Syntometrine Ampoules

Read all of this leaflet carefully before you receive this medicine

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, midwife or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet please tell your doctor, midwife or pharmacist.

You must not receive Syntometrine:

• if you are allergic to oxytocin, ergometrine or if you are allergic to any of the other ingredients in Syntometrine (see section 6 Further information)
• if you are pregnant or if you are in labour but the baby’s head still cannot be seen
• if you suffer from severe liver, kidney, heart or circulation problems
• if you have very high blood pressure
• if you are suffering from eclampsia or pre-eclampsia (which causes high blood pressure, protein in the urine, swelling)
• if you have a serious infection.

If any of the above applies to you, or if you are not sure, speak to your doctor or midwife before you receive Syntometrine.

Take special care with Syntometrine

Before you receive Syntometrine, tell your doctor or midwife if:

• you have raised blood pressure
• you have liver, kidney or heart problems.

If your baby is in a breech position (or any other abnormal position) before birth, Syntometrine will not be given until after your baby has been born.

If you have a multiple pregnancy (e.g. twins, triplets), Syntometrine will not be given until after the last baby has been born.

If any of the above applies to you, or you are not sure, speak to your doctor or midwife before you receive Syntometrine.

Taking other medicines

Tell your doctor or midwife if you are taking or have recently taken any of the following medicines as they may interfere with Syntometrine:

• halothane (a certain type of anaesthetic which you breathe in to put you to sleep during surgery) as it could decrease the effect of Syntometrine
• prostaglandins (used to start labour or to treat stomach ulcers) as the effects of both drugs may be increased
• vasoconstrictors (used to narrow the blood vessels and decrease the flow of blood) as the effect of the drug may be increased.

Please tell your doctor or midwife if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding

Do not take Syntometrine unless your doctor has told you to during pregnancy as this could start labour.

Driving and using machines

Taking Syntometrine can start labour. Women with contractions should not drive or use machines.

Important information about some of the ingredients of Syntometrine

Syntometrine contains:

This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free’.

To help the delivery of the placenta

1ml is injected into a muscle, once your baby’s shoulder can be seen or immediately after delivery of your baby. The doctor or midwife will push gently on your tummy and pull gently on the umbilical Cord to help deliver the placenta.

To prevent and control bleeding after delivery

1ml is injected into a muscle after the placenta is delivered or when bleeding occurs.

Sometimes Syntometrine is injected into a vein (0.5 to 1 ml) instead of into a muscle but this is not generally recommended.

What to do if you receive more Syntometrine than you should

As this medicine is given to you in hospital, it is very unlikely that you will receive an overdose. If anyone accidentally receives this medicine, tell the hospital accident and emergency department or a doctor immediately. Show any left over medicines or the empty packet to the doctor.

An overdose of Syntometrine could cause:

• feeling or being sick
• a fall or rise in blood pressure (dizziness, light headedness, feeling faint)
• vasospastic reactions (pain or discomfort of your fingers caused by a lack of blood reaching the fingertips)
• difficulty breathing
• fits
• coma.

What to do if you miss a dose

As a doctor or midwife is giving you this medicine, you are unlikely to miss a dose. If you have any worries, tell a doctor or midwife.

What is in Syntometrine?

The active ingredients in this medicine are oxytocin and ergometrine maleate.

The other ingredients are sodium chloride, maleic acid and water.

What Syntometrine looks like and contents of the pack

Syntometrine is a clear colourless sterile liquid which comes in a 1 ml (millilitre) clear glass ampoule. Syntometrine comes in packs of five ampoules. Each 1ml ampoule contains 5 IU (International Units) of oxytocin and 0.5 mg (milligrams) of ergometrine maleate.

Marketing Authorisation Holder and Manufacturer

The product licence holder is:

Syntometrine is manufactured by: