ANGUSTA Tablet Ref.[27660] Active ingredients: Misoprostol

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).

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 and the cervix should be assessed carefully before product use.

Angusta should be taken orally with a glass of water.

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.

30 months.

Store in the original package in order to protect from moisture.

Angusta is available in a pack of double layer aluminium foil blister containing 8 tablets.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.