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SYNTOCINON 10 IU/ML CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance: 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

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.

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-eclamptic toxaemia (high blood
pressure, protein in the urine and swelling)
• you have severe problems with your heart or blood circulation.

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Comp. Description: LEAFLET SYNTOCINON LIAM GB
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Format/Dimension: 594 x 148mm
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If any of the above applies to you, or if you are not sure, speak to your doctor or
midwife before you receive Syntocinon.

The following information is intended for medical or healthcare
professionals only

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

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

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.

oxytocin
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.
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

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Warnings and precautions
Syntocinon should only be administered by a healthcare professional in a hospital
setting.
Syntocinon should not be given as rapid injection into a vein as this may cause
decreased blood pressure, a sudden brief sensation of heat (often over the entire
body), and an increased heart rate.
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.

Laura Broadbent

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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.

Note - Syntocinon should not be infused via the same apparatus as blood or
plasma, because the peptide linkages are rapidly inactivated by oxytocininactivating 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.

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.

Syntocinon contains ethanol
Syntocinon contains small amounts of ethanol (alcohol), less than 100mg per dose.

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.

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:

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

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.

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

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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.
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.

4. Possible side effects

Like all medicines, Syntocinon can cause side effects, although not everyone
gets them.
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
• a severe allergic reaction with difficulty in breathing, dizziness and lightheadedness,
feeling faint, nausea, cold and clammy skin or a fast or weak pulse
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.

If you get any side effects, talk to your doctor or midwife. This includes any possible
side effects not listed in this leaflet.

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 November 2014.
2163724 GB

23/02/2015 10:44

The Maltings

Brewery House,
The Maltings,
Silvester Street
Kingston-Upon-Hull
HU1 3HA
Tel: +44 (0) 1482 973000

x Yes
Live Text:
/
No
WO:
1359213
Comp. Description: LEAFLET SYNTOCINON LIAM GB
Comp. Number New: 2163724 GB
Comp. Number Old: n/a
Format/Dimension: 594 x 148mm
Tech. Drawing No.: 799.4.9166/07

/

Both

Production Site:
CTM:
Printing Colours:

Stein
Cowx, Hans
PANTONE 314 C

Technical Colours: Cutting
Dimensions

Minimum Font Size: 10.0pt
Font Type: News Gothic
23/02/2015

Elderly (65 years and over)
There is no information on use in elderly patients. Syntocinon is not intended for use
in the elderly.

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.

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.

Proof Number: 3
Braille:

Driving and using machines
Syntocinon can start labour. Women with contractions should not drive or use
machines.

Laura Broadbent

! P LEASE TU R N OV E R P R I N T I N G O N !
598920_1

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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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