COVERSYL PLUS TABLET 5MG/1.25MG [SIN13633P]

Product Info

COVERSYL PLUS TABLET 5MG/1.25MG

[SIN13633P]

4.1 Therapeutic indications

COVERSYL PLUS 5mg/1.25mg
Treatment of essential hypertension in adults, COVERSYL PLUS 5mg/1.25mg film-coated tablet is indicated in patients whose blood pressure is not adequately controlled on perindopril alone.

COVERSYL PLUS 10mg/2.5mg
COVERSYL PLUS 10mg/2.5mg tablet is indicated as substitution therapy for treatment of essential hypertension, in adult patients already controlled with perindopril and indapamide given concurrently at the same dose level.

4.2 Posology and method of administration

Posology

COVERSYL PLUS 5mg/1.25mg
One COVERSYL PLUS 5mg/1.25mg tablet per day as a single dose, preferably to be taken in the morning and before a meal. When clinically appropriate, direct change from monotherapy to COVERSYL PLUS 5mg/1.25mg film-coated tablet may be considered.

COVERSYL PLUS 10mg/2.5mg
One COVERSYL PLUS 10mg/2.5mg tablet per day as a single dose, preferably to be taken in the morning, and before a meal.

Special populations

Elderly (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)
Treatment should be initiated after considering blood pressure response and renal function.
In elderly, the plasma creatinine must be adjusted in relation to age, weight and gender. Elderly patients can be treated with COVERSYL PLUS 5mg/1.25mg and COVERSYL PLUS 10mg/2.5mg if renal function is normal and after considering blood pressure response.

Renal impairment (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)
In severe renal impairment (creatinine clearance below 30 ml/min), treatment with COVERSYL PLUS is contraindicated.
In moderate renal impairment (creatinine clearance below 60 ml/min), treatment is contraindicated with COVERSYL PLUS 10mg/2.5mg.

COVERSYL PLUS 5mg/1.25mg
In patients with moderate renal impairment (creatinine clearance 30–60 ml/min), it is recommended to start treatment with the adequate dosage of the free combination.
In patients with creatinine clearance greater than or equal to 60 ml/min, no dose modification is required.
Usual medical follow-up will include frequent monitoring of creatinine and potassium.

Hepatic impairment (see sections 4.3, 4.4 and 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)
In severe hepatic impairment, treatment is contraindicated.
In patients with moderate hepatic impairment, no dose modification is required.

Paediatric population
The safety and efficacy of perindopril arginine/indapamide in the paediatric population have not yet been established. No data are available.
COVERSYL PLUS should not be used in children and adolescents.

Method of administration

Oral use

4.3 Contraindications

Linked to perindopril:

• Hypersensitivity to the active substance or to any other ACE inhibitor

• History of angioedema (Quincke’s oedema) associated with previous ACE inhibitor therapy (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)

• Hereditary/idiopathic angioedema

• Pregnancy (see section 4.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)

• Concomitant use of perindopril with aliskiren-containing products in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73m²) (see sections 4.5 and 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• Concomitant use with sacubitril/valsartan therapy, COVERSYL PLUS must not be initiated earlier than 36 hours after the last dose of sacubitril/valsartan (see sections 4.4 and 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• Extracorporeal treatments leading to contact of blood with negatively charged surfaces (see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• Significant bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Linked to indapamide:

• Hypersensitivity to the active substance or to any other sulphonamides

• Severe renal impairment (creatinine clearance below 30 ml/min)

• Hepatic encephalopathy

• Severe hepatic impairment

• Hypokalaemia

Linked to COVERSYL PLUS:

• Hypersensitivity to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information

Linked to COVERSYL PLUS 10mg/2.5mg:

• Severe and moderate renal impairment (creatinine clearance below 60 ml/min)

Due to the lack of sufficient therapeutic experience, COVERSYL PLUS should not be used in:

• Dialysis patients

• Patients with untreated decompensated heart failure.