COVERSYL PLUS 4/1.25 mg/mg Tablets
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
24-04-2018
Summary of Product characteristics
(SPC)
28-04-2018
Active ingredient:
PERINDOPRIL TERT-BUTYLAMINE SALT, INDAPAMIDE
Available from:
Les Laboratoires Servier
ATC code:
C09BA04
INN (International Name):
PERINDOPRIL TERT-BUTYLAMINE SALT, INDAPAMIDE
Dosage:
4/1.25 mg/mg
Pharmaceutical form:
Tablets
Prescription type:
Product subject to prescription which may be renewed (B)
Therapeutic area:
ACE inhibitors and diuretics
Authorization status:
Authorised
Authorization date:
1998-08-14
Patient Information leaflet
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
COVERSYL PLUS 4MG/1.25MG TABLETS
perindopril tert-butylamine/indapamide
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their
symptoms are the same as yours.
-
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please
tell your doctor or pharmacist.
IN THIS LEAFLET:
1.
What COVERSYL PLUS 4MG/1.25MG is and what it is used for
2.
Before you take COVERSYL PLUS 4MG/1.25MG
3.
How to take COVERSYL PLUS 4MG/1.25MG
4.
Possible side effects
5.
How to store COVERSYL PLUS 4MG/1.25MG
6.
Further information
1.
WHAT COVERSYL PLUS 4MG/1.25MG IS AND WHAT IT IS USED FOR
WHAT IS COVERSYL PLUS 4MG/1.25MG?
COVERSYL PLUS 4MG/1.25MG is a combination of two active ingredients,
perindopril and indapamide. It
is an anti-hypertensive and is used in the treatment of high blood
pressure (hypertension).
WHAT IS COVERSYL PLUS 4MG/1.25MG USED FOR ?
Perindopril belongs to a class of medicines called ACE inhibitors.
These work by widening the blood
vessels, which makes it easier for your heart to pump blood through
them. Indapamide is a diuretic. Diuretics
increase the amount of urine produced by the kidneys. However,
indapamide is different from other
diuretics, as it only causes a slight increase in the amount of urine
produced. Each of the active ingredients
reduces blood pressure and they work together to control your blood
pressure.
2.
BEFORE YOU TAKE COVERSYL PLUS 4MG/1.25MG
DO NOT TAKE COVERSYL PLUS 4MG/1.25MG
-
if you are allergic to perindopril or any other ACE inhibitor, or to
indapamide or any other sulphonamides
or any of the other ingredients of COVERSYL PLUS 4MG/1.25MG,
-
if you have experienced symptoms such as wheezing, swelling of the
face or tongue, intense itching or
severe skin rashes with
Read the complete document
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Coversyl Plus 4mg/1.25mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains 3.338 mg perindopril corresponding to 4 mg
perindopril tert-butylamine and 1.25 mg indapamide.
Excipient with known effect : 61.55 mg lactose monohydrate
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
White, rod-shaped tablet.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of essential hypertension in adults, Coversyl Plus
4mg/1.25mg is indicated in patients whose blood pressure
is not adequately controlled on perindopril alone.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
One Coversyl Plus 4mg/1.25mg 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 Plus 4mg/1.25mg tablet
should be used when blood pressure is not adequately controlled on
Coversyl Plus 4mg/1.25mg tablet (where
available).When clinically appropriate, direct change from monotherapy
to Coversyl Plus 4mg/1.25mg tablet may be
considered.
_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 contraindicated.
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)_
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 tert-butylamine/indapami
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