Avancardo 2,5 mg/0,625 mg Filmdragerad tablett

Nazione: Svezia

Lingua: svedese

Fonte: Läkemedelsverket (Medical Products Agency)

Principio attivo:

indapamidhemihydrat; perindoprilarginin

Commercializzato da:

Actavis Group PTC ehf.

Codice ATC:

C09BA04

INN (Nome Internazionale):

indapamidhemihydrat; perindopril arginine

Dosaggio:

2,5 mg/0,625 mg

Forma farmaceutica:

Filmdragerad tablett

Composizione:

laktosmonohydrat Hjälpämne; indapamidhemihydrat 0,625 mg Aktiv substans; perindoprilarginin 2,5 mg Aktiv substans

Tipo di ricetta:

Receptbelagt

Dettagli prodotto:

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

Stato dell'autorizzazione:

Avregistrerad

Data dell'autorizzazione:

2016-01-14

Foglio illustrativo

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
AVANCARDO 2.5 MG/0.625 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 treat

Scheda tecnica

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Avancardo 2.5 mg/0.625 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 2.5 mg perindopril arginine
corresponding to 1.6975 mg perindopril
and 0.625 mg indapamide hemidydrate.
Excipient with known effect:
Each film-coated tablet contains 87 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Avancardo 2.5 mg/0.625 mg film-coated tablets are white, 8.5 mm x 4.3
mm oval and biconvex
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Essential hypertension.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
One Avancardo 2.5 mg/0.625 mg 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
_._
_Elderly (see section 4.4)_
Treatment should be started at the normal dose of one Avancardo 2.5
mg/0.625 mg film-coated tablet
per day
_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), the maximum dose
should be one tablet of Avancardo 2.5 mg/0.625 mg 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.
_Patients with hepatic impairment (see sections 4.3, 4.4 and 5.2)_
In severe hepatic impairment, treatment is contraindicated.
In patients with moderate hepatic impairment, no dose modification is
required.
2
_Paediatric population_
Avancardo should not be used in children and adolescents as the
efficacy and tolerability of
perindopril in children and adolescents, alone or in combination, have
not been established.
Method of administration
Oral use.
4.3
CONTRAINDICATIONS
-
Hypersensitivi