Package Insert: Information for the User

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

Atosiban

Read this package insert carefully before the medicine is administered to you, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor, midwife, or pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if the effects are not listed in this package insert. See section 4.

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

Atosiban 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

• If you are less than 24 weeks pregnant.
• If you are more than 33 weeks pregnant.
• If your water has broken (premature rupture of 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 to start labor so that your baby can be born immediately.
• If you have something called “severe preeclampsia” and your doctor wants to start labor so that 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 something called “eclampsia” which is similar to the “severe preeclampsia” but you will also have convulsions. This will mean that labor must start so that 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 blocks 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.
• If you are allergic to atosiban or any of the other components of this medication (listed in section 6).

Do not use Atosiban Altan if you are affected by any of these situations. If you are unsure, inform your doctor, nurse, or pharmacist before they administer Atosiban Altan.

Warnings and precautions

Consult with your doctor, midwife, or pharmacist before they administer atosiban:

• If you think you have broken your water (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 have contractions again, the atosiban treatment can be repeated up to three more times.
• If your baby is small for the duration of the pregnancy.
• If your uterus, once the baby has been born, is unable to contract. 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 can increase the risk of fluid accumulation in the lungs (pulmonary edema).

If you have any of these situations (or are unsure), inform your doctor, midwife, or pharmacist before they administer atosiban.

Children and adolescents

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

Use of Atosiban Altan 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 or breastfeeding a baby, you should stop breastfeeding during the atosiban treatment.

Atosiban Altan 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 will be administered intravenously in three successive stages:

• A first intravenous injection of 6.75 mg in 0.9 ml will be administered slowly over one minute.
• Then, a continuous infusion (drip) of 18 mg per hour will be administered for 3 hours.
• Next, a continuous infusion (drip) of 6 mg per hour will be 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 may be administered if contractions recur.
The atosiban treatment can be repeated up to three times more.

Your contractions and the fetal heart rate can be monitored during atosiban treatment.

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

Like all medications, this medication may produce adverse effects, although not everyone will 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 Frequent(affect more than 1 in 10 people)

• Feeling of discomfort (nausea).

Frequent(may affect fewer than 1 in 10 people)

• Headache.
• Dizziness.
• Redness.
• Being sick (vomiting).
• Fast heart rate.
• Low blood pressure. Symptoms may include dizziness or feeling lightheaded.
• Reaction at the injection site.
• Increased blood sugar.

Infrequent(affect fewer than 1 in 100 people)

• Increased temperature (fever).
• Difficulty sleeping (insomnia).
• Itching.
• Skin rash.

Rare(affect fewer 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 adverse effects, consult yourdoctor, pharmacist, or nurseeven if they are adverse effects that do not appear in this prospectus. You can also report them directly through the Spanish Medication for Human Use Pharmacovigilance System website:www.notificaram.es.Reporting adverse effects may help provide information on the safety of this medication.

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.

Once the vial is opened, the product must be used immediately.

Store in refrigerator (2° C – 8° C).

Store in the original packaging to protect it from light.

Solution after dilution:Stability has been demonstrated in chemical and physical use for 24 hours under environmental conditions (less than 25°C).

From a microbiological point of view, the medication should be used immediately. If not used immediately, the storage times and conditions in use prior to use are the responsibility of the user and should not exceed 24 hours at 2-8ºC, unless the reconstitution/dilution has been performed in controlled and validated aseptic conditions.

Do not use this medication if particles or discoloration of the content are observed before administration.

Composition of Atosiban Altan

The active ingredient is atosiban.

• Each vial (5 ml of infusion solution) contains 37.5 mg of atosiban (as acetate).
• Each ml of solution contains 7.5 mg of atosiban.
• The other components are: mannitol, concentrated hydrochloric acid, and water for injection preparations.

Appearance of Atosiban Altan and contents of the package

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

A package contains a vial that contains 5 ml of solution. It is a transparent glass vial, type I, closed with a gray bromobutyl rubber stopper, and sealed with a removable aluminum seal.

Marketing Authorization Holder

Altan Pharmaceuticals, S.A.

C/Cólquide, Nº6, Portal 2, 1st Floor, Office F. Edificio Prisma

28230 Las Rozas (Madrid)

Spain

Responsible for manufacturing

ALTAN PHARMACEUTICALS, S.A

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

45950 Casarrubios del Monte (Toledo)

Spain

This medicinal product is authorized in the Member States of the EEA with the following names:

This leaflet was revised in: October 2020

Detailed information about this medicinal product is available on the website ofthe Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/

This information is intended solely 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:

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

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

Preparation of the intravenous infusion

The intravenous infusion is prepared by diluting Atosiban Altan 37.5 mg/5 ml concentrated solution for infusion in:

• sodium chloride solution9 mg/ml (0.9%) for injection,
• lactate Ringer solution
• or 5% glucose solution.

This is achieved by extracting 10 ml of solution from a 100 ml infusion bag and replacing it with 10 ml of Atosiban Altan 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 100 ml infusion bag of a different volume is used, a proportional calculation should be performed for the preparation.

Atosiban Altan should not be mixed with other medicinal products in the infusion bag.