FRUMERON Coated tablet Ref.[28207] Active ingredients: Indapamide

Source: Υπουργείο Υγείας (CY)  Revision Year: 2021  Publisher: Remedica Ltd, Acharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus

Product name and form

Frumeron 2.5 mg coated tablets.

Pharmaceutical Form

Coated tablets.

Light pink, round, coated tablets.

Qualitative and quantitative composition

Each coated tablet contains indapamide 2.5 mg.

Excipients with known effect:

This product contains 38.961 mg lactose, 47.246 mg sucrose and 0.001 mg ponceau 4R E124.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Indapamide

Indapamide is a sulfonamide derivative with an indole ring, pharmacologically related to thiazide diuretics, which acts by inhibiting the reabsorption of sodium in the cortical dilution segment. It increases the urinary excretion of sodium and chlorides and, to a lesser extent, the excretion of potassium and magnesium, thereby increasing urine output and having an antihypertensive action.

List of Excipients

Core:

Lactose monohydrate
Maize starch
Povidone
Microcrystalline cellulose
Pregelatinized starch
Magnesium stearate
Talc

Coating:

Hypromellose
Polyethylene glycol 400
Titanium dioxide E171
Gelatin
Talc
Povidone
Polyethylene glycol 6000
Sucrose
Calcium carbonate
Erythrosine 4R E127
Ponceau 4R E124

Pack sizes and marketing

PVC/Aluminium blisters. Pack sizes of 30 and 1000 coated tablets.

PP containers with PE closure. Pack size of 1000 coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Remedica Ltd, Acharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus

Marketing authorization dates and numbers

10375

Date of first authorisation: 03 February 1986
Date of latest renewal: 19 April 2013

Drugs

Drug Countries
FRUMERON Cyprus, Singapore

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