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<DOCUMENT author="perl program" datec=020199 title="leaflet" book="ABPI" edition="1996-97" section="company">
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<HEAD weight="bold" >
WHAT YOU SHOULD KNOW ABOUT SYNTOMETRINE
</HEAD>


<BLOCK>
Note: This is a patient information leaflet. Doctors and other health care professionals involved in the administration of 
<EMPH weight="bold">
SYNTOMETRINE
</EMPH>
 should consult the data sheet before use.
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<HEAD weight="bold" >
WHAT IS IN YOUR MEDICINE?
</HEAD>


<BLOCK>
SYNTOMETRINE ampoules contain ergometrine maleate and oxytocin.
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<BLOCK>
It is available as an injectable solution containing 500 microgrammes of ergometrine maleate and 5 Units of oxytocin in 1 ml.
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<BLOCK>

<EMPH weight="bold">
SYNTOMETRINE
</EMPH>
 is available in a pack size of 10 ampoules.
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<BLOCK>
The injection also contains sodium chloride, maleic acid and water for injection.
</BLOCK>


<BLOCK>

<EMPH weight="bold">
SYNTOMETRINE
</EMPH>
 is a medicine which makes the muscles of the uterus (womb) contract. It is used in child birth and to control bleeding after delivery of the baby
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<HEAD weight="bold" >
SYNTOMETRINE injection is manufactured by:
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<HEAD>
SANDOZ PHARMA LTD Basle Switzerland
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<BLOCK>
For the product licence holders:
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<BLOCK>
SANDOZ PHARMACEUTICALS Sandoz Pharmaceuticals (UK) Limited Frimley Business Park Frimley Camberley Surrey GU16 5SG <CB n=2>
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<HEAD weight="bold" >
WHAT IS SYNTOMETRINE FOR?
</HEAD>


<BLOCK>
SYNTOMETRINE is an injection which causes contraction of the muscles of the womb. It may be used for:
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<ITEM>

<BLOCK>
The management of the last stage of labour and delivery of the placenta
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</ITEM>


<ITEM>

<BLOCK>
The prevention and control of bleeding after delivery.
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</ITEM>

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SYNTOMETRINE SHOULD NOT BE USED IN PATIENTS:
</EMPH>

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<LIST type="bulleted">

<ITEM>

<BLOCK>
Who have ever had this medicine before and are allergic to it or it has upset them.
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
Who have reacted badly to any of the ingredients present in 
<EMPH weight="bold">
SYNTOMETRINE
</EMPH>
. These are listed at the beginning of the leafl et under the title &quot;What is in your medicine ?&quot;
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</ITEM>


<ITEM>

<BLOCK>
Who are pregnant or in the early stages of labour.
</BLOCK>

</ITEM>


<ITEM>

<BLOCK>
Who have severe liver, kidney or heart problems.
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</ITEM>


<ITEM>

<BLOCK>
Who have a condition known as pre-eclampsia or eclampsia (high blood pressure, protein in the urine, swelling).
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</ITEM>


<ITEM>

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With severe problems with their heart or circulation.
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</ITEM>


<ITEM>

<BLOCK>
With any infections.
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</ITEM>

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<EMPH weight="bold">
SYNTOMETRINE SHOULD BE USED WITH CARE IN PATIENTS:
</EMPH>

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<LIST type="bulleted">

<ITEM>

<BLOCK>
Who have mild or moderate increase in blood pressure.
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</ITEM>


<ITEM>

<BLOCK>
Who have mild or moderate liver, kidney or heart problems.
</BLOCK>

</ITEM>

</LIST>



<BLOCK>
In patients with breech presentation and other abnormal presentations 
<EMPH weight="bold">
SYNTOMETRINE
</EMPH>
 should not be given before the delivery of the child is completed. When given to prevent or control bleeding after delivery, and the bleeding does not stop, investigation into possible causes must be carried out before a further injection may be given.
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<HEAD weight="bold" >
USE WITH OTHER MEDICINES
</HEAD>


<BLOCK>
When 
<EMPH weight="bold">
SYNTOMETRINE
</EMPH>
 is given with other drugs known as prostaglandins or drugs given to constrict the blood vessels the action of these drugs may be enhanced.
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Halothane, a certain type of anaesthetic given by inhalation, may reduce the effect of 
<EMPH weight="bold">
SYNTOMETRINE
</EMPH>
.
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THE USUAL DOSES ARE AS FOLLOWS:
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<EMPH slant = "italic">
Management of the third stage of labour:
</EMPH>
 1 ml injected into the muscle, following delivery of the baby’s shoulder or immediately after delivery of the baby. Expulsion of the placenta should be manually assisted by applying gentle pressure.
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<EMPH slant = "italic">
Prevention and control of bleeding after delivery:
</EMPH>
 1 ml injected into the muscle after delivery of the placenta, or when bleeding occurs.
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<EMPH weight="bold">
SYNTOMETRINE 
</EMPH>
may be injected slowly into the vein (1/2 to 1 ml), but this is not generally recommended.
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<HEAD weight="bold" >
SIDE EFFECTS
</HEAD>


<BLOCK>
Most people who are given 
<EMPH weight="bold">
SYNTOMETRINE
</EMPH>
 injection benefit from it but a few people can be upset by it.
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<BLOCK>
Side effects that have been reported include nausea, vomiting, abdominal pain, headache, dizziness and skin rashes.
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<BLOCK>
On rare occasions a rise or fall in blood pressure, change in heart beat and difficulty in breathing with chest pain may occur especially if the patient is hypersensitive to 
<EMPH weight="bold">
SYNTOMETRINE
</EMPH>
. This may lead to collapse.
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<BLOCK>
Tell your doctor or nurse if you suffer from these or any other side effects not mentioned in this leaflet.
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<HEAD weight="bold" >
STORING THE MEDICINE
</HEAD>


<BLOCK>
Do not use this medicine after the expiry date shown on the label.
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<BLOCK>
This medicine should be stored in a safe place where children cannot reach it. 
<EMPH weight="bold">
SYNTOMETRINE
</EMPH>
 should be stored between 2 and 8°C and protected from light,
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<BLOCK>

<EMPH weight="bold">
SYNTOMETRINE
</EMPH>
 may be stored at temperatures up to 25°C for 2 months when protected from light.
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<EMPH weight="bold">
LEAFLET REVISED 
</EMPH>
October 1995 <CB n=2> FURTHER INFORMATION
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<BLOCK>
REMEMBER: This medicine may only be prescribed by a doctor.
</BLOCK>


<BLOCK>
If you have any further questions about this medicine ask your doctor, nurse or pharmacist. There is an expiry date shown on the outer carton.
</BLOCK>


<BLOCK>
The medicine must not be used after this date.
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<HEAD>
SYNTOMETRINE ampoules PL 0101/5046R
</HEAD>


<BLOCK>

<EMPH weight="bold">
SYNTOMETRINE
</EMPH>
 is a registered Trade Mark.
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