TRIPLIXAM Film-coated tablet Ref.[107764] Active ingredients: Amlodipine Indapamide Perindopril Perindopril, Amlodipine and Indapamide

Source: Health Sciences Authority (SG)  Revision Year: 2023  Publisher: Les Laboratoires Servier – France <u>Manufacturer:</u> Servier (Ireland) Industries Ltd., Moneylands, Gorey Road, Arklow, Co. Wicklow – Ireland

Product name and form

Triplixam 5mg/1.25mg/5mg film-coated tablets.

Triplixam 5mg/1.25mg/10mg film-coated tablets.

Triplixam 10mg/2.5mg/5mg film-coated tablets.

Triplixam 10mg/2.5mg/10mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

Triplixam 5/1.25/5 mg: white, oblong, film-coated tablet, 9.75 mm long and 5.16 mm wide, engraved with on one face and on the other face.

Triplixam 5/1.25/10 mg: white, oblong, film-coated tablet, 10.7 mm long and 5.66 mm wide, engraved with on one face and on the other face.

Triplixam 10/2.5/5 mg: white, oblong, film-coated tablet, 11.5 mm long and 6.09 mm wide, engraved with on one face and on the other face.

Triplixam 10/2.5/10 mg: white, oblong, film-coated tablet, 12.2 mm long and 6.46 mm wide, engraved with on one face and on the other face.

Qualitative and quantitative composition

One film-coated tablet contains 3.395 mg perindopril equivalent to 5 mg perindopril arginine, 1.25 mg indapamide and 6.935 mg amlodipine besilate equivalent to 5 mg of amlodipine.

One film-coated tablet contains 3.395 mg perindopril equivalent to 5 mg perindopril arginine, 1.25 mg indapamide and 13.870 mg amlodipine besilate equivalent to 10mg of amlodipine.

One film-coated tablet contains 6.790 mg perindopril equivalent to 10 mg perindopril arginine, 2.5 mg indapamide and 6.935 mg amlodipine besilate equivalent to 5 mg of amlodipine.

One film-coated tablet contains 6.790 mg perindopril equivalent to 10 mg perindopril arginine, 2.5 mg indapamide and 13.870 mg amlodipine besilate equivalent to 10 mg of amlodipine.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Amlodipine

Amlodipine is a calcium ion influx inhibitor of the dihydropyridine group (slow channel blocker or calcium ion antagonist) and inhibits the transmembrane influx of calcium ions into cardiac and vascular smooth muscle.

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.

Perindopril

Perindopril is an inhibitor of the enzyme that converts angiotensin I into angiotensin II (Angiotensin Converting Enzyme ACE). The converting enzyme, or kinase, is an exopeptidase that allows conversion of angiotensin I into the vasoconstrictor angiotensin II as well as causing the degradation of the vasodilator bradykinin into an inactive heptapeptide. Inhibition of ACE results in a reduction of angiotensin II in the plasma, which leads to increased plasma renin activity (by inhibition of the negative feedback of renin release) and reduced secretion of aldosterone. Since ACE inactivates bradykinin, inhibition of ACE also results in an increased activity of circulating and local kallikrein-kinin systems (and thus also activation of the prostaglandin system).

Perindopril, Amlodipine and Indapamide

Combination of three antihypertensive components with complementary mechanisms to control blood pressure in patient with hypertension. Perindopril is an angiotensin converting enzyme inhibitor, indapamide, a chlorosulphamoyl diuretic and amlodipine, a calcium ion flux inhibitor of the dihydropyridine group.

List of Excipients

Core:

Calcium carbonate starch compound: Calcium carbonate 90%, Pregelatinised maize starch 10%
Cellulose microcrystalline (E460)
Croscarmellose sodium (E468)
Magnesium stearate(E572)
Colloidal anhydrous silica
Pregelatinised starch

Film-coating:

Glycerol (E422)
Hypromellose 6mPa.s (E464)
Macrogol 6000
Magnesium stearate (E572)
Titanium dioxide (E171)

Pack sizes and marketing

10 or 30 film-coated tablets in polypropylene tablet container equipped with a low density polyethylene flow reducer and a low density polyethylene stopper containing a desiccant.

Not all pack sizes may be marketed.

Marketing authorization holder

Les Laboratoires Servier – France

Manufacturer: Servier (Ireland) Industries Ltd., Moneylands, Gorey Road, Arklow, Co. Wicklow – Ireland

Drugs

Drug Countries
TRIPLIXAM Brazil, Cyprus, Ecuador, Estonia, Finland, France, Hong Kong, Croatia, Lithuania, Malta, Netherlands, Poland, Romania, Singapore, Tunisia, Turkey

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