MisoOne 400 microgram tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Misoprostol

Available from:

EXELGYN

ATC code:

G02AD06

INN (International Name):

Misoprostol

Dosage:

400 microgram(s)

Pharmaceutical form:

Tablet

Therapeutic area:

misoprostol

Authorization date:

2019-11-08

Patient Information leaflet

Module
1.3.1.1
Package Leaflet
IE – version 2021/12
Page 1 of 7
PACKAGE LEAFLET: INFORMATION FOR THE USER
MISOONE 400 MICROGRAM TABLETS
Misoprostol
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if
their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor. This includes any
possible side effects not listed in this
leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What MisoOne is and what it is used for
2.
What you need to know before you take MisoOne
3.
How to take MisoOne
4.
Possible side effects
5.
How to store MisoOne
6.
Contents of the pack and other information
1.
WHAT MISOONE IS AND WHAT IT IS USED FOR
MisoOne tablets contain misoprostol, which is similar to a chemical
substance called ‘prostaglandin’ that
your body produces naturally. Misoprostol triggers contractions of the
womb and softens the cervix.
For medical termination of pregnancy: MisoOne is used after taking
another medicine called mifepristone. It
should be taken no later than 49 days after the first day of your last
menstrual period.
For surgical termination of pregnancy: MisoOne is taken on its own
prior to surgical termination of
pregnancy during the first trimester of pregnancy (within 12 weeks
after the first day of your menstruation).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE MISOONE
DO NOT TAKE MISOONE
-
if you are allergic to misoprostol, any other prostaglandin or any of
the other ingredients of this
medicine (listed in section 6).
-
if the pregnancy has not been confirmed by ultrasound scan or
biological tests.
-
if your doctor suspects an ectopic pregnancy (the egg is implanted
outside the womb).
-
if you cannot take mifepristone (when mifepristone is used in
combination with MisoOne).
-
for medical terminatio

Summary of Product characteristics

Health Products Regulatory Authority
30 October 2020
CRN009K05
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
MisoOne 400 microgram tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains 400 microgram misoprostol.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
White, round, flat tablets, with a diameter of 11 mm and thickness of
4.5 mm, with a break line on each side and double "M"
engraved on one side.
The tablet can be divided into equal doses.
4 CLINICAL PARTICULARS
​
For termination of pregnancy, the anti-progesteronemifepristone and
the prostaglandin analogue misoprostol can only be
prescribedand administered in accordance with the countries national
laws and regulations.
4.1 THERAPEUTIC INDICATIONS
Medical termination of developing intra-uterine pregnancy, in
sequential use with mifepristone, up to 49 days of amenorrhea
(see section 4.2).
Cervix uteri preparation prior to surgical termination of pregnancy
during the first trimester.
Misoprostol is indicated in adults.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
- Medical termination of developing intra-uterine pregnancy, in
sequential use with mifepristone, up to 49 days of amenorrhea:
Misoprostol is taken as a single 400 microgram oral dose 36 to 48
hours after taking a single 600 mg oral dose of mifepristone.
Information on the posology of mifepristone can be found in the
product information of mifepristone.
Vomiting within 30 minutes after the intake could lead to a decrease
in misoprostol efficacy: oral intake of a new misoprostol
400 microgram tablet is recommended in this case.
- Cervix uteri preparation prior to surgical termination of pregnancy
during the first trimester:
Misoprostol is taken as a single 400 microgram oral dose 3 to 4 hours
before surgical operation. Vomiting within 30 minutes
after the intake could lead to a decrease in misoprostol efficacy:
oral intake of a new misoprostol 400 microgram tablet is
recommended in this case.
Paediatric population