LIPERCOSYL Capsules, hard Ref.[107849] Active ingredients: Atorvastatin Atorvastatin and Perindopril Perindopril

Source: Health Products Regulatory Authority (IE)  Revision Year: 2022  Publisher: Les Laboratoires Servier, 50, rue Carnot, 92284 Suresnes Cedex, France

Product name and form

Lipercosyl 10 mg/10 mg hard capsules.

Pharmaceutical Form

Capsules, hard.

Size 2 hard gelatin capsule, with black imprint “10 10” on light green body and black imprint on light green cap, containing white to slightly white spherical pellets.

Size 2 hard gelatin capsules are approximately 18 mm in length.

Qualitative and quantitative composition

Each hard capsule contains 10.82 mg atorvastatin calcium trihydrate equivalent to 10 mg atorvastatin, 10 mg perindopril arginine equivalent to 6.79 mg perindopril.

Excipient with known effect: sucrose (54.9 mg for Lipercosyl 10/10 mg).

For the full list of excipients, see section 6.1.

Active Ingredient Description
Atorvastatin

Atorvastatin is a selective, competitive inhibitor of HMG-CoA reductase. Atorvastatin lowers plasma cholesterol and lipoprotein serum concentrations by inhibiting HMG-CoA reductase and subsequently cholesterol biosynthesis in the liver and increases the number of hepatic LDL receptors on the cell surface for enhanced uptake and catabolism of LDL.

Atorvastatin and Perindopril

Atorvastatin is a selective, competitive inhibitor of HMG-CoA reductase. Atorvastatin lowers plasma cholesterol and lipoprotein serum concentrations by inhibiting HMG-CoA reductase and subsequently cholesterol biosynthesis in the liver and increases the number of hepatic LDL receptors on the cell surface for enhanced uptake and catabolism of LDL. Perindopril is an inhibitor of the enzyme that converts angiotensin I into angiotensin II (Angiotensin Converting Enzyme ACE). Inhibition of ACE results in a reduction of angiotensin II in the plasma, which leads to increased plasma renin activity 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

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).

List of Excipients

Capsule content:

Talc (E553b)

Atorvastatin pellets:

Calcium carbonate (E170)
Hydroxypropyl cellulose (E463)
Polysorbate 80 (E433)
Croscarmellose sodium (E468)
Sugar spheres (sucrose and maize starch)

Perindopril arginine pellets:

Hydroxypropyl cellulose (E463)
Sugar spheres (sucrose and maize starch)

Capsule shell:

Titanium dioxide (E171)
Brilliant blue FCF – FD&C Blue 1 (E133)
Yellow iron oxide (E172)
Gelatin

Ink content:

Shellac (E904)
Propylene glycol (E1520)
Strong ammonia solution (E527)
Black iron oxide (E172)
Potassium hydroxide (E525)

Pack sizes and marketing

30 hard capsules in a PP container closed with a LDPE stopper.

90 (3x30) hard capsules in 3 PP containers closed with a LDPE stopper.

100 hard capsules in a HDPE bottle closed with a PP stopper.

Not all pack sizes may be marketed.

Marketing authorization holder

Les Laboratoires Servier, 50, rue Carnot, 92284 Suresnes Cedex, France

Marketing authorization dates and numbers

PA0568/032/004

Date of first authorisation: 26th January 2018

Drugs

Drug Countries
LIPERCOSYL France, Ireland

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