CARBAMAZEPINE Oral suspension

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.

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
Authorization Dates

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

25.03.2008

Marketing authorization number:

PL 31750/0096