Active ingredient
- atosiban acetate
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
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: PLGB 31750/0163.
Atosiban 37.5 mg/5ml concentrate for solution for infusion
Package leaflet: Information for the user
Atosiban SUN 37.5 mg/5 ml concentrate for solution for infusion
atosiban
Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
What is in this leaflet
1. What Atosiban SUN is and what it is used for
2. What you need to know before you are given Atosiban SUN
3. How Atosiban SUN will be given
4. Possible side effects
5. How to store Atosiban SUN
6. Contents of the pack and other information
1. What Atosiban SUN is and what it is used for
Atosiban SUN contains atosiban. Atosiban SUN is used to delay the premature birth of your baby. Atosiban SUN is used in pregnant adult women, from week 24 to week 33 of the pregnancy.
Atosiban SUN works by making the contractions in your womb (uterus) weaker. It also makes the contractions happen less often. It does this by blocking the effect of a natural hormone in your body called “oxytocin” which causes your womb (uterus) to contract.
2. What you need to know before you are given Atosiban SUN
Do not use Atosiban SUN
Do not use Atosiban SUN if any of the above apply to you. If you are not sure, talk to your doctor, midwife or pharmacist before you are given Atosiban SUN.
Warnings and precautions
Talk to your doctor, midwife or pharmacist before you are given Atosiban SUN
If any of the above apply to you (or you are not sure), talk to your doctor, midwife or pharmacist before you are given Atosiban SUN.
Children and adolescents
Atosiban SUN has not been studied in pregnant women less than 18 years old.
Other medicines and Atosiban SUN
Tell your doctor, midwife or pharmacist if you are taking, have recently taken or might take any other medicines.
Pregnancy and breast-feeding
If you are pregnant and breast-feeding an earlier child, you should stop breast-feeding while you are given Atosiban SUN.
3. How Atosiban SUN will be given
Atosiban SUN will be given to you in a hospital by a doctor, nurse or midwife. They will decide how much you need. They will also make sure the solution is clear and free from particles.
Atosiban SUN will be given into a vein (intravenously) in three stages:
Treatment should last no longer than 48 hours in total.
Further treatment with Atosiban SUN can be used if your contractions start again. Treatment with Atosiban SUN can be repeated up to three more times.
During treatment with Atosiban SUN, your contractions and your unborn baby’s heart rate may be monitored.
It is recommended that no more than three re-treatments should be used during a pregnancy.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. The side effects seen in the mother are generally mild. There are no known side effects on the unborn or new-born baby.
The following side effects may happen with this medicine:
Very common (may affect more than 1 in 10 people)
Common (may affect less than 1 in 10 people)
Uncommon (may affect less than 1 in 100 people)
Rare (may affect less than 1 in 1,000 people)
You may experience shortness of breath or lung oedema (accumulation of fluid in the lungs), particularly if you are pregnant with more than one baby and/or are given medicines that can delay the birth of your baby, such as medicines used for high blood pressure.
Reporting of side effects
If you get any side effects, talk to your doctor, midwife or pharmacist. 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 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.
5. How to store Atosiban SUN
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 label after EXP {MM/YYYY}. The expiry date refers to the last day of that month.
Store in a refrigerator (2°C - 8°C). Dilutions for intravenous administration must be used within 24 hours after preparation.
Store in the original package in order to protect from light.
Do not use Atosiban SUN if you notice particulate matter and discoloration prior to administration.
Do not throw away any medicines in wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Atosiban SUN contains
What Atosiban SUN looks like and contents of the pack
Atosiban SUN 37.5 mg/5 ml concentrate for solution for infusion is a clear, colourless solution without particles.
One pack contains one vial containing 5 ml solution.
Marketing Authorisation Holder and Manufacturer
This leaflet was last revised in September 2021
6-9 The Square, Stockley Park, Uxbridge, UB11 1FW, UK
+44 (0) 208 848 8688
+44 (0) 208 848 5052