COSYREL Film-coated tablet Ref.[51621] Active ingredients: Bisoprolol Perindopril Perindopril and Bisoprolol

Source: Health Sciences Authority (SG)  Revision Year: 2023  Publisher: France: Les Laboratoires Servier, 50, rue Carnot, 92284 Suresnes cedex, France Singapore: Servier Singapore Pte Ltd, 67 Ubi Avenue 1, #06-09 StarHub Green, Singapore 408942

Product name and form

Cosyrel film-coated tablets 5 mg/5 mg.

Cosyrel film-coated tablets 5 mg/10 mg.

Cosyrel film-coated tablets 10 mg/5 mg.

Cosyrel film-coated tablets 10 mg/10 mg.

Pharmaceutical Form

Film-coated tablet.

Pink beige, oblong, bilayer scored film-coated tablet of 8.3 mm length and 4.5 mm width, engraved with ' ' on one face and ‘5/5’ on the other face. Cosyrel 5 mg/5 mg scored tablet can be divided into equal doses.

Pink beige, oblong, bilayer scored film-coated tablet of 9.8 mm length and 5.4 mm width, engraved with ' ' on one face and ‘5/10’ on the other face. Cosyrel 5 mg/10 mg scored tablet can be divided into equal doses.

Pink beige, round, bilayer film-coated tablet with a diameter of 7 mm and a curvature radius of 12.7 mm, engraved with ' ' on one face and ‘10/5’ on the other face.

Pink beige, oblong, bilayer film-coated tablet of 10 mm length and 5.7 mm width, engraved with ' ' on one face and ‘10/10’ on the other face.

Qualitative and quantitative composition

One film-coated tablet contains 5 mg of bisoprolol fumarate (equivalent to 4.24 mg bisoprolol) and 5 mg of perindopril arginine (equivalent to 3.395 mg perindopril).

One film-coated tablet contains 5 mg of bisoprolol fumarate (equivalent to 4.24 mg bisoprolol) and 10 mg of perindopril arginine (equivalent to 6.790 mg perindopril).

One film-coated tablet contains 10 mg of bisoprolol fumarate (equivalent to 8.49 mg bisoprolol) and 5 mg of perindopril arginine (equivalent to 3.395 mg perindopril).

One film-coated tablet contains 10 mg of bisoprolol fumarate (equivalent to 8.49 mg bisoprolol) and 10 mg of perindopril arginine (equivalent to 6.790 mg perindopril).

For the full list of excipients, see section 6.1.

Active Ingredient Description
Bisoprolol

Bisoprolol is a potent highly beta1-selective-adrenoceptor blocking agent, lacking intrinsic stimulating and without relevant membrane stabilising activity.

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 and Bisoprolol

Perindopril is an inhibitor of the enzyme that converts angiotensin I into angiotensin II (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. It is possible that this mechanism contributes to the blood pressure-lowering action of ACE inhibitors. Bisoprolol is a highly beta1-selective-adrenoceptor blocking agent, lacking intrinsic stimulating and relevant membrane stabilising activity. Bisoprolol is generally not to be expected to influence the airway resistance and beta2-mediated metabolic effects.

List of Excipients

Core:

Cellulose microcrystalline PH 102 (E460)
Calcium carbonate (E170)
Pregelatinized maize starch
Sodium starch glycolate type A
Silica colloidal anhydrous (E551)
Magnesium stearate (E470b)
Croscarmellose sodium (E468)

Film-coating:

Glycerol (E422)
Hypromellose (E464)
Macrogol 6000
Magnesium stearate (E470b)
Titanium dioxide (E171)
Iron dioxide yellow (E172)
Iron dioxide red (E172)

Pack sizes and marketing

Tablet container of 10 or 30 film-coated tablets: white polypropylene tablet container equipped with a lowdensity polyethylene flow reducer and a white opaque stopper containing a desiccant gel.

Box of 1 tablet container of 10 or 30 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

France: Les Laboratoires Servier, 50, rue Carnot, 92284 Suresnes cedex, France

Singapore: Servier Singapore Pte Ltd, 67 Ubi Avenue 1, #06-09 StarHub Green, Singapore 408942

Marketing authorization dates and numbers

Cosyrel film-coated tablets 5 mg/5 mg: SIN15398P

Cosyrel film-coated tablets 5 mg/10 mg: SIN15399P

Cosyrel film-coated tablets 10 mg/5 mg: SIN15400P

Cosyrel film-coated tablets 10 mg/10 mg: SIN15401P

Drugs

Drug Countries
COSYREL Cyprus, Finland, Romania, Singapore

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