Prospecto: information for the patient

Carbetocina GP-Pharm 100 micrograms injectable solution in pre-filled syringe

Carbetocina

Read this prospectus carefully before starting to use this medication, as it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor, midwife or nurse.
• If you experience any adverse effects, consult your doctor, midwife or nurse, even if they are not listed in this prospectus. See section 4.

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

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

3.How to administer Carbetocina GP-Pharm

4.Possible adverse effects

5.Storage of Carbetocina GP-Pharm

6.Contents of the package and additional information

The active ingredient ofCarbetocinaGP-Pharm is carbetocina. It is similar to a substance called oxytocin, which is naturally produced by the body to contract the uterusduring childbirth.

Carbetocina GP-Pharm 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. Carbetocina GP-Pharm causes the uterus to contract and thus reduces the risk of bleeding.

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

Before using Carbetocina GP-Pharm, your doctor must know any diseases you may have. You must tell your doctor 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 child has not yet been delivered
• To induce labor
• If you areallergicto carbetocina or any of the other components of this medication (listed in section 6).
• If you areallergicto oxytocin (whether 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 haveepilepsy(repeated episodes of convulsions, loss of consciousness).

Consult your doctor, midwife, or nurse if you suffer from any of these symptoms.

Warnings and precautions

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

• If you havemigraines (repeated headache).
• If you haveasthma(respiratory disorder with repeated episodes of breathing difficulty, wheezing, and coughing).
• If you have preeclampsia (elevated blood pressure during pregnancy) or eclampsia (toxemia of pregnancy with intense agitation and involuntary movements).
• If you have problems with yourheartor circulation (such ashigh blood pressure).
• If you have any other disease.

Consult your doctor, midwife, or nurse if you suffer from any of these symptoms.

Carbetocina GP-Pharm may cause fluid accumulation in the body, leading to drowsiness, apathy, and headache.

Children and adolescents

Not relevant in children under 12 years.

The experience with adolescents is limited.

Use of Carbetocina GP-Pharm with other medications

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

Pregnancy and breastfeeding

Carbetocina GP-Pharm should not be used during pregnancy and delivery until the child has been delivered.

Small amounts of carbetocina 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 using Carbetocina GP-Pharm.

Carbetocina GP-Pharm contains sodium

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

Carbetocina GP-Pharm is administered via injectioninto one of its veins or one of its muscles, immediately after the extraction of your baby. The dose is a preloaded 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 haveyou 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 Carbetocina GP-Pharm is administered through a vein after a cesarean section

Very common: may affect more than 1 in 10 women:

• Nausea
• Abdominal pain
• Itching
• Redness (red skin)
• Sensation of heat
• Low blood pressure
• Headache
• Tremors

Common: up to 1 in 10 women:

• Vomiting
• Dizziness
• Back or chest pain
• Metals 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)

Side effects observed with similar products that may be expected with carbetocina:

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, drowsiness, rapid heart rate, sweating, low blood pressure, and loss of consciousness).

Occasionally, some women may experience sweating.

When Carbetocina GP-Pharm is administered in one of its muscles after vaginal delivery

Infrequent: may affect up to 1 in 100 women

• Nausea
• Abdominal pain
• Vomiting
• Low blood pressure
• Anemia
• Headaches
• Dizziness
• Fast heart rate
• Back or chest pain
• Muscle weakness
• Chills
• Fever
• General pain

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

• Redness (red skin)
• Itching
• Dyspnea
• Tremors
• Difficulty urinating

Side effects observed in similar products to carbetocina:

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

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

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor, midwife, or nurse, even if it is possible adverse effects that do not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

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

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 medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Composition of Carbetocina GP-Pharm

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

• The other components are:chlorideofsodium, glacial acetic acid for pH adjustment, water forpreparationsinjectable.

Aspect of the product and content of the package

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

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

Holder of the Marketing Authorization and responsible for manufacturing

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 with the following names:

Last review date of this prospectus: May 2023.

Other sources of information

The detailed information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Productshttp://www.aemps.gob.es/.