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SYNTOCINON 10 IU/ML CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance(s): OXYTOCIN

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2. What you need to know before you receive Syntocinon
PATIENT INFORMATION LEAFLET

Syntocinon® 5 IU/ml and 10 IU/ml
Concentrate for solution for infusion
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.
What is in this leaflet
1. What Syntocinon is and what it is used for
2. What you need to know before you receive Syntocinon
3. How Syntocinon is given to you
4. Possible side effects
5. How to store Syntocinon
6. Contents of the pack and other information
7. Information for the health care professional

1. What Syntocinon is and what it is used for
Syntocinon contains a manufactured form of oxytocin (a natural hormone). It belongs to a
group of medicines called oxytocics that make the muscles of the womb contract.
Syntocinon is used:
• to start or help contractions during childbirth (labour)
• to help in the management of a miscarriage
• to prevent and control bleeding after delivery of your baby
• during a caesarean section.

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You must not receive Syntocinon:
• if you are allergic to oxytocin or any of the ingredients of this medicine
(listed in section 6)
• if your doctor thinks that to start or increase contractions of the womb would be
unsuitable for you, for example:
–– where contractions of the womb are unusually strong
–– where there are obstructions that may prevent delivery
–– where your baby may be short of oxygen
• where labour or vaginal delivery is not advisable, for example:
–– if your baby’s head is too large to fit through your pelvis
–– if your baby is wrongly positioned in the birth canal
–– if the placenta lies near or over the neck of your womb
–– if your baby lacks oxygen due to blood vessels running across the neck of
your womb
–– if the placenta separates from the womb before the baby is born
–– if there are one or more loops of umbilical cord between the baby and the neck of
the womb, either before or after your waters break
–– if your womb is over-extended and more likely to tear, for example if you are
carrying more than one baby or have too much water (amniotic fluid) in
your womb
–– if you have had five or more pregnancies in the past or if your womb is scarred by
previous caesarean section or other surgery
• if you have been given medicines called prostaglandins (used to bring on labour or
treat stomach ulcers). Syntocinon should not be used for 6 hours after vaginal
prostaglandins as the effects of both medicines may be increased
Syntocinon should not be used for prolonged periods if:
• your contractions do not increase with the treatment
• you have a condition known as severe pre-eclampsia (high blood pressure, protein in
the urine and swelling)
• you have severe problems with your heart or blood circulation.

Warnings and precautions
Syntocinon should only be administered by a healthcare professional in a hospital setting.

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

Syntocinon should not be given as rapid injection into a vein as this may cause low blood
pressure, a sudden brief sensation of heat (often over the entire body), and an increased
heart rate.

Other medicines and Syntocinon
Tell your doctor or midwife if you are taking or have recently taken any of the following
medicines as they may interfere with Syntocinon:
• prostaglandins (used to start labour or to treat stomach ulcers) and similar drugs as
the effects of both drugs may be increased
• medicines that can cause an irregular heartbeat, as Syntocinon may increase this effect
• anaesthetics which you breathe in (e.g. to put you to sleep during surgery), such as
halothane, cyclopropane, sevoflurane or desflurane) as these may weaken your
contractions, or cause problems with your heartbeat
• anaesthetic medicines for local or regional pain relief, in particular an epidural for pain
relief during labour. Syntocinon may increase the blood vessel narrowing effect of these
medicines and cause an increase in blood pressure.

Before you receive Syntocinon tell your doctor or midwife if:
• you are prone to chest pain due to pre-existing heart and/or circulation problems
• you have a known irregular heart beat (‘long QT syndrome’) or related symptoms, or
are taking medicines known to cause the syndrome (see section ‘Other medicines and
Syntocinon’)
• you have had a previous caesarean section
• you are more than 35 years old
• you have raised blood pressure or heart problems
• your womb was contracting strongly but has now begun to contract less strongly
• you have been told by a doctor or midwife that normal delivery may be difficult for you
due to the small size of your pelvis
• you have kidney problems, as Syntocinon can cause water retention
• you have had complications during your pregnancy
• you are more than 40 weeks pregnant.
When Syntocinon is given to induce and enhance labour, the infusion rate should be set to
maintain a contraction pattern similar to normal labour and adjusted to individual
response. Too high doses may cause very strong continuous contractions and possibly
tearing of the womb, with serious complications for you and your baby.
Syntocinon may rarely cause disseminated intravascular coagulation which causes
symptoms including abnormal blood clotting, bleeding and anaemia.
High doses of Syntocinon may force amniotic fluid from your womb into your blood. This is
known as amniotic fluid embolism.
Large doses of Syntocinon over a long period of time, whilst drinking or receiving large
volumes of fluid may make your stomach feel very full, cause difficulty in breathing and
lower salt levels in your blood.

Please tell your doctor or midwife if you are taking or have recently taken any other
medicines, including medicines obtained without a prescription.
Syntocinon with food and drink
You may be told to keep the amount of fluids you drink to a minimum.
Pregnancy and breast-feeding
Based on wide experience of use and the nature of this medicine, it is not expected that
Syntocinon would be a risk to your baby when used correctly. Syntocinon may be found in
small amounts in breast milk but is not expected to have harmful effects because it is
quickly inactivated by your baby’s digestive system.
Driving and using machines
Syntocinon can start labour. Women with contractions should not drive or use
machines.
Syntocinon contains ethanol
Syntocinon contains small amounts of ethanol (alcohol), less than 100mg per dose.

The following information is intended for medical or healthcare
professionals only

Syntocinon® 5 IU/ml and 10 IU/ml Concentrate for
solution for infusion
oxytocin

The frequency, strength and duration of contractions as well as the foetal heart rate
must be carefully monitored throughout the infusion. Once an adequate level of uterine
activity is attained, aiming for 3 to 4 contractions every 10 minutes, the infusion rate
can often be reduced. In the event of uterine hyperactivity and/or foetal distress, the
infusion must be discontinued immediately.
Continued overleaf

Method of administration for each indication:
Induction or enhancement of labour
Oxytocin should not be started for 6 hours following administration of vaginal
prostaglandins. Syntocinon should be administered as an i.v. drip infusion or,
preferably, by means of a variable-speed infusion pump. For drip infusion it is
recommended that 5 IU of Syntocinon be added to 500ml of a physiological electrolyte
solution (such as sodium chloride 0.9%). For patients in whom infusion of sodium
chloride must be avoided, 5% dextrose solution may be used as the diluent. To ensure
even mixing, the bottle or bag must be turned upside down several times before use.
The initial infusion rate should be set at 1 to 4 milliunits/minute (2 to 8 drops/minute).
It may be gradually increased at intervals not shorter than 20 minutes and increments
of not more than 1-2 milliunits/minute, until a contraction pattern similar to that of
normal labour is established. In pregnancy near term this can often be achieved with
an infusion of less than 10 milliunits/minute (20 drops/minute), and the
recommended maximum rate is 20 milliunits/minute (40 drops/minute). In the
unusual event that higher rates are required, as may occur in the management of
foetal death in utero or for induction of labour at an earlier stage of pregnancy, when
the uterus is less sensitive to oxytocin, it is advisable to use a more concentrated
Syntocinon solution, e.g., 10 IU in 500ml.
When using a motor-driven infusion pump which delivers smaller volumes than those
given by drip infusion, the concentration suitable for infusion within the recommended
dosage range must be calculated according to the specifications of the pump.

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Method of administration for each indication, continued:
If, in women who are at term or near term, regular contractions are not established
after the infusion of a total amount of 5 IU, it is recommended that the attempt to
induce labour be ceased; it may be repeated on the following day, starting again from
a rate of 1 to 4 milliunits/minute.
Incomplete, inevitable or missed abortion
5 IU by i.v. infusion (5 IU diluted in physiological electrolyte solution and
administered as an i.v. drip infusion or preferably, by means of a variable-speed
infusion pump over 5 minutes), if necessary followed by i.v. infusion at a rate of
20 to 40 milliunits/minute.
Caesarean section
5 IU by i.v. infusion (5 IU diluted in physiological electrolyte solution and administered
as an i.v. drip infusion or, preferably, by means of a variable-speed infusion pump
over 5 minutes) immediately after delivery.
Prevention of postpartum uterine haemorrhage
The usual dose is 5 IU by i.v. infusion (5 IU diluted in physiological electrolyte
solution and administered as an i.v. drip infusion or, preferably, by means of a
variable-speed infusion pump over 5 minutes) after delivery of the placenta. In
women given Syntocinon for induction or enhancement of labour, the infusion should
be continued at an increased rate during the third stage of labour and for the next
few hours thereafter.
Treatment of postpartum uterine haemorrhage
5 IU by i.v. infusion (5 IU diluted in physiological electrolyte solution and administered
as an i.v. drip infusion or, preferably, by means of a variable-speed infusion pump
over 5 minutes), followed in severe cases by i.v. infusion of a solution containing
5 to 20 IU of oxytocin in 500ml of an electrolyte-containing diluent, run at the rate
necessary to control uterine atony.

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Note - Syntocinon should not be infused via the same apparatus as blood or plasma,
because the peptide linkages are rapidly inactivated by oxytocin- inactivating enzymes.
Syntocinon is incompatible with solutions containing sodium metabisulphite as a
stabiliser.
Storage - Store between 2° and 8°C. May be stored up to 30°C for 3 months, but must
then be discarded.
Syntocinon is a registered trademark of Novartis Pharmaceuticals Limited.

3. How Syntocinon is given to you
Your doctor or midwife will decide when and how to treat you with Syntocinon. If you think
that the effect of Syntocinon is too strong or too weak, tell your doctor or midwife. While
you are receiving Syntocinon, both you and your baby will be closely monitored.
Syntocinon is usually diluted before use and given as an intravenous infusion (drip) into
one of your veins.
The usual dose is different in the following circumstances:

Patients with kidney disease
There is no information on use in patients with kidney disease. However, you should tell
your doctor if you suffer from kidney problems (see section 2 ‘Warnings and precautions’)
Patients with liver disease
There is no information on use in patients with liver disease.

Caesarean section
The dose is 5 IU by infusion into a vein immediately after delivery of your baby.

What to do if you receive more Syntocinon 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 Syntocinon could cause:
• very strong contractions of your womb
• damage to your womb which could include tearing
• the placenta to come away from your womb
• amniotic fluid (the fluid around the baby) to enter your bloodstream
• harm to your baby.
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 further questions on the use of this medicine, ask your doctor or midwife.

Prevention of bleeding after delivery
The dose is 5 IU by infusion into a vein after delivery of the placenta.

4. Possible side effects

To start or help contractions during labour
The rate of infusion will start at 2 to 8 drops per minute. This may be gradually increased
to a maximum rate of 40 drops per minute. The infusion rate can often be reduced once
the contractions reach an adequate level, about 3-4 contractions every 10 minutes.
If your contractions do not reach the adequate level after 5 IU the attempt to start labour
should be stopped and then repeated the following day.
Miscarriage
The dose is 5 IU by infusion into a vein. In some cases this may be followed by a drip at
40 to 80 drops per minute.

Treatment of bleeding after delivery
The dose is 5 IU by infusion into a vein. In some cases this may be followed by a drip
containing 5 to 20 IU of oxytocin.
Elderly (65 years and over)
There is no information on use in elderly patients. Syntocinon is not intended for use in the
elderly.
Children and adolescents
There is no information on use in children (2-11 years) or adolescents (12-17 years).
Syntocinon is not intended for use in children or adolescents.

Like all medicines, Syntocinon can cause side effects, although not everyone gets them.
Your doctor may consider it necessary to treat the side effects of Syntocinon with other
medicines.
Some side effects could be serious. If any of the following occur, tell your doctor
straight away:
The following side effect may affect between 1 and 10 in every 10,000 patients:
• a severe allergic (anaphylactic/anaphylactoid) reaction with difficulty in breathing,
dizziness and lightheadedness, feeling faint, nausea, cold and clammy skin or a fast or
weak pulse
• Swelling of the face, lips, tongue, throat, and/or extremities (possible signs of angioedema)

The following side effects have been reported in Syntocinon
Common side effects (more than 1 in 100 patients) of Syntocinon include:
• feeling or being sick
• headache
• fast or slow heartbeat
Uncommon side effects (more than 1 in 1,000 patients) of Syntocinon include:
• an irregular heartbeat.
Rare side effects (more than 1 in 10,000 patients) of Syntocinon include:
• skin rashes
Other side effects
Effects in the mother:
• haemorrhage (bleeding)
• chest pain (angina)
• irregular heartbeat
• excessive or continuous contractions
• tearing of the womb
• fluid retention (water intoxication). Symptoms may include headache, anorexia (loss of
appetite), feeling or being sick, stomach pain, sluggishness, drowsiness,
unconsciousness, low levels of certain chemicals in the blood (e.g. sodium or
potassium), fits
• low blood salt levels
• sudden fluid overload in the lungs
• sudden brief sensation of heat often over the whole body
• abnormal clotting, bleeding and anaemia
• spasm of the muscles of the womb
Effects in the baby:
Excessive contractions may cause low blood salt levels, shortage of oxygen, suffocation
and death.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or midwife. This includes any
possible side effects not listed in this leaflet. You can also report side effects directly via

the Yellow Card Scheme (www.mhra.gov.uk/yellowcard). By reporting side effects you can
help provide more information on the safety of this medicine.

5. How to store Syntocinon
Keep this medicine out of the sight and reach of children.
The hospital pharmacy will store this medicine in a refrigerator between 2º to 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. Syntocinon may be stored at temperatures of up to 30°C for
3 months, 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 Syntocinon contains
The active substance is oxytocin.
The other ingredients are sodium acetate tri-hydrate, chlorobutanol, ethanol, acetic acid
and water for injections.
What Syntocinon looks like and contents of the pack
Syntocinon is a clear, colourless, sterile liquid which comes in a 1ml (millilitre) clear glass
ampoule. Syntocinon comes in packs of five ampoules. Each Syntocinon ampoule contains
either 5 IU (International Units) or 10 IU oxytocin.
Marketing Authorisation Holder and Manufacturer
Novartis Pharmaceuticals UK Ltd., Frimley Business Park, Frimley, Camberley, Surrey,
GU16 7SR, United Kingdom.
The information in this leaflet applies only to Syntocinon. If you have any questions or you
are not sure about anything, ask your doctor, midwife or a pharmacist.
This leaflet was last revised in February 2016
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27/01/2016 15:29

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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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