Leaflet: information for the patient

ANGUSTA 25 microgram tablets

misoprostol

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your midwife, doctor or nurse.

- This medicine has been prescribed for you alone, and you must not give it to others even if they have the same symptoms as you, as it may harm them.

• If you experience any side effects, consult your midwife, doctor or nurse, even if they are not listed in this leaflet. See section 4.

6. Contents of the pack and additional information

Angusta contains the active ingredient misoprostol.

Angusta is used to help initiate the process of labor.

Misoprostol belongs to a group of medications called prostaglandins. Prostaglandins have two actions during labor. One action is to soften the cervix to facilitate the vaginal delivery of the baby. The second action is to cause the onset of contractions, which helps push the baby out of the uterus. There may be various reasons why you may need help initiating this process. Ask your midwife or doctor if you require additional information.

Do not takeAngusta

• if you are allergic to misoprostol or any of the other components of this medication (listed in section 6)
• if labor has begun
• if your midwife or doctor consider that your baby is not in good health and/or is suffering
• if you are being given oxytocic medications (medications used to facilitate labor) and/or other medications that help to start the labor process (see "Warnings and precautions", "Other medications and Angusta" and "How to take Angusta" below)
• if you have had a previous operation on the uterus or cervix, including previous cesarean delivery
• if you have any uterine anomaly such as a "heart-shaped" uterus (bicornuate uterus) that prevents a vaginal delivery
• if your midwife or doctor believe that your placenta blocks the birth canal (placenta previa) or you have had vaginal bleeding after 24 weeks of pregnancyfor unknown causes
• if your baby is in a position that cannot be born naturally (fetal malposition)
• if you have renal function impairment (glomerular filtration rate <15>2)

Warnings and precautions

Consult your midwife, doctor or nurse before starting to take Angusta.

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

Angusta may cause strong uterine stimulation.

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

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

Infections of the membranes that cover the baby (chorioamnionitis) may require a rapid delivery. Your doctor will make the necessary decisions about treatment with antibiotics, induction of labor or cesarean delivery.

The experience of using Angusta in women with membrane rupture for more than 48 hours before using Angusta is limited or non-existent.

Your doctor will carefully evaluate the need to start treatment with oxytocin (medication used to facilitate labor), as treatment with oxytocin 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 medications and Angusta" and "How to take Angusta" below).

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

The experience with the use of Angusta for the initiation of labor in women pregnant with less than 37 weeks is limited (see "Pregnancy, breastfeeding and fertility" below).

You should only take Angusta if your midwife or doctor consider that you need medical help to initiate labor.

The information on the use of Angusta in pregnant women with Bishop score > 6 (the Bishop score is the most commonly used method to establish the degree of cervical maturity) is very limited or non-existent.

A increased risk of forming blood clots in small blood vessels (disseminated intravascular coagulation) has been described after delivery in patients in whom labor 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 medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free".

Other medications andAngusta

Inform your midwife or doctor if you are taking, have taken recently or may need to take any other medication.

You should not take Angusta at the same time as other medications used to facilitate labor and/or help to initiate labor (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, breastfeeding and fertility

Pregnancy

Angusta is used to help initiate labor from 37 weeks 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 of pregnancy as misoprostol may cause birth defects.

Breastfeeding

Misoprostol may be excreted in breast milk, but it is expected to be at very low levels and duration, and should not affect breastfeeding. Breastfeeding can be started 4 hours after the last dose of Angusta.

Fertility

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

Follow exactly the administration instructions for this medication as indicated by your midwife, doctor, or nurse. If in doubt, consult your doctor again. Angusta will be administered by a trained professional in a hospital where facilities are available for your monitoring and that of your baby. Your cervix will be carefully evaluated before taking Angusta.

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

Your midwife or doctor will decide when to stop administering Angusta. Your midwife or doctor will stop the Angusta treatment,

• if you have taken 200 micrograms in a 24-hour period
• when labor has started
• if you are experiencing contractions that are too strong or last too long
• if your baby is starting to suffer
• if you require treatment with oxytocin or other medications used to facilitate labor (see “Do not take Angusta”, “Warnings and precautions” and “Other medications 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 (dose reduction and/or prolongation of dosing intervals).

Use in girls and adolescents

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

If you takemore 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 that your baby starts to suffer. Angusta administration must then be stopped. Your midwife or doctor will decide if you should be given medications to reduce the strength or frequency of your contractions or if your baby should be born by cesarean section.

Like all medicines, this medicine may cause side effects, although not everyone will experience them. The following side effects may occur with the use of Angusta

Very frequent: may affect more than 1 in 10 people

• Nausea1)
• Vomiting1)
• Meconium in the amniotic fluid (early stools that pass from the fetus to the amniotic fluid)
• Postpartum hemorrhage2)(loss of more than 500 ml of blood after delivery)

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

Frequent: may affect up to 1 in 10 people

• Low Apgar score*1)(test performed at 1 minute and 5 minutes after birth, in which the test score determines the baby's condition after birth)
• Fetal heart rate alteration*1)
• Uterine hyperstimulation (excessive, frequent, or prolonged uterine contractions)
• Diarrhea
• Nausea3)
• Vomiting3)
• Postpartum hemorrhage1)(loss of more than 500 ml of blood after delivery)
• Chills
• Increased body temperature

*Adverse effect in the baby

1)Reported as frequent with Angusta 50 micrograms every 4 hours.

2)The uterine hyperstimulation was reported with and without fetal heart rate alterations.

3)Reported as frequent with Angusta 25 micrograms every 2 hours.

Rare: may affect up to 1 in 100 people

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

*Adverse effect in the baby

1)Reported as rare with Angusta 25 micrograms every 2 hours.

Unknown: the frequency cannot be estimated from the available data

• Dizziness
• Neonatal convulsion*(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 blue discoloration of the skin and mucous membranes of the newborn)
• Pruritic eruption (itchy rash)
• Fetal acidosis*(elevated acid levels 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 adverse effects

If you experience any type of adverse effect, consult your midwife, doctor, or nurse, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly to the Spanish System for the Pharmacovigilance of Medicines for Human Use:www.notificaram.es.By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

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

Store in the original packaging to protect it from moisture.

Do not use this medication after the expiration date that appears on the blister pack and on the container after EXP. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains. Ask your midwife, doctor, or pharmacist how to dispose of the containers and medications that you no longer need. By doing so, you will help protect the environment.

Composition of Angusta

• The active ingredient is misoprostol. Each tablet contains 25 micrograms of misoprostol.
• The other components are: hypromellose, microcrystalline cellulose, cornstarch, crospovidone, croscarmellose sodium, anhydrous colloidal silica.

Appearance of Angusta and contents of the packaging

Angusta are white, oval-shaped, non-coated tablets, 7.5 x 4.5 mm in size, scored on one face and smooth on the other face. The score should not be used to break the tablet.

Angusta tablets are presented in blister packs containing 8 tablets.

Holder of the marketing authorization and responsible manufacturer

Holder

Norgine B.V.

Antonio Vivaldistraat 150

1083 HP Amsterdam

Netherlands

Responsible manufacturer

Norgine B.V.

Antonio Vivaldistraat 150

1083 HP Amsterdam

Netherlands

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Norgine de España, S.L.U.

Paseo de la Castellana, 91, 2nd Floor

28046, Madrid

Spain

This medication is authorized 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

Last review date of this leaflet:October 2022

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/