25 micrograms tablets 
misoprostol

1. What Angusta is and what it is used for

Angusta contains the active substance misoprostol.

Angusta is used to help start a birth.

Misoprostol belongs to a group of medicines called prostaglandins. Prostaglandins have two functions during labor. One function is to soften the cervix so that the baby can be born more easily through the vagina. The second function is that they trigger the pains, which help to push the baby out of the uterus ( uterus ). There can be several different reasons why you need help starting labor. Ask your midwife or doctor for more information.

Misoprostol found in Angusta may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

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 the pains have started
  • if the midwife or doctor thinks that your baby is not in good shape and/or is stressed
  • if you are given other medicines that facilitate childbirth (eg oxytocin ) (see “Warning and precautions”, “Other medicines and Angusta” and “How to take Angusta” below)
  • if you have previously operated on the cervix (other than conization) or the uterus, including the cesarean section in the delivery of previous children
  • if you have an abnormal uterus, such as a heart-shaped uterus ( uterus bicornis), which prevents vaginal delivery
  • if the midwife or doctor considers that the placenta covers the birth canal ( placenta praevia) or if you have had unexplained vaginal bleeding after the 24th week of pregnancy
  • if the position of the baby in the womb prevents it from being born the natural way (position anomalies)
  • if you have renal failure ( glomerular filtration rate <15 ml / min / 1.73 m 2 )

Warnings and cautions

Talk to your midwife, doctor, or nurse before taking Angusta.

Angusta should only be given by trained staff in hospitals where equipment is available to monitor you and your baby. The cervix will be examined carefully before you receive Angusta.

Angusta can cause severe stimulation of the uterus.

If the pain is too long or too strong and the doctor or midwife is worried about you and your baby, you will not receive any more tablets, and the midwife or doctor will decide if you need to take medicine to reduce the pain or slow it down the frequency.

The effect of Angusta has not been studied in women with severe preeclampsia (a condition in which pregnant women have high blood pressure, protein in the urine, and sometimes other complications).

In case of infection of the amniotic membranes surrounding the baby (chorioamnionitis), rapid delivery may be necessary. The doctor makes all the necessary decisions regarding treatment with antibiotics, initiation of labor, or cesarean section.

There is no or limited experience with the use of Angusta in women whose placenta has ruptured more than 48 hours before the use of Angusta.

If your doctor comes to the conclusion that you need treatment with oxytocin(medicines used to facilitate childbirth), it will be carefully considered as oxytocin may work in the same way as Angusta. It is recommended to wait 4 hours after the last dose of Angusta before starting oxytocin (see ‘Do not take Angusta’ above and ‘Other medicines and Angusta’ and ‘How to take Angusta’ below).

There is no experience of using Angusta to initiate labor in women who are pregnant with more than one child and there is no experience of using Angusta in women who have previously given birth to 5 or more children vaginally.

There is limited experience with the use of Angusta to initiate labor in women before week 37 of pregnancy (see “Pregnancy, breast-feeding, and fertility” below).

You should only take Angusta if the midwife or doctor considers that there is a medical need to initiate labor.

There is no or limited information on the use of Angusta in pregnant women with Bishop scores higher than 6 (Bishop scores are the most common method of measuring cervical maturity).

An increased risk of blood clot formation in small blood vessels around the body (disseminated intravascular coagulation ) has been seen after delivery in patients whose labor has been initiated, regardless of method.

Dose adjustments may be needed in pregnant women with renal or hepatic impairment (see “How to take Angusta” below).

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 or to start labor (see “Do not take Angusta”). It is recommended that you wait 4 hours after the last dose of Angusta before oxytocin can be given (see “Warnings and Precautions” above and “How to take Angusta” below).

Pregnancy, breastfeeding, and fertility

Pregnancy

Angusta is used to help start childbirth from week 37 of pregnancy. When used at that stage of pregnancy, there is no risk of harm to your baby. You should not use Angusta during any other period of pregnancy as misoprostol may cause malformations in the unborn baby.

Breast-feeding

Misoprostol can be excreted in breast milk, but the amount and for how long it remains is expected to be very limited and should not prevent breast-feeding. Breastfeeding can be started 4 hours after the last dose of Angusta.

Fertility

The use of Angusta to initiate labor from week 37 does not affect fertility.

3. How to take Angusta

Always take this medicine exactly as your midwife, doctor or nurse has told you. Consult a doctor if you are unsure. Angusta will be provided to you by trained staff at hospitals where equipment is available to monitor you and your baby. The uterus will be examined carefully before you receive 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 tablet should not be shared.

The midwife or doctor will decide when to stop treatment with Angusta. The midwife or doctor will discontinue treatment with Angusta:

  • if you have taken 200 micrograms over a 24-hour period
  • when labor begins
  • if the pain is too strong or too prolonged
  • if your child becomes stressed
  • if treatment with oxytocin or other medicines to facilitate childbirth is needed (see “Do not take Angusta”, “Warnings and precautions”, and “Other medicines and Angusta” above).

Use in patients with renal or hepatic impairment

Dose adjustments (lower dose and/or less frequently) may be required in pregnant women with renal or hepatic impairment.

Use for children and adolescents

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

If you take too much Angusta, it may cause too much or too long pain, or the baby may become stressed. The treatment must then be stopped. The midwife or doctor decides if you need to receive medication that reduces the intensity of the pain or slows down the frequency, or if the baby needs to be delivered by cesarean 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 user in 10 )

  • Nausea 1)
  • Vomiting 1)
  • Meconium splashes (feces from the unborn baby in the amniotic fluid)
  • Bleeding after childbirth 2) (loss of more than 500 ml of blood after childbirth)

1) Reported as very common for Angusta 50 varg every four hours.

2) Reported as very common for Angusta 25 µg every two hours.

Common (may affect up to 1 in 10 people)

  • Low Apgar score * 1) (test performed on the baby 1 and 5 minutes after birth, where the score in the test indicates how well the baby is feeling after birth)
  • Abnormal pulse in the fetus * 1)
  • Hyperstimulated uterus 2) (when the pains are too strong, too often, or too long)
  • Diarrhea
  • Nausea 3)
  • Vomiting 3)
  • Bleeding after childbirth 2) (loss of more than 500 ml of blood after childbirth)
  • Overindulge
  • Fever

* Side effect in the child.

1) Reported as usual for Angusta 50 varg every four hours.

2) Hyperstimulated uterus was reported both with and without effect on fetal heart rate.

3) Reported as usual for Angusta 25 µg every two hours.

Uncommon (may affect up to 1 in 100 people)

  • Low Apgar score * 1) (test performed on the baby 1 and 5 minutes after birth, where the score in the test indicates how well the baby is feeling after birth)
  • Abnormal pulse in the fetus * 1)

* Side effect in the child.

1) Reported as less common for Angusta 50 µg every four hours.

Has been reported (occurs in an unknown number of users)

  • Dizziness
  • Cramps *
  • Lack of oxygen in the baby’s brain and organs during childbirth *
  • Lack of oxygen in the blood of the newborn baby * (also called “blue baby syndrome” and means blue staining of the skin and mucous membranes of the newborn baby)
  • Itchy rash
  • Acidosis fetal * (high acid content in the unborn baby’s blood)
  • Premature placental abruption (the placenta detaches from the uterine wall before birth)
  • Uterine rupture

* Side effect in the child.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Angusta

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

Store in the original package. Moisture sensitive.

Do not use this medicine after the expiry date which is stated on the blister and the carton after EXP. The expiration date is the last day of the specified month.

Medicines should not be disposed of via wastewater. Ask your midwife, doctor, or pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is misoprostol.
  • The other ingredients are hypromellose, microcrystalline cellulose, maize starch, crospovidone, croscarmellose sodium, anhydrous silica.

What the medicine looks like and the contents of the pack

Angusta is a white, uncoated oval tablet with dimensions 7.5 x 4.5 with a notch on one side and smooth on the other side. The notch is not intended for splitting the tablet.

Angusta tablets are packaged in blisters in cartons of 8 tablets each.

Marketing Authorisation Holder

Azanta Danmark A / S

Gearhalsvej 1

2500 Valby

Denmark

Manufacturer

Piramal Healthcare (UK) Limited

Whalton Road,

Morpeth,

Northumberland,

NE61 3YA, UK

Azanta Danmark A / S

Gearhalsvej 1

2500 Valby

Denmark

This medicinal product is authorized under the European Economic Area under the names:

Bulgaria: Angusta 25 micrograms tablets

Denmark: Angusta

Estonia: Angusta

Finland: Angusta 25 microg tabletit

France: Angusta 25 micrograms, compressed

Iceland: Angusta 25 microgram tablets

Croatia: Angusta 25 micrograms tablet

Latvia: Angusta 25 micrograms tablets

Norway: Angusta

Slovakia: Angusta 25 micrograms tablets

Slovenia: Angusta 25 microgram tablets

Poland: Angusta

Romania: Angusta 25 micrograme comprimate

Czech Republic: Angusta 25 micrograms tablets

Hungary: Angusta 25 micrograms tablet

Muhammad Nadeem

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