ATOSIBAN ALTAN 6.75 mg/0.9 mL Injectable Solution

Introduction

Package Leaflet: Information for the User

Atosiban Altan 6.75 mg/0.9 ml Solution for Injection EFG

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 further questions, ask your doctor, midwife or pharmacist.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet:

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

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

Atosiban Altan contains atosiban. Atosiban may be used to delay premature birth of your baby. Atosiban is used in adult pregnant women, from the 24th week to the 33rd week of pregnancy.

Atosiban works by making the contractions of your uterus (womb) less strong. It also makes the contractions happen less often. This happens because it prevents the natural hormone called "oxytocin", which causes the uterus to contract, from working.

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

You should not be given Atosiban Altan

• If you are less than 24 weeks pregnant.
• If you are more than 33 weeks pregnant.
• If your waters have broken (premature rupture of your membranes) and you have completed 30 weeks of pregnancy or more.
• If your baby has an abnormal heart beat.
• If you are bleeding from the vagina and your doctor wants you to go into labour so that your baby can be born immediately.
• If you have a condition called severe pre-eclampsia and your doctor wants you to go into labour 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 a condition called "eclampsia" which is similar to severe pre-eclampsia but you will also have fits. This will mean that labour 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 may make it dangerous to continue with the pregnancy.
• If you are allergic to atosiban or any of the other ingredients of this medicine (listed in section 6).

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

Warnings and precautions

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

• 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 can be repeated up to three times more.
• If your baby is small for the length of your pregnancy.
• If your uterus, after your baby is born, is not able to contract. This can cause bleeding.
• If you are pregnant with more than one baby and/or are taking medicines that may delay the birth of your baby, such as medicines used for high blood pressure. This can increase the risk of fluid in the lungs (pulmonary oedema).

If you have any of these conditions (or are not sure), tell your doctor, midwife or pharmacist before you are given atosiban.

Children and adolescents

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

Using Atosiban Altan with other medicines

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

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, breast-feeding should be stopped during treatment with atosiban.

3. How Atosiban Altan will be given to you

Atosiban Altan 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 will be given into a vein (intravenously) in three stages:

• A first intravenous injection of 6.75 mg in 0.9 ml will be given slowly into your vein over one minute.
• Then, an infusion of 18 mg per hour will be given over three hours.
• Then, an infusion of 6 mg per hour will be given for up to 45 hours or until your uterine contractions have stopped.

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

Further treatments with atosiban can be given if you have contractions again. Treatment with atosiban can be repeated up to three times more.

During treatment with atosiban, 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(affects more than 1 in 10 people)

• Feeling sick (nausea).

Common(affects less than 1 in 10 people)

• Headache.
• Feeling dizzy.
• Flushing.
• Being sick (vomiting).
• Fast heart beat.
• Low blood pressure. The signs may include feeling dizzy or faint.
• Reaction at the injection site.
• Increased blood sugar.

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 not being able to contract after the birth of your baby. This can cause bleeding.
• Allergic reactions.

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

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Agency website: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Atosiban Altan

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).

Store in the original package to protect from light.

Once the ampoule is opened, the product should be used immediately.

Do not use this medicine if you notice that it contains particles or discolouration of the contents before administration.

6. Contents of the pack and further information

Composition of Atosiban Altan

The active substance is atosiban.

Each ampoule (0.9 ml solution for injection) contains 6.75 mg of atosiban (as acetate).

The other ingredients are: mannitol, hydrochloric acid and water for injections.

Appearance of Atosiban Altan and contents of the pack

Atosiban Altan 6.75 mg/0.9 ml solution for injection is a clear, colourless solution without particles. One pack contains a glass ampoule (2 ml) which contains 0.9 ml of solution.

Marketing Authorisation Holder

Altan Pharmaceuticals, S.A.

C/Cólquide, Nº6, Portal 2, 1ª Planta, Oficina F. Edificio Prisma

28230 Las Rozas (Madrid)

Spain

Manufacturer

ALTAN PHARMACEUTICALS, S.A

Avda de la Constitución 198-199, Polígono Industrial Monte Boyal

45950 Casarrubios del Monte (Toledo)

Spain

This medicine is authorised in the Member States of the EEA under the following names:

This leaflet was last revised in: October 2020

"Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/".

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

Instructions for use:

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

Atosiban Altan is administered intravenously in three successive stages:

• An initial injection of 6.75 mg in 0.9 ml is given slowly into a vein over one minute.
• An infusion of 18 mg per hour is given over three hours.
• An infusion of 6 mg per hour is given for up to 45 hours or until uterine contractions have stopped.

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