Carbetocin Mercapharm

Package Leaflet: Information for the Patient

Carbetocin Mercapharm, 100 micrograms/mL, Solution for Injection

Carbetocinum

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 those not listed in this leaflet, tell your doctor, midwife or nurse. See section 4.

Table of Contents of the Leaflet

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

1. What is Carbetocin Mercapharm and what is it used for

The active substance of Carbetocin Mercapharm is carbetocin. It is similar to a substance called oxytocin, which is produced by the body to cause uterine contractions during childbirth.
Carbetocin Mercapharm is used to treat women immediately after childbirth.
In some women, after childbirth, the uterus does not contract quickly enough. In such a situation, there is a greater likelihood that women will bleed more than usual. Carbetocin Mercapharm causes the uterus to contract and reduces the risk of bleeding.

2. Important information before using Carbetocin Mercapharm

Carbetocin Mercapharm must not be administered until the baby is born.
Before administering Carbetocin Mercapharm, tell your doctor about any diseases that you may have. You should also tell your doctor about any new symptoms that occur during treatment with Carbetocin Mercapharm.

When not to use Carbetocin Mercapharm

• 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 have ever had an allergic reaction to oxytocin (sometimes given as a drip or injection during or after childbirth);
• 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, tell your doctor, midwife or nurse.

Warnings and precautions

Before starting treatment with Carbetocin Mercapharm, discuss it with your doctor, midwife or nurse:

• if you have migraines;
• if you have asthma;
• if you have pre-eclampsia (high blood pressure during pregnancy) or eclampsia (toxemia of pregnancy);
• if you have heart disease or circulatory disorders (e.g. high blood pressure);
• if you have any other health disorders.

If any of the above situations apply to you, tell your doctor, midwife or nurse.
Carbetocin Mercapharm 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 the medicine in adolescents is limited.

Carbetocin Mercapharm and other medicines

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

Pregnancy and breastfeeding

Do not use Carbetocin Mercapharm 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.
There is no need to limit breastfeeding after using Carbetocin Mercapharm.

Carbetocin Mercapharm contains sodium chloride

This medicine contains less than 1 mmol (23 mg) of sodium per dose, which means that the medicine is considered "sodium-free".

3. How to use Carbetocin Mercapharm

Carbetocin Mercapharm is administered by injection into a vein or into a muscle, immediately after childbirth. The dose is one vial (100 micrograms).
Carbetocin Mercapharm should only be used in a hospital, under proper medical supervision.

Using a higher dose of Carbetocin Mercapharm than recommended

If too much Carbetocin Mercapharm is accidentally administered, the uterus may contract too strongly, which can cause damage or heavy bleeding.
The patient may also experience drowsiness, apathy and headache due to water retention in the body. The patient will be treated with other medicines, and surgical treatment may also be possible.

4. Possible side effects

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

In the case of administering Carbetocin Mercapharm into a vein after a cesarean section

Very common(may affect more than 1 in 10 people):

• Headache
• Tremors
• Low blood pressure
• Hot flashes (redness of the skin)
• Nausea
• Abdominal pain
• Itching
• Feeling of warmth.

Common(may affect less than 1 in 10 people):

• Anemia
• Dizziness
• Back or chest pain
• Shortness of breath
• Metallic taste in the mouth
• Vomiting
• Back pain
• Chills
• Generalized pain.

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

• Rapid heartbeat
• Slow heartbeat, which can lead to cardiac arrest (the heart stops beating).

Side effects observed during the use of similar medicines and which can also be expected after administration of carbetocin:
Irregular heartbeat, chest pain, fainting or palpitations, which may indicate that the heart is not working properly.
Allergic reactions (including sudden, severe allergic reactions with difficulty breathing, swelling, dizziness, rapid heartbeat, sweating, low blood pressure, and loss of consciousness).

In the case of administering Carbetocin Mercapharm into a muscle after a vaginal delivery

Uncommon(may affect less than 1 in 100 people):

• Nausea
• Abdominal pain
• Vomiting
• Low blood pressure
• Anemia
• Headache
• Dizziness
• Rapid heartbeat
• Back or chest pain
• Muscle weakness
• Chills
• Fever
• Generalized pain.

Rare(may affect less than 1 in 1,000 people):

• Hot flashes (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):

• Rapid heartbeat
• Slow heartbeat, which can lead to cardiac arrest (the heart stops beating).

Side effects observed during the use of similar medicines and which can also be expected after administration of carbetocin:
Irregular heartbeat, chest pain, fainting or palpitations, which may indicate that the heart is not working properly.
Allergic reactions (including sudden, severe allergic reactions with difficulty breathing, swelling, dizziness, rapid heartbeat, sweating, low blood pressure, and loss of consciousness).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, midwife or nurse. Side effects can be reported directly to the Department for Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw; tel.: +48 22 49 21 301; fax: +48 22 49 21 309; website: https://smz.ezdrowie.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 Carbetocin Mercapharm

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the vial and carton. The expiry date refers to the last day of the month.
There are no special precautions for storage temperature.
The vials should be stored in the outer packaging to protect from light.
Do not freeze.
After first opening the vial, the solution should be used immediately.
Do not use this medicine if visible particles are present.

6. Contents of the pack and other information

What Carbetocin Mercapharm contains

• The active substance is carbetocin. Each milliliter (mL) of solution contains 100 micrograms of carbetocin.
• The other ingredients are: mannitol, acetic acid, sodium hydroxide, water for injections.

What Carbetocin Mercapharm looks like and contents of the pack

Carbetocin Mercapharm is a clear, colorless solution without visible particles.
A vial made of colorless glass type I, with a gray stopper (type I) coated with fluoropolymer, with an aluminum cap with a polypropylene overlay, of the flip-offtype, in a cardboard box, containing 1 mL of solution for injection.
The pack contains 4 or 5 vials.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Mercapharm Sp. z o.o.
ul. Świętopełka 39
81-524 Gdynia
e-mail: [email protected]

Manufacturer

Pharmidea SIA, Rupnicu Iela 4, Olaine, Olaines Novads, 2114, Latvia

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

Estonia
Carbetocin Auxilia 100 micrograms/mL solution for injection
Latvia
Carbetocin Pharmidea 100 micrograms/mL solution for injection
Date of last revision of the leaflet:24.05.2024
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Information intended for healthcare professionals only:
(See also section 3).

There are no special precautions for storage temperature of the medicinal product.

The vials should be stored in the outer packaging to protect from light.

Do not freeze.

Before using the medicinal product Carbetocin Mercapharm, make sure that the solution does not contain visible particles.
After first opening the vial, the solution should be used immediately.
Method of administration
Intravenous or intramuscular injection.
Carbetocin should be administered only after the baby is born. The medicinal product should be administered as soon as possible after delivery, preferably before the placenta is removed.
In the case of intravenous administration, carbetocin must be administered slowly, over more than 1 minute.
The medicinal product Carbetocin Mercapharm is intended for single use only. Do not administer subsequent doses of carbetocin.