ANGUSTA 25 micrograms tablets

2. What you need to know before you take Angusta

Do not takeAngusta

• if you are allergic to misoprostol or any of the other ingredients of this medicine (listed in section 6)
• if labour has already started
• if your midwife or doctor considers that your baby is not in good health and/or is suffering
• if you are given oxytocic medicines (medicines used to facilitate labour) and/or other medicines that help start the labour process (see "Warnings and precautions", "Other medicines and Angusta" and "How to take Angusta" below).
• if you have had a previous operation on the uterus or cervix, including a previous caesarean section
• if you have any uterine anomaly such as a heart-shaped uterus (bicornuate uterus) that prevents vaginal delivery
• if your midwife or doctor believes that your placenta is blocking the birth canal (placenta previa) or you have had vaginal bleeding after 24 weeks of pregnancy for unknown reasons
• if your baby is in a position that cannot be delivered naturally (malpresentation)
• if you have impaired renal function (glomerular filtration rate < 15 ml/min/1.73 m2)

Warnings and precautions

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

Angusta should only be given by a trained professional in a hospital where monitoring facilities are available for you and your baby. Your cervix will be carefully assessed before you take Angusta.

Angusta may cause strong stimulation of your uterus.

If uterine contractions are prolonged or too strong, or if your doctor or nurse is concerned about you or your baby, you will not be given any more tablets and your midwife or doctor will decide whether to give you medicines to reduce the strength or frequency of contractions.

The effect of Angusta has not been studied in women with severe pre-eclampsia (a condition that causes high blood pressure in pregnant women, protein in the urine, and possibly other complications).

Infections of the membranes surrounding the baby (chorioamnionitis) may require rapid delivery. The doctor will make the necessary decisions about antibiotic treatment, labour induction, or caesarean section.

Experience with the use of Angusta in women with ruptured membranes for more than 48 hours prior to the use of Angusta is limited or non-existent.

Your doctor will carefully assess the need to start treatment with oxytocin (a medicine used to facilitate labour), as oxytocin treatment may affect the functioning of Angusta. It is recommended to wait 4 hours after the last dose of Angusta before receiving oxytocin (see "Do not take Angusta", "Other medicines and Angusta" and "How to take Angusta" below).

There is no experience with the use of Angusta for starting the labour process in women pregnant with more than one baby, nor is there experience with the use of Angusta in women who have had 5 or more previous vaginal deliveries.

Experience with the use of Angusta for starting the labour process in women pregnant for less than 37 weeks is limited (see "Pregnancy, breast-feeding and fertility" below).

You should only take Angusta if your midwife or doctor considers that you need medical help to start the labour process.

Information on the use of Angusta in pregnant women with a Bishop score > 6 (the Bishop score is the most commonly used method to determine the degree of cervical ripening) is very limited or non-existent.

An increased risk of blood clot formation in small blood vessels (disseminated intravascular coagulation) after delivery has been described in patients in whom labour was induced by any method.

Pregnant women with reduced kidney or liver function may require a dose adjustment (see "How to take Angusta" below).

Angusta contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially "sodium-free".

Other medicines and Angusta

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

Do not take Angusta at the same time as other medicines used to facilitate labour and/or help start the labour process (see "Do not take Angusta"). It is recommended to wait 4 hours after the last dose of Angusta before receiving oxytocin (see "Warnings and precautions" and "How to take Angusta" below).

Pregnancy, breast-feeding and fertility

Pregnancy

Angusta is used to help start labour from 37 weeks of pregnancy. When used at this time in pregnancy, there is no risk of birth defects for your baby. However, you should not use Angusta at any other time in pregnancy as misoprostol 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 interfere with breast-feeding. Breast-feeding can start 4 hours after the last dose of Angusta.

Fertility

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

3. How to take Angusta

Follow exactly the administration instructions of this medicine given by your midwife, doctor, or nurse. If you are unsure, talk to your doctor. Angusta will be given by a trained professional in a hospital where monitoring facilities are available for you and your baby. Your cervix will be carefully assessed before you take Angusta.

The recommended dose is 25 micrograms every 2 hours or 50 micrograms every 4 hours. Angusta should be taken orally with a glass of water. Do not break the tablet.

Your midwife or doctor will decide when to stop taking Angusta. Your midwife or doctor will stop treatment with Angusta:

• if you have taken 200 micrograms in a 24-hour period
• when labour has started
• if you have contractions that are too strong or last too long
• if your baby starts to suffer
• if you need treatment with oxytocin or other medicines used to facilitate labour (see "Do not take Angusta", "Warnings and precautions" and "Other medicines and Angusta" above).

Use in patients with reduced kidney or liver function

Dose adjustments may be required in pregnant women with reduced kidney or liver function (reduction of the dose and/or prolongation of the dosing intervals).

Use in girls and adolescents

Angusta has not been studied in pregnant women under 18 years of age.

If you take more Angusta than you should

If you take more Angusta than you should, it may cause contractions that are too strong or last too long, or your baby may start to suffer. The administration of Angusta should then be stopped. Your midwife or doctor will decide whether to give you medicines to reduce the strength or frequency of contractions or whether your baby should be delivered by caesarean section.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may occur with the use of Angusta:

Very common: may affect more than 1 in 10 people

• Nausea
• Vomiting
• Meconium in the amniotic fluid (early passage of faeces by the fetus into the amniotic fluid)
• Postpartum haemorrhage (loss of more than 500 ml of blood after delivery)

1. Reported as very common with Angusta 50 micrograms every 4 hours.
2. Reported as very common with Angusta 25 micrograms every 2 hours.

Common: may affect up to 1 in 10 people

• Low Apgar score* (a test performed at 1 and 5 minutes after birth, in which the test score determines the baby's condition after birth)
• Fetal heart rate abnormality* (abnormal heart rate of the fetus)
• Uterine hyperstimulation (contractions that are too strong, too frequent, or too long)
• Diarrhoea
• Nausea
• Vomiting
• Postpartum haemorrhage (loss of more than 500 ml of blood after delivery)
• Chills
• Increased body temperature

*Adverse effect in the baby

1. Reported as common with Angusta 50 micrograms every 4 hours.
2. The uterine hyperstimulation was reported with and without fetal heart rate abnormalities.
3. Reported as common with Angusta 25 micrograms every 2 hours.

Uncommon: may affect up to 1 in 100 people

• Low Apgar score* (a test performed at 1 and 5 minutes after birth, in which the test score determines the baby's condition after birth)
• Fetal heart rate abnormality* (abnormal heart rate of the fetus)

*Adverse effect in the baby

1. Reported as uncommon with Angusta 25 micrograms every 2 hours.

Unknown: frequency cannot be estimated from the available data

• Dizziness
• Neonatal convulsions* (convulsions in the newborn)
• Neonatal asphyxia* (lack of oxygen in the brain and organs of the baby during delivery)
• Neonatal cyanosis* (also known as "blue baby syndrome", characterized by bluish discoloration of the skin and mucous membranes of the newborn)
• Pruritic rash (rash with itching)
• Fetal acidosis* (high levels of acid in the fetus's blood)
• Premature separation of the placenta (separation of the placenta from the uterine wall before delivery)
• Uterine rupture

*Adverse effect in the baby

Reporting of side effects

If you experience 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 through the Spanish Medicines Agency's website: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Angusta

Keep this medicine out of the sight and reach of children.

Store in the original package to protect from moisture.

Do not use this medicine after the expiry date which is stated on the blister and on the carton after EXP. The expiry date is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Ask your midwife, doctor, or pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

Composition of Angusta

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

Appearance of Angusta and contents of the pack

Angusta are white, oval, uncoated tablets, 7.5 x 4.5 mm in size, scored on one side and smooth on the other side. The score line is not intended for breaking the tablet.

Angusta tablets are available in blister packs containing 8 tablets.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Norgine B.V.

Antonio Vivaldistraat 150

1083HP Amsterdam

Netherlands

Manufacturer

Norgine B.V.

Antonio Vivaldistraat 150

1083 HP Amsterdam

Netherlands

You can obtain further information on this medicine from the local representative of the marketing authorisation holder:

Norgine de España, S.L.U.

Paseo de la Castellana, 91, 2ª Planta

28046, Madrid

Spain

This medicine is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Germany, Austria, Belgium, Bulgaria, Croatia, Cyprus, Denmark, Slovakia, Slovenia, Spain, Estonia, Finland, France, Greece, Hungary, Ireland, Iceland, Italy, Latvia, Luxembourg, Malta, Norway, Netherlands, Poland, Portugal, United Kingdom (Northern Ireland), Czech Republic, Romania, Sweden: ANGUSTA

Date of last revision of this leaflet:October 2022

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/