DURATOBAL 100 micrograms/ml Injectable solution

Contents of the leaflet

1. Introduction
2. What DURATOBAL is and what it is used for
3. What you need to know before you use DURATOBAL
4. How to use DURATOBAL
5. Possible side effects
6. Storage of DURATOBAL
7. Contents of the pack and further information

Introduction

Package Leaflet: Information for theuser

DURATOBAL 100 micrograms/ml solution for injection

Carbetocin

Read all of this leaflet carefully before you start usingthis 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 or pharmacist.
• This medicine has been prescribed for you only, do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• 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 pack

1. What DURATOBAL is and what it is used for
2. What you need to know before you use DURATOBAL
3. How to use DURATOBAL
4. Possible side effects
5. Storage of DURATOBAL
6. Contents of the pack and further information

1. What DURATOBAL is and what it is used for

The active substance of DURATOBAL is carbetocin. It is similar to a substance called oxytocin, which is produced naturally by the body to contract the uterus during childbirth.

DURATOBAL is used in the treatment of women who have just given birth.

In some women, after childbirth, the uterus (womb) does not contract quickly enough. This makes it more likely that they will bleed more than usual. DURATOBAL makes the uterus contract and thus reduces the risk of bleeding.

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2. What you need to know before you use DURATOBAL

DURATOBAL should not be used until after the baby has been delivered.

Before using DURATOBAL, your doctor should know about any diseases you may have. You should tell your doctor about any new symptoms that develop while you are being treated with DURATOBAL.

Do not use DURATOBAL:

• if you are pregnant
• if you are in labor and the baby has not yet been delivered
• to induce labor
• if you are allergic to carbetocin or any of the other components of this medicine (listed in section 6)
• if you are allergic to oxytocin (whether administered by drip or injection during or after childbirth)
• if you have any kidney or liver disease
• if you have any severe coronary disease
• if you have epilepsy (repeated episodes of convulsions, loss of consciousness)

If you experience any of these symptoms, consult your doctor, midwife, or nurse.

Warnings and precautions

Tell your doctor, midwife, or nurse before receiving DURATOBAL

• if you have migraines (recurring headaches)
• if you have asthma (respiratory disorder with recurring episodes of difficulty breathing, wheezing, and coughing)
• if you have pre-eclampsia (high blood pressure during pregnancy) or eclampsia (toxemia of pregnancy - intense agitation, involuntary movements)
• if you have heart or circulation problems (such as high blood pressure)
• if you have any other disease

If you experience any of these symptoms, consult your doctor, midwife, or nurse.

DURATOBAL may cause water retention in the body, which can cause drowsiness, apathy, and headache.

Children and adolescents

Not relevant in children under 12 years.

Experience with adolescents is limited.

Using DURATOBAL with other medicines

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

Pregnancy and breastfeeding

DURATOBAL should not be used during pregnancy and childbirth until the baby has been delivered.

It has been seen that small amounts of carbetocin pass from the blood of breastfeeding mothers into breast milk, but it is assumed to be degraded in the infant's intestine. Breastfeeding does not need to be restricted after using DURATOBAL.

3. How to use DURATOBAL

DURATOBAL is administered by injection into one of your veins or into one of your muscles, immediately after the delivery of your baby. The dose is one vial (100 micrograms).

If you use more DURATOBAL than you should:

If you have accidentally used more DURATOBAL than you should, you may experience uterine hyperactivity with strong contractions that can lead to uterine rupture or postpartum hemorrhage. You may also experience drowsiness, apathy, and headache caused by fluid retention. You should be treated with other medication and possible surgery.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

When DURATOBAL is administered into one of your veins after acesarean

Very common: may affect more than 1 in 10 women

• nausea
• stomach pain
• pruritus (itching)
• flushing (red skin)
• feeling of warmth
• low blood pressure
• headache
• tremors

Common: may affect up to 1 in 10 women

• vomiting
• dizziness
• back or chest pain
• metallic taste in the mouth
• anemia (reduced red blood cells)
• shortness of breath
• chills
• general pain

Unknown: frequency cannot be estimated from the available data

• Accelerated heart rate, slow heart rate that can cause cardiac arrest (when the heart stops beating)
• Allergic reactions (including severe and sudden allergic reaction with difficulty breathing, swelling, dizziness, rapid heartbeat, sweating, low blood pressure, and loss of consciousness)

Side effects observed with similar products that may be expected with carbetocin:

Irregular heartbeats, chest pain, fainting or palpitations that may indicate that the heart is not beating correctly.

Occasionally, some women may experience sweating.

When DURATOBAL is administered into one of your muscles after a vaginal delivery

Uncommon: may affect up to 1 in 100 women

• nausea
• stomach pain
• vomiting
• low blood pressure
• anemia
• headache
• dizziness
• rapid heartbeat
• back or chest pain
• muscle weakness
• chills
• fever
• general pain

Rare: may affect less than 1 in 1,000 women

• flushing (red skin)
• pruritus (itching)
• shortness of breath
• tremors
• difficulty urinating

Unknown: frequency cannot be estimated from the available data

• Allergic reactions (including severe and sudden allergic reaction with difficulty breathing, swelling, dizziness, rapid heartbeat, sweating, low blood pressure, and loss of consciousness)

Side effects observed with similar products that may be expected with carbetocin:

Slow heart rate, irregular heartbeats, chest pain, fainting or palpitations that may indicate that the heart is not beating correctly.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of DURATOBAL

Keep this medicine out of the sight and reach of children.

Do not use DURATOBAL after the expiry date which is stated on the carton or vial after EXP. The expiry date is the last day of the month shown.

The vials of DURATOBAL are stored in the original package to protect from light. Store below 30°C. Do not freeze.

The solution should be used immediately after opening the vial.

6. Contents of the pack and further information

Composition of DURATOBAL:

The active substance is carbetocin. Each milliliter contains 100 micrograms of carbetocin.

The other ingredients are: L-methionine, succinic acid, mannitol, sodium hydroxide, and water for injection.

Appearance of DURATOBAL and contents of the pack.

Duratobal is a clear and colorless solution for injection, prepared for intravenous and intramuscular injection, and provided in packs of five 1 milliliter vials.

DURATOBAL should only be used in specialized obstetric units that are well equipped.

Marketing Authorization Holder:

FERRING S.A.U.

C/ del Arquitecto Sánchez Arcas 3, 1º

Madrid 28040

Spain

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Manufacturer:

FERRING GMBH

Wittland 11, D-24109 Kiel

Germany

This medicine is authorized in other EEA Member States under the following names:

PABAL/ DURATOCIN.

This text was approved in June 2023