Coverdine 10 mg/2.5 mg/5 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Amlodipine; Indapamide; Perindopril arginine

Available from:

Lexon (UK) Ltd

ATC code:

C09BX; C09BX01

INN (International Name):

Amlodipine; Indapamide; Perindopril arginine

Dosage:

10/2.5/5 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

ACE inhibitors, other combinations; perindopril, amlodipine and indapamide

Authorization date:

2018-08-31

Patient Information leaflet

COVERDINE 10 MG/2.5 MG/5 MG FILM-COATED TABLETS
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE
BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor, pharmacist or
nurse.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if their signs of illness are the same
as
yours.
•
If you get any side effects, talk to your doctor, or pharmacist or
nurse. This
includes any possible side effects not listed in this leaflet. See
section 4.
WHAT IS IN THIS LEAFLET:
What Coverdine is and what it is used for
What you need to know before you take Coverdine
How to take Coverdine
Possible side effects
How to store Coverdine
Content of the pack and other information
WHAT COVERDINE IS AND WHAT IT IS USED FOR
Coverdine is a combination of three active ingredients: perindopril,
indapamide and amlodipine. It is an anti-hypertensive medicine used in
the
treatment of high blood pressure (hypertension).
Patients already taking perindopril/indapamide as fixed dose
combination and
amlodipine from separate tablets may instead receive one tablet of
Coverdine which contains the three active ingredients in the same
strength.
Each of the active ingredients reduces blood pressure and they work
together to control your blood pressure:
•
Perindopril belongs to a class of medicines called Angiotensin
Converting
Enzyme (ACE) inhibitors. It works by widening the blood vessels, which
makes it easier for your heart to pump blood through them.
•
Indapamide is a diuretic (which belongs to a class of medicines called
sulphonamide derivatives with an indole ring). 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.
•
Amlodipine is a calcium channel blockers (which belongs to a class of
medici

Summary of Product characteristics

Health Products Regulatory Authority
31 August 2018
CRN008K93
Page 1 of 3
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Coverdine 10mg/2.5mg/5mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains 6.790 mg perindopril equivalent to 10
mg
perindopril arginine, 2.5 mg indapamide and 6.935 mg amlodipine
besilate
equivalent to 5 mg of amlodipine.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
_Product imported from Greece:_
Coverdine 10/2.5/5 mg: white, oblong, film-coated tablet, 11.5 mm long
and 6.09
mm wide engraved with
on one face and
on the other face.
4 CLINICAL PARTICULARS
As per PA0568/024/004
5 PHARMACOLOGICAL PROPERTIES
As per PA0568/024/004
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Tablet core:
Calcium carbonate starch compound calcium carbonate 90%
Maize starch 10%
Microcrystalline cellulose (E460)
Croscarmellose sodium (E468)
Magnesium stearate (E572)
Colloidal anhydrous silica
Pregelatinised starch
Health Products Regulatory Authority
31 August 2018
CRN008K93
Page 2 of 3
Tablet film-coating:
Glycerol (E422)
Hypromellose 6mPa.s (E464)
Polyethylene glycol 6000
Magnesium stearate (E572)
Titanium dioxide (E171)
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
Unopened: The shelf life expiry date for this product shall be the
date shown on the
container label and outer package of the product on the market in the
country of
origin.
Opened: The in-use stability after first opening is 30 days.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
This medicinal product does not require any special storage
conditions.
6.5 NATURE AND CONTENTS OF CONTAINER
30 film-coated tablets in polypropylene tablet container equipped with
a low density
polyethylene flow
reducer and a low density polyethylene stopper containing a desiccant.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
Lexon (UK) Ltd
Unit 18
Oxleasow Road
East Moons Moat
Redditch
Worcestershire
B98 0RE