Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Angusta 25 microgram tablets
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Misoprostol may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for
Angusta contains the active substance misoprostol. Angusta is used to help start the birth process. Misoprostol belongs to a group of medicines called prostaglandins. Prostaglandins have two actions during labour. One action is to soften the cervix so that the baby can be born through the vagina more easily. The second action is to cause contractions to start, which help push the baby out of the womb (uterus). There could be several reasons why you might need help to start this process. Ask your midwife or doctor if you want more information. 2.
What you need to know before you take it
e 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 started if your midwife or doctor consider your baby not to be in good health and/or is distressed if oxytocic medicines (medicines used to facilitate birth) and/or other medicines to help start the birth process are being given (see "Warnings and precautions", "Other medicines and Angusta" and "How to take Angusta" below). if you have had previous surgery to your cervix or womb including a caesarean birth for any earlier babies if you have any womb abnormality such as "heart-shaped" uterus (bicornuate uterus) that would prevent a vaginal delivery if your midwife or doctor judge that your placenta is covering the birth canal (placenta praevia) or if you have had any unexplained vaginal bleeding after the 24th week of pregnancy if your baby is in a position in the womb which prevents it from being born naturally (fetal malpresentation) if you have kidney failure (Glomerular filtration rate <15 ml/min/1.73 m2
1
Warnings and precautions Talk to your midwife, doctor or nurse before taking Angusta. Angusta must only be given by a trained professional in a hospital where facilities for monitoring you and your baby are available. Your cervix will be assessed carefully before you take Angusta. Angusta can cause excessive stimulation of the womb. In case the womb contractions are prolonged or too strong or your doctor or nurse is concerned for you and your baby, you will not be given more tablets and your midwife or doctor will decide if you should be given medicines to reduce the strength or to slow down the frequency of your contractions. The effect of Angusta has not been studied in women with severe pre-eclampsia (a condition where pregnant women suffer from high blood pressure, protein in the urine and possibly other complications). Infections of the membranes surrounding the baby (chorioamnionitis) may necessitate fast delivery. The physician will take the necessary decisions regarding treatment with antibiotics, inducing labour or caesarean section. There are no or limited experience with the use of Angusta in women whose membranes have been ruptured for more than 48 hours before the use of Angusta. If your doctor finds that you need treatment with oxytocin (medicine used to facilitate birth), this will be carefully considered, as the treatment with oxytocin may affect the way Angusta works. It is recommended to wait 4 hours after the last dose of Angusta before giving oxytocin (see "Do not take Angusta" above, and "Other medicines and Angusta" and "How to take Angusta" below). There is no experience with the use of Angusta to start the birth process in women who are pregnant with more than one baby and there is no experience with the use of Angusta in women who have had 5 or more previous babies delivered vaginally. There is limited experience with the use of Angusta to start the birth process in women less than 37 weeks pregnant (see "Pregnancy, breast-feeding and fertility" below). You should only take Angusta if your midwife or doctor judge that you have a medical need for help to start the birth process. There is no or limited information with the use of Angusta in pregnant women with a Bishop Score >6 (Bishop Score is the most commonly used method to rate the readiness of the cervix). An increased risk of formation of blood clots in the small blood vessels throughout the body (disseminated intravascular coagulation) after delivery has been described in patients whose labour has been induced by any method. Dose adjustments may be needed in pregnant women with reduced kidney or liver function (see "How to take Angusta below). Angusta contains sodium This medicine contains less than 1 mmol sodium (23 mg) 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 birth and/or help start labour (see "Do not take Angusta"). It is recommended to wait 4 hours after the last dose of Angusta before giving oxytocin (see "Warnings and precautions" above, and "How to take Angusta" below).
2
Pregnancy, breast-feeding and fertility Pregnancy Angusta is used to help start labour from week 37 of pregnancy. When used at that time of pregnancy, there is no risk of birth defects for your baby. However, you should not use Angusta at any other time during pregnancy because misoprostol can then cause birth defects. Breast-feeding Misoprostol may be excreted in breast milk, but the level and duration is expected to be very limited and should not hinder breast-feeding. Breast-feeding can start 4 hours after the last dose of Angusta is given. Fertility There is no impact on fertility with the use of Angusta to help start labour from week 37 of the pregnancy.
3.
How to take it
Angusta
Always take this medicine exactly as your midwife, doctor or nurse has told you. Check with your doctor if you are not sure. Angusta will be given to you by a trained professional in a hospital where facilities for monitoring you and your baby are available. Your cervix will be assessed carefully before you take 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 broken. Your midwife or doctor will decide when administration of Angusta should stop. Your midwife or doctor will stop administration of Angusta,
- if you have taken 200 micrograms over a period of 24 hours
- when labour starts
- if your contractions are too strong or last too long
- if your baby becomes distressed
- if treatment with oxytocin or other medicines used to facilitate birth is needed (see "Do not take Angusta", "Warnings and precautions" and "Other medicines and Angusta" above). Use in patients with reduced kidney or liver function Dose adjustments (lower dose and/or prolonged dosing intervals) may be needed in pregnant women with reduced kidney or liver function. Use in children and adolescents The use of Angusta has not been studied in pregnant women less than 18 years of age. If you take more Angusta than you should If you take more Angusta than you should, it may cause contractions to be too strong or last too long or the baby may become distressed. Administration of Angusta must then be stopped. Your midwife or doctor will decide if you should be given medicines to reduce the strength or to slow down the frequency of your contractions or if the baby should be delivered by caesarean section.
4.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. The following
Possible side effects
may occur when using Angusta. Very Common: may affect more than 1 in 10 people
- Nausea1)
- Vomiting 1)
- Meconium stain (early faeces (stool) passed by the unborn baby into the amniotic fluid)
- Postpartum bleeding2) (loss of over 500 ml blood after delivery) 1) Reported as very common for Angusta 50 μg every 4 hours. 2) Reported as very common for Angusta 25 μg every 2 hours. 3
Common: may affect up to 1 in 10 people
- Apgar score low*1) (test performed at the baby at 1 and 5 minutes after birth, where the score of the test determines how well the baby is doing after being born)
- Foetal heart rate abnormal*1)
- Uterine hyperstimulation2) (uterine contractions are too strong, too frequent, or last too long)
- Diarrhoea
- Nausea3)
- Vomiting3)
- Postpartum bleeding1) (loss of over 500 ml blood after delivery)
- Chills
- Elevation of body temperature
- Side effect in the baby 1) Reported as common for Angusta 50 μg every 4 hours. 2) Uterine hyperstimulation was reported both with and without foetal heart rate changes. 3) Reported as common for Angusta 25 μg every 2 hours. Uncommon: may affect up to 1 in 100 people
- Apgar score low*1) (test performed at the baby at 1 and 5 minutes after birth, where the score of the test determines how well the baby is doing after being born)
- Foetal heart rate abnormal*1)
- Side effect in the baby 1) Reported as uncommon for Angusta 25 μg every 2 hours. Not known: Frequency cannot be estimated from the available data
- Dizziness
- Convulsion neonatal* (seizures in the newborn baby)
- Neonatal asphyxia* (lack of oxygen to the baby's brain and organs during the birth)
- Cyanosis neonatal* (also called "blue baby syndrome" characterised by blue coloration of the skin and mucous membranes in the newborn baby)
- Rash pruritic (itchy rash)
- Foetal acidosis* (high acid level in the unborn baby's blood)
- Premature separation of placenta (separation of the placenta from the wall of the uterus before birth)
- Uterine (uterus) rupture
- Side effect in the baby Reporting of side effects If you get any side effects, talk to your midwife, doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App store. By reporting side effects, you can help provide more information on the safety of this medicine.
5.
How to store it
Angusta
Keep this medicine out of the sight and reach of children. Store in the original package in order to protect from moisture. Do not use this medicine after the expiry date which is stated on the foil and carton after EXP. The expiry date refers to the last day of that month. Do not throw away any medicines via wastewater. Ask your midwife, doctor or pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6.
Contents of the pack and other information
4
What Angusta contains The active substance is misoprostol. Each tablet contains 25 micrograms of misoprostol. The other ingredients are: hypromellose; cellulose, microcrystalline; maize starch; crospovidone; croscarmellose sodium; silica, colloidal anhydrous. What Angusta looks like and contents of the pack Angusta is a white, uncoated oval shaped tablet with the dimensions 7.5 x 4.5 mm with a score line on one side and plain on the other. The score line is not intended for breaking the tablet. Angusta tablets are packaged in blister packs supplied in a cardboard box containing 8 tablets. Marketing Authorisation Holder Norgine Pharmaceuticals Limited ARC Uxbridge, Building 01, Sanderson Road, Uxbridge, UB8 1DH, UK Manufacturer Norgine B.V. Antonio Vivaldistraat 150 1083 HP Amsterdam The Netherlands
This leaflet was last revised in 06/2025.
Other sources of information If you need the information on this leaflet in an alternative format, such as large print, or Braille please ring 0800 198 5000.
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Frequently asked questions about Angusta 25 microgram tablets
How do I take Angusta 25 microgram tablets?
Angusta 25 microgram tablets comes as tablet containing 25mcg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Angusta 25 microgram tablets?
The active substance in Angusta 25 microgram tablets is misoprostol.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Angusta 25 microgram tablets, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Angusta 25 microgram tablets without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: misoprostol
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Angusta is indicated for induction of labour.
4.2. Posology and method of administration
Posology
The recommended dosing regimen for Angusta is 25 micrograms orally every two hours or 50 micrograms orally every four hours according to hospital practice. The maximum dose is 200 micrograms over a period of 24 hours.
There may be a synergistic/additive effect of misoprostol and oxytocin. Plasma concentrations of misoprostol acid are negligible after 5 half-lives (3.75 hours), see section 5.2. It is recommended to wait 4 hours after the last dose of Angusta before administration of oxytocin (see sections 4.3, 4.4 and 4.5).
Due to the lack of clinical data, the use of Angusta is recommended from 37th week of pregnancy when the cervix is unfavourable (Bishop score <7).
Special populations
A lower dose and/or prolonged dosing intervals should be considered in pregnant women with renal or hepatic impairment (see section 5.2).
Paediatric population
The safety and efficacy of Angusta in pregnant women aged less than 18 years has not been established in clinical trials. No data are available.
Method of administration
• Angusta should only be administered by trained obstetric personnel in a hospital setting where facilities for continuous fetal and uterine monitoring is available.
• The cervix should be assessed carefully before Angusta is administered.
• Angusta should be taken orally with a glass of water.
4.3. Contraindications
Angusta is contraindicated:
- When there is hypersensitivity to the active substance or to any of the excipients listed in section 6.1
- When labour has started
- When there is suspicion or evidence of foetal compromise prior to induction (e.g., failed non-stress or stress test, meconium staining or diagnosis or history of non-reassuring foetal status)
- When oxytocic drugs and/or other labour induction agents are being given (see section 4.2, 4.4, 4.5 and 5.2)
- When there is suspicion or evidence of uterine scar resulting from previous uterine or cervical surgery, e.g. caesarean delivery
- When there is uterine abnormality (e.g. bicornuate uterus) preventing vaginal delivery
- When there is placenta praevia or unexplained vaginal bleeding after 24 weeks gestation with this pregnancy
- When there is foetal malpresentation, contraindicating vaginal delivery
- In patients with kidney failure (GFR <15 ml/min/1.73 m2).
4.4. Special warnings and precautions for use
Angusta should only be administered by trained obstetric personnel in a hospital setting where facilities for continuous fetal and uterine monitoring is available and the cervix should be assessed carefully before product use.
Angusta can cause excessive uterine stimulation.
If uterine contractions are prolonged or excessive, or there is a clinical concern for the mother or baby, additional Angusta tablets should not be administered. If excessive uterine contractions continue, treatment according to local guidelines should be started.
In women with pre-eclampsia, evidence or suspicion of foetal compromise should be ruled out (refer to section 4.3). There are no or limited clinical data with misoprostol in pregnant women with severe pre-eclampsia marked by Haemolytic anaemia; Elevated Liver enzymes; Low Platelet count (HELLP) syndrome, other end organ affliction or CNS findings other than mild headache.
Chorioamnionitis may necessitate fast delivery. Decisions regarding antibiotic treatment, induced labour or caesarean section will be at the physician's discretion.
There are no or limited clinical data with misoprostol in women whose membranes have been ruptured for more than 48 hours prior to administration of misoprostol.
There may be synergistic/additive effects of misoprostol and oxytocin. Concomitant administration of oxytocin is contraindicated. See section 4.3. Angusta is eliminated after 4 hours. See section 5.2. It is recommended to wait 4 hours after last dose of Angusta before administration of oxytocin (see sections 4.2 and 4.5).
There are no or limited clinical data with misoprostol in multiple pregnancies. There are no or limited clinical data with misoprostol in grand multiparity.
There are no or limited clinical data with misoprostol before week 37 of gestation (see section 4.6).
Angusta should be used only when induction of labour is clinically indicated.
There are no or limited clinical data with misoprostol in pregnant women with Bishop score (mBS) >6.
An increased risk of post-partum disseminated intravascular coagulation has been described in patients whose labour has been induced by any physiological or pharmacological method.
A lower dose and/or prolonged dosing intervals should be considered in pregnant women with renal or hepatic impairment (see section 5.2).
This medicinal product contains 0,874 mg sodium per tablet that is to say essentially 'sodium-free'.
4.5. Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed with Angusta.
Concurrent use of oxytocic drugs or other labour induction agents is contraindicated due to the potential of increased uterotonic effects (see sections 4.2, 4.3, 4.4 and 5.2).
4.6. Fertility, pregnancy and lactation
Pregnancy
Angusta has been studied in pregnant women ≥37 weeks of gestation.
Angusta should only be used prior to 37 weeks of gestation if medically indicated (see section 4.4).
Angusta is used for labour induction at a low misoprostol dosage for a short period of time at the very end of pregnancy. When used at that time of pregnancy, there is no risk of foetal malformations. Angusta should not be used at any other time during pregnancy: a threefold increased risk of foetal malformations (including Moebius syndrome, amniotic band syndrome and central nervous system anomalies) has been reported in pregnancies exposed to misoprostol in first trimester.
Breast-feeding
No studies have been performed to investigate the amount of misoprostol acid in colostrum or breast milk following the use of Angusta.
Misoprostol has been detected in human milk following oral administration of misoprostol in tablet form.
Pharmacokinetic trials reveal that oral misoprostol (at dose levels of 600 µg and 200 µg) is excreted into breast milk with drug levels that rise and fall very quickly. The maximum concentration of misoprostol acid in expressed breast milk was achieved within 1 hour after dosing and was 7.6 pg/ml (% CV 37%) and 20.9 pg/ml (% CV 62%) after single 200 mcg and 600 mcg misoprostol administration, respectively. Negligible amounts of misoprostol acid remain in maternal plasma after 5 half-lives (3.75 hours), and even lower concentrations will remain in breast milk. Breast-feeding can start 4 hours after the last dose of Angusta is administered.
Fertility
Studies of fertility and embryo development in rats have shown that misoprostol may have an impact on implantation and resorption. This is, however, considered of no relevance for the indicated use of Angusta in late pregnancy.
4.7. Effects on ability to drive and use machines
Not relevant.
4.8. Undesirable effects
The undesirable effects listed in the table below have been reported in 41 trials where a total of 3,152 women were exposed to oral misoprostol at doses of 20-25 µg every 2 hours or 50 µg every 4 hours. In addition, adverse events reported in a compassionate use program, where approximately 29,000 women have been exposed to Angusta for induction of labour are also listed.
System Organ Class
Very common (≥ 1/10)
Common (≥ 1/100 to < 1/10)
Uncommon (≥ 1/1,000 to < 1/100)
Not known (cannot be estimated from the available data) 1)
Nervous system disorders
Dizziness Convulsion neonatal*
Respiratory, thoracic and mediastinal disorders
Neonatal asphyxia*Cyanosis neonatal*
Gastrointestinal disorders
With 50 µg, 4-hourly: Nausea2)Vomiting3)
DiarrhoeaWith 25 µg, 2-hourly:Nausea2)Vomiting3)
Skin and subcutaneous tissue disorders
Rash pruritic
Pregnancy, puerperium and perinatal conditions
Meconium stainWith 25 µg, 2-hourly:Postpartum haemorrhage5)
Uterine hyperstimulation4)With 50 µg, 4-hourly:Postpartum haemorrhage5)
Foetal acidosis*Premature separation of placentaUterine rupture
General disorders and administration site conditions
Chills
Pyrexia
Investigations
With 50 µg, 4-hourly: Apgar score low*6)Foetal heart rate abnormal*7)
With 25 µg, 2-hourly: Apgar score low*6)Foetal heart rate abnormal*7)
* Neonatal adverse reaction
1) ADRs which were reported from the compassionate use programme including birth hospitals in Denmark, Norway and Finland, where approximately 29,000 women have been exposed to Angusta for induction of labour.2) Nausea was common with 25 µg every 2 hours and very common with 50 µg every 4 hours.3) Vomiting was common with 25 µg every 2 hours and very common with 50 µg every 4 hours.4) Uterine hyperstimulation was reported both with and without foetal heart rate changes.
5) Postpartum haemorrhage was very common with 25 µg every 2 hours and common with 50 µg every 4 hours.6) Apgar score low was uncommon with 25 µg every 2 hours and common with 50 µg every 4 hours.
7) Foetal heart rate abnormal was reported in connection with uterine hyperstimulation.Uterine hyperstimulation with foetal heart rate changes was uncommon with 25 µg every 2 hours and common with 50 µg every 4 hours.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple Store.
4.9. Overdose
There is no information on overdose with Angusta.In case of overdose symptoms (e.g. excessive uterine stimulation causing prolonged or excessive contractions), dosing with Angusta should be arrested and treatment according to local guidelines should be started. The potential consequences of uterine hyperstimulation include foetal heart rate disorders and asphyxia in which case caesarean section should be considered.
🇷🇴 Known in Romania as
Medicines sold in Romania with the same active substance: Cunoscut în România ca
- TOPOGYNE 400 micrograme prescriptionMISOPROSTOLUM · taken by mouth
- ANGUSTA 25 micrograme prescriptionMISOPROSTOLUM · taken by mouth
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
- CytotecMisoprostolum · taken by mouth
- AngustaMisoprostolum · taken by mouth
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
💬 Ask about this leaflet
Ask anything about Angusta 25 microgram tablets. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.