Perindopril tert-butylamine/amlodipine HCS 8 mg/5 mg tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Perindopril tert-butylamine; Amlodipine besilate

Available from:

HCS bvba

ATC code:

C09BB; C09BB04

INN (International Name):

Perindopril tert-butylamine; Amlodipine besilate

Dosage:

8mg/5mg 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:

2017-08-18

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PERINDOPRIL TERT-BUTYLAMINE/AMLODIPINE HCS 4 MG/5 MG TABLETS
PERINDOPRIL TERT-BUTYLAMINE/AMLODIPINE HCS 4 MG/10 MG TABLETS
PERINDOPRIL TERT-BUTYLAMINE/AMLODIPINE HCS 8 MG/5 MG TABLETS
PERINDOPRIL TERT-BUTYLAMINE/AMLODIPINE HCS 8 MG/10 MG TABLETS
Perindopril tert-butylamine/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 Perindopril tert-butylamine/amlodipine HCS is and what it is used
for
2.
What you need to know before you take Perindopril
tert-butylamine/amlodipine HCS
3.
How to take Perindopril tert-butylamine/amlodipine HCS
4.
Possible side effects
5.
How to store Perindopril tert-butylamine/amlodipine HCS
6.
Contents of the pack and other information
1.
WHAT PERINDOPRIL TERT-BUTYLAMINE/AMLODIPINE HCS IS AND WHAT IT IS USED
FOR
Perindopril tert-butylamine/amlodipine HCS 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 tert-butylamine/amlodipine HCS which contains both
ingredients.
Perindopril tert-butylamine/amlodipine HCS 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 wide

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Perindopril tert-butylamine/amlodipine HCS 8 mg/5 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 8 mg perindopril tert-butylamine (equivalent to
6.68 mg perindopril) and 5 mg amlodipine (as
besilate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
White to almost white, round, biconvex tablets with bevelled edges,
engraved with mark U 3 on one side of the tablet.
Diameter: 9 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Perindopril tert-butylamine/amlodipine HCS 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
Recommended dose is one tablet per day.
The fixed dose combination is not suitable for initial therapy.
If a change of posology is required, the dose of Perindopril
tert-butylamine/amlodipine HCS could be modified or
individual titration with free combination may be considered.
_Special populations_
_Patients with 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 tert-butylamine/amlodipine HCS 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.
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