Atosiban SUN 6.75 mg/0.9 ml injectable solution

2. What you need to know before you are given Atosiban SUN

You should not be given Atosiban SUN

• If you are allergic to atosiban or any of the other ingredients of this medicine (listed in section 6).
• If you are pregnant for less than 24 weeks.

• If you are pregnant for more than 33 weeks.
• If your waters have broken (premature rupture of your 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 go into labor so that your baby can be born immediately.
• If you have something called "severe pre-eclampsia" and your doctor wants you to go into labor so that your baby can be born immediately. Severe pre-eclampsia 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 pre-eclampsia" but you also have seizures. This means that labor should be started so that your baby can be born immediately.
• If your baby has died.

• If you have or may have an infection in the uterus (womb).
• 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 dangerous to continue with the pregnancy.

Do not use Atosiban SUN if you are affected by any of these situations. If you are not sure, tell your doctor, midwife or pharmacist before you are given Atosiban SUN.

Warnings and precautions

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

• If you think your waters 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 you have contractions again, treatment with Atosiban SUN can be repeated up to three times more.
• If your baby is small for the duration of the pregnancy.
• Your uterus is not able to contract after the birth of the baby. This can cause bleeding.
• If you are pregnant with more than one baby and/or are taking medications that can delay the birth of your baby, such as medications used for high blood pressure. This can increase the risk of fluid accumulation in the lungs (pulmonary edema).

If you have any of these conditions (or are unsure), tell your doctor, midwife or pharmacist before you are given Atosiban SUN.

Children and adolescents

Atosiban SUN has not been studied in pregnant women under 18 years of age.

Using Atosiban SUN with other medicines

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

Pregnancy and breastfeeding

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

3. How Atosiban SUN will be given to you

Atosiban SUN 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 that the solution is clear and free of particles.

Atosiban SUN is given into a vein (intravenously) in three stages:

• A first intravenous injection of 6.75 mg in 0.9 ml is given slowly into a vein over one minute.
• Then, a continuous infusion (drip) of a dose of 18 mg per hour is given for 3 hours.
• Then, a continuous infusion (drip) of a dose of 6 mg per hour is given for up to 45 hours, or until the uterine contractions have stopped.

The total duration of treatment should not be more than 48 hours.

More treatments with Atosiban SUN can be given if you have contractions again. Treatment with Atosiban SUN can be repeated up to three times more.

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

It is recommended not to repeat treatment more than three times 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 mothers were generally mild. There are no known side effects on the fetus or newborn.

The following side effects may occur with this medicine:

Very common (affect more than 1 in 10 people)

• Feeling sick (nausea).

Common (affect less than 1 in 10 people)

• Headache.

• Feeling dizzy.
• Flushes.
• Being sick (vomiting).
• Fast heart rate.
• Low blood pressure. The signs may include feeling dizzy or lightheaded.
• Reaction at the injection site.
• Increased blood sugar.

Uncommon (affect less than 1 in 100 people)

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

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

• Your uterus is not able to contract after the birth of the baby. This can cause bleeding.

• Allergic reactions.

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

Reporting of side effects

If you experience any side effects, talk to your doctor, midwife or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Atosiban SUN

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 is the last day of the month shown.

Store in a refrigerator (2°C - 8°C). Once the vial is opened, the medicine should be used immediately.

Store in the original packaging to protect from light.

Do not use this medicine if you notice particles or discoloration of the contents before administration.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

Composition of Atosiban SUN

• The active substance is atosiban.
• Each vial of Atosiban SUN 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 1M and water for injections.

Appearance and packaging of the product

Atosiban SUN 6.75 mg/0.9 ml solution for injection is a clear, colorless solution without particles.

A pack contains one vial containing 0.9 ml of solution.

Marketing authorisation holder and manufacturer

Sun Pharmaceutical Industries Europe B.V

Polarisavenue 87

2132 JH Hoofddorp

Netherlands

You can request more information about this medicine from the local representative of the marketing authorisation holder.

Germany

Sun Pharmaceuticals Germany GmbH

Hemmelrather Weg 201

51377 Leverkusen

Germany

tel. +49 214 403 990

Spain

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya 53-55

08007 Barcelona

Spain

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

Italy

Sun Pharma Italia Srl

Viale Giulio Richard, 3

20143 Milano

Italy

tel. +39 02 33 49 07 93

Poland

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

ul. Idzikowskiego 16

00-710 Warszawa

Poland

tel. +48 22 642 07 75

Romania

Terapia S.A.

Str. Fabricii nr 124

Cluj-Napoca, Judetul Cluj

Romania

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

Date of last revision of this leaflet:

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.

Information intended 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 should 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 given slowly into a vein over one minute.

• A continuous infusion is given for 3 hours at a rate of 24 ml/hour.

• A continuous infusion is given for up to 45 hours, or until the uterine contractions have stopped, at a rate of 8 ml/hour.

The total duration of treatment should not be more than 48 hours. New cycles of treatment with Atosiban SUN can be given if contractions occur again. It is recommended not to repeat treatment more than three times during a pregnancy.