Duratocin

Package leaflet: Information for the patient

DURATOCIN 100 micrograms/ml injection solution

carbetocin
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, midwife, or nurse.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor, midwife, or nurse. See section 4.

Contents of this leaflet:

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

1. What DURATOCIN is and what it is used for

The active substance of DURATOCIN is carbetocin. It is similar to a substance called oxytocin, which is naturally produced by the body to cause the uterus to contract during childbirth.
DURATOCIN is used for the treatment of women who have given birth.
In some women, after childbirth, the uterus does not contract quickly enough. This increases the likelihood of excessive bleeding.
DURATOCIN causes the uterus to contract, thereby reducing the risk of bleeding.

2. What you must know before you are given DURATOCIN

DURATOCIN must not be used until after the baby has been born.
Before DURATOCIN is administered, your doctor must be informed of your clinical condition. You must also
inform your doctor of any new symptoms that may occur during treatment with DURATOCIN.
DURATOCIN must not be administered to you:

• if you are pregnant.
• if you are in labour and the baby has not yet been delivered.
• to induce labour.
• if you are allergic to carbetocin or to any of the ingredients of this medicine (listed in section 6).
• if you are allergic to oxytocin (sometimes administered by infusion or injection during or after childbirth).
• if you have liver or kidney problems.
• if you suffer from severe heart disease.
• if you have epilepsy.

If any of the above apply to you, inform your doctor, midwife or nurse.
Warnings and precautions
Talk to your doctor, midwife or nurse before DURATOCIN is administered to you

• if you suffer from migraines
• if you suffer from asthma
• if you have pre-eclampsia (high blood pressure during pregnancy) or eclampsia (a toxic condition of pregnancy)
• if you have heart or circulatory problems (e.g. high blood pressure)
• if you have other medical conditions.

If any of the above apply to you, inform your doctor, midwife or nurse.
DURATOCIN may cause water retention in the body, which may lead to drowsiness, difficulty concentrating, and headache.
Children and adolescents
Not applicable in children under 12 years of age.
Experience in adolescents is limited.
Other medicines and DURATOCIN
Inform your doctor, midwife and nurse if you are taking, have recently taken, or might take any other medicines.
Pregnancy and breastfeeding
Do not use DURATOCIN during pregnancy and labour until after the baby has been delivered.
It has been shown that small amounts of carbetocin pass from maternal blood into breast milk, but are believed to be degraded in the infant’s intestine.
Breastfeeding does not need to be restricted after the use of DURATOCIN.

3. How DURATOCIN is administered

DURATOCIN is administered intravenously or intramuscularly, immediately after the baby's birth.
The dose is 1 vial (100 micrograms).
If you are given more DURATOCIN than you should have received
If an excessive dose of DURATOCIN is accidentally administered, your uterus may contract so strongly that it becomes damaged or causes heavy bleeding. You may also experience drowsiness, difficulty concentrating, and headache, caused by an increase in fluid in your body. You will need to be treated with other medicines and, if necessary, surgery.

4. Possible side effects

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

When DURATOCIN is administered intravenously after caesarean section

Very common: may affect more than 1 in 10 people

• nausea
• stomach pain
• itching
• skin redness
• sensation of warmth
• low blood pressure
• headache
• tremors

Common: may affect up to 1 in 10 people

• vomiting
• dizziness
• back or chest pain
• metallic taste in the mouth
• anaemia
• shortness of breath
• chills
• general pain

Not known: frequency cannot be estimated from the available data

• fast heartbeat, slowed heartbeat which may lead to cardiac arrest (when the heart stops beating)
• Allergic reactions (including severe and sudden allergic reaction with difficult breathing, swelling, mild confusion, fast heartbeat, sweating, low blood pressure, and loss of consciousness).

Side effects observed with similar products that could also occur with carbetocin:
irregular heartbeat, chest pain, fainting or palpitations which may mean that the heart is not beating properly.
Rarely, some women may experience sweating.

When DURATOCIN is administered intramuscularly after vaginal delivery

Uncommon: may affect up to 1 in 100 people

• nausea
• stomach pain
• vomiting
• low blood pressure
• anaemia
• headache
• dizziness
• fast heartbeat
• back or chest pain
• muscle weakness
• chills
• fever
• general pain

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

• skin redness
• itching
• shortness of breath
• tremors
• difficulty urinating

Not known: frequency cannot be estimated from the available data

• Allergic reactions (including severe and sudden allergic reaction with difficult breathing, swelling, mild confusion, fast heartbeat, sweating, low blood pressure, and loss of consciousness).

Side effects observed with similar products that could also occur with carbetocin:
slowed heartbeat, irregular heartbeat, chest pain, fainting or palpitations which may mean that the heart is not beating properly.

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, talk to your doctor, midwife, or nurse. You can also report side effects directly via the national reporting system at the following website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store DURATOCIN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and vial after EXP.
The expiry date refers to the last day of that month.
Store the vials in the original carton to protect them from light. Store below 30°C. Do not freeze.
The solution should be used immediately after opening the vial.

6. Package contents and other information

What DURATOCIN contains
The active substance is carbetocin. Each millilitre contains 100 micrograms of carbetocin.
The other ingredients are: L-methionine, succinic acid, mannitol, sodium hydroxide, and water for
injections.
Description of the appearance of DURATOCIN and contents of the pack
DURATOCIN is a ready-to-use clear, colourless solution for injection, intended for intravenous or
intramuscular administration, supplied in packs of 5 vials of 1 ml each.
DURATOCIN must only be used in well-equipped, specialized obstetrics departments.
Marketing Authorization Holder and Manufacturer
Ferring S.p.A. - via C. Imbonati, 18 - 20159 Milan, Italy
Manufacturer
Ferring GmbH, Wittland 11, D-24109 Kiel, Germany.
This medicinal product is authorized in the Member States of the European Economic Area under the
following names:
PABAL/DURATOBAL.