Tractocile 7.5 mg/ml Solution for Injection

• 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.

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

• 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.

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.

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

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

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

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

Ireland

• The active substance is atosiban.
• Each vial of Tractocile 6.75 mg/0.9 ml solution for injection contains atosiban acetate equivalent to 6.75 mg of atosiban in 0.9 ml.
• The other ingredients are mannitol, hydrochloric acid and water for injections.

Tractocile 6.75 mg/0.9 ml solution for injection is a clear, colourless solution without particles. One pack contains one vial containing 0.9 ml solution.

EU/1/99/124/001

PLGB 03194/0137