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Losarb plus (2010)

Active ingredients: Losartan Hydrochlorothiazide

Product Name and Form

Pharmaceutical form

Qualitative and Quantitative Composition

The active substances are losartan potassium and hydrochlorothiazide.

Losarb Plus 50 mg/12.5 mg: Each Tablet contains 50 mg of losartan potassium equivalent to 45.8 mg of losartan and 12.5 mg of hydrochlorothiazide.

Losarb Plus 100 mg/25 mg: Each Tablet contains 100 mg of losartan potassium equivalent to 91.6 mg of losartan and 25 mg of hydrochlorothiazide.

The other ingredients are: microcrystalline cellulose, lactose monohydrate, pregelatinised maize starch, sodium starch glycolate type A, magnesium stearate, hydroxypropyl cellulose (E463), hypromellose 6cp (E464), titanium dioxide (E171).

Chemical substance
Description
Losartan

Losartan is a synthetic oral angiotensin-II receptor (type AT1) antagonist. Antihypertensive activity and suppression of plasma aldosterone concentration are maintained, indicating effective angiotensin II receptor blockade.

Hydrochlorothiazide

Hydrochlorothiazide is a diuretic and an antihypertensive agent. It affects the distal renal tubular mechanism of electrolyte reabsorption and increases excretion of sodium and chloride in approximately equivalent amounts.

List of excipients

Microcrystalline cellulose
Lactose monohydrate
Pregelatinised maize starch
Sodium starch glycolate type A
Magnesium stearate
Hydroxypropyl cellulose (E463)
Hypromellose 6cp (E464)
Titanium dioxide (E171)

Pack sizes and Marketing

50 mg/12.5 mg: White, oblong, biconvex film-coated tablets measuring approximately 13.7 × 6.7 mm with a scoreline on both sides.

The scoreline is to facilitate breaking for ease of shallowing and not to divide into equal doses.

100 mg/25 mg: White, oblong, biconvex film-coated tablets measuring approximately 15.3 × 6.7 mm with a scoreline on both sides.

The tablet can be divided into equal halves.

Tablets are provided in PVC/PE/PVDC/Aluminium blisters.

Pack sizes: 30 film-coated tablets.

Marketing authorization holder
Authorization dates

Specifar S.A.
1, 28 Octovriou str.
Ag Varvara 123 51
Athens
Greece

Marketing authorization number: