Product name and form

ISTIN 5 mg tablets.

Pharmaceutical Form

White to off-white, emerald shaped tablets engraved AML 5 and breaker score on one side and Pfizer logo on the other side.

The 5 mg tablet can be divided into equal halves.

Qualitative and quantitative composition

Each tablet contains amlodipine besilate equivalent to 5 mg amlodipine.

Excipients: For a full list of excipients, see section 6.1.

List of Excipients

Microcrystalline cellulose
Dibasic calcium phosphate anhydrous
Sodium starch glycolate
Magnesium stearate

Pack sizes and marketing

PVC-PVDC/Al blisters containing 4, 10, 14, 20, 28, 30, 50, 60, 98, 100, 300, 500 tablets.

PVC-PVDC/Al blisters in calendar packs containing 28 and 98 tablets.

PVC-PVDC/Al unit dose blisters containing 50x1 and 500x1 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder
Authorization Dates

Pfizer Limited
Ramsgate Road
CT13 9NJ
United Kingdom

30 January 1995 / 25 April 2001

Marketing authorization number:

PL 00057/0297