Atosiban Sun

Package leaflet: Information for the user

Atosiban SUN 6.75 mg/0.9 ml injection solution

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

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

Contents of this leaflet:

1. What Atosiban SUN is and what it is used for
2. What you need to know before using Atosiban SUN
3. How to use Atosiban SUN
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 the premature birth of your baby.
Atosiban SUN is used in adult pregnant women between the 24th and 33rd week of pregnancy.
Atosiban SUN works by reducing the intensity of uterine contractions. It also slows down the frequency of contractions. It acts by blocking the effects of a natural hormone in the body called "oxytocin" which causes uterine contractions.

2. What you need to know before using Atosiban SUN

Do not use Atosiban SUN

• If you are allergic to atosiban or to any of the other ingredients of this medicine (listed in section 6).
• If you are less than 24 weeks pregnant.
• If you are more than 33 weeks pregnant.
• If you have rupture of membranes (premature rupture of membranes) after 30 completed weeks of gestation.
• If the baby (fetus) has an abnormal heart rate.
• If you have vaginal bleeding which, in the doctor's judgment, requires immediate delivery.
• If you have a condition called "severe pre-eclampsia" which, according to the doctor's judgment, requires immediate delivery. Severe pre-eclampsia is a condition characterized by high blood pressure, fluid retention, and/or presence of protein in the urine.
• If you have a condition called "eclampsia", which is similar to "severe pre-eclampsia" but with the addition of seizures. This condition requires immediate delivery.
• In case of fetal death.
• If you have or suspect you have a uterine infection.
• If the placenta covers the birth canal.
• In case of placental abruption (placenta detaching from the uterine wall).
• In any other condition affecting you or the fetus where continuing the pregnancy would be dangerous.

Do not use Atosiban SUN if you are in any of the above conditions. If you are unsure, consult your
doctor, midwife, or pharmacist before using Atosiban SUN.
Warnings and precautions
Talk to your doctor, midwife, or pharmacist before using Atosiban SUN:

• If you think you may have experienced rupture of membranes (premature rupture of membranes).
• If you have kidney or liver problems.
• If your pregnancy is between 24 and 27 weeks.
• If you are carrying multiple fetuses (multiple pregnancy).
• If contractions recur, treatment with Atosiban SUN may be repeated up to three more times.
• If the fetus is small for gestational age.
• After delivery, the uterus may have reduced contractile ability. This may lead to bleeding.
• If you are carrying twins and/or are taking medicines that may delay your baby's birth, such as medications used for high blood pressure. These conditions may increase the risk of pulmonary edema (fluid accumulation in the lungs).

If you are in any of the above conditions, or if you are unsure, consult your doctor, midwife, or
pharmacist before using Atosiban SUN.
Children and adolescents
Atosiban SUN has not been studied in pregnant women under 18 years of age.
Other medicines and Atosiban SUN
Inform your doctor, midwife, or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription, as well as herbal medicines.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding from a previous delivery, you must stop breastfeeding while being treated with Atosiban SUN.

3. How to use Atosiban SUN

Atosiban SUN is a medicinal product intended for hospital use only, which will be administered to you solely by a doctor, nurse, or midwife. They will determine the amount necessary for you and ensure that the solution is clear and free from particles.
Atosiban SUN is administered intravenously (by intravenous infusion) in three consecutive steps:

• An initial intravenous injection of 6.75 mg in 0.9 ml is slowly injected into a vein over one minute.
• Subsequently, a continuous infusion (intravenous drip) at a dose of 18 mg/hour is administered for a period of 3 hours.
• Then, a continuous infusion (intravenous drip) at a dose of 6 mg/hour is administered for a maximum period of 45 hours, or until uterine contractions have ceased. The total duration of treatment must not exceed 48 hours.

Additional treatment cycles with Atosiban SUN may be used if uterine contractions recur. Treatment with Atosiban SUN may be repeated up to three additional times.
During treatment with Atosiban SUN, your uterine contractions and the fetal heart rate may be monitored.
It is recommended not to perform more than three additional treatment cycles during one pregnancy.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone experiences them. The side effects observed in the mother have generally been mild in severity. No side effects in the fetus or newborn are known.
The following are side effects that may occur with the use of this medicine:

Very common (affects more than 1 in 10 people)

• Feeling unwell (nausea).

Common (affects up to 1 in 10 people)

• Headache.
• Dizziness.
• Flushing.
• Feeling of discomfort (vomiting).
• Increased heart rate.
• Low blood pressure. Symptoms may include dizziness or a feeling of lightheadedness.
• Reaction at the injection site.
• Elevated blood sugar levels.

Uncommon (affects up to 1 in 100 people)

• High temperature (fever).
• Difficulty sleeping (insomnia).
• Itching.
• Skin rashes.

Rare (affects up to 1 in 1,000 people)

• After delivery, the uterus may have reduced contractile ability. This may lead to bleeding.
• Allergic reactions.

You may experience difficulty breathing or pulmonary edema (fluid accumulation in the lungs), particularly if you are carrying twins and/or are taking other medicines that can delay childbirth, such as medicines used for high blood pressure.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. You may also report side effects directly through the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Atosiban SUN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after Exp. {MM/YYYY}. The expiry date refers to the last day of that month.
Store in a refrigerator (2°C - 8°C). After opening the vial, the medicine must be used immediately.
Store in the original packaging to protect from light.
Do not use this medicine if you notice the presence of particles or a change in colour.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Atosiban SUN contains

• 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 components are: mannitol, hydrochloric acid 1M, and water for injections.

Description of the appearance of Atosiban SUN and contents of the pack
Atosiban SUN 6.75 mg/0.9 ml solution for injection is a clear, colourless solution free from particles.
One pack contains one vial with 0.9 ml of solution.

Marketing Authorisation Holder and Manufacturer
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien/България/Česká republika/
Danmark/Eesti/Ελλάδα/Hrvatska/Ireland/Ísland/Κύπρος/
Latvija/Lietuva/Luxembourg/Luxemburg/Magyarország/
Malta/Nederland/Norge/Österreich/Portugal/Slovenija/
Slovenská republika/Suomi/Finland/Sverige
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
Nederland/Pays-Bas/Niederlande/Нидерландия/Nizozemsko/
Nederlandene/Ολλανδία/Nizozemska/The Netherlands/Holland/
Ολλανδία/Nīderlande/Nyderlandai/Pays-Bas/Niederlande/
Hollandia/L-Olanda/Nederland/Niederlande/Países Baixos/
Nizozemska/Holandsko/Alankomaat/Nederländerna
Tel./тел./tlf./τηλ./Sími/τηλ./Tlf./Puh./
+31 (0)23 568 5501

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
11-15, Quai de Dion Bouton
92800 Puteaux
France
Tel. +33 1 41 44 44 50

Italia
Sun Pharma Italia Srl
Viale Giulio Richard, 1
20143 Milano
Italy
Tel. +39 02 33 49 07 93

Polska
Ranbaxy (Poland) Sp. Z o.o.
ul. Kubickiego 11
02-954 Warszawa
Poland
Tel. +48 22 642 07 75

România
Terapia S.A.
Str. Fabricii nr 124
Cluj-Napoca, Judeţul 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

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu.

INSTRUCTIONS FOR HEALTHCARE PROFESSIONALS
The following information is intended exclusively for healthcare professionals:
(see also section 3)

Instructions for use

Before using Atosiban SUN, the solution must be examined to ensure it is clear and free from particles.
Atosiban SUN is administered intravenously in three successive stages:

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

The total duration of treatment must not exceed 48 hours. Additional treatment cycles with Atosiban SUN may be used if contractions recur. It is recommended not to administer more than 3 additional treatment cycles during a single pregnancy.

Package leaflet: information for the user

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

atosiban
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, midwife or pharmacist.
• If you experience any side effect, including those not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Atosiban SUN is and what it is used for
2. What you need to know before using Atosiban SUN
3. How to use Atosiban SUN
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 birth of your baby. Atosiban SUN is used in adult pregnant women between the 24th and 33rd week of pregnancy.
Atosiban SUN works by reducing the strength of uterine contractions. It also slows down the frequency of contractions. It acts by blocking the effects of a natural hormone in the body called "oxytocin" which causes uterine contractions.

2. What you need to know before using Atosiban SUN

Do not use Atosiban SUN

• If you are allergic to atosiban or to any of the other ingredients of this medicine (listed in section 6).
• If you are less than 24 weeks pregnant.
• If you are more than 33 weeks pregnant.
• If you have rupture of membranes (premature rupture of membranes) after 30 completed weeks of gestation.
• If the baby (the fetus) has an abnormal heart rate.
• If you have vaginal bleeding which, in the doctor’s judgment, requires immediate delivery.
• If you have a condition called “severe pre-eclampsia” which, according to the doctor’s judgment, requires immediate delivery. Severe pre-eclampsia is a condition characterized by high blood pressure, fluid retention, and/or presence of protein in the urine.
• If you have a condition called “eclampsia”, which is similar to “severe pre-eclampsia” but with the addition of seizures. This condition requires immediate delivery.
• In case of fetal death.
• If you have or suspect you have an infection of the uterus.
• If the placenta covers the birth canal.
• In case of placental abruption (placenta detaching from the uterine wall).
• In any other condition affecting you or the fetus in which continuing the pregnancy is considered dangerous.

Do not use Atosiban SUN if you are in any of the conditions described above. If you are unsure, ask your
doctor, midwife, or pharmacist before using Atosiban SUN.
Warnings and precautions
Talk to your doctor, midwife, or pharmacist before using Atosiban SUN:

• If you think you may have experienced rupture of membranes (premature rupture of membranes).
• If you suffer from kidney or liver disorders.
• If your pregnancy is between 24 and 27 weeks.
• If you have a multiple pregnancy.
• If contractions recur, treatment with Atosiban SUN may be repeated up to three more times.
• If the fetus is small for gestational age.
• After delivery, the uterus may have reduced contractile ability. This may lead to bleeding.
• If you have a twin pregnancy and/or are taking medicines that may delay your baby’s birth, such as medications used for high blood pressure. These conditions may increase the risk of pulmonary edema (fluid accumulation in the lungs).

If you are in any of the conditions listed above, or if you are unsure, consult your doctor, midwife, or
pharmacist before using Atosiban SUN.
Children and adolescents
Atosiban SUN has not been studied in pregnant women under 18 years of age.
Other medicines and Atosiban SUN
Inform your doctor, midwife, or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription and herbal medicines.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding from a previous delivery, you must stop breastfeeding during treatment with Atosiban SUN.

3. How to use Atosiban SUN

Atosiban SUN is a medicinal product intended for hospital use only and will be administered to you exclusively by a doctor, nurse, or midwife. They will determine the dose required for you and ensure that the solution is clear and free from particles.
Atosiban SUN is administered intravenously (by intravenous infusion) in three consecutive phases:

• An initial intravenous bolus injection of 6.75 mg in 0.9 ml is slowly injected into a vein over one minute.
• Subsequently, a continuous infusion (intravenous drip) at a dose of 18 mg/hour is administered for a period of 3 hours.
• Then, a continuous infusion (intravenous drip) at a dose of 6 mg/hour is administered for a maximum period of 45 hours, or until uterine contractions have ceased. The total duration of treatment must not exceed 48 hours.

Additional treatment cycles with Atosiban SUN may be used if uterine contractions recur. Treatment with Atosiban SUN may be repeated up to three additional times.
During treatment with Atosiban SUN, your uterine contractions and the fetal heart rate may be monitored.
It is recommended not to perform more than three additional treatment cycles 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 have generally been mild in nature. There are no known side effects in the fetus or newborn.
The following are side effects that may occur with the use of this medicine:
Very common (affects more than 1 in 10 people)

• Malaise (nausea).

Common (affects less than 1 in 10 people)

• Headache.
• Dizziness.
• Hot flushes.
• Feeling of malaise (vomiting).
• Increased heart rate.
• Low blood pressure. Symptoms may include dizziness or a sensation of emptiness in the head.
• Reaction at the injection site.
• High blood sugar levels.

Uncommon (affects less than 1 in 100 people)

• High temperature (fever).
• Difficulty sleeping (insomnia).
• Itching.
• Skin rashes.

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

• After childbirth, the uterus may have reduced ability to contract. 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 twins and/or are taking other medicines that can delay childbirth, such as medicines used for high blood pressure.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Atosiban SUN

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after Exp. {MM/YYYY}. The expiry date refers to the last day of that month.
Store in a refrigerator (2°C - 8°C). Diluted solutions 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 the presence of particles or a change in colour.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Atosiban SUN contains

• 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.

Description of the appearance of Atosiban SUN 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

For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien/България/Česká republika/
Danmark/Eesti/Ελλάδα/Hrvatska/Ireland/Ísland/Κύπρος/
Latvija/Lietuva/Luxembourg/Luxemburg/Magyarország/
Malta/Nederland/Norge/Österreich/Portugal/Slovenija/
Slovenská republika/Suomi/Finland/Sverige
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
Nederland/Pays-Bas/Niederlande/Нидерландия/Nizozemsko/
Nederlandene/Ολλανδία/Nizozemska/The Netherlands/Holland/
Ολλανδία/Nīderlande/Nyderlandai/Pays-Bas/Niederlande/
Hollandia/L-Olanda/Nederland/Niederlande/Países Baixos/
Nizozemska/Holandsko/Alankomaat/Nederländerna
Tel./тел./tlf./τηλ./Sími/τηλ./Tlf./Puh./
+31 (0)23 568 5501

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
11-15, Quai de Dion Bouton
92800 Puteaux
France
Tel. +33 1 41 44 44 50

Italia
Sun Pharma Italia Srl
Viale Giulio Richard, 1
20143 Milano
Italy
Tel. +39 02 33 49 07 93

Polska
Ranbaxy (Poland) Sp. Z o.o.
ul. Kubickiego 11
02-954 Warszawa
Poland
Tel. +48 22 642 07 75

România
Terapia S.A.
Str. Fabricii nr 124
Cluj-Napoca, Judeţul 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

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu.

INSTRUCTIONS FOR HEALTHCARE PROFESSIONALS
The following 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 from particles.
Atosiban SUN is administered intravenously in three successive stages:

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

The total duration of treatment must not exceed 48 hours. Further treatment cycles with Atosiban SUN may be used if contractions recur. It is recommended not to perform more than 3 additional treatment cycles during one pregnancy.

Preparation of intravenous infusion
The intravenous infusion is prepared by diluting Atosiban SUN 37.5 mg/5 ml concentrate for solution for infusion in a sodium chloride 9 mg/ml (0.9%) solution, in Ringer's lactate solution, or in a 5% w/v glucose solution. This is done by removing 10 ml of solution 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, prepared from two 5 ml vials, resulting in a concentration of 75 mg of atosiban in 100 ml. If an infusion bag of different volume is used, a proportional calculation must be performed for the preparation of the solution.
Atosiban SUN must not be mixed in the infusion bag with other medicinal products.