Acerycal 5mg/5mg tablets

Country: Ирска

Језик: Енглески

Извор: HPRA (Health Products Regulatory Authority)

Активни састојак:

Perindopril arginine; Amlodipine

Доступно од:

Les Laboratoires Servier

АТЦ код:

C09BB

INN (Међународно име):

Perindopril arginine; Amlodipine

Дозирање:

5 mg/5 milligram(s)

Фармацеутски облик:

Tablet

Тип рецептора:

Product subject to prescription which may be renewed (B)

Терапеутска област:

ACE inhibitors and calcium channel blockers

Статус ауторизације:

Marketed

Датум одобрења:

2008-06-13

Информативни летак

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ACERYCAL 5MG / 5MG TABLETS
ACERYCAL 10MG / 5MG TABLETS
ACERYCAL 5MG / 10MG TABLETS
ACERYCAL 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 Acerycal is and what it is used for
2.
What you need to know before you take Acerycal
3.
How to take Acerycal
4.
Possible side effects
5.
How to store Acerycal
6.
Content of the pack and other information
1.
WHAT ACERYCAL IS AND WHAT IT IS USED FOR
Acerycal 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
Acerycal which contains both ingredients.
Acerycal 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 ACERYCAL
DO NOT TAKE ACERYCAL
-
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 Section

Карактеристике производа

Health Products Regulatory Authority
08 August 2022
CRN00D0G8
Page 1 of 18
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Acerycal 5mg/5mg 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
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.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Acerycal 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 Acerycal could be
modified or individual titration with free combination may
be considered.
_Special populations_
_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.
Acerycal 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
recommended in the elderly, but increase of the dosage should take
place with care. Changes in amlodipine plasma
concentrations are not correlated with degree of renal impairment.
Amlodipine is not dialysable.