Pabal 100 micrograms in 1ml solution for injection

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, midwife or nurse.
• If you get any side effects, talk to your doctor, midwife or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

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

• if you are pregnant.
• if you are in labour and the baby has not been delivered.
• to induce labour.
• if you are allergic to carbetocin or any of the other ingredients of this medicine (listed in section 6).
• if you are allergic to oxytocin (sometimes given as a drip or injection during or after labour).
• if you have any disease of the liver or kidneys.
• if you have any serious heart disease.
• if you have epilepsy.

If any of these apply to you, tell your doctor, midwife or nurse.

Talk to your doctor, midwife or nurse before you are given Pabal

• if you get migraines.
• if you have asthma.
• if you have pre-eclampsia (high blood pressure in pregnancy) or eclampsia (toxaemia of pregnancy).
• if you have problems with your heart or your circulation (such as high blood pressure).
• if you have any other medical condition.

If any of these apply to you, tell your doctor, midwife or nurse.

Pabal may cause a build up of water in the body which can lead to drowsiness, listlessness and headache.

Not relevant in children below 12 years of age.

The experience with adolescents is limited.

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

Do not use Pabal during pregnancy and labour until after the baby has been delivered. Small amounts of carbetocin have been shown to pass from the nursings mother’s blood into the breast milk, but it is assumed to be degraded in the infant’s bowels. Breastfeeding does not need to be restricted after the use of Pabal.

If you are accidentally given too much Pabal, your womb may contract strongly enough to become damaged or to bleed heavily. You may also suffer drowsiness, listlessness and headache, caused by water building up in your body. You will be treated with other medication, and possibly surgery.

Very common: may affect more than 1 in 10 people

• nausea
• pain in the stomach
• itching
• flushing (red skin)
• feeling of warm
• low blood pressure
• headaches
• shakiness

Common: may affect up to 1 in 10 people

• vomiting
• dizziness
• pain in the back or chest
• a metallic taste in the mouth
• anaemia
• breathlessness
• chills
• general pain

Not known: frequency cannot be estimated from the available data

• fast heartbeat, slow heartbeat which may lead to cardiac arrest (when the heart stops beating)
• allergic reactions (including sudden, severe allergic reaction with breathing difficulty, swelling, light-headedness, fast heartbeat, sweating, low blood pressure and loss of consciousness)

Side effects seen with similar products that might be expected with carbetocin: irregular heartbeat, chest pain, fainting or palpitations which may mean the heart is not beating properly.

Infrequently some women might experience sweating.

Uncommon: may affect up to 1 in 100 people

• nausea
• pain in the stomach
• vomiting
• low blood pressure
• anaemia
• headaches
• dizziness
• rapid heartbeat
• pain in the back or chest
• muscle weakness
• chills
• fever
• general pain

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

• flushing (red skin)
• itching
• breathlessness
• shakiness
• difficulty to pass urine

Not known: frequency cannot be estimated from the available data

• allergic reactions (including sudden, severe allergic reaction with breathing difficulty, swelling, light-headedness, fast heartbeat, sweating, low blood pressure and loss of consciousness)

Side effects seen with similar products that might be expected with carbetocin: slow heartbeat, irregular heartbeat, chest pain, fainting or palpitations which may mean the heart is not beating properly.

If you get any side effects, talk to your doctor, midwife or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see below). By reporting side effects you can help provide more information on the safety of this medicine.

United Kingdom:

or search for MHRA Yellow Card in the Google Play or Apple App Store.

Ireland:

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.

Pabal is clear colourless solution for injection, ready for intravenous or intramuscular injection, supplied in packs of five vials of 1 ml.

Pabal should be used only in well-equipped specialist obstetrics units.

UK marketing authorisation holder - PL 03194/0058

Irish product authorisation holder - PA 1009/21/1