CLONAZEPAM THAME Oral solution Ref.[7175] Active ingredients: Clonazepam

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Syri Limited t/a Thame Laboratories, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK

Product name and form

Clonazepam Thame 0.5mg/5ml Oral Solution.

Pharmaceutical Form

Oral Solution.

Clear, colourless to pale yellow colour solution.

Qualitative and quantitative composition

Each 5ml solution contains 0.5mg Clonazepam.

Excipients with known effect: Each 5ml solution contains 64.68mg of ethanol (96%).

For the full list of excipients, see section 6.1.

Active Ingredient 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

Ethanol (96%)
Medium chain triglycerides

Pack sizes and marketing

Bottle: Ph. Eur. Type III Amber glass bottle.

Closure: a tamper-evident, child-resistant plastic cap with polypropylene inner, polyethylene outer and expanded polyethylene (EPE) liner.

Dosing Device: a 10ml oral syringe with 0.25ml graduation mark and a syringe adaptor.

Pack size: 150ml.

Marketing authorization holder

Syri Limited t/a Thame Laboratories, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK

Marketing authorization dates and numbers

PL 39307/0052

03/08/2017

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