DIACOMIT Hard capsule Ref.[7680] Active ingredients: Stiripentol

Source: European Medicines Agency (EU)  Revision Year: 2021  Publisher: Biocodex, 7 Avenue Gallieni, 94250, Gentilly, France

Product name and form

Diacomit 250 mg hard capsules.

Pharmaceutical Form

Hard capsule.

Size 2, pink capsule, imprinted with “Diacomit 250 mg”.

Qualitative and quantitative composition

Each capsule contains 250 mg of stiripentol.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Stiripentol

Stiripentol potentiates the efficacy of other anticonvulsants, such as carbamazepine, sodium valproate, phenytoin, phenobarbital and many benzodiazepines, as the result of pharmacokinetic interactions. The second effect of stiripentol is mainly based on metabolic inhibition of several isoenzymes, in particular CYP450 3A4 and 2C19, involved in the hepatic metabolism of other anti-epileptic medicines.
List of Excipients

Capsule core:

Povidone
Sodium starch glycolate
Magnesium stearate (E470b)

Capsule shell:

Gelatine
Titanium dioxide (E171)
Erythrosine (E127)
Indigotine (E132)

Printing ink:

Shellac (E904)
Black iron oxide (E172)

Pack sizes and marketing

Polypropylene bottle with tamper-evident seal and polyethylene screw cap containing 30 and 90 capsules.

An opaque polyethylene bottle closed with a child-resistant tamper-evident polypropylene screw cap containing 60 capsules.

Bottles are packed in cardboard cartons.

Not all pack sizes may be marketed.

Marketing authorization holder

Biocodex, 7 Avenue Gallieni, 94250, Gentilly, France

Marketing authorization dates and numbers

EU/1/06/367/001-3

Date of first authorization: 04 January 2007
Date of latest renewal: 20 September 2018

Drugs

Drug Countries
DIACOMIT Austria, Australia, Canada, Estonia, Spain, Finland, France, Croatia, Ireland, Japan, Lithuania, Netherlands, Poland, Romania, United Kingdom, United States, South Africa
 
Next: Usage >

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.

⇈