DIPYRIDAMOLE Oral Suspension Ref.[7997] Active ingredients: Dipyridamole

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Syri Limited t/a Thame Laboratories, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK

Product name and form

Dipyridamole 200mg/5ml Oral Suspension.

Pharmaceutical Form

Oral Suspension.

Yellow coloured suspension with orange flavor.

Qualitative and quantitative composition

Each 5ml of oral suspension contains 200mg dipyridamole.

Excipients with known effect: Each 5ml of oral suspension contains 9mg of methyl parahydroxybenzoate (E218), 0.9mg of propyl parahydroxybenzoate (E216), 2040mg of liquid maltitol (E965) and 545.20mg of propylene glycol (E1520).

For the full list of excipients, see section 6.1.

Active Ingredient Description
Dipyridamole

Dipyridamole is an antithrombotic agent with antiplatelet activity. Dipyridamole has an antithrombotic action based on its ability to modify various aspects of platelet function, such as platelet aggregation, adhesion and survival, which are factors associated with the initiation of thrombus formation.

List of Excipients

Methyl parahydroxybenzoate (E218)
Propyl parahydroxybenzoate (E216)
Polysorbate 80 (E433)
Simeticone emulsion 30% (containing polydimethylsiloxane, sorbitan monostearate, polyoxyethylene 20 sorbitan, silicon dioxide, xanthan gum, benzoic acid, sorbic acid, potassium hydroxide, hydrogen chloride and deionised water)
Liquid maltitol (E965)
Xanthan gum (E415)
Aluminium magnesium silicate (E553a)
Citric acid monohydrate (E330)
Disodium phosphate anhydrous (E339)
Ammonium glycyrrhizinate
Propylene glycol (E1520)
Orange flavour (containing propylene glycol (E1520))
Purified water

Pack sizes and marketing

*ottle: Ph.Eur Type III Amber glass

Closure: Tamper evident, child resistant, plastic (Polypropylene/Polyethylene) cap with an EPE liner.

Dosing Device: Double ended white polypropylene plastic spoon with 2.5ml and 5ml measuring ends.

Pack size: 150ml and 300ml.

Not all pack sizes may be marketed.

Marketing authorization holder

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

Marketing authorization dates and numbers

PL 39307/0041

06/01/2016

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