Pabal

Package Leaflet: Information for the User

PABAL, 100 micrograms/ml, Solution for Injection

Carbetocin

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, midwife or nurse.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor, midwife or nurse. See section 4.

Table of Contents of the Leaflet:

• 1. What Pabal is and what it is used for
• 2. Important information before using Pabal
• 3. How to use Pabal
• 4. Possible side effects
• 5. How to store Pabal
• 6. Contents of the pack and other information

1. What Pabal is and what it is used for

The active substance of Pabal is carbetocin. It is similar to oxytocin, which is produced by the body to contract the uterus after childbirth. Pabal is used to treat women immediately after giving birth. In some women, after childbirth, the uterus does not contract quickly enough. In such cases, there is a higher risk that women will bleed more than usual. Pabal causes the uterus to contract and reduces the risk of bleeding.

2. Important information before using Pabal

Pabal must not be administered before the baby is born. Before administering Pabal, inform your doctor about any health problems you have. You should also inform your doctor about any new symptoms that appear during treatment with Pabal.

When not to use Pabal

• if you are pregnant,
• if you are in labor and the baby has not been born yet,
• to induce labor,
• if you are allergic to carbetocin or any of the other ingredients of this medicine (listed in section 6),
• if you are allergic to oxytocin (sometimes given during labor or after childbirth as a drip or injection),
• if you have liver or kidney disease,
• if you have severe heart disease,
• if you have epilepsy.

If any of the above situations apply to you, you should inform your doctor, midwife or nurse.

Warnings and precautions

Before starting treatment with Pabal, discuss it with your doctor, midwife or nurse. Page 1 of 5

• if you have migraines,
• if you have asthma,
• if you have pre-eclampsia (high blood pressure during pregnancy) or eclampsia (pregnancy poisoning),
• if you have heart disease or circulatory disorders, such as high blood pressure,
• if you have any other health problems. Inform your doctor, midwife or nurse about any of the above situations.

Pabal may cause water retention in the body, which can lead to drowsiness, apathy or headache.

Children and adolescents

This medicine is not intended for use in children under 12 years of age. Experience with the use of Pabal in adolescents is limited.

Pabal and other medicines

Tell your doctor, midwife or nurse about all medicines you are taking, or have recently taken, and about any medicines you plan to take.

Pregnancy and breastfeeding

Pabal should not be used during pregnancy and childbirth until the baby is born. It has been shown that small amounts of carbetocin pass from the blood into the breast milk of nursing mothers, but it is thought to be broken down in the baby's gut. It is not necessary to stop breastfeeding after using Pabal.

3. How to use Pabal

Pabal is given as an injection into one of the veins or into one of the muscles immediately after childbirth. One vial (100 micrograms) is administered.

Using more Pabal than recommended

If you accidentally receive too much Pabal, your uterus may contract too strongly, which can cause damage or heavy bleeding. You may also experience drowsiness, apathy and headache due to water retention in the body. You will be treated with other medicines and possibly surgically.

4. Possible side effects

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

When Pabal is administered into a vein after a cesarean section

Very common: may affect more than 1 in 10 people

• nausea,
• abdominal pain,
• itching of the skin,
• flushes (redness of the skin),
• feeling of warmth,
• low blood pressure,
• headache,
• tremors. Common: may affect up to 1 in 10 people

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• vomiting,
• dizziness,
• back pain or chest pain,
• metallic taste in the mouth,
• anemia,
• shortness of breath,
• chills,
• generalized pain.

Frequency not known: frequency cannot be estimated from the available data

• rapid heartbeat, slow heartbeat that can lead to cardiac arrest (when the heart stops working).
• allergic reactions (including severe allergic reactions with difficulty breathing, swelling, dizziness, rapid heartbeat, sweating, low blood pressure and loss of consciousness)

Side effects observed with similar medicines and which can also be expected with carbetocin: irregular heartbeat, chest pain, fainting or palpitations, which may indicate that the heart is not working properly. Rarely, some women may experience sweating.

When Pabal is administered into a muscle after a vaginal delivery

Uncommon: may affect up to 1 in 100 people

• nausea,
• abdominal pain,
• vomiting,
• low blood pressure,
• anemia,
• headache,
• dizziness,
• rapid heartbeat,
• back pain or chest pain,
• muscle weakness,
• chills,
• fever,
• generalized pain.

Rare: may affect up to 1 in 1,000 people

• flushes (redness of the skin),
• itching of the skin,
• shortness of breath,
• tremors
• difficulty urinating. Frequency not known: frequency cannot be estimated from the available data
• allergic reactions (including severe allergic reactions with difficulty breathing, swelling, dizziness, rapid heartbeat, sweating, low blood pressure and loss of consciousness). Side effects observed with similar medicines and which can also be expected with carbetocin:

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slow heartbeat, irregular heartbeat, chest pain, fainting or palpitations, which may indicate that the heart is not working properly.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please inform your doctor, midwife or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Aleje Jerozolimskie 181C, 02-222 Warsaw, Tel: +48 22 49 21 301, Fax: +48 22 49 21 309, e-mail: ndl@urpl.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Pabal

Keep the medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the carton and label after EXP. The expiry date refers to the last day of the month. Store the vials in the outer carton in order 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 other information

What Pabal contains

• The active substance is carbetocin. 1 ml of solution contains 100 micrograms of carbetocin.
• The other ingredients are: L-methionine, 1,4-butanediol, mannitol, sodium hydroxide and water for injections.

What Pabal looks like and contents of the pack

Pabal is a clear, colorless solution for injection for intravenous or intramuscular administration, available in vials of 1 ml. Each pack contains 5 vials. Pabal should only be used in well-equipped, specialized obstetric units.

Marketing authorization holder and manufacturer:

Ferring GmbH, Wittland 11, D-24109 Kiel, Germany

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

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PABAL:
Austria, Belgium, Denmark, Estonia, Finland, France, Greece, Netherlands, Ireland, Iceland, Lithuania, Luxembourg, Germany, Norway, Poland, Portugal, Slovakia, Sweden, Hungary, United Kingdom, Italy
DURATOCIN:
Czech Republic
DURATOBAL: Spain
For more detailed information, please contact the representative of the marketing authorization holder: Ferring Pharmaceuticals Poland Sp. z o.o., ul. Szamocka 8, 01-748 Warsaw, Tel.: +48 22 246 06 80, Fax: +48 22 246 06 81
Date of last revision of the leaflet: June 2023
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