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Rivotril 0.5 mg and 2 mg Tablets (2011)

Active ingredients: Clonazepam

Product Name and Form

Rivotril 0.5mg Tablets.

Rivotril 2mg Tablets.

Pharmaceutical form

Tablets.

Rivotril 0.5mg Tablets: Round, dull pinkish-buff tablets with ‘ROCHE 0,5’ imprinted on one face and a single break mark on the other.

The Tablets can be broken into equal halves to facilitate dosing.

Rivotril 2mg Tablets: Round, white tablets with ‘ROCHE ·2·’ imprinted on one face and cross break marks on the other.

The tablets can be broken into equal halves or quarters to facilitate dosing.

Qualitative and Quantitative Composition

Rivotril 0.5mg Tablets: Each tablet contains 0.5mg clonazepam.

Excipients: Also contains 40mg lactose monohydrate.

Rivotril 2mg Tablets: Each tablet contains 2mg clonazepam.

Excipients: Also contains 121.5mg lactose anhydrous.

For a full list of excipients, see section 6.1.

Chemical substance
Description
Clonazepam

Clonazepam exhibits pharmacological properties which are common to benzodiazepines and include anticonvulsive, sedative, muscle relaxing and anxiolytic effects. Animal data and electroencephalographic investigations in man have shown that clonazepam rapidly suppresses many types of paroxysmal activity including the spike and wave discharge in absence seizures (petit mal), slow spike wave, generalised spike wave, spikes with temporal or other locations as well as irregular spikes and waves.

List of excipients

Rivotril 0.5mg tablets:

Lactose (monohydrate)
Maize starch
Pregelatinised potato starch
Talc
Magnesium stearate
Deionised water
Dye iron oxide red E172
Dye iron oxide yellow E172

Rivotril 2mg tablets:

Lactose (anhydrous)
Pregelatinised maize starch
Magnesium stearate
Microcrystalline cellulose.

Pack sizes and Marketing

Rivotril 0.5mg Tablets: Amber glass bottles with polyethylene screw closures, containing 50, 100 or 150 tablets.

Rivotril 2mg Tablets: Amber glass bottles with polyethylene screw closures, containing 30 or 100 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder
Authorization dates

Roche Products Limited
6 Falcon Way
Shire Park
Welwyn Garden City
AL7 1TW
United Kingdom

26 July 1983 / 27 May 2005

Marketing authorization number:

Rivotril 0.5mg Tablets: PL 00031/0076R

Rivotril 2mg Tablets: PL 00031/0077R