Angusta

Leaflet attached to the packaging: information for the user

ANGUSTA, 25 micrograms, tablets

Misoprostol

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a midwife, doctor, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform the midwife, doctor, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Angusta and what is it used for
• 2. Important information 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 is Angusta and what is it used for

Angusta contains the active substance misoprostol.
Angusta is used to facilitate the initiation of the labor process.
Misoprostol belongs to a group of medicines called prostaglandins. Prostaglandins have a dual effect during labor. One is to relax the cervix so that the baby can pass through the vagina more easily. The other is to induce contractions that help push the baby out of the uterus. There may be several reasons why assistance may be needed to initiate this process. The doctor can provide more 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 labor has already begun;
• if the midwife or doctor considers that the condition of the fetus is unsatisfactory and/or if the fetus is at risk;
• if uterotonic drugs (which facilitate the birth of the baby) are being administered and/or other medicines are being used to induce labor (see below "Warnings and precautions", "Angusta and other medicines" and "How to take Angusta");
• if previous operations have been performed on the cervix or uterus, including previous cesarean sections;
• if the midwife or doctor finds that the placenta covers the birth canal (placenta previa) or if the patient has had unexplained vaginal bleeding after the 24th week of the current pregnancy;
• if the baby is not in the correct position in the uterus to allow for a natural birth (abnormal fetal position);
• if the patient has renal failure (glomerular filtration rate <15 ml min 1.73 m).< li>

Warnings and precautions

Before starting Angusta, the patient should discuss it with the midwife, doctor, or nurse.
Angusta should only be administered by trained obstetric personnel in a hospital setting, allowing for continuous monitoring of the fetus 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, the patient will not receive any more tablets. The midwife or doctor may decide that it is necessary to use medicines 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 rapid delivery.
The doctor will make the necessary decisions regarding antibiotic treatment, induction of labor, or cesarean section.
There is limited experience with the use of Angusta in women who have had their water break more than 48 hours before taking Angusta.
If the doctor considers that it is necessary to start oxytocin (a medicine used to facilitate labor), they will do so with caution, as oxytocin treatment may affect the action of Angusta. It is recommended to wait 4 hours after the last dose of Angusta before administering oxytocin (see above "When not to take Angusta" and below "Angusta and other medicines" and "How to take Angusta").
There is no experience with the use of Angusta to induce labor in women with multiple pregnancies or in women who have had five or more previous vaginal deliveries.
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 considers that, from a medical point of view, the patient needs help to initiate labor.
There is limited information on the use of Angusta in pregnant women with a Bishop score > 6 (the Bishop score is the most commonly used method to assess cervical maturity for natural birth).
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 labor.
In patients with impaired renal or hepatic function, it may be necessary to reduce the dose (see "How to take Angusta").

Angusta contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means that the medicine is considered "sodium-free".

Angusta and other medicines

The patient should tell the midwife or doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Angusta should not be administered at the same time as medicines used to facilitate labor and/or medicines that help induce labor (see above "When not to take 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 labor from the 37th week of pregnancy.
The use of the medicine during this period of pregnancy is not associated with a risk of congenital anomalies in the baby. However, Angusta should not be used during any other period of pregnancy, as misoprostol may cause congenital anomalies in this case.
Breastfeeding
Misoprostol may pass into breast milk, but it is assumed that the concentrations and the time of passage are very limited and should not prevent breastfeeding. Breastfeeding can be started 4 hours after the last dose of Angusta.
Fertility
The use of Angusta to induce labor from the 37th week of pregnancy does not affect fertility.

3. How to take Angusta

This medicine should always be taken according to the recommendations of the midwife, doctor, or nurse. If in doubt, the patient should consult a doctor. Angusta should only be administered by trained obstetric personnel in a hospital setting, allowing for continuous monitoring of the fetus 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. The tablets should not be crushed.
The midwife or doctor will decide when to stop taking Angusta. The use of Angusta will be discontinued if:
the patient has received 200 micrograms of the medicine within 24 hours;
labor has begun;
uterine contractions are too strong or prolonged;
there are signs of fetal distress;
it is necessary to administer oxytocin or other medicines used to facilitate labor (see above "When not to take Angusta", "Warnings and precautions", and "Angusta and other medicines").

Use in patients with impaired renal or hepatic function.

In pregnant women with impaired renal or hepatic function, it may be necessary to adjust the dose (use a smaller dose and/or increase the intervals between doses).

Use in children and adolescents

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

Taking a higher dose of Angusta than recommended

Taking a higher dose of Angusta than recommended may lead to increased uterine contractions or fetal distress. The use of Angusta should be discontinued. The midwife or doctor may decide that it is necessary to use medicines that reduce the strength or frequency of uterine contractions or to perform a cesarean section.

4. Possible side effects

Like all medicines, Angusta can cause side effects, although not everybody gets them.
The following side effects may occur after taking Angusta.
Very common: may affect more than 1 in 10 people
Nausea
Vomiting
Meconium in the amniotic fluid (early stool passed by the baby into the amniotic fluid)
Postpartum hemorrhage (loss of more than 500 ml of blood after delivery)
Common: may affect up to 1 in 10 people
Low Apgar score* (a test performed on the baby at 1 and 5 minutes after birth, assessing the baby's health)
Abnormal fetal heart rate*
Uterine hyperstimulation (too strong, too frequent, and too long uterine contractions)
Diarrhea
Nausea
Vomiting
Postpartum hemorrhage (loss of more than 500 ml of blood after delivery)
Chills
Increased body temperature
*Side effects in the baby
Uncommon: may affect up to 1 in 100 people
Low Apgar score* (a test performed on the baby at 1 and 5 minutes after birth, assessing the baby's health)
Abnormal fetal heart rate*
*Side effects in the baby
Rare: may affect up to 1 in 1,000 people
Dizziness
Seizures in the newborn*
Asphyxia in the newborn* (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)
Pruritic rash
Fetal acidosis* (increased acid levels in the baby's blood)
Placental abruption (separation of the placenta from the uterus before delivery)
Uterine rupture
*Side effects in the baby

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the patient should inform the midwife, doctor, or nurse. Side effects can be reported directly to the Department of Medicinal Product Monitoring, 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Angusta

The medicine should be stored 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:
Expiry date (EXP). The expiry date refers to the last day of the month.
The batch number is stated after: Batch number (Lot).
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack 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), maize 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, 7.5 mm x 4.5 mm in size, with a score line on one side and a smooth surface on the other. The score line is not intended for breaking the tablet.
Angusta is packaged in blisters and supplied in a cardboard box containing 8 tablets.

Marketing authorization holder

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

Manufacturer

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

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, and United Kingdom (Northern Ireland): ANGUSTA
Date of last revision of the leaflet:October 2023