Coversyl Arginine Plus 5mg/1.25mg tablets

Țară: Regatul Unit

Limbă: engleză

Sursă: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredient activ:

Perindopril arginine; Indapamide

Disponibil de la:

Servier Laboratories Ltd

Codul ATC:

C09BA04

INN (nume internaţional):

Perindopril arginine; Indapamide

Dozare:

5mg ; 1.25mg

Forma farmaceutică:

Oral tablet

Calea de administrare:

Oral

Clasă:

No Controlled Drug Status

Tip de prescriptie medicala:

Valid as a prescribable product

Rezumat produs:

BNF: 02050501; GTIN: 5017476171405

Prospect

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Caracteristicilor produsului

OBJECT 1
COVERSYL ARGININE PLUS 5 MG/1.25 MG FILM-COATED
TABLETS
Summary of Product Characteristics Updated 21-Mar-2017 | Servier
Laboratories Limited
1. Name of the medicinal product
Coversyl Arginine Plus 5mg/1.25mg film-coated tablets
2. Qualitative and quantitative composition
One film-coated tablet contains 3.395 mg perindopril corresponding to
5 mg perindopril arginine and 1.25
mg indapamide.
Excipient with known effect: 71.33 mg lactose monohydrate
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet.
White, rod-shaped film-coated tablet.
4. Clinical particulars
4.1 Therapeutic indications
Treatment of essential hypertension in adults, Coversyl Arginine Plus
5mg/1.25mg film-coated tablet is
indicated in patients whose blood pressure is not adequately
controlled on perindopril alone.
4.2 Posology and method of administration
Posology
One Coversyl Arginine Plus 5mg/1.25mg film-coated tablet per day as a
single dose, preferably to be
taken in the morning, and before a meal.
When possible individual dose titration with the components is
recommended. Coversyl Arginine Plus
5mg/1.25mg film-coated tablet should be used when blood pressure is
not adequately controlled on
Coversyl Arginine Plus 2.5mg/0.625mg film-coated tablet (where
available). When clinically appropriate,
direct change from monotherapy to Coversyl Arginine Plus 5mg/1.25mg
film-coated tablet may be
considered.
Special populations
_Elderly (see section 4.4)_
Treatment should be initiated after considering blood pressure
response and renal function.
_Renal impairment (see section 4.4)_
In severe renal impairment (creatinine clearance below 30 ml/min),
treatment is contra-indicated.
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