Label: information for the user

Tractocile 6.75 mg/0.9 ml injectable solution

atosiban

Read the label carefully before the medication is administered to you, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• Ifyouexperienceadverse effects, consult your doctor, or pharmacist,evenifthe adverse effectsdo notappearin this label. See section 4.

6.Contents of the package and additional information

Tractocile contains 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 the contractions of your uterus (womb) less strong. It also makes contractions occur less frequently. This occurs because the natural hormone called “oxytocin”, the hormone that contracts the uterus (womb), 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 of pregnancy or more.
• 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 your 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 may 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, midwife 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.
• SIf you are between 24 and 27 weeks pregnant.
• If you are pregnant with more than one baby.
• If you experience contractions again, Tractocile treatment may be repeated up to three times more.
• If your baby is small for the duration of the pregnancy.
• If your uterus, once the baby has been born, is unable to contract. This may 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 may increase the risk of pulmonary edema (accumulation of fluid 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 pregnant women under 18 years old.

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 a baby, breastfeeding should be interrupted during Tractocile treatment.

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

Tractocile will be administered intravenously in three stages:

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

The total duration of treatment should not exceed 48 hours.

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

Your contractions and the baby's heart rate can be monitored during Tractocile treatment.

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

Like all medications,this medicationmay cause adverse effects, although not all people will experience them.

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

The following adverse effects may occur with this medication:

Very Common(affect more than 1 in 10 people)

• Feeling of discomfort (nausea).

Common(affect less than 1 in 10 people)

• Headache.
• Dizziness.
• Redness.
• 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(affect less than 1 in 100 people)

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

Rare(affect 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 Adverse Effects:

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

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 original packaging to protect it from light.

Once the vial is opened, the product must be used immediately.

Do not use this medication if you observe particles or discoloration of the content before administration.

Composition of Tractocile

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

Appearance of Tractocile and contents of the package

Tractocile 6.75 mg/0.9 ml injectable solution is a clear, colorless solution without particles. A package contains a vial containing 0.9 ml of solution.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Ferring Pharmaceuticals A/S

Amager Strandvej 4052770 KastrupDenmark

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 holder of the marketing authorization.

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 intendedonlyfor 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:

• An initial injection of 6.75 mg in 0.9 ml is administered slowly into a vein over one minute.
• For 3 hours, a continuous infusion is administered at a rate of 24 ml/hour.
• For a maximum of 45 hours, or until uterine contractions have decreased, a continuous infusion is administered 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 repeat treatment more than three times during a pregnancy.