Coveram Tablets 5mg/10mg
Country: Malta
Language: English
Source: Medicines Authority
Patient Information leaflet
(PIL)
01-07-2022
Summary of Product characteristics
(SPC)
05-07-2022
Active ingredient:
AMLODIPINE, PERINDOPRIL ARGININE
Available from:
Les Laboratoires Servier 50 Rue Carnot, 92284 Suresnes Cedex, France
ATC code:
C09BB04
INN (International Name):
AMLODIPINE 10 mg PERINDOPRIL ARGININE 5 mg
Pharmaceutical form:
TABLET
Composition:
AMLODIPINE 10 mg PERINDOPRIL ARGININE 5 mg
Prescription type:
POM
Therapeutic area:
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
Authorization status:
Authorised
Authorization date:
2008-12-05
Patient Information leaflet
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
COVERAM 5MG / 5MG TABLETS
COVERAM 10MG / 5MG TABLETS
COVERAM 5MG / 10MG TABLETS
COVERAM 10MG / 10MG TABLETS
perindopril arginine / 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, 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, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Coveram is and what it is used for
2.
What you need to know before you take Coveram
3.
How to take Coveram
4.
Possible side effects
5.
How to store Coveram
6.
Content of the pack and other information
1.
WHAT COVERAM IS AND WHAT IT IS USED FOR
Coveram is prescribed for treatment of high blood pressure
(hypertension) and/or treatment of stable
coronary artery disease (a condition where the blood supply to the
heart is reduced or blocked).
Patients already taking perindopril and amlodipine from separate
tablets may instead receive one tablet of
Coveram which contains both ingredients.
Coveram is a combination of two active ingredients, perindopril and
amlodipine.
Perindopril is an ACE (angiotensin converting enzyme) inhibitor.
Amlodipine is a calcium antagonist (which
belongs to a class of medicines called dihydropyridines). Together
they work to widen and relax the blood
vessels so that blood passes through them more easily and makes it
easier for your heart to maintain a good
blood flow.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE COVERAM
DO NOT TAKE COVERAM
-
if you are allergic to perindopril or any other ACE inhibitor, or to
amlodipine or any other calcium
antagonists, or any of the other ingredients of this medicine (listed
in Sec
Read the complete document
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Coveram 5mg/5mg tablets
[Coveram 5mg/10mg tablets]
[Coveram 10mg/5mg tablets]
[Coveram 10mg/10mg tablets]
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains 3.395 mg perindopril equivalent to 5 mg
perindopril arginine and 6.935 mg amlodipine
besilate equivalent to 5 mg amlodipine.
[One tablet contains 3.395 mg perindopril equivalent to 5 mg
perindopril arginine and 13.870 mg amlodipine
besilate equivalent to 10 mg amlodipine]
[One tablet contains 6.790 mg perindopril equivalent to 10 mg
perindopril arginine and 6.935 mg amlodipine
besilate equivalent to 5 mg amlodipine]
[One tablet contains 6.790 mg perindopril equivalent to 10 mg
perindopril arginine and 13.870 mg
amlodipine besilate equivalent to 10 mg amlodipine]
Excipient with known effect: lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
White, rod-shaped tablet, 8.5 mm long and 4.5 mm wide, engraved with
5/5 on one face and
on the
other face.
[White, square-shaped tablet, 8 mm long and 8 mm wide, engraved with
5/10 on one face and
on the
other face.]
[White, triangular-shaped tablet, 9.5 mm x 8.8 mm x 8.8 mm, engraved
with 10/5 on one face and
on the
other face.]
[White, round tablet, 8.5 mm diameter, engraved with 10/10 on one face
and
on the other face.]
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Coveram is indicated as substitution therapy for treatment of
essential hypertension and/or stable coronary
artery disease, in patients already controlled with perindopril and
amlodipine given concurrently at the same
dose level.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Posology _
_ _
Oral route.
One 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 posology is required, the dose of Coveram could be
modified or individual titration with free
combination may be considered.
3
_Special populations _
_ _
_
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