CARBAMAZEPINE Oral suspension Ref.[6520] Active ingredients: Carbamazepine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Sun Pharmaceutical Industries Europe B.V., Polarisavenue 87, 2132 JH Hoofddorp, The Netherlands

Product name and form

Carbamazepine SUN 100 mg/5 ml Oral Suspension.

Pharmaceutical Form

Oral suspension.

An orange to pale orange suspension.

Qualitative and quantitative composition

Each 5 ml of the oral suspension contains 100 mg carbamazepine.

Excipients with known effect: Sorbitol (E420) and orange yellow S

For the full list of excipients, see section 6.1.

Active Ingredient

Carbamazepine is a derivative of dibenzazepine. It belongs to the pharmaceutical class of antiepileptic, neurotropic and psychotropic drugs. Carbamazepine helps control the transmission of messages from the brain to the muscles.
List of Excipients

Sucralose
Poloxamer 188
Xanthan gum
Potassium sorbate
Propylene glycol
Citric acid monohydrate
Orange yellow S
Sorbitol (E420)
Natural and artificial flavour orange
Water, purified

Pack sizes and marketing

PET/Glass bottles using a polypropylene child resistant plastic cap.

Pack sizes: 300 ml & 500 ml.

Not all pack sizes may be marketed.

Marketing authorization holder

Sun Pharmaceutical Industries Europe B.V., Polarisavenue 87, 2132 JH Hoofddorp, The Netherlands

Marketing authorization dates and numbers

PL 31750/0096

25.03.2008

 
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