What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 40369/0005 .


OXYTOCIN 5 IU & 10 IU Solution for Injection

PATIENT INFORMATION LEAFLET

OXYTOCIN 5 IU

OXYTOCIN 10 IU

Solution for Injection

Read all of this leaflet carefully before you start using this medicine.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor or your pharmacist.
  • This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours
  • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet please tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

In this leaflet:

1. What Oxytocin 5 IU and Oxytocin 10 IU solutions for injection are and what they are used for
2. Before you take Oxytocin 5 IU and Oxytocin 10 IU solutions for injection
3. How to take Oxytocin 5 IU and Oxytocin 10 IU solutions for injection
4. Possible side effects
5. Storing your Oxytocin 5 IU and Oxytocin 10 IU solutions for injection
6. Contents of the pack and other information

1. WHAT OXYTOCIN 5 IU SOLUTION FOR INJECTION OR OXYTOCIN 10 IU SOLUTION FOR INJECTION ARE AND WHAT THEY ARE USED FOR.

Each Oxytocin ampoule contains oxytocin EP, 5 IU (International Units) or 10 IU in 1 ml solution, equivalent to 8.5 micrograms or 17 micrograms respectively. Oxytocin is a drug that belongs to the group of medicines called oxytocins and it is identical with oxytocin, a hormone released by the pituitary gland, which has an effect on the muscles of the uterus (womb). Oxytocin is used to help the muscles of the womb contract.

Oxytocin may be used to induce labour, or to stimulate labour where the contractions are not adequate, or after delivery of the baby where there may be weak or absent contraction of the uterus or to prevent or treat uterine bleeding. It may also be used during caesarean section or as additional therapy for the management of miscarriage.

2. BEFORE YOU TAKE OXYTOCIN 5 IU SOLUTION FOR INJECTION OR OXYTOCIN 10 IU SOLUTION FOR INJECTION

Do not take Oxytocin:

  • if you are allergic (hypersensitive) to oxytocin or any of the other ingredients of the solution
  • if you have any of the following conditions :
    • dystocia, fragility or overdistension of the uterus,
    • where your healthcare professional considers spontaneous delivery is inadvisable for foetal or maternal reasons, (such as foetal malpresentation, placenta praevia (the placenta is over the cervix), cord presentation, previous classical caesarean section, and other conditions which your healthcare professional will advise you about).

Oxytocin will not be used for a prolonged period if:

  • Your contractions do not respond,
  • You have severe problems with your heart or circulation,
  • You have a condition known as pre-eclamptic toxaemia (high blood pressure, swelling and protein in the urine),
  • You have hypertonic uterine contractions or foetal distress, when delivery is not imminent,
  • You have predisposition to amniotic fluid embolism (foetal death in utero, retroplacentar hematoma).

Special care with Oxytocin will be taken:

  • if you are over 35 years old,
  • if you have had a previous caesarean section,
  • if you have mild or moderately raised blood pressure or heart problems,
  • if normal delivery may be difficult for you due to the small size of your pelvis or the large head of the baby,
  • if you are likely to need high doses over a long period of time,
  • if you have had an epidural (caudal) anaesthetic block, oxytocin may increase the effects of some drugs used to constrict the blood vessels,
  • if you are taking or have taken other medicines:
  • prostaglandins in the last 6 hours (the effect may be increased ),
  • some anaesthetics given by inhalation such as halothane or cyclopropane (they may reduce the effect of oxytocin or may cause heart problems).

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

Important information about some of the ingredients of Oxytocin:

Each ampoule contains 2.9 mg (0.13 mmol) of sodium.

Latex allergy

The active substance in might cause a severe allergic reaction (anaphylaxis) in patients with latex allergy. Please tell your doctor if you know you are allergic to latex.

3. TREATMENT WITH OXYTOCIN

Oxytocin should only be given under medical supervision and in a hospital.

The dose used will vary depending on the reason for its use.

  • When being used for induction of labour or to stimulate existing labour, oxytocin will usually be diluted in 500 ml Saline or 5% Dextrose before use and will be given directly into a vein (intravenously) by drip infusion (slowly) or using an infusion pump. The initial infusion rate will be 2 to 8 drops/min; this may be gradually increased to a maximum rate of 40 drops/min. Once your contractions reach an adequate level of about 3-4 contractions per 10 minutes, the infusion rate will often be reduced.
  • For caesarean section, 5 IU will slowly be injected into the vein immediately after delivery of your baby.
  • For prevention of bleeding after delivery, 5 IU will slowly be injected into your vein after delivery of the placenta.
  • For treatment of bleeding after delivery, 5 IU will be slowly injected into your vein, followed, in some cases, by a drip containing 5 to 20 IU oxytocin.
  • For miscarriage, 5 IU will be slowly injected into your vein, followed, if necessary by a drip at a high rate (40 to 80 drops/min).

If you receive more Oxytocin than you should or if you miss a dose:

As this medicine will be given to you by a healthcare professional in hospital, it is very unlikely that an overdose or missed dose will happen.

If you have any further questions on the use of this product, ask your doctor or midwife.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Oxytocin can cause side effects, although not everybody gets them.

Rare side effects (more than 1 in 10,000 patients) of Oxytocin include:

  • Nausea, vomiting,
  • Fast or slow heartbeat,
  • A blood clot following the birth of your baby.

Very rarely, if high doses of Oxytocin are given with large volumes of fluids through a drip the condition of water intoxication may occur.

Symptoms may include:

  • Headache, nausea, vomiting, seizures,

Exceptionally, side effects of Oxytocin include: skin rashes and anaphylactoid reactions, hypotension, or anaphylactic shock.

If any of the side effects gets worse, or if you notice any side effects not listed in this leaflet, please tell your doctor or midwife.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme. Website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE OXYTOCIN

The hospital pharmacy will store this medicine in a refrigerator at 2°C to 8°C. It may be stored at 25°C for 6 months, but then discarded.

Keep Oxytocin out of the reach and sight of children.

The pharmacy will not use OXYTOCIN after the expiry date that is stated on the label.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Oxytocin contains:

The active substance is oxytocin.

The other ingredients are sodium chloride, sodium acetate trihydrate, acetic acid, glacial and water for injection.

What Oxytocin looks like and contents of the pack:

Your medicinal product comes in a clear glass 1 ml ampoule. Boxes of 5, 10, 50 or 100 ampoules.

Marketing Authorisation Holder:

EVER Neuro Pharma GmbH
Oberburgau 3
A-4866 Unterach
Austria

Manufacturer:

EVER Pharma Jena GmbH
Otto-Schott-Strasse 15
07745 Jena
Germany

EVER Neuro Pharma GmbH
Oberburgau 3
A-4866 Unterach
Austria

Distributed by:

KENT Pharmaceuticals Limited
Joshna House
Crowbridge Road
Ashford
Kent
TN24 0GR
United Kingdom

This leaflet was last updated in September 2015.