Coverdine 5mg/1.25mg/5mg film-coated tablets
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
04-07-2023
Summary of Product characteristics
(SPC)
04-07-2023
Active ingredient:
Perindopril arginine; Indapamide; Amlodipine
Available from:
Les Laboratoires Servier
ATC code:
C09BX; C09BX01
INN (International Name):
Perindopril arginine; Indapamide; Amlodipine
Dosage:
5 mg/1.25 mg/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 status:
Marketed
Authorization date:
2014-04-16
Patient Information leaflet
1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
COVERDINE 5MG/1.25MG/5MG FILM-COATED TABLETS
COVERDINE 5MG/1.25MG/10MG FILM-COATED TABLETS
COVERDINE 10MG/2.5MG/5MG FILM-COATED TABLETS
COVERDINE 10MG/2.5MG/10MG FILM-COATED TABLETS
perindopril arginine/indapamide/amlodipine
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 differen
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Summary of Product characteristics
Health Products Regulatory Authority
04 July 2023
CRN00DKJW
Page 1 of 25
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Coverdine 5mg/1.25mg/5mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains 3.395 mg perindopril equivalent to 5
mg perindopril arginine, 1.25 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.
Coverdine 5/1.25/5 mg: white, oblong, film-coated tablet, 9.75 mm long
and 5.16 mm wide engraved with
on one face
and
on the other face.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Coverdine is indicated as substitution therapy for treatment of
essential hypertension, in patients already controlled with
perindopril/indapamide fixed dose combination and amlodipine, taken at
the same dose level.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
One Coverdine film-coated tablet per day as a single dose, preferably
to be taken in the morning and before a meal_._
The fixed dose combination is not suitable for initial therapy.
If a change of the posology is required, titration should be done with
the individual components.
Special population
_Renal impairment (see section 4.3 and 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), Coverdine at the doses 10mg/2.5mg /5mg
and 10mg/2.5mg/10mg is contraindicated. It is recommended to start
treatment with the adequate dosage of the free
combination.
Usual medical follow-up will include frequent monitoring of creatinine
and potassium.
Concomitant use of perindopril with aliskiren is contraindicated in
patients with renal impairment (GFR < 60 ml/min/1.73 m2)
(see section 4.3).
_Hepatic impairment (see sections 4.3, 4.4 and 5.2)_
In severe hepatic impairment, Coverdine is contraindicated.
In patients with mild to moderate hepatic impairment, Coverdine
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