Carbetocin mercapharm

Package leaflet: Information for the patient

Carbetocin Mercapharm, 100 micrograms/mL, solution for injection
Carbetocinum
Please read all of this leaflet carefully before the medicine is administered, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor, midwife or nurse.
• If you experience any adverse reactions after administration of this medicine, including any adverse reactions not listed in this leaflet, inform your doctor, midwife or nurse. See section 4.

Table of contents

1. What Carbetocin Mercapharm is and what it is used for
2. Important information before administration of 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 Carbetocin Mercapharm is and what it is used for

The active substance in Carbetocin Mercapharm is carbetocin. It is similar to a substance called oxytocin, which is naturally produced by the body to induce uterine contractions during childbirth.
Carbetocin Mercapharm is used in women immediately after childbirth.
In some women, the uterus does not contract sufficiently after delivery. In such cases, there is an increased risk of excessive bleeding. Carbetocin Mercapharm causes the uterus to contract and thereby reduces the risk of bleeding.

2. Information before using Carbetocin Mercapharm

Carbetocin Mercapharm must not be administered until the baby has been delivered.
Before administering Carbetocin Mercapharm, inform the doctor about any medical conditions the patient may have.
Also, inform the doctor about any new symptoms that occur during treatment with Carbetocin Mercapharm.

When not to use Carbetocin Mercapharm

• if the patient is pregnant;
• if the patient is in labour and the baby has not yet been born;
• for the induction of labour;
• if the patient is allergic to carbetocin or to any of the other ingredients of this medicine (listed in section 6);
• if the patient has ever had an allergic reaction to oxytocin (sometimes given by infusion or injection during or after childbirth);
• if the patient has liver or kidney disease;
• if the patient has severe heart disease;
• if the patient has epilepsy.

If any of the above situations apply to the patient, inform the doctor, midwife, or nurse.

Warnings and precautions
Before starting treatment with Carbetocin Mercapharm, discuss the following with the doctor, midwife, or nurse:

• if the patient suffers from migraine headaches;
• if the patient has asthma;
• if the patient has pre-eclampsia (high blood pressure during pregnancy) or eclampsia (toxemia of pregnancy);
• if the patient has heart disease or circulatory disorders (e.g. high blood pressure);
• if the patient has any other health disorders.

If any of the above situations apply to the patient, inform the doctor, midwife, or nurse.

Carbetocin Mercapharm may cause water retention in the body, which may 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 this medicine in adolescents is limited.

Other medicines and Carbetocin Mercapharm
Inform the doctor, midwife, or nurse about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

Pregnancy and breastfeeding
Carbetocin Mercapharm must not be used during pregnancy or labour until the baby has been delivered.
It has been shown that small amounts of carbetocin pass from the blood into breast milk; however, it is believed to be broken down in the infant's intestines.
There is no need to restrict breastfeeding after administration of Carbetocin Mercapharm.

Carbetocin Mercapharm contains sodium chloride
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. it is considered "sodium-free".

3. How to use Carbetocin Mercapharm

Carbetocin Mercapharm is administered by injection into one of the veins or into one of the muscles, immediately after delivery of the baby. The dose is one vial (100 micrograms).
Carbetocin Mercapharm must only be used in a hospital setting and under appropriate medical supervision.
Use of a higher than recommended dose of Carbetocin Mercapharm
If an overdose of Carbetocin Mercapharm is accidentally administered, the uterus may contract so strongly that it becomes damaged or significant bleeding may occur.
The patient may also experience drowsiness, apathy, and headache caused by fluid accumulation in the body. The patient will be treated with other medications; surgical treatment may also be necessary.

4. Possible adverse reactions

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

When Carbetocin Mercapharm is administered intravenously following a caesarean section

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

• Headache
• Tremor
• Low blood pressure
• Flushing (reddening of the skin)
• Nausea
• Abdominal pain
• Itching
• Feeling of warmth.

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

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

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

• Fast heartbeat
• Slow heartbeat, which may lead to cardiac arrest (heart stops beating).

Adverse reactions observed with similar medicines and which may also be expected with carbetocin:
Irregular heartbeat, chest pain, fainting or palpitations, which may indicate that the heart is not working properly.
Allergic reactions (including sudden, severe allergic reaction with breathing difficulties, swelling, dizziness, fast heartbeat, sweating, low blood pressure and loss of consciousness).
Rarely, some women may experience sweating.

When Carbetocin Mercapharm is administered intramuscularly after a natural delivery

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

• Nausea
• Abdominal pain
• Vomiting
• Low blood pressure
• Anaemia
• Headache
• Dizziness
• Fast heartbeat
• Back or chest pain
• Muscle weakness
• Chills
• Fever
• Generalised pain.

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

• Flushing (reddening of the skin)
• Itching of the skin
• Shortness of breath
• Tremor
• Difficulty in urination.

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

• Fast heartbeat
• Slow heartbeat, which may lead to cardiac arrest (heart stops beating).

Adverse reactions observed with similar medicines and which may also be expected with carbetocin:
Irregular heartbeat, chest pain, fainting or palpitations, which may indicate that the heart is not working properly.
Allergic reactions (including sudden, severe allergic reaction with breathing difficulties, swelling, dizziness, fast heartbeat, sweating, low blood pressure and loss of consciousness).

Reporting of adverse reactions

If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, midwife or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Carbetocin Mercapharm

Keep the medicine out of 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 stated month.
No special temperature storage requirements for this medicine.
Store vials 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 any particulate matter is visible.

6. Contents of the pack and other information

What Carbetocin Mercapharm contains

• The active substance is carbetocin. Each millilitre (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, colourless solution free from visible particles.
A vial made of colourless glass type I, with a grey stopper (type I) coated with fluoropolymer,
fitted with an aluminium cap with a polipropylene disc, of the flip-off type, 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 Authorisation 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 medicinal product is authorised in the member countries of the European Economic Area under the following names:
Estonia Carbetocin Auxilia 100 microgrammi/ml süstelahus
Latvia Carbetocin Pharmidea ml šķīdums injekcijām

Information intended exclusively for medical professionals:

(See also section 3).
No special storage temperature requirements for the medicinal product.
Vials should be stored in the outer packaging to protect from light.
Do not freeze.
Before using the medicinal product Carbetocin Mercapharm, ensure that the solution
does not contain visible particles.
After first opening the vial, the solution must be used immediately.
Route of administration
Intravenous or intramuscular administration.
Carbetocin should only be administered after the birth of the child. The medicinal product should be given as soon as possible after delivery, preferably before removal of the placenta.
When administered intravenously, carbetocin must be given slowly, over more than 1 minute.
The medicinal product Carbetocin Mercapharm is intended for single use only. Do not administer additional doses of carbetocin.