Syntocinon (oxytocin) – not marketed in Serbia: what it is used for and which oxytocin is used in Serbia

Syntocinon is a medicine containing oxytocin, a synthetic form of the hormone that is produced naturally in the body and plays a key role in childbirth and breastfeeding. Oxytocin stimulates rhythmic contractions of the uterine muscle, and after birth it helps the uterus to contract and reduces bleeding.

In countries where it is authorised, for example in Spain (Syntocinon 10 IU/mL solution for injection and infusion, marketing authorisation holder Alfasigma S.p.A.), the medicine is used, according to the official Summary of Product Characteristics, to induce and strengthen labour for medical reasons and to prevent and treat bleeding after childbirth. It is given only in hospital, under continuous supervision of healthcare staff. All information on this page comes from the official documents listed in the sources.

What is Syntocinon, when is it used and which oxytocin is used in Serbia?

Key facts about the medicine

What is oxytocin used for?

According to the Summary of Product Characteristics (Syntocinon, Spain 2026; Oxytocin synthetic, ALIMS 2023):

• before birth: induction of labour for medical reasons – for example in post-term pregnancy, premature rupture of the membranes or high blood pressure in pregnancy (pre-eclampsia); strengthening weak contractions during labour
• after birth: prevention and treatment of bleeding caused by insufficient contraction of the uterus, after vaginal birth and caesarean section
• according to the documents of the medicine authorised in Serbia, also as additional treatment in incomplete or missed miscarriage, and for the diagnostic oxytocin challenge test in high-risk pregnancies

How is it used?

To induce or strengthen labour, oxytocin is given only as an intravenous drip infusion, preferably with an infusion pump, with continuous monitoring of contractions and the baby's heartbeat. The infusion rate is increased gradually according to the response of the uterus. After birth it can also be given intramuscularly or by slow infusion. The medicine is never given quickly as an intravenous (bolus) injection.

This information describes the official product information and is not an individual recommendation – the dose is decided by the doctor according to the official instructions.

Important safety information from the official documents

• The medicine must not be used in hypersensitivity to oxytocin, in excessively strong (hypertonic) uterine contractions, in fetal distress when delivery is not imminent, and when vaginal birth is not possible (for example marked disproportion between the baby's head and the pelvis, abnormal fetal position, placenta praevia, cord prolapse).
• It is not used within 6 hours after vaginal prostaglandins; using it at the same time as other medicines that stimulate contractions may cause excessive contractions and rupture of the uterus.
• Excessive stimulation of the uterus can be dangerous for both mother and baby – continuous monitoring in the delivery ward is therefore mandatory.
• Because of its mild antidiuretic effect, long use of high doses with large volumes of fluid can cause "water intoxication" (low blood sodium) and pulmonary oedema.
• Caution in heart disease, long QT syndrome and with medicines that prolong the QT interval.
• Anaphylactic reactions after oxytocin have been reported in women with latex allergy.
• Rarely, pharmacological induction of labour increases the risk of disseminated intravascular coagulation (DIC), especially in women over 35, with pregnancy complications or a pregnancy longer than 40 weeks.
• Breastfeeding: small amounts of oxytocin pass into the milk, but no harmful effect on the baby is expected because it is quickly broken down in the baby's digestive tract.
• Possible side effects in the mother: headache, nausea, vomiting, fast or slow heartbeat, rhythm disorders, fall or rise in blood pressure; serious but rare: excessive contractions, uterine rupture, water intoxication and severe allergic reactions.

What is available in Serbia?

Oxytocin is not a medicine that is bought in a pharmacy or used at home. The decision to use it during and after labour is made by the obstetrician, and the medicine is given by healthcare staff in the delivery ward.

Composition, pack and manufacturer

• Active substance: oxytocin 10 IU in 1 mL of solution (ampoule).
• Syntocinon (Spain): marketing authorisation holder Alfasigma S.p.A., Bologna, Italy; the medicine contains less than 23 mg sodium per mL.
• Medicine authorised in Serbia (Oksitocin Gedeon Richter): clear, colourless solution; 1 mL ampoules; excipient with known effect – ethanol (40 mg/mL, less than 100 mg per dose); authorisation holder Representative Office of Richter Gedeon Nyrt, Belgrade.

Storage

• Store in a refrigerator at 2 °C to 8 °C, in the original package (protected from light).
• Syntocinon (Spain): unopened ampoules may also be kept for up to 3 months below 25 °C.
• The medicine is stored and prepared by healthcare staff.

Frequently asked questions

Can Syntocinon be bought in Serbia?

No. Syntocinon has no marketing authorisation in Serbia and is not listed in the National Register of Medicines. The oxytocin authorised in Serbia (Gedeon Richter) is used only in healthcare institutions and is not supplied by pharmacies.

Which oxytocin is used in maternity wards in Serbia?

Oxytocin 10 IU/mL made by Gedeon Richter is authorised in Serbia, formerly under the name Oxytocin synthetic and since 2024 under the name Oksitocin Gedeon Richter. It contains the same active substance and strength as Syntocinon.

Why is oxytocin not given at home?

To induce labour, oxytocin is given only by intravenous infusion, with continuous monitoring of contractions, the baby's heartbeat and the mother's blood pressure, because excessively strong contractions can be dangerous for mother and baby.

Does oxytocin pass into breast milk?

According to the official documents, small amounts of oxytocin may pass into the milk, but no harmful effect on the baby is expected, because oxytocin is quickly broken down in the baby's digestive tract.

Sources

• CIMA/AEMPS (Spain) – Summary of Product Characteristics Syntocinon 10 IU/mL (revised 06/2026, Spanish)
• ALIMS – Summary of Product Characteristics Oxytocin synthetic 10 IU/mL (February 2023, Serbian)
• ALIMS – Package leaflet Oxytocin synthetic 10 IU/mL (February 2023, Serbian)
• ALIMS – New authorisations and renewals 16 January–28 February 2023 (Oxytocin synthetic, Serbian)
• ALIMS – Change of medicine name 1 July 2024–31 March 2025 (Oksitocin Gedeon Richter, Serbian)
• ALIMS – National Register of Medicines 2019 (Serbian)
• ALIMS – National Register of Medicines 2021 (Serbian)

Sources checked on: 23 October 2026.