Coripren tablets film-coated

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

lercanidipine (lercanidipine hydrochloride), enalapril (enalapril maleate)

Available from:

Recordati Industria Chimica e Farmaceutica S.p.A.

ATC code:

C09BB02

INN (International Name):

lercanidipine (lercanidipine hydrochloride), enalapril (enalapril maleate)

Dosage:

10mg+ 20mg

Pharmaceutical form:

tablets film-coated

Units in package:

(28/2x14/) blisters

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2016-07-20

Summary of Product characteristics

CORIPREN 20 mg/10 mg rev Mar 2015
Page 1 of 21
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
CORIPREN 20 mg/10 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 20 mg enalapril maleate (equivalent
to 15.29 mg enalapril) and 10
mg lercanidipine hydrochloride (equivalent to 9.44 mg lercanidipine).
Excipient with known effect: each tablet contains 92.0 mg of lactose
monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Yellow, circular, biconvex tablets of 8.5 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of essential hypertension in patients whose blood pressure
is not adequately controlled by
enalapril 20 mg alone.
Fixed
combination
CORIPREN
20
mg/10
mg
should
not
be
used
for
initial
treatment
of
hypertension.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Patients whose blood pressure is not adequately controlled by
treatment with enalapril 20 mg alone
could either be titrated up to the higher dose of enalapril
monotherapy or switched to fixed
combination CORIPREN 20mg/10mg.
Individual dose titration with the components can be recommended. When
clinically appropriate,
direct switch from monotherapy to the fixed combination may be
considered.
Posology
The recommended dose is one tablet once a day at least 15 minutes
before meals.
_ELDERLY PATIENTS:_ The dose should depend on the patient's renal
function (see "Use in renal
impairment").
_PATIENTS WITH RENAL IMPAIRMENT:_ CORIPREN is contraindicated in
patients with severe renal
dysfunction (creatinine clearance <30 ml/min) or in patients
undergoing haemodialysis (see section
4.3 and 4.4). Particular caution is needed when initiating treatment
in patients with mild to moderate
renal dysfunction.
_PATIENTS WITH HEPATIC IMPAIRMENT: _ CORIPREN is contraindicated in
severe hepatic dysfunction.
Particular caution is needed when initiating treatment in patients
with mild to moderate hepatic
dysfunction.
_PAEDIATRIC POPULATION:_ There is