Author: Unknown

WHAT YOU SHOULD KNOW ABOUT SYNTOMETRINE®
Note: This is a patient information leaflet. Doctors and other health care professionals involved in the administration of SYNTOMETRINE® should consult the data sheet before use.
WHAT IS IN YOUR MEDICINE?
SYNTOMETRINE® ampoules contain ergometrine maleate and oxytocin.
It is available as an injectable solution containing 500 microgrammes of ergometrine maleate and 5 Units of oxytocin in 1 ml.
SYNTOMETRINE® is available in a pack size of 10 ampoules.
The injection also contains sodium chloride, maleic acid and water for injection.
SYNTOMETRINE® 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
SYNTOMETRINE® injection is manufactured by:
SANDOZ PHARMA LTD
Basle
Switzerland
For the product licence holders:
SANDOZ PHARMACEUTICALS
Sandoz Pharmaceuticals (UK) Limited
Frimley Business Park
Frimley
Camberley
Surrey GU16 5SG

WHAT IS SYNTOMETRINE® FOR?
SYNTOMETRINE® is an injection which causes contraction of the muscles of the womb. It may be used for:
I)	The management of the last stage of labour and delivery of the placenta
II)	The prevention and control of bleeding after delivery.
SYNTOMETRINE® SHOULD NOT BE USED IN PATIENTS:
•	Who have ever had this medicine before and are allergic to it or it has upset them.
•	Who have reacted badly to any of the ingredients present in SYNTOMETRINE®. These are listed at the beginning of the leafl et under the title “What is in your medicine ?”
•	Who are pregnant or in the early stages of labour.
•	Who have severe liver, kidney or heart problems.
•	Who have a condition known as pre‑eclampsia or eclampsia (high blood pressure, protein in the urine, swelling).
•	With severe problems with their heart or circulation.
•	With any infections.
SYNTOMETRINE® SHOULD BE USED WITH CARE IN PATIENTS:
•	Who have mild or moderate increase in blood pressure.
•	Who have mild or moderate liver, kidney or heart problems.
In patients with breech presentation and other abnormal presentations SYNTOMETRINE® 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.
USE WITH OTHER MEDICINES
When SYNTOMETRINE® is given with other drugs known as prostaglandins or drugs given to constrict the blood vessels the action of these drugs may be enhanced.
Halothane, a certain type of anaesthetic given by inhalation, may reduce the effect of SYNTOMETRINE®.
continued

THE USUAL DOSES ARE AS FOLLOWS:
Management of the third stage of labour: 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.
Prevention and control of bleeding after delivery: 1 ml injected into the muscle after delivery of the placenta, or when bleeding occurs.
SYNTOMETRINE® may be injected slowly into the vein (1/2 to 1 ml), but this is not generally recommended.
SIDE EFFECTS
Most people who are given SYNTOMETRINE® injection benefit from it but a few people can be upset by it.
Side effects that have been reported include nausea, vomiting, abdominal pain, headache, dizziness and skin rashes.
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 SYNTOMETRINE®. This may lead to collapse.
Tell your doctor or nurse if you suffer from these or any other side effects not mentioned in this leaflet.
STORING THE MEDICINE
Do not use this medicine after the expiry date shown on the label.
This medicine should be stored in a safe place where children cannot reach it. SYNTOMETRINE® should be stored between 2 and 8°C and protected from light,
SYNTOMETRINE® may be stored at temperatures up to 25°C for 2 months when protected from light.
LEAFLET REVISED October 1995

FURTHER INFORMATION
REMEMBER: This medicine may only be prescribed by a doctor.
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.
The medicine must not be used after this date.

SYNTOMETRINE® ampoules PL 0101/5046R
SYNTOMETRINE® is a registered Trade Mark.