Perindopril arginine/Indapamide TAD 10 mg/2.5 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 10 mg/2.5 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg perindopril arginine (equivalent to 6.790
mg perindopril) and 2.5 mg indapamide.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
White or almost white round, biconvex tablet, with engraved mark A2 on
one side of the tablet. Tablet dimension: diameter
approx. 8 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Perindopril arginine/Indapamide TAD 10 mg/2.5 mg tablets is indicated
as substitution therapy for treatment of essential
hypertension, in patients already controlled with perindopril and
indapamide given concurrently at the same dose level.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The usual dose is one Perindopril arginine/Indapamide TAD 10 mg/2.5 mg
tablet per day as a single dose, preferably to be
taken in the morning and before a meal.
_Elderly (see section 4.4)_
In the elderly, the plasma creatinine must be adjusted in relation to
age, weight and gender. Elderly may be treated if renal
function is normal and after considering blood pressure response.
_Renal impairment (see section 4.4)_
In patients with severe and moderate renal impairment (creatinine
clearance below 60 ml/min), treatment is contraindicated.
Usual medical follow-up will include frequent monitoring of creatinine
and potassium.
_Hepatic impairment (see sections 4.3, 4.4 and 5.2)_
In severe hepatic impairment, treatment is contraindicated.
In patients with moderate hepatic impairment, no dose modification is
required.
_ _
_Paediatric population_
The safety and efficacy of perindopril arginine/indapamide in the
paediatric population have not yet been established. No data
are available.
Perindopril arginine/Indapamide TAD should not be used in children and
adolescents.
Method of administration
_ _
Oral use.
4.3 CONTRAINDICATIONS
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