TRIFLUOPERAZINE Oral solution Ref.[8847] Active ingredients: Trifluoperazine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Focus Pharmaceuticals Limited, Capital House, 85 King William Street, London, EC4N 7BL, United Kingdom

Product name and form

Trifluoperazine 5 mg/5 ml Oral Solution.

Pharmaceutical Form

Oral Solution.

A clear, yellow coloured solution with characteristic orange odour.

Qualitative and quantitative composition

Each 5 ml of oral solution contains 5 mg trifluoperazine present as the hydrochloride.

Excipients with known effect: Each 1 ml of Trifluoperazine 5 mg/5 ml Oral Solution contains 0.86 mg sodium, 0.005 mg ethanol, 1 mg sodium benzoate, 100.95 mg propylene glycol and 0.0257 mg benzyl alcohol.

For a full list of excipients see section 6.1.

Active Ingredient Description
Trifluoperazine

Trifluoperazine is one of the phenothiazine class of compounds and as such has many pharmacodynamic effects which relate to its therapeutic actions and side effects. The most notable action of phenothiazines is antagonism at dopamine receptors in the CNS.

List of Excipients

Sodium benzoate
Propylene glycol
Citric acid, anhydrous
Sodium citrate
Sucralose
Orange flavour (SP 14104/04) (including propylene glycol, ethanol, benzyl alcohol)
Natracol curcumin (E100) (including propylene glycol)
Citric acid
Purified water

Pack sizes and marketing

Amber (Type III) glass bottle of 150 ml fill volume, with child-resistant, tamper-evident screw cap with an LDPE liner.

A 5 ml dosing syringe with intermediate graduations of 0.1 ml and a “press-in” syringe/bottle adaptor are provided. A 20 ml dosing cup with intermediate graduations is also provided with the product.

Marketing authorization holder

Focus Pharmaceuticals Limited, Capital House, 85 King William Street, London, EC4N 7BL, United Kingdom

Marketing authorization dates and numbers

PL 20046/0300

17/07/2018

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