Perindopril Arginine/Amlodipine Servier 5mg/10mg tablets
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
27-11-2018
Summary of Product characteristics
(SPC)
27-11-2018
Active ingredient:
Perindopril arginine; Amlodipine besylate
Available from:
Les Laboratoires Servier
ATC code:
C09BB; C09BB04
INN (International Name):
Perindopril arginine; Amlodipine besylate
Dosage:
5mg/10 milligram(s)
Pharmaceutical form:
Tablet
Prescription type:
Product subject to prescription which may be renewed (B)
Therapeutic area:
ACE inhibitors and calcium channel blockers; perindopril and amlodipine
Authorization status:
Not marketed
Authorization date:
2008-07-04
Patient Information leaflet
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Perindopril arginine/Amlodipine Servier 5MG / 5MG TABLETS
Perindopril arginine/Amlodipine Servier 10MG / 5MG TABLETS
Perindopril arginine/Amlodipine Servier 5MG / 10MG TABLETS
Perindopril arginine/Amlodipine Servier 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 Perindopril arginine/Amlodipine Servier is and what it is used
for
2.
What you need to know before you take Perindopril arginine/Amlodipine
Servier
3.
How to take Perindopril arginine/Amlodipine Servier
4.
Possible side effects
5.
How to store Perindopril arginine/Amlodipine Servier
6.
Content of the pack and other information
1.
WHAT PERINDOPRIL ARGININE/AMLODIPINE SERVIER IS AND WHAT IT IS USED
FOR
Perindopril arginine/Amlodipine Servier 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
Perindopril arginine/Amlodipine Servier which contains both
ingredients.
Perindopril arginine/Amlodipine Servier 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
ve
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Summary of Product characteristics
Health Products Regulatory Authority
26 November 2018
CRN008L3G
Page 1 of 30
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Perindopril Arginine/Amlodipine Servier 5mg/10mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains 3.395 mg perindopril equivalent to 5 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, square-shaped tablet, 8 mm long x 8 mm wide, engraved with 5/10
on one
face and
on the other face
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Perindopril arginine/Amlodipine Servier 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 Perindopril
arginine/Amlodipine
Servier could be modified or individual titration with free
combination may be
considered.
Special populations
Health Products Regulatory Authority
26 November 2018
CRN008L3G
Page 2 of 30
_Renal impairment and elderly: (see sections 4.4 and 5.2)_
Elimination of perindoprilat is decreased in the elderly and in
patients with renal
failure. Therefore, the usual medical follow-up will include frequent
monitoring of
creatinine and potassium.
Perindopril arginine/Amlodipine Servier can be administered in
patients with Clcr ≥
60ml/min, and is not suitable for patients with Clcr < 60ml/min. In
these patients, an
individual dose titration with the monocomponents is recommended.
Amlodipine used at similar doses in elderly or younger patients is
equally well
tolerated. Normal dosage regimens are recommen
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