SPC, UK: ISTIN Tablets (2018)

Product Name and Form

ISTIN 5 mg tablets.

Pharmaceutical form

Tablet.

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 the full list of excipients, see section 6.1.

List of excipients

Microcrystalline cellulose
Calcium hydrogen phosphate anhydrous
Sodium starch glycolate Type A
Magnesium stearate

Pack sizes and Marketing

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

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

PVC-PVDC/Aluminium foil blister strips containing 50x1 and 500x1 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder
Authorization dates

Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom

18th September 1989 / 8th February 2013

Marketing authorization number:

PL 00057/0297