Oxytocin 10 IU/ml Solution for infusion

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

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

• if you are allergic to oxytocin or any of the other ingredients of this medicine (listed in section 6);
• if your doctor thinks that to start or increase contractions of the womb would be unsuitable for you, for example:
  • where contractions of the womb are unusually strong;
  • where there are obstructions that may prevent delivery;
  • where your baby may be short of oxygen;
• where labour or vaginal delivery is not advisable, for example:
  • if your baby’s head is too large to fit through your pelvis;
  • if your baby is wrongly positioned in the birth canal;
  • if the placenta lies near or over the neck of your womb;
  • if your baby lacks oxygen due to blood vessels running across the neck of your womb;
  • if the placenta separates from the womb before the baby is born;
  • if there are one or more loops of umbilical cord between the baby and the neck of the womb, either before or after your waters break;
  • if your womb is over-extended and more likely to tear, for example if you are carrying more than one baby or have too much water (amniotic fluid) in your womb;
  • if you have had five or more pregnancies in the past or if your womb is scarred by previous caesarean section or other surgery;
• if you have been given medicines called prostaglandins (used to bring on labour or treat stomach ulcers). Oxytocin should not be used for 6 hours after vaginal prostaglandins as the effects of both medicines may be increased.

Oxytocin 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.

Oxytocin should only be administered by a healthcare professional in a hospital setting.

Oxytocin should not be given as rapid injection into a vein as this may cause decreased blood pressure, a sudden brief sensation of heat (often over the entire body), and an increased heart rate.

Talk to your doctor or midwife before you receive Oxytocin if:

• you are prone to chest pain due to pre-existing heart and/or circulation problems;
• you have a known irregular heart beat (‘long QT syndrome’) or related symptoms, or are taking medicines known to cause the syndrome (see section ‘Other medicines and Oxytocin’);
• you have had a previous caesarean section;
• you are more than 35 years old;
• you have raised blood pressure or heart problems;
• your womb was contracting strongly but has now begun to contract less strongly;
• you have been told by a doctor or midwife that normal delivery may be difficult for you due to the small size of your pelvis;
• you have kidney problems, as Oxytocin can cause water retention;
• you have had complications during your pregnancy;
• you are more than 40 weeks pregnant.

When Oxytocin is given to induce and enhance labour, the infusion rate should be set to maintain a contraction pattern similar to normal labour and adjusted to individual response. Too high doses may cause very strong continuous contractions and possibly tearing of the womb, with serious complications for you and your baby.

Oxytocin may rarely cause disseminated intravascular coagulation which causes symptoms including abnormal blood clotting, bleeding and anaemia.

High doses of Oxytocin may force amniotic fluid from your womb into your blood. This is known as amniotic fluid embolism.

Large doses of Oxytocin over a long period of time, whilst drinking or receiving large volumes of fluid may make your stomach feel very full, cause difficulty in breathing and lower salt levels in your blood.

If any of the above applies to you, or if you are not sure, speak to your doctor or midwife before you receive Oxytocin.

The active substance in Oxytocin 10 IU/ml Solution for infusion might cause a severe allergic reaction (anaphylaxis) in patients with latex allergy. Please tell your doctor if you know you are allergic to latex.

Tell your doctor or midwife if you are taking or have recently taken any of the following medicines as they may interfere with Oxytocin:

• prostaglandins (used to start labour or to treat stomach ulcers) and similar drugs as the effects of both drugs may be increased;
• medicines that can cause an irregular heartbeat, as Oxytocin may increase this effect;
• anaesthetics which you breath in (e.g. to put you to sleep during surgery), such as halothane, cyclopropane, sevoflurane or desflurane), as these may weaken your contractions, or cause problems with your heartbeat;
• anaesthetic medicines for local or regional pain relief, in particular an epidural for pain relief during labour. Oxytocin may increase the blood vessel narrowing effect of these medicines and cause an increase in blood pressure.

Please tell your doctor or midwife if you are taking or have recently taken any other medicines including medicines obtained without a prescription.

You may be told to keep the amount of fluids you drink to a minimum.

Based on the wide experience of use and the nature of this medicine, it is not expected that Oxytocin would be a risk to your baby when used correctly. Oxytocin may be found in small amounts in breast milk but is not expected to have harmful effects because it is quickly inactivated by your baby’s digestive system.

Oxytocin can start labour. Women with uterine contractions should not drive or use machines.

This medicinal product contains less than 1 mmol sodium (23 mg) per 1 ml ampoule, i.e. essentially ‘sodium-free’.

As this medicine is given to you in hospital, it is very unlikely that you will receive an overdose.

If anyone accidentally receives this medicine, tell the hospital accident and emergency department or a doctor immediately. Show any left over medicines or the empty packet to the doctor.

An overdose of Oxytocin could cause:

• very strong contractions of your womb;
• damage to your womb which could include tearing;
• the placenta to come away from your womb;
• amniotic fluid (the fluid around the baby) to enter your bloodstream;
• harm to your baby.

As a doctor or midwife is giving you this medicine, you are unlikely to miss a dose.

The following side effect may affect between 1 and 10 in every 10,000 patients:

• a severe allergic (anaphylactic/anaphylactoid) reaction with difficulty in breathing, dizziness and lightheadedness, feeling faint, nausea, cold and clammy skin or a fast or weak pulse
• Swelling of the face, lips, tongue, throat, and/or extremities (possible signs of angioedema)

The following side effects have been reported in Oxytocin.

Common side effects (affects more than 1 in 100 patients)

• Headache
• Fast or slow heartbeat
• Feeling or being sick.

Uncommon side effects (affects more than 1 in 1,000 patients)

• An irregular heartbeat.

Rare side effects (affects more than 1 in 10,000 patients)

• Skin rashes.

Effects in the mother:

Not known (cannot be estimated from the available data)

• Chest pain (angina)
• Irregular heartbeat (QTc prolongation seen on electrocardiogram)
• Haemorrhage (bleeding)
• Excessive or continuous contractions
• Tearing of the womb
• Fluid retention (water intoxication). Symptoms may include headache, anorexia (loss of appetite), feeling or being sick, stomach pain, sluggishness, drowsiness, unconsciousness, low levels of certain chemicals in the blood (e.g. sodium or potassium), fits
• Low blood salt levels
• Sudden fluid overload in the lungs
• Sudden brief sensation of heat often over the whole body
• Abnormal blood clotting, bleeding and anaemia (disseminated intravascular coagulation)
• spasm of the muscles of the womb.

Effects in the baby:

Not known (cannot be estimated from the available data) Excessive contractions may cause:

• Shortage of oxygen, suffocation and death
• Low blood salt levels.

If you get any side effects, talk to your doctor or midwife. This includes any possible side effects not listed in this leaflet.

You can also report side effects directly via: Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

The active substance is oxytocin.

Each ml of solution contains 10 IU (16.7 micrograms) oxytocin.

The other ingredients are: acetic acid, glacial; sodium acetate trihydrate; sodium chloride; sodium hydroxide; water for injections.

Colourless, clear liquid with characteristic odour.

Transparent 1 ml type 1 glass ampoules.

Pack sizes:

5 ampoules

10 ampoules

Not all pack sizes may be marketed.