MISOONE
As listed in the register: MISOONE 400 microgrammes, comprimé sécable
400 microgrammes · comprimé sécable
- Prescription only
- Active substance
- Misoprostol
- Made by
- EXELGYN
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
What it is for
Mediclarum has not yet retrieved and stored the official label for this product, so none of its text is shown here. Open the official leaflet
How it works
From the US prescribing label for the same active substance (misoprostol). It describes the substance, not this exact product.
Misoprostol is extensively absorbed, and undergoes rapid de-esterification to its free acid, which is responsible for its clinical activity and, unlike the parent compound, is detectable in plasma.
The alpha side chain undergoes beta oxidation and the beta side chain undergoes omega oxidation followed by reduction of the ketone to give prostaglandin F analogs.
Maximum plasma concentrations of misoprostol acid are diminished when the dose is taken with food and total availability of misoprostol acid is reduced by use of concomitant antacid.
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2026-08-25
Safety of the active substance
From the US prescribing label for the same active substance (misoprostol). It describes the substance, not this exact product.
WARNINGS MISOPROSTOL ADMINISTRATION TO WOMEN WHO ARE PREGNANT CAN CAUSE BIRTH DEFECTS, ABORTION, PREMATURE BIRTH OR UTERINE RUPTURE.
- Misoprostol should not be taken by pregnant women to reduce the risk of ulcers induced by nonsteroidal anti-inflammatory drugs (NSAIDs).
- Misoprostol should not be taken by anyone with a history of allergy to prostaglandins.
The most frequent gastrointestinal adverse events were diarrhea and abdominal pain.
Quoted from the US prescribing label for the same active substance. Your own pack’s leaflet is the authority for your product. DailyMed
Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
Medicine passport: one printable page to show a pharmacist abroad
United StatesNo exact match for this strength and form
CanadaNo exact match for this strength and form
Netherlands1 matching products
Details
| Made by | EXELGYN |
|---|---|
| Active substance | Misoprostol |
| Strength | 400 microgrammes |
| Form | comprimé sécable |
| Route | orale |
| Dispensing (as stated by the register) | liste I · hors établissement de santé : prescription réservée aux médecins, sages-femmes et centres habilités conformément à l'article L.2212-2 du code de la santé publique |
| Marketed | Yes, according to the register |
| Authorisation procedure | Procédure décentralisée |
| Name in the register | MISOONE 400 microgrammes, comprimé sécable |
| Packs | plaquette(s) thermoformée(s) polyamide aluminium PVC-Aluminium de 1 comprimé(s) · plaquette(s) thermoformée(s) polyamide aluminium PVC-Aluminium de 16 comprimé(s) |
| CIS | 61240145 |
| CIP13 | 3400927426681 |
| CIP13 | 3400958496684 |
Source: Base de données publique des médicaments · 2026-09-30 · not reviewed by a clinician
Source : Base de données publique des médicaments (ANSM / Ministère de la Santé), sous Licence Ouverte. Reuse terms: Licence Ouverte / Open Licence (Etalab).
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.