Perindopril arginine Actavis 5 mg Filmdragerad tablett

Land: Sverige

Sprog: svensk

Kilde: Läkemedelsverket (Medical Products Agency)

Aktiv bestanddel:

perindoprilarginin

Tilgængelig fra:

Actavis Group PTC ehf.

ATC-kode:

C09AA04

INN (International Name):

perindopril arginine

Dosering:

5 mg

Lægemiddelform:

Filmdragerad tablett

Sammensætning:

laktosmonohydrat Hjälpämne; perindoprilarginin 5 mg Aktiv substans

Recept type:

Receptbelagt

Produkt oversigt:

Förpacknings: Blister, 5 tabletter; Blister, 120 tabletter; Blister, 100 tabletter; Blister, 90 tabletter; Blister, 60 tabletter; Blister, 50 tabletter; Blister, 30 tabletter; Blister, 20 tabletter; Blister, 14 tabletter; Blister, 10 tabletter; Burk, 30 tabletter; Burk, 500 tabletter; Burk, 90 tabletter; Burk, 60 tabletter

Autorisation status:

Avregistrerad

Autorisation dato:

2016-01-14

Indlægsseddel

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
PERINDOPRIL ARGININE ACTAVIS 5 MG FILM-COATED TABLETS
Perindopril arginine
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 Actavis is and what it is used for
2.
What you need to know before you take Perindopril arginine Actavis
3.
How to take Perindopril arginine Actavis
4.
Possible side effects
5.
How to store Perindopril arginine Actavis
6.
Contents of the pack and other information
1.
WHAT PERINDOPRIL ARGININE ACTAVIS IS AND WHAT IT IS USED FOR
Perindopril arginine Actavis is an angiotensin converting enzyme (ACE)
inhibitor. These work by
widening the blood vessels, which makes it easier for your heart to
pump blood through them.
Perindopril arginine Actavis is used:
-
to treat high blood pressure (hypertension)
-
to treat heart failure (a condition where the heart is unable to pump
enough blood to meet the
body’s needs)
-
to reduce the risk of cardiac events, such as heart attack, in
patients with stable coronary artery
disease (a condition where the blood supply to the heart is reduced or
blocked) and who have
already had a heart attack and/or an operation to improve the blood
supply to the heart by
widening the vessels that supply it
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PERINDOPRIL ARGININE ACTAVIS
DO NOT TAKE PERINDOPRIL ARGININE ACTAVIS
-
if you are allergic to perindopril, to any other ACE inhibitor or any
of the other ingredients of
this medicine (listed in section 6)
-
if you have experienced symptoms such as wheez

Produktets egenskaber

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Perindopril arginine Actavis 5 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 5 mg perindopril arginine equivalent
to 3.395 mg perindopril.
Excipient with known effect:
Each film-coated tablet contains 70.78 mg lactose monohydrate
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Perindopril arginine Actavis 5 mg film-coated tablets are white, 8 x 4
mm oval, biconvex with side
scores and with two dots on one side. The tablet can be divided into
equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Hypertension:
Treatment of hypertension.
Heart failure:
Treatment of symptomatic heart failure.
Stable coronary artery disease:
Reduction of risk of cardiac events in patients with a history of
myocardial infarction and/or
revascularisation.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dose should be individualised according to the patient profile
(see section 4.4) and blood pressure
response.
_Hypertension:_
Perindopril arginine Actavis may be used in monotherapy or in
combination with other classes of
anti-hypertensive therapy (see sections 4.3, 4.4, 4.5 and 5.1).
The recommended starting dose is 5 mg given once daily in the morning.
Patients with a strongly activated renin-angiotensin-aldosterone
system (in particular, renovascular
hypertension, salt and/or volume depletion, cardiac decompensation or
severe hypertension) may
experience an excessive drop in blood pressure following the initial
dose. A starting dose of 2.5 mg is
recommended in such patients and the initiation of treatment should
take place under medical
supervision.
The dose may be increased to 10 mg once daily after one month of
treatment.
2
Symptomatic hypotension may occur following initiation of therapy with
Perindopril arginine Actavis;
this is more likely in patients who are being treated concurrently
with diuretics. Caution is therefore
recommended since these p