TAPCLOB Oral suspension Ref.[50136] Active ingredients: Clobazam

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: Martindale Pharmaceuticals Ltd, Bampton Road, Harold Hill, Essex, RM3 8UG

Product name and form

Tapclob 5mg/5ml Oral Suspension.

Clobazam Martindale Pharma 5mg/5ml Oral Suspension.

Pharmaceutical Form

Oral Suspension.

An off white viscous suspension with an odour of raspberry.

Qualitative and quantitative composition

Each 5ml of suspension contains 5mg of Clobazam.

Excipients with known effect: Each 5ml of suspension contains 1250mg of Sorbitol, 10.3mg of Sodium Methyl Hydroxybenzoate and 1.12mg of Sodium Propyl Hydroxybenzoate.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Clobazam

Clobazam is a 1,5-benzodiazepine and the pharmacodynamic activity is qualitatively similar to that of other compounds of the class of Muscle relaxant, Anxiolytic, Sedative, Hypnotic, Anticonvulsant, Amnesic.

List of Excipients

Sorbitol (E420)
Xanthan gum (E415)
Acesulfame potassium (E950)
Raspberry flavour
Sodium propyl hydroxybenzoate (E217)
Sodium methyl hydroxybenzoate (E219)
Disodium hydrogen phosphate dihydrate (for pH-adjustment)
Sodium dihydrogen phosphate dihydrate (for pH-adjustment)
Purified water

Pack sizes and marketing

Amber glass bottles sealed with tamper evident, child-proof plastic screw caps. The bottle is packed in a cardboard carton containing a 1 ml and a 5ml syringe with an adaptor and a 30ml measuring cup along with the patient information leaflet.

Pack sizes: 100 ml, 150 ml and 250 ml.

Not all pack sizes may be marketed.

Marketing authorization holder

Martindale Pharmaceuticals Ltd, Bampton Road, Harold Hill, Essex, RM3 8UG

Marketing authorization dates and numbers

PL 00156/0322

11/02/2013

Drugs

Drug Countries
TAPCLOB New Zealand, United Kingdom

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