Information about Tensocard Plus
COMPOSITION:

Each tablet of Tensocard Plus 4/1.25 contains: Perindopril erbumine 4 mg, Indapamide1.25 mg.

PHARMACOLOGICAL PROPERTIES:

Tensocard Plus is an antihypertensive combination of Perindopril erbumine, anangiotensin-converting enzyme (ACE) inhibitor, and indapamide, a chlorosulphamoyl diuretic. The pharmacological properties are derived from those of each of the components, in addition to those due to the additive synergistic action of the two products when combined.

PHARMACOKINETICS:

The co-administration of perindopril and indapamide does not change their pharmacokinetic properties by comparison to separate administration. After oral administration, perindopril is rapidly absorbed with peak plasma concentrations occurring at about one hour, with a bioavailability of 65 -70%, whilst indapamideis rapidly and completely absorbed after oral administration. After absorption,perindopril is converted into perindoprilat, its active metabolite, with a mean bioavailability of about 20% Peak plasma concentration of perindoprilat is attained within 4-7 hours and corresponding peak pharmacodynamics activity occurs at about 6 hours. Indapamide reaches its peak blood levels after 1 to 2 hours, and it is metabolized to a marked degree.

INDICATIONS:

Tensocard Plus is indicated for the treatment of mild to moderate essential hypertensionin patients for whom combination therapy is appropriate.

DOSAGEAND ADMINISTRATION:

The recommended dose of Tensocard Plus 2/0.625 to treat hypertension is one tablet per day, preferred in morning before meal.

The doctor may decide to increase the dose to two tablets of Tensocard Plus 2/0.625 or one tablet daily of Tensocard Plus 4/1.25.

The recommended dose of Tensocard Plus 4/1.25 or of Tensocard Plus 8/2.5 is one tablet per day.

Therefore,it is recommended that Tensocard Plus be taken before a meal. Tablets should be swallowed whole with a glass of water, preferably in the morning before a meal.If a dose is missed a double dose shouldn't be taken to make up for forgotten doses bal. Just carry on with the next dose at the usual lime.

Inpatients with moderate renal impairment (creatinine clearance 30-60 ml/min), Tensocard Plus 8/2.5 is contraindicated and it is recommended to start treatment with Tensocard Plus 2/0.625 or Tensocard Plus 4/1.25, and the initial dosage of Tensocard Plus should be adjusted according to the patient's creatinine clearance and then as a function of the patient's response totreatment. Routine monitoring of potassium and creatinine are part of normal medical practice for those patients.

Caution should be exercised especially in the elderly patients as greater sensitivityin the elderly cannot be ruled out, so Treatment should be initiated after considering blood pressure response and renal function.

In patients with creatinine clearance greater than or equal to 60 ml/min, no dose modification is required.

Packaging:

Packs of 30 tablets.