Package Insert: Information for the User

Atosiban Altan 6.75 mg/0.9 ml Injectable Solution 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 read 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 they are not listed in this package insert. See section 4.

Atosiban Altan contains atosiban. Atosiban may be used to delay premature birth 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 Altan

• 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 are 30 weeks pregnant or more.
• If your baby has an abnormal heart rate.
• If you are bleeding from the vagina and your doctor wants to start labor so your baby can be born immediately.
• If you have severe preeclampsia and your doctor wants to start labor so 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 severe preeclampsia but you will also have seizures. This means labor must start so 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 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 be dangerous 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, midwife or pharmacist before Atosiban Altan is administered to you.

Warnings and precautions

Consult with your doctor, midwife or pharmacist before Atosiban is administered to you:

• If you think your water has broken (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 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 carrying 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.

If you have any of these situations (or are unsure), inform your doctor, midwife or pharmacist before Atosiban is administered to you.

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 pharmacistif you are taking, have taken recently or may need to take any other medication.

Pregnancy and breastfeeding

If you are pregnantorbreastfeedinga baby, you should stop breastfeeding during the treatment with atosiban.

Atosiban Altan will be administered by a doctor, nurse, or midwife in a hospital. 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 stages:

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

The total duration of treatment should not exceed 48 hours.

Additional treatments with atosiban may be administered if contractions recur. Atosiban treatment can be repeated up to three times.

During atosiban treatment, your contractions and the fetal heart rate can be monitored.

It is recommended not to repeat treatment more than three times during a 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 Medicines Vigilance 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.

Store in refrigerator (2° C – 8° C).

Store in the original packaging to protect it from light.

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

Do not use this medication if you observe that it presents particles or discoloration of the content before its administration.

Composition of Atosiban Altan

The active ingredient is atosiban.

Each ampoule (0.9 ml of injection solution) contains6.75 mg of atosiban in 0.9 ml (as acetate).

The other components are: mannitol, concentrated hydrochloric acid and water for injectable preparations.

Appearance of Atosiban Altan and contents of the package

Atosiban Altan 6.75 mg/0.9 ml injection solution is a transparent, colorless solution without particles. A package contains a type I glass ampoule (2 ml), which contains 0.9 ml of solution.

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 last revised in: October 2020

“Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for 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 must 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 administered slowly into a vein over one minute.
• For 3 hours, a continuous infusion at a rate of 24 ml/hour is administered.
• For a maximum of 45 hours, or until uterine contractions have decreased, a continuous infusion at a rate of 8 ml/hour is administered.

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 repeat treatment more than three times during a pregnancy.