ZANIDIP Film-coated tablet Ref.[50868] Active ingredients: Lercanidipine

Source: Health Products Regulatory Authority (IE) Revision Year: 2021 Publisher: Recordati Industria Chimica e Farmaceutica s.p.A., Via Matteo Civitali, 1 20148, Milan, Italy

Product name and form

ZANIDIP 10mg Film-coated Tablets.

Pharmaceutical Form
Film-coated tablet. Yellow, circular, biconvex tablet of 6.5 mm, scored on one side. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

Qualitative and quantitative composition

Each tablet contains 10 mg lercanidipine hydrochloride equivalent to 9.4 mg lercanidipine.

Excipient(s) with known effect: One film-coated tablet contains 30 mg of lactose monohydrate.

For the full list of excipients, see section 6.1.

Active Ingredient	Description
Lercanidipine	Lercanidipine is a calcium antagonist of the dihydropyridine group and inhibits the transmembrane influx of calcium into cardiac and smooth muscle. The mechanism of its antihypertensive action is due to a direct relaxant effect on vascular smooth muscle thus lowering total peripheral resistance.

List of Excipients
Tablet core: Lactose monohydrate Microcrystalline cellulose Sodium starch glycolate (Type A) Povidone K30 Magnesium stearate Film coating mixture: Hypromellose Talc Titanium dioxide (E171) Macrogol 6000 Ferric oxide (E172)

Pack sizes and marketing

Aluminium/opaque PVC blister.

Packs of 14, 28, 35, 50 and 100 tablets.*

^* Not all pack sizes may be marketed

Marketing authorization holder

Recordati Industria Chimica e Farmaceutica s.p.A., Via Matteo Civitali, 1 – 20148, Milan, Italy

Marketing authorization dates and numbers

PA0812/001/001

Date of first authorisation: 17^th May 2001
Date of last renewal: 17^th May 2006

Drugs

Drug	Countries
ZANIDIP	Austria, Australia, Brazil, Spain, Finland, France, Hong Kong, Ireland, Mexico, Tunisia, United Kingdom, South Africa

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