ALGIDRIN PEDIATRIC Oral suspension Ref.[51137] Active ingredients: Ibuprofen

Source: Medicines Authority (MT)  Revision Year: 2022  Publisher: LABORATORIO DE APLICACIONES FARMACODINÁMICAS, S.A. – FARDI, Grassot, 16 – 08025-Barcelona (Spain) <u>Local representative:</u> Europharma Ltd, Catalunya Buildings, Psaila Street, Birkirkara. BKR 9076. ...

Product name and form

Algidrin pediatric 20 mg/ml oral suspension.

Pharmaceutical Form

Oral suspension.

Red coloured oral suspension with wild berry aroma and flavour.

Qualitative and quantitative composition

Each ml of oral suspension contains: 20 mg of ibuprofen (provided by 34.17 mg of ibuprofen lysine).

Excipients with known effect: Sorbitol (E-420) 25 mg, maltitol (E-965)100 mg, Allura Red AC dye (E-129) 0.0786 mg, methyl para-hydroxybenzoate (E-218) 1.45 mg, ethyl parahydroxybenzoate (E-214) 0.32 mg propyl para-hydroxybenzoate (E-216) 0.22 mg.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Ibuprofen

Ibuprofen is a propionic acid derivative NSAID that has demonstrated its efficacy by inhibition of prostaglandin synthesis. In humans ibuprofen reduces inflammatory pain, swellings and fever. Furthermore, ibuprofen reversibly inhibits platelet aggregation.

List of Excipients

Purified water
Microcrystalline cellulose
Sodium carboxymethylcellulose
Sorbitol (E-420)
Maltitol (E-965)
Beta-cyclodextrin
Sodium saccharin
Sucralose (E-955)
Aroma of wild berries
Allura Red AC dye (E-129)
Methyl para-hydroxybenzoate (E-218)
Ethyl para-hydroxybenzoate (E-214)
Propyl para-hydroxybenzoate (E-216)

Pack sizes and marketing

Topaz-coloured 100 ml, 120 ml or 200 ml PET bottle, with white polyethylene cap, fitted with a safety mechanism for children and a translucent polyethylene stopper. It contains a 5 ml graduated syringe for oral dosage.

Not all pack sizes may be marketed.

Marketing authorization holder

LABORATORIO DE APLICACIONES FARMACODINÁMICAS, S.A. – FARDI, Grassot, 16 – 08025-Barcelona (Spain)

Local representative: Europharma Ltd, Catalunya Buildings, Psaila Street, Birkirkara. BKR 9076.

Marketing authorization dates and numbers

MA774/00302

Date of First Authorisation: 11th November 2020

Drugs

Drug Countries
ALGIDRIN Spain, Malta

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