Avancardo 10 mg/2,5 mg Filmdragerad tablett

Ülke: İsveç

Dil: İsveççe

Kaynak: Läkemedelsverket (Medical Products Agency)

Aktif bileşen:

indapamidhemihydrat; perindoprilarginin

Mevcut itibaren:

Actavis Group PTC ehf.

ATC kodu:

C09BA04

INN (International Adı):

indapamidhemihydrat; perindopril arginine

Doz:

10 mg/2,5 mg

Farmasötik formu:

Filmdragerad tablett

Kompozisyon:

perindoprilarginin 10 mg Aktiv substans; indapamidhemihydrat 2,5 mg Aktiv substans; laktosmonohydrat Hjälpämne

Reçete türü:

Receptbelagt

Ürün özeti:

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

Yetkilendirme durumu:

Avregistrerad

Yetkilendirme tarihi:

2016-01-14

Bilgilendirme broşürü

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
AVANCARDO 10 MG/2.5 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).
Avancardo 10 mg/2.5 mg is prescribed for patients already receiving
perindopril 10 mg and
indapamide 2.5 mg from separate tablets, these patients may instead
receive one tablet of Avancardo
10 mg/2.5 mg which contains both ingredients.
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
sulphonam

Ürün özellikleri

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Avancardo 10 mg/2.5 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10 mg perindopril arginine
corresponding to 6.79 mg perindopril and
2.5 mg indapamide hemidydrate.
Excipient with known effect:
Each film-coated tablet contains 167 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Avancardo 10 mg/2.5 mg film-coated tablets are white, 8.5 mm round and
biconvex
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Avancardo 10 mg/2.5 mg is indicated as substitution therapy for
treatment of essential hypertension, in
patients already controlled with perindopril and indapamide given
concurrently at the same dose level.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
One Avancardo 10 mg/2.5 mg tablet per day as a single dose, preferably
to be taken in the morning,
and before a meal.
_Elderly (see section 4.4)_
In elderly, the plasma creatinine must be adjusted in relation to age,
weight and gender. Elderly
patients can be treated if renal function is normal and after
considering blood pressure response.
_Patients with renal impairment (see section 4.4)_
In severe and moderate renal impairment (creatinine clearance below 60
ml/min), treatment is
contraindicated.
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.
_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.
2
Method of administration
Oral use.
4.3
CONTRAINDICATIONS
-
Hypersensitivity to the active substances, to any other ACE inhibitor,
or to any other
sulphonamides or to any of the e