What this product is and what it is used for The active ingredient in PABAL® RTS is carbetocin. It is similar to a substance called oxytocin, which is naturally produced by the body to make the womb contract during childbirth. PABAL® RTS is used to treat women who have just had a baby. In some women, after delivery, the womb (uterus) doesn’t contract (shrink) quickly enough. This makes it more likely that they’ll bleed more than normal. PABAL® RTS makes the womb contract and so reduces the risk of bleeding. 2. What you need to know before you use this product PABAL® RTS must not be given until after the baby has been delivered. Before giving you PABAL® RTS, your doctor needs to know about any medical conditions you may have. You should also tell your doctor about any new symptoms that develop while you are being treated with PABAL® RTS. You must not be given PABAL® RTS 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 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. Warnings and precautions Talk to your doctor, midwife or nurse before you are given PABAL® RTS 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. PABAL® RTS may cause a build up of water in the body which can lead to drowsiness, listlessness and headache. Children and adolescents Not relevant in children below 12 years of age. The experience with adolescents is limited. Other medicines and PABAL® RTS Tell your doctor, midwife or nurse if you are taking, or have recently taken, any other medicines. Pregnancy and breast-feeding Do not use PABAL® RTS during pregnancy and labour until after the baby has been delivered. Small amounts of carbetocin have been shown to pass from the nursing 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® RTS. 3. How to use this product. PABAL® RTS is given as an injection into one of your veins or into one of your muscles, immediately after your baby has been delivered. The dose is one vial (100 micrograms). If you are given more PABAL® RTS than you should have been given If you are accidentally given too much PABAL® RTS, 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. 4. Possible side effects Like all medicines, PABAL® RTS can have side effects, but not everybody gets them. When PABAL® RTS is given through one of your veins after caesarian section 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 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. Occasionally some women may experience sweating. When PABAL® RTS is given into one of your muscles after vaginal delivery 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 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. 5. How to store this product Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton and vial. The expiry date refers to the last day of that month.