ANGUSTA

Package leaflet: Information for the user

ANGUSTA 25 micrograms tablets

misoprostol
Please read all of this leaflet carefully before you take this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your midwife, doctor or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your midwife, doctor or nurse. See section 4.

Contents of this 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 stimulate the onset of labour.
Misoprostol belongs to a group of medicines called prostaglandins. Prostaglandins have a dual action during labour. One is to soften the cervix, thus facilitating the baby's vaginal birth. The other is to induce contractions that help push the baby out of the uterus. There are several reasons why you might need assistance to start this process. If you would like more information, please ask your midwife or doctor.

2. What you should know before taking Angusta

Do not take Angusta:

• if you are allergic to misoprostol or to any of the other ingredients of this medicine (listed in section 6)
• if labour has already started
• if your midwife or doctor considers that the baby is not in good health and/or is in distress
• if you have already been given oxytocic medicines (medicines used to facilitate childbirth) and/or other medicines to induce labour (see below “Warnings and precautions”, “Other medicines and Angusta”, and “How to take Angusta”)
• if you have previously undergone surgical procedures on the cervix or uterus, including a caesarean section in previous pregnancies
• if you have any uterine abnormalities such as a “heart-shaped” uterus (bicornuate uterus), which would prevent vaginal delivery
• if your midwife or doctor determines that the placenta covers the birth canal (placenta praevia) or if you have experienced unexplained vaginal bleeding after the 24th week of pregnancy
• if the baby is in a position within the uterus that prevents natural birth (abnormal fetal presentation)
• if you have renal failure (glomerular filtration rate <15 ml/min/1.73 m²)

Warnings and precautions
Contact your midwife, doctor, or nurse before taking Angusta.
Angusta must be administered exclusively by trained personnel in a hospital setting where continuous monitoring equipment for both mother and baby is available. The cervix will be carefully assessed before taking Angusta.
Angusta may cause excessive stimulation of the uterus.
If prolonged or overly strong uterine contractions occur, or if your doctor or nurse is concerned about your condition or that of the baby, no further tablets will be given, and your midwife or doctor will decide whether to administer medicines to reduce the intensity or frequency of contractions.
The effects of Angusta have not been studied in women with severe pre-eclampsia (a condition in which pregnant women experience high blood pressure, protein in the urine, and other possible complications).
In cases of infection of the membranes surrounding the baby (chorioamnionitis), it may be appropriate to accelerate delivery. Your doctor will decide on antibiotic therapy, labour induction, or caesarean section.
There is no experience or only limited experience with the use of Angusta in women whose membranes have ruptured more than 48 hours before administration of Angusta.
If your doctor considers oxytocin treatment (a medicine used to facilitate childbirth) necessary, this will be carefully evaluated, as oxytocin may influence the effects of Angusta. It is recommended to wait 4 hours after the last dose of Angusta before administering oxytocin (see the previous section “Do not take Angusta” and the following sections “Other medicines and Angusta” and “How to take Angusta”).
There is no experience with the use of Angusta for labour induction in women with multiple pregnancies or in women who have previously delivered vaginally five or more times.
Only a limited number of cases are available regarding the use of Angusta for labour induction before the 37th week of gestation (see the following section “Pregnancy, breastfeeding, and fertility”).
You should take Angusta only if your midwife or doctor considers that your clinical condition indicates the need to induce labour.
There is no or limited information available 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 ripeness).
In patients in whom labour has been induced by any method, an increased risk of formation of clots in small blood vessels throughout the body (disseminated intravascular coagulation) has been reported after delivery.
Dose adjustment may be required in pregnant women with impaired renal or hepatic function (see below “How to take Angusta”).

Angusta contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially “sodium-free”.

Other medicines and Angusta
Inform your midwife or doctor if you are taking, have recently taken, or might take any other medicines.
You must not take Angusta concomitantly with other medicines used to facilitate childbirth and/or induce labour (see “Do not take Angusta”). It is recommended to wait 4 hours after the last dose of Angusta before administering oxytocin (see the previous section “Warnings and precautions” and the following section “How to take Angusta”).

Pregnancy, breastfeeding, and fertility
Pregnancy
Angusta is used to induce labour from the 37th week of gestation. When used at this stage of pregnancy, there is no risk of congenital malformations for the newborn. However, do not use Angusta at any other time during pregnancy, as misoprostol may cause congenital malformations at birth.

Breastfeeding
Misoprostol may be excreted in breast milk; however, the concentration and duration are considered 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 for labour induction from the 37th week of gestation has no impact on fertility.

3. How to take Angusta

Take this medicine exactly as instructed by your midwife, doctor, or nurse. If you have any doubts, consult your doctor. Angusta will be administered by qualified personnel in a hospital setting where equipment for continuous monitoring of both mother and baby is available. The cervix will be carefully evaluated before Angusta is given.

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. The tablet must not be broken.

Your midwife or doctor will decide when to stop administration of Angusta. Administration of Angusta will be discontinued:

• if you have received 200 micrograms within 24 hours
• when labour begins
• if contractions are too strong or prolonged
• if the baby is in distress
• if treatment with oxytocin or other medicines used to assist delivery becomes necessary (see previous sections “Do not take Angusta”, “Warnings and precautions”, and “Other medicines and Angusta”).

Use in patients with renal or hepatic impairment
Dose adjustments (lower dose and/or prolonged dosing intervals) may be required in pregnant women with impaired renal or hepatic function.

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

If you take more Angusta than you should
Taking more Angusta than recommended may cause contractions that are too strong or prolonged, or distress in the baby. In such cases, administration of Angusta must be stopped. Your midwife or doctor will decide whether to administer medicines to reduce the intensity or frequency of contractions, or whether to deliver the baby 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 when using Angusta.

Very common: may affect more than 1 in 10 people

• Nausea
• Vomiting
• Meconium in amniotic fluid (passing of the baby's first stool into the amniotic fluid before birth)
• Postpartum haemorrhage (loss of more than 500 ml of blood after childbirth)
  Reported as very common for Angusta 50 µg every 4 hours.
  Reported as very common for Angusta 25 µg every 2 hours.

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, the result of which helps assess the baby's health status after delivery)
• Fetal heart rate abnormalities*
• Uterine hyperstimulation (uterine contractions that are too strong, frequent, or prolonged)
• Diarrhoea
• Nausea
• Vomiting
• Postpartum haemorrhage (loss of more than 500 ml of blood after childbirth)
• Chills
• Increase in body temperature
  * Side effect in the baby
  Reported as common for Angusta 50 µg every 4 hours.
  Uterine hyperstimulation has been reported with and without fetal heart rate abnormalities.
  Reported as common for Angusta 25 µg every 2 hours.

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, the result of which helps assess the baby's health status after delivery)
• Fetal heart rate abnormalities*
  * Side effect in the baby
  Reported as uncommon for Angusta 25 µg every 2 hours.

Not known: frequency cannot be estimated from the available data

• Dizziness
• Neonatal seizures* (seizure episodes in the newborn)
• Neonatal asphyxia* (lack of oxygen to the baby's brain and organs during childbirth)
• Neonatal cyanosis* (also known as “blue baby syndrome”, characterized by a bluish discoloration of the skin and mucous membranes of the newborn)
• Itchy rash
• Fetal acidosis* (elevated level of acids in the newborn's blood)
• Premature placental abruption (placenta detaching from the uterine wall before delivery)
• Uterine rupture
  * Side effect in the baby

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your midwife, doctor or nurse. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Angusta

Keep this medicine out of the sight and reach of children.
Store in the original packaging to protect the medicine from moisture.
Do not use this medicine after the expiry date stated on the blister and on the carton after EXP and Scad., respectively. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Angusta contains

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

Description of the appearance of Angusta and contents of the pack
Angusta is available as white, oval, film-coated tablets of size 7.5 x 4.5 mm, with a score line on one side and smooth on the other.
The score line is not intended for breaking the tablet.
Angusta tablets are packed in blisters within a cardboard box containing 8 tablets.

Marketing Authorisation Holder
Norgine Italia S.r.l.
Via Fabio Filzi 25
20124 Milano
Italy

Manufacturer
Azanta Danmark A/S
Gearhalsvej 1
2500 Valby
Denmark
Norgine B.V.
Antonio Vivaldistraat 150
1083 HP Amsterdam
The Netherlands

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