Syntocinon 5 Iu Injection

What SYNTOCINON is: SYNTOCINON belongs to a group of medicines called oxytocics that makes the muscles of the womb contract.

What SYNTOCINON is used for: Before birth • To induce labour (childbirth) for medical reasons. • Enhancement of labour (childbirth) in selected cases. • SYNTOCINON may also be indicated in early stage of pregnancy, as management of miscarriage. After birth • During caesarean section, after the delivery of the child. • Prevention and treatment of bleeding after delivery of the baby.

SYNTOCINON should not be administered to you: • If you have a known allergy or if you are hypersensitive (allergic) to oxytocin or to any of the other ingredients of SYNTOCINON (listed in section 6.1). • If you previously had a reaction to SYNTOCINON injection. • If your doctor thinks that to start or increase contractions of the womb would be unsuitable for you, for example where : – The contractions of the womb are unusually strong. – There may be an oxygen shortage to your baby. – There are obstructions preventing delivery. • If labour or vaginal delivery is not advisable, for example where:

• The baby’s head may be too large to fit through your pelvis.
• The baby is incorrectly positioned in the birth canal.
• The placenta is wrongly positioned or separates from the womb.
• The oxygen shortage occurs due to blood vessels passing near to the cervix (the lower, narrow end of the uterus that forms a canal between the uterus and vagina).
• Parts of the umbilical cord are present between the baby and the cervix (before or after your water breaks).
• You have too much amniotic fluid (important fluid for you baby’s development).
• You have had previous pregnancies and/or your womb is scarred from previous caesarean section.

Warnings and precautions Tell your doctor or healthcare provider before being given the injection if: • you have a known irregular heartbeat (‘long QT syndrome’) or you are taking medicines that are known for “long QT syndrome” or medicines that are known to prolong the QTc interval on the Electrocardiogram (ECG); • you are allergic to latex, as this can result in severe allergic reactions when receiving SYNTOCINON; • you have had a previous caesarean section; • you have a small pelvis; • you have liver or kidney problems as SYNTOCINON can cause water retention (fluid build-up in your body); • you are older than 35 years; • you have raised blood pressure, heart problems/disease, circulation problems or are prone to chest pain; • your womb was contracting strongly but has now begun to contract less strongly; • you had complications during your pregnancy; • you are more than 40 weeks pregnant. If any of the above applies to you, or if you are not sure, speak to your doctor or midwife before you receive SYNTOCINON. Take special care with SYNTOCINON: • While drinking large volumes of water, as it can result in water intoxication with low doses of sodium in your blood. • SYNTOCINON should only be used for medical reasons and not for convenience. • SYNTOCINON should only be administrated in hospital under supervision of a qualified healthcare professional. • SYNTOCINON should only be administrated as an IV infusion and not as a rapid injection into the vein as this may cause low blood pressure, a sudden brief sensation of heat (often over the entire body), and an increased heart rate. • SYNTOCINON can cause a rare but serious condition that causes abnormal blood clotting, bleeding and anaemia (shortage of oxygen). This increases if the women has additional risk factors for this condition. • SYNTOCINON in high doses can cause amniotic fluid to move from your womb into your blood (known as amniotic fluid embolism), and can result in heart failure in your baby. SYNTOCINON should not be used for prolonged periods if: • your contractions do not increase with the treatment; • you have a condition known as severe pre-eclamptic toxaemia (high blood pressure, protein in the urine and swelling); • you have severe problems with your heart or blood circulation.

SYNTOCINON will only be administered in a hospital setting under qualified medical supervision. Do not share medicines prescribed for you with any other person.

The dose you will receive is different in the following circumstances: – To start or help contractions during labour. – Miscarriage. – Caesarean section. – Prevention/treatment of bleeding after delivery. – Incomplete, inevitable or missed abortion. Duration of treatment Your doctor will tell you how long your treatment with SYNTOCINON will last. If you have the impression that the effect of SYNTOCINON is too strong or too weak, tell your doctor or pharmacist. Method of administration You will not be expected to give yourself SYNTOCINON. It will be given to you by a person who is qualified to do so. Dosage in patients with kidney or liver impairment: If you have kidneys/liver that does not function normally, please consult your doctor. If you are given more SYNTOCINON than you should Since a healthcare professional will administer SYNTOCINON, he/she will control the dosage. However, in the event of overdose your doctor will manage the overdose. If you missed a dose of SYNTOCINON Since a healthcare professional will administer SYNTOCINON, it is unlikely that the dose will be missed.

SYNTOCINON can have side effects. Not all side effects reported for SYNTOCINON are included in this leaflet. Should your general health worsen or if you experience any untoward effects while receiving SYNTOCINON, please consult your healthcare provider for advice. If any of the following happens, stop receiving SYNTOCINON and tell your doctor immediately or go to the casualty department at your nearest hospital: • Swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing; • rash or itching; • fainting. These are all very serious side effects. If you have them, you may have had a serious allergic reaction to SYNTOCINON. You may need urgent medical attention or hospitalisation. Tell your doctor if you notice any of the following: The following side effects have been reported frequently: • feeling nauseous and vomiting; • headache; • fast or slow heart rate; • low blood pressure; • shock; • flushing; • bleeding.

The following side effects have been reported less frequently: • irregular heartbeat; • increase in blood pressure; • skin rashes; • severe allergic reaction (anaphylaxis) causing dizziness, lightheadedness, difficulty breathing, low blood pressure and shock. The following side effects have been reported but the frequency is unknown: • Disseminated intravascular coagulation (DIC), a rare but serious condition that causes abnormal blood clotting throughout the body’s blood vessels. • Swelling of the deeper layers of the skin caused by a build-up of fluid in the body (angioedema). • Increased fluid intake (water intoxication) can cause loss of sodium in the mother and baby. • Reduced blood flow to the heart resulting in loss of oxygen. • QTc prolongation (irregular heartbeat). • Decrease in blood pressure. • Hot flushes. • Foetal distress (baby experiences distress during labour). • A condition where the body is deprived of oxygen (asphyxia). • Sudden fluid overload in lungs. • Spasm of the muscles of the womb. • Contractions or rupture of the womb. If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Store all medicines out of reach of children. Store at or between 2 °C – 8 °C (in a refrigerator). Store in the original package/container. Keep the container in the outer carton. Protect from direct light. Do not store in a bathroom. Do not use after the expiry date stated on the label/carton/bottle. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).