ANGUSTA 25 MICROGRAMMI Coated tablet

Зміст інструкції

1. ANGUSTA 25 micrograms tablets
   1. What is Angusta and what is it 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

ANGUSTA 25 micrograms tablets

misoprostol

Read this leaflet carefully before you start taking this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 ingredient misoprostol.
Angusta is used to stimulate the onset of labour.
Misoprostol belongs to a group of medicines called prostaglandins. Prostaglandins
perform a dual action during labour. One is to soften the cervix in order to
facilitate the birth of the baby vaginally. The other is to induce the onset of contractions
that help to push the baby out of the uterus. There are several reasons why you may need
help to start this process. If you would like more information, ask your midwife or
doctor.

2. What you need to know before taking Angusta

Do not take Angusta:

• if you are allergic to misoprostol or any of the other ingredients of this medicine (listed in section 6)
• if labour has begun
• if the midwife or doctor believes 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 had previous surgical interventions on the cervix or uterus, including a caesarean section for previous pregnancies
• if you have any uterine abnormality such as a “heart-shaped” uterus (bicornuate uterus), which prevents a vaginal delivery
• if the midwife or doctor believes that the placenta covers the birth canal (placenta previa) or if you have had unexplained vaginal bleeding after the 24th week of pregnancy
• if the baby is in a position in the uterus that prevents it from being born naturally (malpresentation of the fetus)
• if you have kidney failure (glomerular filtration rate <15 ml/min/1.73 m²)

Warnings and precautions
Consult your midwife, doctor or nurse before taking Angusta.
Angusta must be administered exclusively by qualified personnel in a hospital where equipment for continuous monitoring of the mother and baby is available. The cervix will be
subject to careful evaluation before taking Angusta.
Angusta may cause excessive stimulation of the uterus.
In case of prolonged or too strong uterine contractions or if the doctor or nurse are
concerned about your condition or that of the baby, you will not be given any further tablets and
the 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 have high blood pressure, protein in the urine and other possible
complications).
In the presence of infections of the membranes surrounding the baby (chorioamnionitis) it may be
appropriate to accelerate delivery. The doctor will decide on antibiotic therapy, induction of
labour or caesarean section.
There is limited or no experience with the use of Angusta in women in whom rupture of the
membranes occurred more than 48 hours before the use of Angusta.
If the doctor deems it necessary to administer oxytocin (a medicine used to facilitate
childbirth), this will be carefully evaluated as treatment with oxytocin may affect the effects of
Angusta. It is recommended to wait 4 hours after the last dose of Angusta before administering oxytocin
(see the previous paragraph “Do not take Angusta” and the following paragraphs “Other medicines and
Angusta” and “How to take Angusta”).
There is no experience regarding the use of Angusta for the induction of labour in women with
multiple pregnancies and the use of Angusta in women who have previously given birth 5 or more times
vaginally.
Only limited experience is available on the use of Angusta for the induction of
labour before the 37th week of gestation (see the following paragraph “Pregnancy,
breastfeeding and fertility”).
You should only take Angusta if the midwife or doctor believes that your clinical condition
suggests the need to induce labour.
There is limited or no information regarding the use of Angusta in pregnant women with
a Bishop score >6 (the Bishop score is the most commonly used method to assess
cervical ripening).
In patients in whom labour has been induced by any method, an increased
risk of formation of clots in the small blood vessels throughout the body (disseminated
intravascular coagulation) has been described after delivery.
A dose adjustment may be required in pregnant women with reduced
kidney or liver function (see below “How to take Angusta”).

Angusta contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, that is to say 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.
You must not take Angusta at the same time as 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 paragraph “Warnings and precautions”
and the following paragraph “How to take Angusta”).

Pregnancy, breastfeeding and fertility
Pregnancy
Angusta is used to induce labour from the 37th week of gestation. If used in this
stage of pregnancy, there is no risk of birth defects for the newborn. However, do not use
Angusta at any other time during pregnancy as misoprostol can cause birth defects.
Breastfeeding
Misoprostol may be excreted in breast milk; however, the concentration and
duration are believed to be very limited and should not prevent breastfeeding. Breastfeeding can begin 4
hours after taking the last dose of Angusta.
Fertility
The use of Angusta for the induction of labour from the 37th week of gestation has no
impact on fertility.

3. How to take Angusta

Take this medicine following exactly the instructions of the midwife, doctor or
nurse. If you have any doubts, ask your doctor. Angusta will be given to you by qualified personnel in a
hospital where equipment for continuous monitoring of the mother and the
child is available. The cervix will be carefully assessed 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. The tablet must not be broken.
The midwife or doctor will decide when to stop giving Angusta. The midwife
or doctor will stop giving Angusta:

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

Use in patients with reduced kidney or liver function
In pregnant women with reduced kidney or liver function, dose adjustments may be required
(lower dose and/or prolonged administration intervals).

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

If you take more Angusta than you should
Taking more Angusta than you should can cause contractions that are too strong or prolonged or
suffering for the baby. In this case, the administration of Angusta must be stopped.
The midwife or doctor will decide whether to give you medicines to reduce the intensity or
frequency of the contractions or to deliver the baby by caesarean section.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The following side effects may occur when using Angusta.
Very common: may affect more than 1 in 10 people

• Nausea
• Vomiting
• Presence of meconium in the amniotic fluid (evacuation of the baby's first stools into the amniotic fluid before birth)
• Postpartum hemorrhage (loss of more than 500 ml of blood after delivery) 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* (test performed on the baby at 1 and 5 minutes after birth, the score of which helps to assess the baby's health condition after birth)
• Alteration of fetal heart rate*
• Uterine hyperstimulation (uterine contractions that are too strong, frequent, or prolonged)
• Diarrhea
• Nausea
• Vomiting
• Postpartum hemorrhage (loss of more than 500 ml of blood after delivery)
• Chills
• Increased body temperature * Adverse effect in the baby Reported as common for Angusta 50 µg every 4 hours. Uterine hyperstimulation has been reported with and without alterations in fetal heart rate. Reported as common for Angusta 25 µg every 2 hours.

Uncommon: may affect up to 1 in 100 people

• Low Apgar score* (test performed on the baby at 1 and 5 minutes after birth, the score of which helps to assess the baby's health condition after birth)
• Alteration of fetal heart rate* * Adverse effect in the baby Reported as uncommon for Angusta 25 µg every 2 hours.

Not known: frequency cannot be estimated based on available data

• Dizziness
• Neonatal seizures* (convulsive crises 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 the bluish discoloration of the skin and mucous membranes of the newborn)
• Itchy rash
• Fetal acidosis* (high level of acids in the blood of the newborn)
• Premature placental detachment (detachment 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, including those not listed in this leaflet, please contact
your midwife, doctor or nurse. You can also report side effects directly
through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-
reazioni-avverse . By reporting side effects, you 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 which is stated on the blister and on the box after EXP
and Scad. respectively. The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater. Ask your pharmacist how to dispose of medicines that
you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Angusta contains

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

Description of the appearance of Angusta and contents of the pack
Angusta is available as uncoated tablets, white, oval in shape, with dimensions of 7.5 x 4.5 mm,
with a score line on one side and smooth on the other. The score line is not designed to break the
tablet.
Angusta tablets are packaged in blisters in 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
Netherlands

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