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SYNTOMETRINE 500 MICROGRAMS/5 IU SOLUTION FOR INJECTION

Active substance(s): ERGOMETRINE MALEATE / OXYTOCIN

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Artwork Information
Product Title:

Syntometrine® Ampoules 500 micrograms/5IU/ml

Date:

11-12-15

Product Size:

148 x 297mm

Label Number:

15-032

Colours Used:

Black

Fonts Used:

Helvetica Condensed, Zapf Dingbats

Version:

V3

Font size:

7pt

Magenta text, keylines and shading are NOT to be printed

PATIENT INFORMATION LEAFLET
Syntometrine ® 500 micrograms/5IU Solution for Injection
ergometrine maleate and oxytocin

Read all of this leaflet carefully before you receive this
medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor,
midwife or pharmacist.
• If you get any side effects, talk to your doctor, midwife or
pharmacist. This includes any possible side effects not
listed in this leaflet. See section 4.

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What is in this leaflet
1. What Syntometrine is and what it is used for
2. What you need to know before you receive Syntometrine
3. How Syntometrine is given to you
4. Possible side effects
5. How to store Syntometrine
6. Contents of the pack and other information
1. What Syntometrine is and what it is used for
• Syntometrine belongs to a group of medicines called
oxytocics. This means it makes the muscles of the uterus
(womb) contract.
Syntometrine is used:
• to help the delivery of the placenta
• to prevent or control bleeding after delivery of your baby.
2. What you need to know before you receive
Syntometrine
You must not receive Syntometrine:
• if you are allergic to oxytocin, ergometrine or any of the
other ingredients of this medicine (listed in section 6)
• if you are pregnant or if you are in labour but the baby’s
shoulder still cannot be seen
• if your womb is not contracting properly
• 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.
Warnings and precautions
Talk to your doctor or midwife before you receive
Syntometrine if:
• you have raised blood pressure
• you have liver or kidney problems
• you have any heart problems, including ‘long QT
syndrome’ (irregular heartbeats)
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.
Other medicines and Syntometrine
Tell your doctor or midwife if you are taking or have recently
taken any of the following medicines as they may interfere
with Syntometrine:

• anaesthetics which you breathe in to put you to sleep
during surgery (e.g. halothane, cyclopropane, sevoflurane,
desflurane, isoflurane) as they could decrease the effect of
Syntometrine
• prostaglandins (used to start labour or to treat stomach
ulcers) and similar drugs as the effects of both drugs may
be increased
• vasoconstrictors (used to narrow the blood vessels and
decrease the flow of blood) and sympathomimetics (used
in the treatment of asthma, nasal congestion and low
blood pressure in emergency situations) as the effect of
the drug may be increased. This includes where these
types of medicines are part of a local anaesthetic
• medicines that can cause an irregular heartbeat
• antiviral drugs used to treat HIV, AIDS or hepatitis (e.g.
ritonavir, indinavir, nelfinavir, delavirdine, nevirapine)
• antifungal drugs (e.g. ketoconazole, itraconazole,
voriconazole)
• quinolones (antibacterial drugs, e.g. ciprofloxacin,
levofloxacin, ofloxacin)
• certain types of antibiotics (including troleandomycin,
erythromycin, clarithromycin, quinupristin, dalfopristin,
rifampicin)
• cimetidine (for ulcers and heartburn)
• ergot alkaloids (e.g. methysergide) or ergot derivatives,
used to treat headaches and migraines)
• triptans (e.g. sumatriptan, zolmitriptan, rizatriptan,
almotriptan, eletriptan), used to treat headaches and
migraines
• beta-blockers, used to treat certain heart or eye problems,
anxiety or prevent migraines
• anti-anginal medicines including glyceryl trinitrate
Please tell your doctor or midwife if you are taking or have
recently taken any other medicines, including medicines
obtained without a prescription.
Syntometrine with food and drink
Tell your doctor or midwife if you have recently had any
grapefruit juice. It is recommended that you do not drink
grapefruit juice around the same time as your treatment with
Syntometrine as these may interact.
Pregnancy and breast-feeding
Pregnancy:
You must not receive Syntometrine if you are pregnant or if
you are in labour but the baby’s shoulder still cannot be seen.
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.
Breast-feeding:
The ergometrine in Syntometrine may reduce breast milk
production, therefore repeated use should be avoided.
Driving and using machines
Taking Syntometrine can start labour. Women with
contractions should not drive or use machines.

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Syntometrine can cause the side effects of dizziness and low
blood pressure (symptoms of which are light-headedness
and blurred vision) in some people. If affected you should not
drive or use machinery.
Syntometrine contains sodium
This medicinal product contains less than 1 mmol sodium
(23 mg) per dose, i.e. essentially ‘sodium-free’.
3. How Syntometrine is given to you
Your doctor or midwife will decide when and how to treat
you with Syntometrine.
The usual dosage is different in the following circumstances:
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 pull gently on the umbilical cord to
help deliver the placenta.

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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.
If you have any further questions on the use of this product,
ask your doctor or midwife.
4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everyone gets them.
Tell your doctor or contact your nearest hospital straight
away if you notice or suspect any of the following
symptoms. You may need urgent medical treatment.
• Signs of a severe allergic reaction, such as:
- swelling of the face, tongue or throat
- difficulty breathing
- low blood pressure (which can cause fainting or
dizziness and lightheadedness)
- severe irritation, reddening or blistering of your skin
- collapse
- shock

• heart attack (which can cause chest pain or pain down
left arm)
Other side effects of Syntometrine include:
• headache
• dizziness
• an irregular or slow heartbeat
• chest pain
• high blood pressure
• feeling or being sick
• stomach pain
• rash
Reporting of side effects
If you get any side effects, talk to your doctor or midwife.
This includes any possible side effects not listed in this
leaflet. You can also report side effects directly via the
internet at www.mhra.gov.uk/yellowcard or call Freephone
0808 100 3352. By reporting side effects you can help
provide more information on the safety of this medicine
5. How to store Syntometrine
Keep this medicine out of the sight and reach of children.
The hospital pharmacy will store this medicine in a
refrigerator between 2° and 8°C and make sure that it is not
used after the expiry date on the pack. The expiry date refers
to the last day of that month. It will also be kept in the dark.
Syntometrine may be stored up to 25°C for 2 months when
protected from light, but must then be discarded.
If your doctor decides to stop your treatment, return any
unused medicine to the pharmacist. Only keep it if your
doctor tells you to.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist on how to dispose of
medicines no longer required. These measures will help
protect the environment.
6. Contents of the pack and other information
What Syntometrine contains
The active ingredients in this medicine are oxytocin and
ergometrine maleate.
The other ingredients are sodium chloride, maleic acid, water
for injections, chlorobutanol, sodium acetate trihydrate and
acetic acid.
What Syntometrine looks like and contents of the pack
Syntometrine is a clear, colourless, faintly bluish fluorescent
sterile liquid which comes in a 1 ml (millilitre) clear glass
ampoule. Syntometrine comes in packs of five ampoules.
Each 1ml ampoule contains 500 micrograms of ergometrine
maleate and 5 IU (International Units) of oxytocin.
Marketing Authorisation Holder and Manufacturer
The product licence holder is: Alliance Pharmaceuticals
Limited, Avonbridge House, Chippenham, Wiltshire, SN15
2BB, UK.
Syntometrine is manufactured by: Rotexmedica GmbH,
Arzneimittelwerk, Bunsenstrasse 4, 22946 Trittau, Germany.
The information in this leaflet applies only to Syntometrine.
If you have any questions or you are not sure about anything,
ask your doctor or a pharmacist.
This leaflet was last revised in December 2015
Syntometrine, Alliance and associated devices are registered
trademarks of Alliance Pharmaceuticals Limited.
© Alliance Pharmaceuticals Limited 2015.

The following information is intended for healthcare professionals only

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Syntometrine ® 500 micrograms/5IU Solution for Injection

ergometrine maleate and oxytocin
Indication

Active management of 3rd stage
of labour

Prevention and treatment of postpartum
haemorrhage

Method of Administration

Intramuscular injection of 1 ml after delivery of
the anterior shoulder, or at the latest,
immediately after delivery of the child.

Intramuscular injection of 1 ml following
expulsion of the placenta, or when bleeding
occurs.

Additional administration notes:

Expulsion of the placenta, which is normally
separated by the first strong uterine
contraction, should be assisted by controlled
cord traction.

In cases of severe haemorrhage due to uterine
atony only; intravenous administration of
Syntometrine is possible (0.5 to 1 ml by slow
injection).

Overdose
In the event of maternal intoxication the most likely symptoms would be those of ergometrine intoxication: nausea, vomiting, hypertension or
hypotension, vasospastic reactions, respiratory depression, convulsions, coma. Treatment would have to be symptomatic.
Accidental administration to the newborn infant has been reported and has proved fatal. In these accidental neonatal overdosage cases, symptoms
such as respiratory depression, convulsions, cyanosis, oliguria, hypertonia and heart arrhythmia have been reported. Treatment has been
symptomatic in most cases; respiratory and cardiovascular support have been required.
Storage
For prolonged periods store between 2° and 8°C. Protect from light. Syntometrine may be stored up to 25°C for 2 months when protected from
light, but must then be discarded.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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