Patient leaflet - Gyxiny 25 microgram tablets
1. What Gyxiny is and what it is used for
Gyxiny contains the active substance misoprostol which belongs to a group of medicines called prostaglandins.
Gyxiny is used to help start childbirth (labour).
2. What you need to know before you take Gyxiny
Do not take Gyxiny if:
- you are allergic to misoprostol or any of the other ingredients of this medicine (listed in section 6) or to other prostaglandins.
- labour has started.
- your midwife or doctor consider your baby not to be in good health and/or is distressed.
- oxytocin and/or other medicines to start or help the childbirth process are being given (see “Warnings and precautions”, “Other medicines and Gyxiny” and “How to take Gyxiny” below).
- you have had previous surgery to your cervix or womb including a previous caesarean birth.
- vaginal delivery is not advised.
- your midwife or doctor believe that your placenta is covering the birth canal (placenta praevia) or if you have had any unexplained vaginal bleeding after the 24th week of pregnancy.
- you have kidney failure (Glomerular filtration rate <15 ml/min/1.73 m2).
Warnings and precautions
Talk to your midwife, doctor or nurse before taking Gyxiny.
Gyxiny should only be given by a trained professional in a hospital where facilities for monitoring you and your baby are available. Your cervix will be assessed carefully before you take Gyxiny.
Gyxiny can cause excessive stimulation of the womb.
In case the womb contractions are prolonged or too strong, or your doctor or nurse is concerned for you or your baby, you will not be given more tablets. Your midwife or doctor will decide if you should be given medicines to reduce the strength or to slow down the frequency of your contractions.
The effect of this medicine has not been studied in women with severe pre-eclampsia (a condition where pregnant women suffer from high blood pressure, protein in the urine and possibly other complications).
There is no or limited experience with the use of this medicine in women whose water sac (membranes) has ruptured for more than 48 hours before taking this medicine.
Infections of the membranes surrounding the baby (chorioamnionitis) may require a fast delivery. Your doctor will make decisions regarding treatment with antibiotics, inducing labour or caesarean section.
If your doctor decides you need treatment with oxytocin (a medicine used to facilitate birth), this will be carefully considered, as treatment with oxytocin may affect the way this medicine works. It is recommended to wait 4 hours after the last dose of this medicine before taking oxytocin (see “Do not take Gyxiny” above, and “Other medicines and Gyxiny” and “How to take Gyxiny” below).
There is no or limited experience with the use of this medicine to start the birth process in women less than 37 weeks pregnant (see “Pregnancy, breast-feeding and fertility” below).
There is no or limited experience with the use of this medicine to start the birth process in women who are pregnant with more than one baby or in women who have had 5 or more previous babies delivered vaginally.
You should only take this medicine if your midwife or doctor decide that you have a medical need to help to start the birth process.
There is no or limited information in the use of this medicine in pregnant women with a Bishop Score of more than 6 (Bishop Score is a method used to predict the likelihood of spontaneous vaginal delivery).
An increased risk of formation of blood clots in the small blood vessels throughout the body (disseminated intravascular coagulation) after delivery has been described in patients whose labour has been induced by any method.
Dose adjustments may be needed in pregnant women with reduced kidney or liver function (see “How to take Gyxiny below).
Children and adolescents
This medicine has not be studied in pregnant women aged less than 18 years.
Other medicines and Gyxiny
Tell your midwife or doctor if you are taking, have recently taken or might take any other medicines.
You must not take this medicine at the same time as other medicines used to start or help childbirth (see “Do not take Gyxiny”). It is recommended to wait 4 hours after the last dose of misoprostol before taking oxytocin (see “Warnings and precautions” above, and “How to take Gyxiny” below).
Pregnancy, breast-feeding and fertility
Pregnancy
This medicine should only be used to help start labour from week 37 of pregnancy. When used at that time of pregnancy, there is no risk of birth defects for your baby. You should not use this medicine at any other time during pregnancy as it may cause birth defects.
Breast-feeding
Misoprostol may be excreted in breast milk, but the level and duration are expected to be very limited and should not delay the start of breast-feeding after delivery.
Fertility
There is no impact on fertility with the use of this medicine to help start labour from week 37 of pregnancy.
Gyxiny contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.
3. How to take Gyxiny
Always take this medicine exactly as your midwife, doctor or nurse has told you. Check with your midwife or doctor if you are not sure.
It will be given to you by a trained professional in a hospital. Your cervix will be assessed carefully before you take this medicine. You and your baby will be monitored during the treatment duration.
The recommended dose is 25 microgram every two hours or 50 microgram every four hours.
The maximum daily dose of this medicine is 200 microgram.
The tablets should be taken by mouth with a glass of water. Do not break the tablets.
If you take more Gyxiny than you should
As this medicine is given to you in hospital, it is very unlikely that you will receive an overdose. If you take more medicine than you should, it may cause your contractions to be too strong or last too long, or the baby may become distressed. You should tell your midwife or doctor if you think you are experiencing this and administration of this medicine must be stopped. Your midwife or doctor will decide if you should be given medicines to reduce the strength or slow down the frequency of your contractions, or if your baby should be delivered by caesarean section.
Use in patients with reduced kidney or liver function
Dose adjustments, such as a lower dose or longer dosage intervals, may be needed if you have reduced kidney or liver function. Talk to your midwife or doctor if you have reduced kidney or liver function.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may occur when using this medicine:
Possible side effects on the pregnant women
Very common (may affect more than 1 in 10 people):
- Nausea1)
- Vomiting1)
- Meconium stain (early faeces (stool) passed by the unborn baby into the amniotic fluid) 1)
- Reported as very common at the dose of 50 microgram every 4 hours.
Common (may affect up to 1 in 10 people):
- Diarrhoea
- Nausea2)
- Vomiting2)
- Meconium stain (early faeces (stool) passed by the unborn baby into the amniotic fluid) 2)
- Contractions of the womb that are too strong, too frequent, or last too long3)
- Increased bleeding after birth (loss of over 500 ml blood after delivery)
- Chills
- Increased body temperature
- Reported as common at the dose of 25 microgram every 2 hours.
- Uterine hyperstimulation was reported both with and without foetal heart rate changes.
Not known (frequency cannot be estimated from the available data):
- Dizziness
- Itchy rash
- Separation of the placenta from the wall of the womb before birth
- Tearing to the wall of the womb (rupture)
Possible side effects on the baby
Common (may affect up to 1 in 10 people):
- Low Apgar score (test performed at the baby at 1 and 5 minutes after birth, the test score determines how well the baby is doing after being born).
- Abnormal foetal heart rate.
Uncommon (may affect up to 1 in 100 people):
- Lack of oxygen to the baby’s brain and organs during the birth1)
- Reported as uncommon at the dose of 50 microgram every 4 hours.
Not known (frequency cannot be estimated from the available data):
- Blue coloration of the skin and mucous membranes of the newborn baby, also called ‘blue baby syndrome’.
- Seizures in the newborn baby.
- High acid levels in the unborn baby’s blood.
- Lack of oxygen to the baby’s brain and organs during the birth2).
- Reported as not known at the dose of 25 microgram every 2 hours.
Reporting of side effects
If you get any side effects, talk to your midwife, doctor 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 or search for MHRA Yellow Card in the Google Play App Store. By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Gyxiny
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 blister after EXP. The expiry date refers to the last day of that month.
Store in the original package in order to protect from light and moisture.
This medicine does not require any special temperature storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your midwife, doctor or 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 Gyxiny contains
- The active substance is misoprostol. Each tablet contains 25 microgram of misoprostol.
- The other excipients are hypromellose, microcrystalline cellulose, sodium starch glycolate (type A).
What Gyxiny looks like and contents of the pack
White to off-white, 4.5 mm round, flat, rounded edge tablet.
Available in blisters containing 8 tablets.
Marketing Authorisation Holder
Afyx Therapeutics A/S
Slotsmarken 11
2970 Hoersholm,
Denmark
Manufacturer
Afyx Therapeutics A/S
Slotsmarken 11
2970 Hoersholm,
Denmark
This leaflet was last revised in 07/2026.
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