Package Leaflet: Information for the User

Tractocile 37.5 mg/5 ml Concentrate for Solution for Infusion

atosiban

Read the entire package leaflet carefully before you are given the medicine because it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• If you experience any side effects, consult your doctor or pharmacist even if they are not listed in this package leaflet. See section 4.

1.What is Tractocile and what it is used for

2.What you need to know before you are given Tractocile

3.How you will be given Tractocile

4.Possible side effects

5.Storage of Tractocile

6.Contents of the pack and other information

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

Tractocile works by making uterine (uterus) contractions less strong. It also makes contractions occur less frequently. This occurs because the natural hormone called “oxytocin”, the hormone that contracts the uterus, is prevented from acting.

No 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 membranes) and you have completed 30 weeks or more of pregnancy.
• If your baby (fetus) has an abnormal heart rate.
• If you are bleeding from the vagina and your doctor wants you to start labor so your baby can be born immediately.
• If you have something called “severe preeclampsia” and your doctor wants you to start labor so your baby can be born immediately. Severe preeclampsia is when you have very high blood pressure, fluid retention and/or protein in the urine.
• If you have something called “eclampsia” which is similar to “severe preeclampsia” but you will also have seizures. This will mean that labor must start so your baby can be born immediately.
• If your baby has died.
• If you have or may have an infection in the uterus.
• If your placenta is blocking the birth canal.
• If your placenta is separating from the wall of your uterus.
• If you or your baby have other conditions that could be hazardous to continue with the pregnancy.

-SIf you are allergic to atosiban or any of the other components of this medication (listed in section 6).

Do not use Tractocile if you are affected by any of these situations. If you are unsure, inform your doctor, nurse or pharmacist before Tractocile is administered to you.

Warnings and precautions

Consult with your doctor, midwife or pharmacist before Tractocile is administered to you:

• If you think your waters have broken (premature rupture of 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 you experience contractions again, Tractocile treatment can be repeated up to three more times.
• If your baby is small for the duration of pregnancy.
• If your uterus is unable to contract once the baby has been born. This can cause bleeding.
• If you are pregnant with more than one baby and/or taking medications that may delay your baby's birth, such as medications used for high blood pressure. This can increase the risk of pulmonary edema (fluid accumulation in the lungs).

If you have any of these situations (or are unsure), inform your doctor, midwife or pharmacist before Tractocile is administered to you.

Children and adolescents

Tractocile has not been studied in women under 18 years of age who are pregnant.

Use of Tractocile with other medications:

Inform your doctor, midwife or pharmacist if you are taking, have taken recently or may need to take any other medication.

Pregnancy and lactation

If you are pregnant and breastfeeding, you should stop breastfeeding during Tractocile treatment.

Tractocile will be administered in a hospital by a doctor, nurse, or midwife. They will decide how much you need. They will also ensure that the solution is clear and free of particles.

Tractocile is administered intravenously in three successive stages:

• A first intravenous injection of 6.75 mg in 0.9 ml is administered slowly over one minute.
• Then, a continuous infusion (drip) of 18 mg per hour is administered for 3 hours.
• Next, a continuous infusion (drip) of 6 mg per hour is administered for a maximum of 45 hours, or until uterine contractions have stopped.

The total duration of treatment should not exceed 48 hours.

Additional treatments with Tractocile can be administered if contractions recur. Tractocile treatment can be repeated up to three times.

During Tractocile treatment, contractions and fetal heart rate can be monitored.

It is recommended not to repeat treatment more than three times during a pregnancy.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

The side effects observed in mothers were generally of mild intensity. There are no known side effects on the fetus or newborn.

The following side effects may occur with this medicine:

Very common(affects more than 1 in 10 people)

• Feeling unwell (nausea).

Common(affects less than 1 in 10 people)

• Headache.
• Dizziness.
• Flushing.
• Being sick (vomiting).

-Fast heart rate.

-Low blood pressure. Symptoms may include dizziness or feeling dizzy.

-Reaction at the injection site.

-Increased blood sugar.

Uncommon(affects less than 1 in 100 people)

• Increased temperature (fever).
• Difficulty sleeping (insomnia).
• Itching.
• Rash.

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

• The uterus is unable to contract after the birth of the baby. This may cause bleeding.

-Allergic reactions.

You may experience difficulty breathing or pulmonary edema (fluid accumulation in the lungs), particularly if you are pregnant with more than one baby and/or are being treated with other medications that may delay the birth of your baby, such as medications used to treat high blood pressure.

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: http;//www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medicationafter the expiration date that appears onthe label after CAD.The expiration date is the last day of the month indicated.

Store in refrigerator (2° C – 8° C).

Store in the original packaging to protect it from light.

Solutions for intravenous administration must be used within 24 hours of preparation.

Do not use this medication if particles or discoloration of the content are observed before administration.

Composition of Tractocile

• The active principle is atosiban.
• Each vial of TRACTOCILE 37.5 mg/5 ml concentrated solution for intravenous infusion contains atosiban acetate equivalent to 37.5 mg of atosiban in 5 ml.
• The other components are mannitol, hydrochloric acid, and water for injection.

Appearance of Tractocile and contents of the package

Tractocile 37.5 mg/5 ml concentrated solution for intravenous infusion is a clear, colorless solution without particles. A package contains a vial containing 5 ml of solution.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Ferring Pharmaceuticals A/S

Amager Strandvej 4052770 Kastrup

Denmark

Tel: +45 88 33 88 34

Responsible for manufacturing:

Ferring GmbH

Wittland 11

D-24109 Kiel

Germany

You can request more information about this medication by contacting the local representative of the marketing authorization holder.

Last review date of thisleaflet:

The detailed information about this medication is available on the website of the European Medicines Agency:http://www.ema.europa.eu.

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This information is intended solely for healthcare professionals:

(See also section 3).

Instructions for use:

Before using Tractocile, the solution should be examined to ensure it is clear and free of particles.

Tractocile is administered intravenously in three successive stages:

• Administered slowly into a vein an initial injection of 6.75 mg in 0.9 ml, over one minute.
• Administered over 3 hours, a continuous infusion at a rate of 24 ml/hour.
• Administered for a maximum of 45 hours, or until uterine contractions have decreased, a continuous infusion at a rate of 8 ml/hour.

The total duration of treatment should not exceed 48 hours. New cycles of treatment with Tractocile may be administered if contractions recur. It is recommended not to use the treatment more than three times during a pregnancy.

Preparation of the intravenous infusion

The intravenous infusion is prepared by diluting Tractocile 37.5 mg/5 ml, concentrated solution for intravenous infusion in a sodium chloride 9 mg/ml (0.9%) injection solution, a lactate Ringer solution, or a 5% glucose solution. This is achieved by extracting 10 ml of solution from a 100 ml infusion bag and replacing it with 10 ml of Tractocile 37.5 mg/5 ml, concentrated solution for intravenous infusion from two 5 ml vials to obtain a concentration of atosiban of 75 mg in 100 ml. If an infusion bag of a different volume is used, a proportional calculation should be performed for the preparation.

Tractocile should not be mixed with other medications in the infusion bag.