Angusta 25 micrograms Misoprostol Tablets
1. What Angusta Is And What Is It Used For
This medicine 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 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 in this medicine may also be approved for treating other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have further questions, and always follow their instructions.
2. What You Need To Know Before Taking Angusta
Do Not Take:
- If you are allergic to misoprostol or any of the other ingredients of this medicine (listed in section 6).
- If the pain has started
- If the midwife or doctor thinks that your baby is not in good shape and 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 this medicine. This medicine 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 this medicine.
This medicine 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 this medicine in women whose placenta has ruptured more than 48 hours before the use of this medicine.
Suppose your doctor concludes that you need treatment with oxytocin(medicines used to facilitate childbirth). In that case, it will be carefully considered as oxytocin may work in the same way as this medicine.
It is recommended to wait 4 hours after the last dose of this medicine 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 this medicine to initiate labor in pregnant women with more than one child. There is no experience using this medicine in women who have previously given birth to 5 or more children vaginally.
There is limited experience using this medicine to initiate labor in women before week 37 of pregnancy (see “Pregnancy, breast-feeding, and fertility” below).
You should only take this medicine 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 this medicine simultaneously as other medicines used to facilitate childbirth or start labor (see “Do not take Angusta”).
It is recommended that you wait 4 hours after the last dose of this medicine before oxytocin can be given (see “Warnings and Precautions” above and “How to take Angusta” below).
Pregnancy, Breastfeeding, And Fertility
Pregnancy
This medicine 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 this medicine 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 breastfeeding. Breastfeeding can be started 4 hours after the last dose of this medicine.
Fertility
The use of this medicine to initiate labor from week 37 does not affect fertility.
3. How To Take Angusta
Angusta tablet uses
Always take this medicine exactly as your midwife, doctor or nurse has told you. Consult a doctor if you are unsure. This medicine 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 this medicine. 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 this medicine:
- If you have taken 200 micrograms over 24 hours
- 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 this medicine has not been studied in pregnant women under 18 years of age. Taking too much this medicine 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 Angusta Side Effetcs
Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may occur when using this medicine:
Very common (may affect more than 1 user in 10 )
- Nausea
- Vomiting
- 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)
- Reported as very common for Angusta 50 varg every four hours
- Reported as very common for Angusta 25 µg every two hours
Common side effects (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.
- Reported as usual for Angusta 50 varg every four hours.
- Hyperstimulated uterus was reported both with and without effect on fetal heart rate.
- 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.
- 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 tablet 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 tablet
Poland: Angusta
Romania: Angusta 25 micrograme comprimate
Czech Republic: Angusta 25 micrograms tablets
Hungary: Angusta 25 micrograms tablet