Avancardo 5 mg/1,25 mg Filmdragerad tablett

Krajina: Švédsko

Jazyk: švédčina

Zdroj: Läkemedelsverket (Medical Products Agency)

Aktívna zložka:

indapamidhemihydrat; perindoprilarginin

Dostupné z:

Actavis Group PTC ehf.

ATC kód:

C09BA04

INN (Medzinárodný Name):

indapamidhemihydrat; perindopril arginine

Dávkovanie:

5 mg/1,25 mg

Forma lieku:

Filmdragerad tablett

Zloženie:

perindoprilarginin 5 mg Aktiv substans; laktosmonohydrat Hjälpämne; indapamidhemihydrat 1,25 mg Aktiv substans

Typ predpisu:

Receptbelagt

Prehľad produktov:

Förpacknings: Burk, 30 tabletter; Burk, 60 tabletter; Burk, 90 tabletter; Burk, 100 tabletter; Blister, 30 tabletter; Blister, 60 tabletter; Blister, 90 tabletter; Blister, 100 tabletter

Stav Autorizácia:

Avregistrerad

Dátum Autorizácia:

2016-01-14

Príbalový leták

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
AVANCARDO 5 MG/1.25 MG FILM-COATED TABLETS
perindopril arginine/indapamide hemihydrate
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 Avancardo is and what it is used for
2.
What you need to know before you take Avancardo
3.
How to take Avancardo
4.
Possible side effects
5.
How to store Avancardo
6.
Contents of the pack and other information
1.
WHAT AVANCARDO IS AND WHAT IT IS USED FOR
Avancardo is a combination of two active ingredients, perindopril and
indapamide. It is an
antihypertensive and is used in the treatment of high blood pressure
(hypertension).
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 work together to
control your blood pressure.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE AVANCARDO
DO NOT TAKE AVANCARDO
-
if you are allergic to perindopril or any other ACE inhibitor, or to
indapamide or any other
sulphonamides or any of the other ingredients of this medicine (listed
in section 6).
-
if you have experienced symptoms such as wheezing, swelling of the
face or tongue, intense
itching or severe skin rashes with previous ACE inhibitor treatmen

Súhrn charakteristických

Perindopril (arginine)/Indapamide, film-coated tablets, SE/H/1426/002,
12.02.2019
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Avancardo 5 mg/1.25 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains 5 mg perindopril arginine
corresponding to 3.395 mg perindopril and
1.25 mg indapamide hemidydrate
Excipient with known effect:
Each film-coated tablet contains 84 mg lactose monohydrate
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Avancardo 5 mg/1.25 mg film-coated tablets are blue, 8.5 mm x 4.3 mm
oval, biconvex with
horizontal line on one side
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of essential hypertension, Avancardo 5 mg/1.25 mg
film-coated tablet is indicated in
patients whose blood pressure is not adequately controlled on
perindopril alone.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
One Avancardo 5 mg/1.25 mg film-coated tablet per day as a single
dose, preferably to be taken in the
morning, and before a meal.
When possible individual dose titration with the components is
recommended. Avancardo
5 mg/1.25 mg film-coated tablet should be used when blood pressure is
not adequately controlled on
Avancardo 2.5 mg/0.625 mg film-coated tablet (where available). When
clinically appropriate, direct
change from monotherapy to Avancardo 5 mg/1.25 mg film-coated tablet
may be considered.
_Elderly (see section 4.4)_
Treatment should be initiated after considering blood pressure
response and renal function.
_Patients with renal impairment (see section 4.4)_
In severe renal impairment (creatinine clearance below 30 ml/min),
treatment is contra-indicated.
In patients with moderate renal impairment (creatinine clearance 30-60
ml/min), it is recommended to
start treatment with the adequate dosage of the free combination.
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 monitorin