Prospect: information for theuser

DURATOBAL 100 micrograms/ml injectable solution

Carbetocina

Read this prospect carefully before starting to usethis medication, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects,consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1. What isDURATOBALand for what it is used

2. What you need to knowbefore starting to useDURATOBAL

3. How to useDURATOBAL

4. Possible adverse effects

5. Storage ofDURATOBAL

6. Contents of the package and additional information

The active ingredient of DURATOBAL iscarbetocin. It issimilar to a substance called oxytocin, which is naturally produced 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 (the womb) does not contract quickly enough. This makes it more likely that they will bleed more than normal. DURATOBAL causes the uterus to contract and thus reduces the risk of bleeding.

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Do not use DURATOBAL until after the baby has been delivered.

Before using DURATOBAL, your doctor must know any diseases you may have. You must tell your doctor any new symptoms you develop while 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 medication (listed in section 6)

- if you are allergic to oxytocin (whether it has been administered by infusion or injection during or after delivery)

- 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

Inform your doctor, midwife, or nurse before receiving DURATOBAL

- if you have migraines (repeated headaches)

- if you have asthma (respiratory disorder with repeated episodes of difficulty breathing, wheezing, and coughing)

- if you have preeclampsia (elevated 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 fluid accumulation 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.

Use of Duratobal with other medications

Inform your doctor, midwife, or nurse if you are taking,have taken recentlyor may need to take any other medication.

Pregnancy and breastfeeding

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

Small amounts of carbetocin have been seen to pass from the mother's blood during lactation to the breast milk, but it is assumed to be degraded in the infant's intestine. Breastfeeding does not need to be restricted after the use of DURATOBAL.

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

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 may lead to uterine rupture or postpartum hemorrhage. You may also experience drowsiness, apathy, and headache, caused by fluid accumulation. You will need to be treated with other medication and possible surgery.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

When DURATOBAL is administered into one of your veins after a cesarean section

Very common: may affect more than 1 in 10 women

- Nausea.

- Stomach pain.

- Itching (pruritus).

- Redness (erythema).

- Sensation of heat.

- Low blood pressure.

- Headache.

- Tremors.

Common: up to 1 in 10 women,

- Vomiting.

- Dizziness.

- Back or chest pain.

- Metallic taste in the mouth.

- Anemia (decreased red blood cells).

- Dyspnea (difficulty breathing).

- Chills

- General pain.

Not known: the frequency cannot be estimated based on available data

• Accelerated heart rate, slow heart rate that may cause cardiac arrest (when the heart stops beating).
• Allergic reactions (including severe and sudden allergic reaction with difficulty breathing, swelling, drowsiness, rapid heart rate, 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 mean 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

Infrequent: may affect up to 1 in 100 women

- Nausea.

- Stomach pain.

- Vomiting.

- Low blood pressure.

- Anemia.

- Headaches.

- Dizziness.

- Rapid heart rate.

- Back or chest pain.

- Muscle weakness.

- Chills.

- Fever.

- General pain.

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

- Redness (erythema)

- Itching (pruritus).

- Dyspnea.

- Tremors.

- Difficulty urinating.

Not known: the frequency cannot be estimated based on available data

• Allergic reactions (including severe and sudden allergic reaction with difficulty breathing, swelling, drowsiness, rapid heart rate, 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 mean the heart is not beating correctly.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus.You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: www.notificaram.es.

By reporting adverse effects, you can contribute to providing more information about the safety of this medicine.

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

Do not use DURATOBAL after the expiration date that appears on the packaging or vial after CAD.The expiration date is the last day of the month indicated.

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

The solution must be used immediately after opening the vial.

Composition of DURATOBAL:

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

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

Appearance of DURATOBAL and contents of the packaging.

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

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

Holder of the Marketing Authorization:

FERRING S.A.U.

C

C/ del Arquitecto Sánchez Arcas 3, 1st

Madrid 28040

Spain

.

Responsible for manufacturing:

FERRING GMBH

Wittland 11, D-24109 Kiel

Germany

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

PABAL/ DURATOCIN.

This text was approved in June 2023