxypropylcellulose and titanium dioxide.
</BLOCK>


<BLOCK justified=center>
'Nolvadex' is produced as tablets in three different strengths.
</BLOCK>


<BLOCK justified=center>
These are 'Nolvadex' tablets which contain 10mg of tamoxifen, 'Nolvadex' D tablets which contain 20mg of tamoxifen and 'Nolvadex' Forte tablets which contain 40mg of tamoxifen.
</BLOCK>


<BLOCK justified=center>
'Nolvadex', 'Nolvadex' D and 'Nolvadex' Forte tablets are produced in packs of 30 and 250 tablets. The 250 tablet pack may not be available.
</BLOCK>


<BLOCK justified=center>
Tamoxifen is one of a group of medicines called anti-oestrogens.
</BLOCK>


<BLOCK justified=center>
The product licence holder and manufacturer is:
</BLOCK>

<DIV>

<HEAD weight="bold"  justified="center" >
ZENECA Limited Macclesfield Cheshire United Kingdom
</HEAD>


<BLOCK justified=center>
'Nolvadex' is used to treat breast cancer.
</BLOCK>


<BLOCK justified=center>
It can also be used to treat infertility caused by a failure to ovulate properly.
</BLOCK>

<FIGURE></FIGURE>

<HEAD>
continued
</HEAD>

</DIV>
<DIV>

<HEAD weight="bold"  justified="center" >
BEFORE TAKING YOUR MEDICINE
</HEAD>


<LIST type="bulleted">

<ITEM>

<BLOCK>
Are you pregnant?
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
Are you breast feeding?
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
Are you taking any anticoagulant tablets?
</BLOCK>

</ITEM>

</LIST>


<BLOCK>
If the answer is yes- to any of these questions, tell your doctor or pharmacist. 'Nolvadex' should not be taken by women who are pregnant or breast feeding and it can also interact with certain types of anticoagulant medicine.
</BLOCK>


<BLOCK>
You should not become pregnant when taking 'Nolvadex'. Please see your doctor for advice on what contraceptive precautions you should take, as some may be affected by 'Nolvadex'.
</BLOCK>


<BLOCK>
‘Nolvadex' tablets contain lactose and titanium dioxide. These may cause a problem in a small number of people who are sensitive to them.
</BLOCK>

</DIV>
<DIV>

<HEAD weight="bold"  justified="center" >
TAKING YOUR MEDICINE
</HEAD>


<BLOCK>
Follow your doctor’s instructions about when and how to take your medicine. Also read the label. Your pharmacist can also help if you are not sure.
</BLOCK>


<BLOCK>
The usual dosage to treat breast cancer is 20 mg daily. The daily dose can either be taken as a single dose every day or the dose can be divided in two and taken in the morning and evening.
</BLOCK>


<BLOCK>
The dosage for infertility depends on the menstrual cycle. In women who are having regular periods, treatment usually begins by taking 20 mg of 'Nolvadex' daily on the second, third, fourth and fifth days of the menstrual cycle. If this is not successful, your doctor may increase the dosage on these days to 40 mg or 80 mg daily. In women who are not having regular periods, the treatment can be started on any day.
</BLOCK>


<BLOCK>
If you forget to take a dose, take it as soon as you remember and then can y on as before.
</BLOCK>

</DIV>
<DIV>

<HEAD weight="bold"  justified="center" >
AFTER TAKING YOUR MEDICINE
</HEAD>


<BLOCK>
As with all medicines, undesirable events can sometimes be experienced with ‘Nolvadex’. Occasionally, a few people can suffer from stomach or gut upsets, lightheadedness, menstrual disturbances, hot flushes, genital itching, vaginal discharge or bleeding fluid retention, skin rashes or thinning of the hair.
</BLOCK>


<BLOCK>
Other possible events are changes in vision or difficulty seeing properly as a result of cataracts or changes to the cornea or retina, an Increased risk of blood clots, a tendency to bruise more easily. ovarian cysts or certain liver problems such as jaundice. Other possible events are effects on the endometrium (lining of the womb) which may also be seen as vaginal bleeding or fibroids (causes enlargement of the womb) which may also be seen as discomfort in the pelvis or as vaginal bleeding.
</BLOCK>


<BLOCK>
It is important that you tell your doctor immediately if you have any unusual vaginal bleeding, menstrual irregularities, vaginal discharge or discomfort in the pelvis such as pain or pressure when you are taking 'Nolvadex' or anytime afterwards. This is because a number of changes to the lining of the womb (the endometrium) may occur, some of which may be serious and could Include cancer.
</BLOCK>


<BLOCK>
At the beginning of treatment for breast cancer, the symptoms of the disease can sometimes get worse, for example an increase in pain or an increase in the size of the affected tissue. In addition, if you get excessive nausea, vomiting or thirst, tell your doctor because this may mean that there are changes in the amount of calcium in your blood and your doctor may want to check on this.
</BLOCK>


<BLOCK>
Do not be alarmed by this list of possible events. You may not have any of them.
</BLOCK>


<BLOCK>
If you get any other undesirable events or if you think your medicine is causing any problems, tell your doctor or pharmacist.
</BLOCK>

</DIV>
<DIV>

<HEAD weight="bold"  justified="center" >
STORING YOUR MEDICINE
</HEAD>


<BLOCK>
Check the expiry date on the canon and don't use the medicine after that date.
</BLOCK>


<BLOCK>
Keep your medicine in a safe place where children cannot see it or reach it. Your medicine could harm them.
</BLOCK>


<BLOCK>
Keep your medicine below 30°C and away from strong light.
</BLOCK>


<BLOCK>
If your doctor decides to stop treatment. return any left-over tablets to your pharmacist. Only keep them if the doctor tells you to.
</BLOCK>


<HEAD>
Date of Preparation: March 1995
</HEAD>

</DIV>
<DIV>

<HEAD weight="bold"  justified="center" >
FURTHER INFORMATION
</HEAD>


<BLOCK>
This leaflet does not contain the complete information on 'Nolvadex'. If you have any questions, or are not sure about anything ask your doctor or pharmacist.
</BLOCK>


<BLOCK>
Remember: This medicine is only for you. Only a doctor can prescribe it for you. Never give it to someone else. It may harm them even if their symptoms are the same as yours.
</BLOCK>


<HEAD>
The information applies only to ‘Nolvadex’   ‘Nolvadex’ is a trademark   
</HEAD>


<PB n=3>


<CB n=1>


<CB n=2>


<FIGURE></FIGURE>


<CB n=1>


<BLOCK>
Distributed by:
</BLOCK>


<BLOCK>

<EMPH weight="bold">
ZENECA Pharma
</EMPH>
 King’s Court, Water Lane Wilmslow, Cheshire, SK9 5AZ 3/IE/UK/1013634&#9;P 2133305
</BLOCK>

</DIV>

</DIV>

</DOCUMENT>
