Perindopril tosilate/Indapamide Teva 2.5 mg/0.625 mg Film-coated tablets

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

Perindopril tosilate; Indapamide

Dostopno od:

Teva Pharma B.V.

Koda artikla:

C09BA; C09BA04

INN (mednarodno ime):

Perindopril tosilate; Indapamide

Odmerek:

2.5 mg/0.625 milligram(s)

Farmacevtska oblika:

Film-coated tablet

Tip zastaranja:

Product subject to prescription which may be renewed (B)

Terapevtsko območje:

ACE inhibitors and diuretics; perindopril and diuretics

Status dovoljenje:

Marketed

Datum dovoljenje:

2013-02-22

Navodilo za uporabo

Perindopril tosilate/indapamide 2.5 mg/0.625 mg, NL/H/2467/001,
16.05.2022
Perindopril tosilate/indapamide 2.5 mg/0.625 mg, NL/H/2467/001,
19.01.2023
Day 20 second round: shaded in turquoise
PACKAGE LEAFLET: INFORMATION FOR THE USER
PERINDOPRIL TOSILATE/INDAPAMIDE TEVA 2.5 MG/0.625 MG FILM-COATED
TABLETS
perindopril tosilate/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 tosilate/indapamide Teva is and what it is used for
2.
What you need to know before you take Perindopril tosilate/indapamide
Teva
3.
How to take Perindopril tosilate/indapamide Teva
4.
Possible side effects
5.
How to store Perindopril tosilate/indapamide Teva
6.
Contents of the pack and other information
1.
WHAT [PRODUCT NAME] IS AND WHAT IT IS USED FOR
WHAT IS PERINDOPRIL TOSILATE/INDAPAMIDE TEVA ?
Perindopril tosilate/indapamide Teva is a combination of two active
ingredients, perindopril and
indapamide. It is an anti-hypertensive and is used in the treatment of
high blood pressure (hypertension) in
adults.
WHAT IS PERINDOPRIL TOSILATE/INDAPAMIDE TEVA USED FOR?
Perindopril belongs to a class of medicines called 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

Lastnosti izdelka

Health Products Regulatory Authority
23 February 2023
CRN00D4Z6
Page 1 of 20
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Perindopril tosilate/Indapamide Teva 2.5 mg/0.625 mg Film-coated
tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 1.704 mg perindopril corresponding to
2.5 mg perindopril tosilate, converted _in situ _
to
perindopril sodium, and 0.625 mg indapamide.
Excipient with known effect:
Each film-coated tablet contains 74.056 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
White, capsule shaped biconvex film-coated tablet of approx. 4 mm
width and 8 mm length, debossed breakline on one side
and plain on the other side.
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
Essential hypertension.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The usual dose is one Perindopril tosilate/indapamide Teva
2.5mg/0.625mg film-coated tablet per day as a single dose,
preferably to be taken in the morning and before a meal. If blood
pressure is not controlled after one month of treatment, the
dose can be doubled.
Special populations
_Elderly (see section 4.4)_
Treatment should be started at the normal dose of one Perindopril
tosilate/indapamide Teva 2.5mg/0.625mg film-coated
tablet per day.
_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), the maximum dose should be one tablet of
Perindopril tosilate/indapamide Teva 2.5mg/0.625mg per day.
In patients with creatinine clearance greater than or equal to 60
ml/min, no dose modification is required.
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 con