Perindopril Tosilate/Amlodipine Teva B.V. 5 mg/5 mg Tablets

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

Perindopril tosilate; Amlodipine

Disponibil de la:

Teva B.V.

Codul ATC:

C09BB04

INN (nume internaţional):

Perindopril tosilate; Amlodipine

Dozare:

5 mg/5 milligram(s)

Forma farmaceutică:

Tablet

Zonă Terapeutică:

perindopril and amlodipine

Statutul autorizaţiei:

Not marketed

Data de autorizare:

2021-11-19

Prospect

PACKAGE LEAFLET: INFORMATION FOR THE USER
PERINDOPRIL TOSILATE/AMLODIPINE TEVA B.V. 5 MG/5 MG TABLETS
PERINDOPRIL TOSILATE/AMLODIPINE TEVA B.V. 5 MG/10 MG TABLETS
PERINDOPRIL TOSILATE/AMLODIPINE TEVA B.V. 10 MG/5 MG TABLETS
PERINDOPRIL TOSILATE/AMLODIPINE TEVA B.V. 10 MG/10 MG TABLETS
perindopril tosilate/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 Tosilate/Amlodipine Teva B.V. is and what it is used
for
2.
What you need to know before you take Perindopril Tosilate/Amlodipine
Teva B.V.
3.
How to take Perindopril Tosilate/Amlodipine Teva B.V.
4.
Possible side effects
5.
How to store Perindopril Tosilate/Amlodipine Teva B.V.
6.
Contents of the pack and other information
1.
WHAT PERINDOPRIL TOSILATE/AMLODIPINE TEVA B.V. IS AND WHAT IT IS USED
FOR
Perindopril Tosilate/Amlodipine Teva B.V. is a combination of two
active ingredients, perindopril and
amlodipine.
Perindopril Tosilate/Amlodipine Teva B.V.
5 MG/5 MG TABLETS
contains 5 mg of perindopril tosilate and 5
mg of amlodipine.
Perindopril Tosilate/Amlodipine Teva B.V.
5 MG/10 MG TABLETS
contains 5 mg of perindopril tosilate and 10
mg of amlodipine.
Perindopril Tosilate/Amlodipine Teva B.V.
10 MG/5 MG TABLETS
contains 10 mg of perindopril tosilate and 5
mg of amlodipine
Perindopril Tosilate/Amlodipine Teva B.V.
10 MG/10 MG TABLETS
contains 10 mg of perindopril tosilate and
10 mg of amlodipine
Perindopril Tosilate/Amlodipine Teva B.V. is prescribed for treatment
of high blood pressure (hypertension)
and/or treatment of sta

Caracteristicilor produsului

Health Products Regulatory Authority
08 August 2022
CRN00D051
Page 1 of 19
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Perindopril Tosilate/Amlodipine Teva B.V. 5 mg/5 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg perindopril tosilate equivalent to 3.408 mg
perindopril converted _in situ_ to perindopril sodium and
6.935 mg amlodipine besilate equivalent to 5 mg amlodipine.
Excipient with known effect:
Each Perindopril Tosilate/Amlodipine Teva B.V. 5 mg/5 mg tablet
contains 86.6 mg of isomalt
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
White, oval, biconvex tablet, debossed "5/5" on one side and plain on
the other side.
Dimensions: Approx. 9 x 5 mm
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Perindopril Tosilate/Amlodipine Teva B.V. 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
One tablet per day as a single dose, preferably in the morning and
before a meal.
The fixed dose combination is not suitable for initial therapy.
If a change of posology is required, the dose of the perindopril and
amlodipine combination 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 routine medical
follow-up will include frequent monitoring of creatinine and
potassium.
The combination of perindopril and amlodipine can be administered in
patients with Clcr ≥ 60ml/min, but is not recommended
in patients with a Clcr < 60ml/min. In these patients, an individual
dose titration with the mono-components is recommended.
Amlodipine used at similar doses in elderly or younger patients is
equal