Angusta 25 microgram tablets

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your midwife, doctor or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your midwife, doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

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

• if you are allergic to misoprostol or any of the other ingredients of this medicine (listed in section 6)
• if labour has started
• if your midwife or doctor consider your baby not to be in good health and/or is distressed
• if oxytocic medicines (medicines used to facilitate birth) and/or other medicines to help start the birth process are being given (see “Warnings and precautions”, “Other medicines and Angusta” and “How to take Angusta” below).
• if you have had previous surgery to your cervix or womb including a caesarean birth for any earlier babies
• if you have any womb abnormality such as “heart-shaped” uterus (bicornuate uterus) that would prevent a vaginal delivery
• if your midwife or doctor judge that your placenta is covering the birth canal (placenta praevia) or if you have had any unexplained vaginal bleeding after the 24^th week of pregnancy
• if your baby is in a position in the womb which prevents it from being born naturally (fetal malpresentation)
• if you have kidney failure (Glomerular filtration rate <15 ml/min/1.73 m²

Talk to your midwife, doctor or nurse before taking Angusta.

Angusta must 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 Angusta.

Angusta 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 and your baby, you will not be given more tablets and 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 Angusta 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).

Infections of the membranes surrounding the baby (chorioamnionitis) may necessitate fast delivery. The physician will take the necessary decisions regarding treatment with antibiotics, inducing labour or caesarean section.

There are no or limited experience with the use of Angusta in women whose membranes have been ruptured for more than 48 hours before the use of Angusta.

If your doctor finds that you need treatment with oxytocin (medicine used to facilitate birth), this will be carefully considered, as the treatment with oxytocin may affect the way Angusta works. It is recommended to wait 4 hours after the last dose of Angusta before giving oxytocin (see “Do not take Angusta” above, and “Other medicines and Angusta” and “How to take Angusta” below).

There is no experience with the use of Angusta to start the birth process in women who are pregnant with more than one baby and there is no experience with the use of Angusta in women who have had 5 or more previous babies delivered vaginally.

There is limited experience with the use of Angusta to start the birth process in women less than 37 weeks pregnant (see “Pregnancy, breast-feeding and fertility” below).

You should only take Angusta if your midwife or doctor judge that you have a medical need for help to start the birth process.

There is no or limited information with the use of Angusta in pregnant women with a Bishop Score >6 (Bishop Score is the most commonly used method to rate the readiness of the cervix).

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 Angusta below).

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

Tell your midwife or doctor if you are taking, have recently taken or might take any other medicines.

You must not take Angusta at the same time as other medicines used to facilitate birth and/or help start labour (see “Do not take Angusta”). It is recommended to wait 4 hours after the last dose of Angusta before giving oxytocin (see “Warnings and precautions” above, and “How to take Angusta” below).

Pregnancy

Angusta is 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. However, you should not use Angusta at any other time during pregnancy because misoprostol can then cause birth defects.

Breast-feeding

Misoprostol may be excreted in breast milk, but the level and duration is expected to be very limited and should not hinder breast-feeding. Breast-feeding can start 4 hours after the last dose of Angusta is given.

Fertility

There is no impact on fertility with the use of Angusta to help start labour from week 37 of the pregnancy.

Dose adjustments (lower dose and/or prolonged dosing intervals) may be needed in pregnant women with reduced kidney or liver function.

The use of Angusta has not been studied in pregnant women less than 18 years of age.

If you take more Angusta than you should, it may cause contractions to be too strong or last too long or the baby may become distressed. Administration of Angusta must then be stopped. 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 or if the baby should be delivered by caesarean section.

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 or Apple App store.

By reporting side effects, you can help provide more information on the safety of this medicine.

• The active substance is misoprostol. Each tablet contains 25 micrograms of misoprostol.
• The other ingredients are: hypromellose; cellulose, microcrystalline; maize starch; crospovidone; croscarmellose sodium; silica, colloidal anhydrous.

Angusta is a white, uncoated oval shaped tablet with the dimensions 7.5 x 4.5 mm with a score line on one side and plain on the other. The score line is not intended for breaking the tablet.

Angusta tablets are packaged in blister packs supplied in a cardboard box containing 8 tablets.