ZURAMPIC Film-coated tablet Ref.[7621] Active ingredients: Lesinurad

Source: European Medicines Agency (EU)  Revision Year: 2017  Publisher: Grünenthal GmbH, Zieglerstr. 6, 52078, Aachen, Germany, Tel.: +49-241-569-0

Product name and form

Zurampic 200 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet (tablet).

Oval, 5.7 × 12.9 mm, blue tablets.

Tablets are engraved with “LES200” on one side.

Qualitative and quantitative composition

Each film-coated tablet contains 200 mg of lesinurad.

Excipient with known effect: Each tablet contains 52.92 mg of lactose (as monohydrate).

For the full list of excipients, see section 6.1.

Active Ingredient Description
Lesinurad

Lesinurad is a selective uric acid reabsorption inhibitor that inhibits uric acid transporter URAT1. URAT1 is responsible for the majority of the reabsorption of filtered uric acid from the renal tubular lumen. By inhibiting URAT1, lesinurad increases uric acid excretion and thereby lowers serum uric acid (sUA). Lesinurad also inhibits OAT4, a uric acid transporter involved in diuretic-induced hyperuricaemia.
List of Excipients

Tablet core:

Hypromellose
Microcrystalline cellulose
Lactose monohydrate
Crospovidone type A
Magnesium stearate

Tablet coat:

Hypromellose
Titanium dioxide
Triacetin
Indigo Carmine
Brilliant Blue FCF

Pack sizes and marketing

Clear (PVC/PVDC/Aluminium) blister of 10 or 14 (calendar blister) tablets.

Pack sizes of 10, 28, 30, 98 in non-perforated blisters.

Pack size of 100 × 1 film-coated tablet in perforated unit dose blisters.

Not all pack sizes may be marketed.

Marketing authorization holder

Grünenthal GmbH, Zieglerstr. 6, 52078, Aachen, Germany, Tel.: +49-241-569-0

Marketing authorization dates and numbers

EU/1/15/1080/001 10 film-coated tablets
EU/1/15/1080/002 28 film-coated tablets
EU/1/15/1080/003 30 film-coated tablets
EU/1/15/1080/004 98 film-coated tablets
EU/1/15/1080/005 100x1 film-coated tablets (unit dose)

Date of first authorisation: 18 February 2016

 
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