CARBETOCINA GP-PHARM 100 micrograms Injectable Solution in Pre-filled Syringe

Introduction

Package Leaflet: Information for the Patient

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

Carbetocina

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

• Keep this package 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, talk to your doctor, midwife or nurse, even if they are not listed in this package leaflet. See section 4.

Contents of the package leaflet

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

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

The active substance of 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 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 normal. Carbetocina GP-Pharm makes the uterus contract and thus reduces the risk of bleeding.

2. What you need to know before you are given Carbetocina GP-Pharm

Do not useCarbetocina GP-Pharm until the baby has been delivered.

Before using Carbetocina GP-Pharm, your doctor should know about any diseases you may have. You should tell your doctor about any new symptoms you develop while 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 been delivered
• To induce labor
• If you are allergicto carbetocin or any of the other components of this medicine (listed in section 6).
• If you are allergicto oxytocin (whether administered by drip or injection during or after childbirth)
• If you have any kidneyor liverdisease.
• If you have severe coronary heart 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

Tell your doctor, midwife or nurse before receiving Carbetocina GP-Pharm:

• If you have migraines (repeated headaches).
• If you have asthma(respiratory disorder with repeated episodes of breathing difficulties, 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 problems with your heartor circulation(such as high blood pressure).
• If you have any other disease.

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

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

Children and adolescents

Not relevant in children under 12 years.

Experience with adolescents is limited.

Use of Carbetocina GP-Pharm 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

Carbetocina GP-Pharm 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 to 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 Carbetocina GP-Pharm.

Carbetocina GP-Pharm contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per ml, i.e. it is essentially "sodium-free".

3. How Carbetocina GP-Pharm is given

Carbetocina GP-Pharm is given by injectioninto one of your veins or into one of your muscles, immediately after the delivery of your baby. The dose is one pre-filled syringe (100 micrograms).

If you are given more Carbetocina GP-Pharm than you should

If you have been accidentally given more Carbetocina GP-Pharm 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 Carbetocina GP-Pharm is given 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 of the skin (flushing)
• 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 (reduction of red blood cells)
• Shortness of breath (dyspnea)
• Chills
• General pain

Not known: frequency cannot be estimated from the available data

• Accelerated heart rate
• Slow heart rate that can cause cardiac arrest (when the heart stops beating)

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.

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

Some women may occasionally experience sweating.

When Carbetocina GP-Pharm is given into one of your muscles after 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 up to 1 in 1,000 women

• Redness of the skin (flushing)
• Itching (pruritus)
• Shortness of breath (dyspnea)
• Tremors
• Difficulty urinating

Side effects observed with similar products to carbetocin:

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

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 side effects:

If you experience any side effects, talk to your doctor, midwife or nurse, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines Agency's website: https://www.notificaram.es. By reporting side 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.

The pre-filled syringes of Carbetocina GP-Pharm are stored in the original packaging to protect them from light. Store in a refrigerator (2°C - 8°C).

Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry date is the last day of the month stated.

6. Contents of the pack and other information

Composition of Carbetocina GP-Pharm

• The active substance is carbetocin. Each pre-filled syringe contains 1 ml with 100 micrograms of carbetocin.

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

Appearance of the product and contents of the pack

Carbetocina GP-Pharm is a clear and colorless solution, prepared for intravenous or intramuscular injection and provided in packs containing five pre-filled syringes of 1 ml.

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

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 medicine 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 last revision of this package leaflet: May 2023.

Other sources of information

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Productshttp://www.aemps.gob.es/.