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

Ülke: İrlanda

Dil: İngilizce

Kaynak: HPRA (Health Products Regulatory Authority)

Aktif bileşen:

Perindopril arginine; Indapamide; Amlodipine

Mevcut itibaren:

Originalis B.V.

ATC kodu:

C09BX; C09BX01

INN (International Adı):

Perindopril arginine; Indapamide; Amlodipine

Farmasötik formu:

Film-coated tablet

Terapötik alanı:

ACE inhibitors, other combinations; perindopril, amlodipine and indapamide

Yetkilendirme tarihi:

2022-12-09

Bilgilendirme broşürü

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:
1.
What Coverdine is and what it is used for
2.
What you need to know before you take Coverdine
3.
How to take Coverdine
4.
Possible side effects
5.
How to store Coverdine
6.
Content of the pack and other information
1.
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 dihydropyridines). It works
by relaxing blood vessels, so blood passes through easily.
2.
W

Ürün özellikleri

Health Products Regulatory Authority
23 October 2023
CRN00DJVS
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Coverdine 10mg/2.5mg/10mg 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 Latvia. _
A white, oblong, film-coated tablet, 12.2 mm long and 6.46 mm,
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
_Core:_
Calcium carbonate starch compound: Calcium carbonate 90%,
Pregelatinised maize starch 10%
Cellulose microcrystalline (E460),
Croscarmellose sodium (E468),
Magnesium stearate (E572),
Colloidal anhydrous silica,
Pregelatinised starch
_Film-coating:_
Glycerol (E422),
Hypromellose 6mPa.s (E464),
Macrogol 6000,
Magnesium stearate (E572),
Titanium dioxide (E 171)
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.
Health Products Regulatory Authority
23 October 2023
CRN00DJVS
Page 2 of 2
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.
Box of 60 (2 tablet containers of 30), 90 (3 tablet containers of 30).
Not all pack sizes may be marketed.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
No special requirements.
7 PARALLEL PRODUCT AUTHORISATIO