Carbetocin GP-Pharm 100 micrograms solution for injection in pre-filled syringe

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Carbetocina GP-Pharm 100 micrograms solution for injection in pre-filled syringe

Carbetocin

Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, midwife or nurse.
• If you experience any side effects, talk to your doctor, midwife or nurse, even if they are side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Carbetocina GP-Pharm is and what it is used for
2. What you need to know before being given Carbetocina GP-Pharm
3. How Carbetocina GP-Pharm is administered
4. Possible side effects
5. How to store Carbetocina GP-Pharm
6. Contents of the pack and other information

1. What Carbetocina GP-Pharm is and what it is used for

The active substance in Carbetocina GP-Pharm is carbetocin. It is similar to a substance called oxytocin, which is naturally produced by the body to contract the uterus during childbirth.

Carbetocina GP-Pharm is used for the treatment of women who have just given birth.

In some women, after childbirth the uterus does not contract quickly enough. This increases the likelihood of excessive bleeding. Carbetocina GP-Pharm causes the uterus to contract, thereby reducing the risk of bleeding.

2. What you need to know before Carbetocina GP-Pharm is administered to you

Carbetocina GP-Pharm must not be used until the baby has been delivered.

Before using Carbetocina GP-Pharm, your doctor must be aware of any medical conditions you may have. You must inform your doctor of any new symptoms that develop while you are being treated with Carbetocina GP-Pharm.

Do not use Carbetocina GP-Pharm

• 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 to any of the other ingredients of this medicine (listed in section 6)
• If you are allergic to oxytocin (whether administered by infusion or injection during or after labor)
• If you have any severe kidney or liver disease
• If you have any severe coronary disease
• If you have epilepsy (repeated episodes of seizures, 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 Carbetocina GP-Pharm:

• If you have migraines (recurring headaches)
• If you have asthma (a respiratory disorder with repeated episodes of breathing difficulty, wheezing, and coughing)
• If you have preeclampsia (high blood pressure during pregnancy) or eclampsia (severe toxemia with intense agitation and involuntary movements)
• If you have any heart or circulatory problems (such as high blood pressure)
• If you have any other medical conditions

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

Carbetocina GP-Pharm may cause water retention in the body, which can lead to drowsiness, apathy, and headache.

Children and adolescents

Not relevant for children under 12 years of age.

Experience in adolescents is limited.

Use of Carbetocina GP-Pharm with other medicines

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

Pregnancy and breastfeeding

Carbetocina GP-Pharm must not be used during pregnancy and labor until the baby has been delivered.

Small amounts of carbetocin have been shown to pass from the blood of breastfeeding mothers into breast milk; however, it is assumed to be degraded in the infant's intestine.

Breastfeeding does not need to be restricted after use of Carbetocina GP-Pharm.

Carbetocina GP-Pharm contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per ml; therefore, it is essentially “sodium-free”.

3. How Carbetocin GP-Pharm is administered

Carbetocin GP-Pharm is administered by injection into one of your veins or into one of your muscles, immediately after your baby has been delivered. The dose is one pre-filled syringe (100 micrograms).

If you are given more Carbetocin GP-Pharm than you should have

If you have accidentally been given more Carbetocin GP-Pharm than you should have, you may experience uterine hyperstimulation with strong contractions, which could lead to uterine rupture or postpartum hemorrhage. You may also experience somnolence, apathy, and headache caused by fluid retention. Treatment with other medications and possibly surgery will be required.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

When Carbetocina GP-Pharmen is administered into one of your veins after a caesarean section

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
• Anaemia (reduction in red blood cells)
• Dyspnoea (difficulty breathing)
• Chills
• General pain

Not known: frequency cannot be estimated from the available data

• Increased heart rate
• Slow heartbeats that may lead to cardiac arrest (when the heart stops beating)

Side effects observed with similar products that could also be expected with carbetocin:

Irregular heartbeat, chest pain, fainting or palpitations, which may mean the heart is not beating properly.

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

Occasionally, some women may experience sweating.

When Carbetocina GP-Pharmen is administered into one of your muscles after vaginal delivery

Uncommon: may affect up to 1 in 100 women

• Nausea
• Stomach pain
• Vomiting
• Low blood pressure
• Anaemia
• 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)
• Dyspnoea (difficulty breathing)
• Tremors
• Difficulty urinating

Side effects observed with similar carbetocin products:

Slow heartbeats, irregular heartbeats, chest pain, fainting or palpitations, which may mean the heart is not beating properly.

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

Reporting of adverse effects:

If you experience any adverse effect, talk to your doctor, midwife, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Carbetocina GP-Pharm

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

Carbetocina GP-Pharm pre-filled syringes should be stored in the original packaging to protect from light. Store in a refrigerator (2°C – 8°C).

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

6. Pack contents and other information

Composition of Carbetocina GP-Pharm

• The active substance is carbetocin. Each pre-filled syringe contains one milliliter with 100 micrograms of carbetocin.

• The other components are: sodium chloride, glacial acetic acid for pH adjustment, water for injectable preparations.

Appearance of the medicinal product and contents of the pack

Carbetocina GP-Pharm is a clear, colourless solution for intravenous or intramuscular injection, supplied in packs containing five 1 ml pre-filled syringes.

Carbetocina GP-Pharm should only be used in well-equipped specialized obstetric units.

Marketing Authorization Holder and manufacturers

GP Pharm, S.A.

Pol. Ind. Els Vinyets – Els Fogars Sector 2. Carretera Comarcal C-244, Km. 22

08777 Sant Quintí de Mediona (Barcelona)

Spain

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

Spain: Carbetocina GP-Pharm 100 micrograms solution for injection in pre-filled syringe

Germany: Carbetocin Aguettant 100 Mikrogramm/ml Injektionslösung in einer Fertigspritze

Austria: Carbetocin Aguettant 100 Mikrogramm/ml Injektionslösung in einer Fertigspritze

Italy: Carbetocina Aguettant

France: Carbetocine Aguettant 100 microgrammes/ml, solution injectable en seringue pré-remplie

Belgium: Carbetocine Aguettant 100 microgrammes/ml solution injectable en seringue préremplie / 100 Mikrogramm/ml Injektionslösung in einer Fertigspritze / 100 microgram/ml oplossing voor injectie in voorgevulde spuit

Denmark: Carbetocin Aguettant 100 mikrogram/ml injektionsvæske, opløsning i fyldt injektionssprøjte

Finland: Carbetocin Aguettant 100 mikrogram/ml, injektioneste, liuos, esitäytetty ruisku

Norway: Carbetocin Aguettant 100 mikrogram/ml injeksjonsvæske, oppløsning i ferdigfylt sprøyte

Sweden: Carbetocin Aguettant 100 mikrogram/ml injektionsvätska, lösning i förfylld spruta

Date of the most recent review of this leaflet: May 2023

Other sources of information

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products: http://www.aemps.gob.es/.