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

Nchi: Ayalandi

Lugha: Kiingereza

Chanzo: HPRA (Health Products Regulatory Authority)

Viambatanisho vya kazi:

Indapamide; Amlodipine; Perindopril arginine

Inapatikana kutoka:

Lexon Pharmaceuticals (Ireland) Limited

ATC kanuni:

C09BX; C09BX01

INN (Jina la Kimataifa):

Indapamide; Amlodipine; Perindopril arginine

Kipimo:

10/2.5/10 milligram(s)

Dawa fomu:

Film-coated tablet

Eneo la matibabu:

ACE inhibitors, other combinations; perindopril, amlodipine and indapamide

Idhini ya tarehe:

2018-08-31

Taarifa za kipeperushi

COVERDINE 10 MG/2.5 MG10MG 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 or pharmacist.
•
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. 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
medicines called dihydro

Tabia za bidhaa

Health Products Regulatory Authority
04 October 2023
CRN00DQDW
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Coverdine 10 mg/2.5 mg/10 mg 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 13.870
mg amlodipine besilate equivalent to 10 mg of amlodipine.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
_Product imported from Greece:_
Coverdine 10/2.5/10 mg: white, oblong, film-coated tablet, 12.2 mm
long and 6.46 mm wide engraved with
on one face
and
on the other face.
4 CLINICAL PARTICULARS
As per PA0568/024/005
5 PHARMACOLOGICAL PROPERTIES
As per PA0568/024/005
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Tablet core:
Calcium carbonate starch compound calcium carbonate 90%
Pregelatinised Maize starch 10%
Microcrystalline cellulose (E460)
Croscarmellose sodium (E468)
Magnesium stearate (E572)
Colloidal anhydrous silica
Pregelatinised starch
Tablet film-coating:
Glycerol (E422)
Hypromellose 6mPa.s (E464)
Polyethylene glycol 6000
Magnesium stearate (E572)
Titanium dioxide (E171)
6.2 INCOMPATIBILITIES
Not applicable.
Health Products Regulatory Authority
04 October 2023
CRN00DQDW
Page 2 of 2
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 Pharmaceuticals (Ireland) Limited
Block 3
Harcourt Cen