Acetylsalicylic acid Krka 100 mg Enterotablett

Maa: Ruotsi

Kieli: ruotsi

Lähde: Läkemedelsverket (Medical Products Agency)

Aktiivinen ainesosa:

acetylsalicylsyra

Saatavilla:

Krka d.d., Novo mesto

ATC-koodi:

B01AC06

INN (Kansainvälinen yleisnimi):

acetylsalicylic acid

Annos:

100 mg

Lääkemuoto:

Enterotablett

Koostumus:

natriumlaurilsulfat Hjälpämne; laktosmonohydrat Hjälpämne; acetylsalicylsyra 100 mg Aktiv substans

Prescription tyyppi:

Receptbelagt

Tuoteyhteenveto:

Förpacknings: Blister, 28 tabletter; Blister, 30 tabletter; Blister, 50 tabletter; Blister, 56 tabletter; Blister, 60 tabletter; Blister, 84 tabletter; Blister, 90 tabletter; Blister, 100 tabletter; Blister, 168 tabletter

Valtuutuksen tilan:

Godkänd

Valtuutus päivämäärä:

2017-02-10

Pakkausseloste

PACKAGE LEAFLET: INFORMATION FOR THE USER
ACETYLSALICYLIC ACID KRKA 75 MG GASTRO-RESISTANT TABLETS
ACETYLSALICYLIC ACID KRKA 100 MG GASTRO-RESISTANT TABLETS
ACETYLSALICYLIC ACID KRKA 160 MG GASTRO-RESISTANT TABLETS
acetylsalicylic acid
_[For medicines available only on prescription:]_
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.
_[For medicines available without a prescription: ]_
READ ALL OF THIS LEAFLET CAREFULLY BEFORE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always take this medicine exactly as described in this leaflet or as
your doctor or pharmacist or nurse
has have told you.
-
Keep this leaflet. You may need to read it again.
-
Ask your pharmacist if you need more information or advice.
-
If you get any side effects, talk to your doctor or pharmacist or
nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
-
You must talk to a doctor if you do not feel better or if you feel
worse.
WHAT IS IN THIS LEAFLET
1.
What is and what it is used for
2.
What you need to know before you take
3.
How to take
4.
Possible side effects
5.
How to store
6.
Contents of the pack and other information
1.
WHAT IS AND WHAT IT IS USED FOR
contains acetylsalicylic acid, which in low doses
belong to a group of medicines
called anti-platelet agents. Platelets are tiny cells in the blood
that cause the blood to clot and are
involved in thrombosis. When a blood clot occurs in an

Valmisteyhteenveto

PRODUKTRESUMÉ
1.
LÄKEMEDLETS NAMN
Acetylsalicylic acid Krka 75 mg enterotabletter
Acetylsalicylic acid Krka 100 mg enterotabletter
Acetylsalicylic acid Krka 160 mg enterotabletter
2.
KVALITATIV OCH KVANTITATIV SAMMANSÄTTNING
Varje enterotablett innehåller 75 mg, 100 mg eller 160 mg
acetylsalicylsyra.
Hjälpämnen med känd effekt:
75 mg:
Laktosmonohydrat...........................................................................................45
mg per tablett.
Para-orange (E110)
..................................................................................0,0006
mg per tablett.
100 mg:
Laktosmonohydrat
…………………………………………………………60
mg per tablett.
160 mg:
Laktosmonohydrat...........................................................................................96
mg per tablett.
Sojalecitin
(E322).........................................................................................0,42
mg per tablett.
För fullständig förteckning över hjälpämnen, se avsnitt 6.1.
3.
LÄKEMEDELSFORM
Enterotablett
75 mg: rosa, runda, bikonvexa enterotabletter med en diameter på
ungefär 7,2 mm.
100 mg: Vita, runda, bikonvexa enterotabletter med en diameter på
ungefär 8,1 mm.
160 mg: gula, runda, bikonvexa enterotabletter med en diameter på
ungefär 9,2 mm.
4.
KLINISKA UPPGIFTER
4.1
TERAPEUTISKA INDIKATIONER
-
Sekundärprofylax efter hjärtinfarkt.
-
Profylax mot kardiovaskulär dödlighet hos patienter med stabil
angina pectoris.
-
Anamnes på instabil angina pectoris, förutom under den akuta fasen.
-
Profylax mot graftocklusion efter CABG (Coronary Artery Bypass
Grafting).
-
Vidkoronarangioplastik, förutom under den akuta fasen.
-
Sekundärprofylax efter TIA (transitoriska ischemiska attacker) och
ischemiska
cerebrovaskulära händelser, givet att intracerebral blödning har
uteslutits.
Acetylsalicylic acid Krka rekommenderas ej vid akuta situationer.
Användningen är begränsad till
sekundärprofylax vid kronisk behandling.
4.2
DOSERING OCH ADMINISTRERINGSSÄTT
Doserin