Perindopril arginine/Indapamide TAD 5 mg/1.25 mg tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Perindopril arginine; Indapamide

Available from:

TAD Pharma GmbH

ATC code:

C09BA04

INN (International Name):

Perindopril arginine; Indapamide

Pharmaceutical form:

Tablet

Therapeutic area:

perindopril and diuretics

Authorization status:

Marketed

Authorization date:

2022-09-09

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PERINDOPRIL ARGININE/INDAPAMIDE TAD 5 MG/1.25 MG TABLETS
PERINDOPRIL ARGININE/INDAPAMIDE TAD 10 MG/2.5 MG TABLETS
perindopril arginine/indapamide
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/Indapamide TAD is and what it is used for
2.
What you need to know before you take Perindopril arginine/Indapamide
TAD
3.
How to take Perindopril arginine/Indapamide TAD
4.
Possible side effects
5.
How to store Perindopril arginine/Indapamide TAD
6.
Contents of the pack and other information
1.
WHAT PERINDOPRIL ARGININE/INDAPAMIDE TAD IS AND WHAT IT IS USED FOR
WHAT ARE PERINDOPRIL ARGININE/INDAPAMIDE TAD TABLETS?
Perindopril arginine/Indapamide TAD is a combination of two active
ingredients, perindopril and
indapamide. Perindopril arginine/Indapamide TAD is an
anti-hypertensive and is used in the treatment
of high blood pressure (hypertension) in adults.
WHAT PERINDOPRIL ARGININE/INDAPAMIDE TAD TABLETS
ARE USED FOR?
Perindopril belongs to a class of medicines called
angiotensin-converting enzyme inhibitors (ACE
inhibitors). These work by widening the blood vessels, which makes it
easier for your heart to pump
blood through them. Indapamide is a diuretic. Diuretics increase the
amount of urine produced by the
kidneys. However, indapamide is different from other diuretics, as it
only causes a slight increase in
the amount of urine produced. Each of the active ingredients reduces
blood pressure and they work
together to control your blood pre

Summary of Product characteristics

Health Products Regulatory Authority
28 September 2022
CRN00D5XQ
Page 1 of 19
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Perindopril arginine/Indapamide TAD 5 mg/1.25 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg perindopril arginine (equivalent to 3.395 mg
perindopril) and 1.25 mg indapamide
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
White or almost white, capsule-shaped tablet, scored on both sides.
Tablet is engraved with mark A on one side of the score
line and with mark 1 on the other side of the score line. Tablet
dimensions: approx. 8 mm x 5 mm.
The tablet can be divided into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of essential hypertension in adults. Perindopril
arginine/indapamide TAD 5 mg/1.25 mg tablets is indicated in
patients whose blood pressure is not adequately controlled on
perindopril alone.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
One Perindopril arginine/indapamide TAD 5 mg/1.25 mg tablet per day as
a single dose, preferably to be taken in the morning,
and before a meal. When possible individual dose titration with the
components is recommended. Perindopril/indapamide TAD
5 mg/1.25 mg tablet should be used when blood pressure is not
adequately controlled on perindopril arginine 2.5
mg/indapamide 0.625 mg (half a Perindopril arginine/indapamide TAD 5
mg/1.25 mg tablet).
When clinically appropriate, direct change from monotherapy to
Perindopril arginine/indapamide TAD 5 mg/1.25 mg tablets
may be considered.
_Elderly (see section 4.4)_
Treatment with Perindopril arginine/indapamide TAD 5 mg/1.25 mg tablet
should be initiated after considering blood pressure
response and renal function.
_ _
_Renal impairment (see section 4.4)_
In severe renal impairment (creatinine clearance below 30 ml/min),
treatment is contraindicated.
In patients with moderate renal impairment (creatinine clearance 30-60
ml/min), it is recommended to initiate treatment with
the adequate dose