Perindopril arginine/amlodipine TAD 10 mg/10 mg tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Perindopril arginine; Amlodipine

Available from:

TAD Pharma GmbH

ATC code:

C09BB04

INN (International Name):

Perindopril arginine; Amlodipine

Pharmaceutical form:

Tablet

Therapeutic area:

perindopril and amlodipine

Authorization date:

2022-04-14

Patient Information leaflet

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

Summary of Product characteristics

Health Products Regulatory Authority
14 March 2024
CRN00D0PV
Page 1 of 21
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Perindopril arginine/amlodipine TAD 10 mg/10 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg perindopril arginine (equivalent to 6.79 mg
perindopril) and 10 mg amlodipine (equivalent to
13.87 mg amlodipine besilate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
Light brownish-yellow, oval, biconvex tablets with possible individual
darker spots, scored on one side. One side of the breaker
score is marked with S and the other with 4. Tablet dimensions:
approx. 12 mm x 7 mm. The score line is only to facilitate
breaking for ease of swallowing and not to divide into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Perindopril arginine/amlodipine TAD 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
arginine/amlodipine TAD 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.
Perindopril arginine/amlodipine TAD 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 ar