PLENDIL Prolonged-release tablet Ref.[6817] Active ingredients: Felodipine

Source: Health Products Regulatory Authority (IE)  Revision Year: 2023  Publisher: Glenwood GmbH, Pharmazeutische Erzeugnisse, Arabellastrasse 17, 81925 Munich, Germany

Product name and form

Plendil 2.5 mg prolonged-release tablets.

Pharmaceutical Form

Prolonged-release tablet.

Plendil 2.5 mg: The tablet is yellow, circular, biconvex, engraved A/FL on one side and 2.5 on the other side, with a diameter of 8.5 mm.

Qualitative and quantitative composition

Each tablet contains 2.5 mg felodipine.

Excipients with known effect: Each tablet contains 28 mg lactose and 2.5 mg macrogolglycerol hydroxystearate.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Felodipine

Felodipine is a vascular selective calcium antagonist, which lowers arterial blood pressure by decreasing systemic vascular resistance. Felodipine is effective in all grades of hypertension.

List of Excipients

Tablet core:

Hydroxypropylcellulose
Hypromellose 50 mPaยทs
Hypromellose 10000 mPaยทs
Lactose anhydrous
Macrogolglycerol hydroxystearate
Microcrystalline cellulose
Propyl gallate
Sodium aluminium silicate
Sodium stearyl fumarate

Coating:

Carnauba wax
Iron oxide yellow (E172)
Hypromellose 6 mPaยทs
Macrogol 6000
Titanium dioxide (E171)

Pack sizes and marketing

High-density polyethylene bottle with a standard cap of polypropylene.

PVC/PVDC/Aluminium blister.

Blister pack:

20 tablets (blister pack)
28 tablets (calendar blister pack)
30 tablets (blister pack)
50 tablets (unit-dose pack)
98 tablets (calendar blister pack)
100 tablets (blister pack)

Plastic bottle:

30 tablets (bottle)
100 tablets (bottle)
500 tablets (bottle for dose dispensing)

Not all pack sizes may be marketed.

Marketing authorization holder

Glenwood GmbH, Pharmazeutische Erzeugnisse, Arabellastrasse 17, 81925 Munich, Germany

Marketing authorization dates and numbers

PA2256/005/001

Date of first authorisation: 19 May 1997
Date of last renewal: 18 May 2007

Drugs

Drug Countries
PLENDIL Austria, Australia, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, Hong Kong, Ireland, Italy, Lithuania, Malta, Mexico, Nigeria, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, South Africa

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