Angusta

Package leaflet: Information for the user

ANGUSTA, 25 micrograms, tablets
Misoprostol
Please read all of this leaflet carefully before taking this medicine because it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your midwife, doctor or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your midwife, doctor or nurse. See section 4.

Contents of the leaflet

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

1. What Angusta is and what it is used for

Angusta contains the active substance misoprostol.
Angusta is used to help initiate the process of labour.
Misoprostol belongs to a group of medicines called prostaglandins. Prostaglandins have a dual effect during labour. One effect is to soften and dilate the cervix so that the baby can be born more easily through the vagina. The other effect is to induce contractions that help expel the baby from the uterus. There may be several reasons why assistance in initiating this process is needed. Your doctor can provide further information.

2. Important information before taking Angusta

When not to take Angusta:

• if the patient is allergic to misoprostol or any of the other ingredients of this medicine (listed in section 6);
• when labour has already started;
• if the midwife or doctor considers that the baby's health condition is unsatisfactory and (or) if the baby is at risk;
• if medicines stimulating uterine contractions (to facilitate childbirth) and (or) other medicines to initiate labour are being administered (see below "Warnings and precautions", "Angusta with other medicines" and "How to take Angusta");
• if the patient has previously undergone cervical or uterine surgery, including prior caesarean sections;
• in case of uterine abnormalities, such as a heart-shaped uterus (bicornuate uterus), which may prevent vaginal delivery;
• if the midwife or doctor determines that the placenta covers the birth canal (placenta praevia) or if the patient has experienced unexplained vaginal bleeding after the 24th week of the current pregnancy;
• if the baby is not positioned correctly in the uterus to allow vaginal delivery (abnormal fetal presentation);
• if the patient has renal failure (glomerular filtration rate <15 ml/min/1.73 m²).

Warnings and precautions
Before starting treatment with Angusta, discuss this with your midwife, doctor, or nurse.
Angusta should be administered only by trained midwifery staff in a hospital setting allowing continuous monitoring of fetal condition and uterine activity. The doctor will carefully assess the condition of the cervix before administering Angusta.
Angusta may cause excessive uterine stimulation.
If uterine contractions are prolonged or too strong, or if the doctor or nurse is concerned about the patient's or baby's condition, no further tablets will be administered. The midwife or doctor may decide that it is necessary to administer medications that reduce the strength or frequency of uterine contractions.
The effects of Angusta have not been studied in women with severe pre-eclampsia (a condition in which a pregnant woman has high blood pressure, protein in the urine, and possibly other complications).
Infection of the membranes surrounding the baby (chorioamnionitis) may require prompt delivery.
The doctor will make necessary decisions regarding antibiotic treatment, labour induction, or caesarean section.
There is no experience or limited experience with the use of Angusta in women whose membranes have ruptured more than 48 hours before administration of Angusta.
If the doctor considers initiating oxytocin (a medicine used to facilitate labour), this will be carefully evaluated, as oxytocin treatment may influence the effect of Angusta. After the last dose of Angusta, it is recommended to wait 4 hours before administering oxytocin (see above "When not to use Angusta" and below "Angusta with other medicines" and "How to take Angusta").
There is no experience or limited experience with the use of Angusta to initiate labour in women with multiple pregnancies or in women who have previously delivered five or more children vaginally.
There is limited experience with the use of Angusta before the 37th week of pregnancy (see below "Pregnancy, breastfeeding and fertility").
Angusta should only be used when the midwife or doctor determines, from a medical standpoint, that the patient requires assistance in initiating labour.
There is no or limited information on the use of Angusta in pregnant women whose cervical score is >6 on the Bishop score (the Bishop score is the most commonly used method to assess cervical readiness for vaginal delivery).
An increased risk of blood clot formation in small blood vessels throughout the body (disseminated intravascular coagulation) after delivery has been reported in patients, regardless of the method used to induce labour.
In pregnant patients with impaired kidney or liver function, dose reduction may be necessary (see "How to take Angusta").

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

Angusta with other medicines
Inform your midwife or doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Angusta must not be administered simultaneously with medicines used to facilitate labour and (or) medicines that help initiate labour (see above "When not to use Angusta").
It is recommended to wait 4 hours after the last dose of Angusta before administering oxytocin (see above "Warnings and precautions" and below "How to take Angusta").

Pregnancy, breastfeeding and fertility

Pregnancy
Angusta is used to facilitate the initiation of labour from the 37th week of pregnancy.
Use of the medicine during this period of pregnancy is not associated with a risk of congenital malformations in the baby. However, Angusta should not be used at any other time during pregnancy, as misoprostol may cause congenital malformations.

Breastfeeding
Misoprostol may pass into breast milk, but concentrations and duration of transfer are thought to be very limited and should not interfere with breastfeeding. Breastfeeding may be initiated 4 hours after the last dose of Angusta.

Fertility
The use of Angusta to initiate labour from the 37th week of pregnancy has no effect on fertility.

3. How to take Angusta

This medicine should always be taken exactly as recommended by a midwife, doctor, or nurse. If in
doubt, consult your doctor. Angusta should be administered only by trained midwifery personnel in
a hospital setting that allows continuous monitoring of fetal condition and uterine activity. The doctor
will carefully assess the condition of the cervix before administering Angusta.

The recommended dose is 25 micrograms every two hours or 50 micrograms every four hours.
Angusta should be taken orally, with a glass of water. Tablets must not be crushed.

The midwife or doctor will decide when to discontinue administration of Angusta. Treatment with
Angusta will be stopped if:

• the patient has received 200 micrograms of the medicine within 24 hours;
• labour has started;
• uterine contractions are too strong or prolonged;
• there are signs of fetal distress;
• administration of oxytocin or other drugs used to assist delivery becomes necessary (see above
  "Contraindications", "Warnings and precautions" and "Angusta with other medicines").

Use in patients with renal or hepatic impairment
Dosage adjustment may be necessary in pregnant women with impaired kidney or liver function
(lower dose and/or longer intervals between doses).

Use in children and adolescents
The use of Angusta has not been studied in pregnant women under 18 years of age.

Overdose of Angusta
Taking more than the recommended dose of Angusta may lead to intensified contractions or fetal
distress. Administration of Angusta should be discontinued. The midwife or doctor may decide
that it is necessary to administer medications that reduce the strength or frequency of uterine
contractions or to perform delivery by caesarean section.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The following adverse reactions may occur after administration of Angusta.

Very common: may occur in more than 1 in 10 people

• Nausea
• Vomiting
• Meconium in amniotic fluid (early passage of the baby's first stool into the amniotic fluid)
• Postpartum haemorrhage (loss of more than 500 ml of blood after delivery)

Very commonly reported after administration of Angusta at a dose of 50 µg every 4 hours.
Very commonly reported after administration of Angusta at a dose of 25 µg every 2 hours.

Common: may occur in up to 1 in 10 people

• Low Apgar score* (a test performed on the newborn at 1 and 5 minutes after birth to assess the newborn's health status)
• Fetal heart rate abnormalities*
• Excessive uterine stimulation (excessively strong, frequent, and prolonged uterine contractions)
• Diarrhoea
• Nausea
• Vomiting
• Postpartum haemorrhage (loss of more than 500 ml of blood after delivery)
• Chills
• Increased body temperature

*Adverse reactions in the newborn
Commonly reported after administration of Angusta at a dose of 50 µg every 4 hours.
Excessive uterine stimulation has been reported both with and without fetal heart rate abnormalities.
Very commonly reported after administration of Angusta at a dose of 25 µg every 2 hours.

Uncommon: may occur in up to 1 in 10 people

• Low Apgar score* (a test performed on the newborn at 1 and 5 minutes after birth to assess the newborn's health status)
• Fetal heart rate abnormalities*

*Adverse reactions in the newborn
Uncommonly reported after administration of Angusta at a dose of 25 µg every 2 hours.

Unknown frequency: cannot be estimated from the available data

• Dizziness
• Seizures in the newborn*
• Neonatal asphyxia* (lack of oxygen to the baby's brain and organs during delivery)
• Cyanosis in the newborn* (also known as "blue baby syndrome", characterized by a bluish discoloration of the skin and mucous membranes in the newborn)
• Itchy rash
• Fetal acidosis* (increased acid levels in the baby's blood)
• Premature placental abruption (separation of the placenta from the uterine wall before delivery of the baby)
• Uterine rupture

*Adverse reactions in the newborn

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your midwife, doctor, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Angusta

Keep this medicine out of sight and reach of children.
Store in the original packaging to protect from moisture.
Do not use this medicine after the expiry date stated on the blister and carton after:
EXP (expiry date). The expiry date refers to the last day of the stated month.
Batch number is indicated after: Lot (batch).
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What Angusta contains

• The active substance is misoprostol. Each tablet contains 25 micrograms of misoprostol.
• The other ingredients are: hypromellose (3 mPa∙s), microcrystalline cellulose (PH102), corn starch, sodium croscarmellose, crospovidone (type B), colloidal anhydrous silica.

What Angusta looks like and contents of the pack
Angusta is a white, uncoated, oval tablet measuring 7.5 mm x 4.5 mm, with a score line on one side and smooth on the other. The score line on the tablet is not intended for dividing the tablet.
Angusta is packed in blister packs and supplied in a cardboard box containing 8 tablets.

Marketing Authorisation Holder
Norgine B.V.
Antonio Vivaldistraat 150
1083 HP Amsterdam
The Netherlands

Manufacturer
Norgine B.V.
Antonio Vivaldistraat 150
1083 HP Amsterdam
The Netherlands

This medicinal product is authorised in the Member States of the European Economic Area under the following name:
Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Greece, Spain, The Netherlands, Ireland, Iceland, Luxembourg, Latvia, Malta, Germany, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Sweden, Hungary and Italy: ANGUSTA