Perindopril tosilate/Amlodipine Teva 5mg/5mg tablets

Country: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

Perindopril tosilate; Amlodipine

Fáanlegur frá:

Teva Pharma B.V.

ATC númer:

C09BB; C09BB04

INN (Alþjóðlegt nafn):

Perindopril tosilate; Amlodipine

Skammtar:

5 mg/5 milligram(s)

Lyfjaform:

Tablet

Gerð lyfseðils:

Product subject to prescription which may be renewed (B)

Lækningarsvæði:

ACE inhibitors and calcium channel blockers; perindopril and amlodipine

Leyfisstaða:

Marketed

Leyfisdagur:

2014-06-13

Upplýsingar fylgiseðill

Perindopril/Amlodipine, NL/H/2842/001-004, 28.06.2021
PACKAGE LEAFLET: INFORMATION FOR THE USER
[INVENTED NAME] 5 MG/5 MG TABLETS
[INVENTED NAME] 5 MG/10 MG TABLETS
[INVENTED NAME] 10 MG/5 MG TABLETS
[INVENTED NAME] 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 [invented name] is and what it is used for
2.
What you need to know before you take [invented name]
3.
How to take [invented name]
4.
Possible side effects
5.
How to store [invented name]
6.
Contents of the pack and other information
1.
WHAT [INVENTED NAME] IS AND WHAT IT IS USED FOR
[invented name] is a combination of two active ingredients,
perindopril and amlodipine.
[invented name] 5 MG/5 MG TABLETS contains 5 mg of perindopril
tosilate and 5 mg of amlodipine.
[invented name] 5 MG/10 MG TABLETS contains 5 mg of perindopril
tosilate and 10 mg of amlodipine.
[invented name] 10 MG/5 MG TABLETS contains 10 mg of perindopril
tosilate and 5 mg of amlodipine
[invented name] 10 MG/10 MG TABLETS contains 10 mg of perindopril
tosilate and 10 mg of 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
easier for your heart to maintain a good
blood flow.
[invented name] is prescribed for treatment of high blood pressure
(hypertension) and/or treatment of stable

Vara einkenni

Health Products Regulatory Authority
09 August 2022
CRN00D0GK
Page 1 of 18
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Perindopril tosilate/Amlodipine Teva 5mg/5mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg perindopril tosilate equivalent to 3.4 mg
perindopril converted _in situ_ to perindopril sodium and
6.935 mg amlodipine besilate equivalent to 5 mg amlodipine.
Excipient with known effect:
Each tablet contains 41.672 mg of lactose monohydrate.
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. 4.3 mm width and 8.1 mm length.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Perindopril tosilate/Amlodipine Teva 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
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_
_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.
The combination of perindopril and amlodipine 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 mono-components is recommended.
Amlodipine used at similar doses in elderly or younger patients is
equally well tolerated. Normal dosage regimens are
recommended in the elderly, but increase of the dosage should take
place with ca