Atosiban SUN 37.5 mg/5 ml concentrate for infusion solution EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Atosiban SUN 37.5 mg/5 ml concentrate for solution for infusion EFG

atosiban

Read all of this leaflet carefully before you are given this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, midwife or pharmacist.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Atosiban SUN is and what it is used for
2. What you need to know before you are given Atosiban SUN
3. How Atosiban SUN will be administered to you
4. Possible side effects
5. How to store Atosiban SUN
6. Contents of the pack and other information

1. What Atosiban SUN is and what it is used for

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

Atosiban SUN works by making the contractions of your uterus (womb) less strong. It also makes contractions occur less frequently. This happens because it blocks the action of a natural hormone called "oxytocin", which is the hormone that causes the womb (uterus) to contract.

2. What you need to know before Atosiban SUN is administered to you

Do not administer Atosiban SUN to you if:

• You are allergic to atosiban or to any of the other ingredients of this medicine (listed in section 6).

• You are pregnant for less than 24 weeks.

• You are pregnant for more than 33 weeks.

• You have experienced rupture of membranes (premature rupture of membranes) and are at or beyond 30 weeks of pregnancy.

• Your baby (fetus) has an abnormal heartbeat.

• You are experiencing vaginal bleeding and your doctor has decided to induce labor so your baby is born immediately.

• You have a condition called "severe preeclampsia" and your doctor has decided to induce labor so your baby is born immediately. Severe preeclampsia is when you have very high blood pressure, fluid retention, and/or protein in the urine.

• You have a condition called "eclampsia," which is similar to "severe preeclampsia" but also includes seizures. This means labor must be induced so your baby is born immediately.

• Your baby has died.

• You have or may have an infection in the uterus.

• Your placenta is blocking the birth canal.

• Your placenta is detaching from the wall of your uterus.

• You or your baby have other conditions that could make continuing the pregnancy dangerous.

Do not use Atosiban SUN if any of these situations apply to you. 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 you have experienced rupture of membranes (premature rupture of membranes).

• If you have kidney or liver problems.

• If you are between 24 and 27 weeks pregnant.

• If you are carrying more than one baby.

• If you experience contractions again, treatment with Atosiban SUN may be repeated up to three additional times.

• If your baby is small for the gestational age.

• If your uterus is unable to contract after delivery. This may cause bleeding.

• If you are carrying more than one baby and/or are taking medications that may delay delivery, such as medications used for high blood pressure. This may increase the risk of pulmonary edema (fluid accumulation in the lungs).

If any of these situations apply to you (or if you 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 pregnant women under 18 years of age.

Use of Atosiban SUN with other medicines

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

Pregnancy and breastfeeding

If you are pregnant and breastfeeding, breastfeeding must be discontinued during treatment with Atosiban SUN.

3. How Atosiban SUN will be administered to you

Atosiban SUN will be administered to you in a hospital by a doctor, nurse, or midwife. They will determine the dose you need. They will also ensure that the solution is clear and free from particles.

Atosiban combustible is administered intravenously in three steps:

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

The total duration of treatment must not exceed 48 hours.

Additional treatments with Atosiban SUN may be given if contractions return. Treatment with Atosiban SUN may be repeated up to three more times.

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them. The side effects observed in mothers were generally mild in 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.
• Feeling sick (vomiting).
• Fast heartbeat.
• Low blood pressure. Signs may include feeling dizzy or lightheaded.
• Reaction at the injection site.
• Increased blood sugar levels.

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)

• Your uterus is unable to contract after the baby’s birth. 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 medicines that may delay your baby’s birth, such as medicines used for high blood pressure.

Reporting of side effects

If you experience any type of side effect, talk to your doctor, midwife, or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the national reporting system included 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 refers to the last day of the month indicated.

Store in a refrigerator (2°C - 8°C). Dilutions for intravenous administration must be used within 24 hours of preparation.

Keep 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 must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of containers you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of Atosiban SUN

• The active substance is atosiban.
• Each vial of Atosiban SUN 37.5 mg/5 ml concentrate for 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 injections.

Appearance of the product and contents of the pack

Atosiban SUN 37.5 mg/5 ml concentrate for solution for infusion is a clear, colourless solution free from particles.

One pack contains one vial containing 5 ml of solution.

Marketing Authorisation Holder and Manufacturer

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH Hoofddorp

The Netherlands

Further information on this medicinal product can be obtained by contacting the local representative of the Marketing Authorisation Holder.

Deutschland

Sun Pharmaceuticals Germany GmbH

Hemmelrather Weg 201

51377 Leverkusen

Germany

tel. +49 214 403 990

España

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

Italia

Sun Pharma Italia Srl

Viale Giulio Richard, 3

20143 Milano

Italy

tel. +39 02 33 49 07 93

Polska

Ranbaxy (Poland) Sp. z o.o.

ul. Idzikowskiego 16

00-710 Warszawa

Poland

tel. +48 22 642 07 75

România

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 the most recent revision of this leaflet:

Other sources of information

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

INFORMATION INTENDED ONLY FOR HEALTHCARE PROFESSIONALS

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

Instructions for use:

Before using Atosiban SUN, the solution should be inspected visually to ensure it is clear and free of particles.

Atosiban SUN is administered intravenously in three successive stages:

• An initial intravenous injection of 6.75 mg in 0.9 ml is given slowly into a vein over one minute.
• A continuous infusion is administered at a rate of 24 ml/hour for 3 hours.
• A continuous infusion is administered at a rate of 8 ml/hour for up to 45 hours, or until uterine contractions have decreased.

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

Preparation of the intravenous infusion

The intravenous infusion is prepared by diluting Atosiban SUN 37.5 mg/5 ml concentrate for solution for infusion in either a 9 mg/ml (0.9%) sodium chloride solution for injection, a Ringer's lactate solution, or a 5% w/v 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 concentrate for solution for infusion from two 5 ml vials, resulting in a final atosiban concentration of 75 mg in 100 ml. If an infusion bag of different volume is used, a proportional calculation must be performed for preparation.

Atosiban SUN must not be mixed with other medicinal products in the infusion bag.