Label: Information for the User

Atosiban SUN 37.5 mg/5 ml Concentrate for Solution for Infusion EFG

atosiban

Read this label carefully before starting to take this medicine, 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, midwife, or pharmacist.
• If you experience any side effects, consult your doctor or pharmacist. Even if they are not listed in this label. See section 4.

Atosiban SUN contains atosiban. Atosiban SUN is used to delay premature labor in your baby. Atosiban SUN is used in adult pregnant women, from week 24 to week 33 of pregnancy.

Atosiban SUN 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.

Do not administer Atosiban SUN

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

• 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 to start labor so your baby can be born immediately.
• If you have a condition called “severe preeclampsia” and your doctor wants 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 a condition called “eclampsia” which is similar to “severe preeclampsia” but you also have seizures. This means that labor should 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.

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

Warnings and precautions

Consult your doctor, midwife, or pharmacist before Atosiban SUN 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, Atosiban SUN treatment can be repeated up to three more times.
• If your baby is small for the duration of the pregnancy.
• Your uterus is unable to contract after the baby is 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 may increase the risk of fluid accumulation in the lungs (pulmonary edema).

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

Children and adolescents

Atosiban SUN has not been studied in women under 18 years old.

Use of Atosiban SUN 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 breastfeeding

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

Atosiban SUN will be administered to you 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.

Atosiban SUN is administered intravenously in three steps:

• A first intravenous injection of 6.75 mg in 0.9 ml is administered slowly into a vein over one minute.
• Then, a continuous infusion (drip) of 18 mg per hour is administered for 3 hours.
• After that, 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 Atosiban SUN may be administered if contractions recur. Treatment with Atosiban SUN can be repeated up to three times more.

During treatment with Atosiban SUN, your contractions and the baby's heart rate can be monitored.

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

Like all medications, this medication may produce adverse effects, although not all people may 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)

• Nausea (feeling of illness).

Common (affect less than 1 in 10 people)

• Headache.

• Dizziness.
• Heat sensation.
• Vomiting.
• Fast heart rate.
• Low blood pressure. Symptoms may include dizziness or feeling lightheaded.
• 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, midwife, or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the national notification system included in Appendix V.

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

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

Store in refrigerator (2° C - 8°C). The dilutions for intravenous administration should be used within 24 hours after preparation.

Store in original packaging to protect it from light.

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

Medications should not be thrown away through drains or trash. Ask your pharmacist how to dispose of empty containers. This will help protect the environment.

Atosiban SUN Composition

• The active ingredient is atosiban.
• Each vial of Atosiban SUN 37.5 mg/5 ml concentrated solution for infusion contains atosiban acetate equivalent to 37.5 mg of atosiban in 5 ml.
• The other components are mannitol, hydrochloric acid 1M, and water for injection preparations.

Product Appearance and Packaging Content

Atosiban SUN 37.5 mg/5 ml concentrated solution for infusion is a transparent, colorless solution without particles.

A package contains a vial containing 5 ml of solution.

Marketing Authorization Holder and Responsible Manufacturer

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH Hoofddorp

Netherlands

For more information about this medication, please contact the local representative of the marketing authorization holder.

Deutschland

Sun Pharmaceuticals Germany GmbH

Hemmelrather Weg 201

51377 Leverkusen

Deutschland

tel. +49 214 403 990

España

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya 53-55

08007 Barcelona

España

tel. +34 93 342 78 90

France

Sun Pharma France

31 Rue des Poissonniers

92200 Neuilly-Sur-Seine

France

tel. +33 1 41 44 44 50

Italia

Sun Pharma Italia Srl

Viale Giulio Richard, 3

20143 Milano

Italia

tel. +39 02 33 49 07 93

Polska

Ranbaxy (Poland) Sp. z. o. o.

ul. Idzikowskiego 16

00-710 Warszawa

Polska

tel. +48 22 642 07 75

România

Terapia S.A.

Str. Fabricii nr 124

Cluj-Napoca, Judetul Cluj

România

tel. +40 (264) 501 500

United Kingdom (Northern Ireland)

Ranbaxy UK Ltd, a Sun Pharma Company

Millington Road 11

Hyde Park, Hayes 3

5th Floor

UB3 4AZ HAYES

United Kingdom

tel. +44 (0) 208 848 8688

Last revision date of this leaflet

Other sources of information

For detailed information about this medication, please visit the European Medicines Agency website:http://www.ema.europa.eu.

INFORMATION FOR HEALTHCARE PROFESSIONALS ONLY

This information is intended for healthcare professionals only: (See also section 3).

Instructions for use:

Before using Atosiban SUN, the solution must be examined to ensure it is clear and free of particles.

Atosiban SUN 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.
• For 3 hours, a continuous infusion at a rate of 24 ml/hour is administered.
• For a maximum of 45 hours, or until uterine contractions have decreased, a continuous infusion at a rate of 8 ml/hour is administered.

The total duration of treatment should not exceed 48 hours. Additional treatment cycles with Atosiban SUN may be administered if contractions recur. It is recommended not to repeat treatment more than three times during a pregnancy.

Preparation of the intravenous infusion

The intravenous infusion is prepared by diluting Atosiban SUN 37.5 mg/5 ml, concentrated solution for 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 removing 10 ml from a 100 ml infusion bag and replacing it with 10 ml of Atosiban SUN 37.5 mg/5 ml, concentrated solution for infusion from two 5 ml vials to obtain a concentration of atosiban of 75 mg in 100 ml. If a different infusion bag volume is used, a proportional calculation must be performed for the preparation.

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