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Tractocile 7.5 mg/ml Concentrate for Solution for Infusion

Active Ingredient:
atosiban acetate
Company:  
Ferring Pharmaceuticals Ltd See contact details
ATC code: 
G02CX01
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About Medicine
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Prescription only medicine
Healthcare Professionals (SmPC) Patient Leaflet (PIL)
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The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine.
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Last updated on emc: 04 Aug 2025
{pdf} View or print the patient leaflet as PDF

Below is a text only representation of the Patient Information Leaflet (ePIL).

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on {phone} 0800 198 5000. The product code(s) for this leaflet is: PLGB 03194/0137.

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Tractocile 7.5 mg/ml Concentrate for Solution for Infusion

Package leaflet: Information for the user

Tractocile®

37.5 mg/5 ml concentrate for solution for infusion

Atosiban

Read all of this leaflet carefully before you are given 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Tractocile is and what it is used for
2. What you need to know before you are given Tractocile
3. How Tractocile will be given
4. Possible side effects
5. How to store Tractocile
6. Contents of the pack and other information

1. What Tractocile is and what it is used for

Tractocile contains atosiban. Tractocile can be used to delay the premature birth of your baby. Tractocile is used in pregnant adult women, from week 24 to week 33 of the pregnancy.

Tractocile works by making the contractions in your womb (uterus) less strong. It also makes the contractions happen less often. It does this by blocking the effect of a natural hormone in your body called “oxytocin” which causes your womb (uterus) to contract.

2. What you need to know before you are given Tractocile
Do not use Tractocile:
  • if you are less than 24 weeks pregnant.
  • if you are more than 33 weeks pregnant.
  • if your waters have broken (premature rupture of your membranes) and you have completed 30 weeks of your pregnancy or more.
  • if your unborn baby (foetus) has an abnormal heart rate.
  • if you have bleeding from your vagina and your doctor wants your unborn baby to be delivered straight away.
  • if you have something called “severe pre-eclampsia” and your doctor wants your unborn baby to be delivered straight away. Severe pre-eclampsia is when you have very high blood pressure, fluid retention and/or protein in your urine.
  • if you have something called “eclampsia” which is similar to “severe pre-eclampsia” but you would also have fits (convulsions). This will mean your unborn baby needs to be delivered straight away.
  • if your unborn baby has died.
  • if you have or could have an infection of your womb (uterus).
  • if your placenta is covering the birth canal.
  • if your placenta is detaching from the wall of your womb.
  • if you or your unborn baby have any other conditions where it would be dangerous to continue with your pregnancy.
  • if you are allergic to atosiban or any of the other ingredients of this medicine (listed in section 6).

Do not use Tractocile if any of the above apply to you. If you are not sure, talk to your doctor, midwife or pharmacist before you are given Tractocile.

Warnings and precautions

Talk to your doctor, midwife or pharmacist before you are given Tractocile:

  • if you think your waters might have broken (premature rupture of your membranes).
  • if you have kidney or liver problems.
  • if you are between 24 and 27 weeks pregnant.
  • if you are pregnant with more than one baby.
  • if your contractions start again, treatment with Tractocile can be repeated up to three more times.
  • if your unborn baby is small for the time of your pregnancy.
  • Your womb may be less able to contract after your baby has been born. This may cause bleeding.
  • if you are pregnant with more than one baby and/or are given medicines that can delay the birth of your baby, such as medicines used for high blood pressure. This may increase the risk of lung oedema (accumulation of fluid in the lungs).

If any of the above apply to you (or you are not sure), talk to your doctor, midwife or pharmacist before you are given Tractocile.

Children and adolescents

Tractocile has not been studied in pregnant women less than 18 years old.

Other medicines and Tractocile

Tell your doctor, midwife or pharmacist if you are taking, have recently taken or might take any other medicines.

Pregnancy and breast-feeding

If you are pregnant and breast-feeding an earlier child, you should stop breast-feeding while you are given Tractocile.

3. How Tractocile will be given

Tractocile will be given to you in a hospital by a doctor, nurse or midwife. They will decide how much you need. They will also make sure the solution is clear and free from particles.

Tractocile will be given into a vein (intravenously) in three stages:

  • The first injection of 6.75 mg in 0.9 ml will be slowly injected into your vein over one minute.
  • Then a continuous infusion (drip) will be given at a dose of 18 mg per hour for 3 hours.
  • Then another continuous infusion (drip) at a dose of 6 mg per hour will be given for up to 45 hours, or until your contractions have stopped.

Treatment should last no longer than 48 hours in total.

Further treatment with Tractocile can be used if your contractions start again. Treatment with Tractocile can be repeated up to three more times.

During treatment with Tractocile, your contractions and your unborn baby’s heart rate may be monitored.

It is recommended that no more than three re-treatments should be used during a pregnancy.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The side effects seen in the mother are generally of a mild severity. There are no known side effects on the unborn or new-born baby.

The following side effects may happen with this medicine:

Very common (affects more than 1 in 10 people)

  • feeling sick (nausea)

Common (affects less than 1 in 10 people)

  • headache
  • feeling dizzy
  • hot flushes
  • being sick (vomiting)
  • fast heartbeat
  • Low blood pressure. Signs may include feeling dizzy or light-headed.
  • A reaction at the site where the injection was given.
  • high blood sugar

Uncommon (affects less than 1 in 100 people)

  • high temperature (fever)
  • difficulty sleeping (insomnia)
  • itching
  • rash

Rare (affects less than 1 in 1,000 people)

  • Your womb may be less able to contract after your baby has been born. This may cause bleeding.
  • allergic reactions

You may experience shortness of breath or lung oedema (accumulation of fluid in the lungs), particularly if you are pregnant with more than one baby and/or are given medicines that can delay the birth of your baby, such as medicines used for high blood pressure.

Reporting of side effects

If you get any side effects, talk to your doctor, midwife or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see below). By reporting side effects you can help provide more information on the safety of this medicine.

United Kingdom

Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard

Ireland

HPRA Pharmacovigilance,
Website: www.hpra.ie.

5. How to store Tractocile

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label after EXP. The expiry date refers to the last day of that month.

Store in a refrigerator (2°C - 8°C).

Store in the original package in order to protect from light.

Dilutions for intravenous administration must be used within 24 hours after preparation.

Do not use this medicine if you notice particulate matter and discoloration prior to administration.

6. Contents of the pack and other information
What Tractocile contains
  • The active substance is atosiban.
  • Each vial of Tractocile 37.5 mg/5 ml concentrate for solution for infusion contains atosiban acetate equivalent to 37.5 mg of atosiban in 5 ml.
  • The other ingredients are mannitol, hydrochloric acid and water for injections.

What Tractocile looks like and contents of the pack

Tractocile 37.5 mg/5 ml concentrate for solution for infusion is a clear, colourless solution without particles. One pack contains one vial containing 5 ml solution.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder in EU:

Ferring Pharmaceuticals A/S
Amager Strandvej 405
2770 Kastrup
Denmark
Tel: +45 88 33 88 34

EU/1/99/124/002

Marketing Authorisation Holder in GB:

Ferring Pharmaceuticals Ltd
Drayton Hall
Church Road
West Drayton
UB7 7PS
United Kingdom

PLGB 03194/0136

Manufacturer:

Ferring GmbH
Wittland 11
D-24109 Kiel
Germany

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

United Kingdom (Great Britain)
Ferring Pharmaceuticals Ltd.
Tel: +44 844 931 0050
Email: [email protected]

United Kingdom (Northern Ireland)
Ferring Ireland Ltd.
Tel: +353 1 4637355
Email: [email protected]

This leaflet was last revised in April 2022.

Detailed information on this medicine is available on the European Medicines Agency web site:

http://www.ema.europa.eu.

Tractocile, FERRING and the FERRING Logo are trademarks of Ferring B.V.© 2022 Ferring B.V.

5009000994

Ferring Pharmaceuticals Ltd
Company image
Address
Drayton Hall, Church Road, West Drayton, UB7 7PS, UK
Telephone
+44 (0)844 931 0050
Fax
+44 (0)844 931 0051
Medical Information e-mail
[email protected]
WWW
http://www.ferring.co.uk
Customer Care direct line
0800 111 4125