Acetylsalicylsyra Hexal 100 mg Enterotablett

Land: Sverige

Språk: svenska

Källa: Läkemedelsverket (Medical Products Agency)

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Bipacksedel Bipacksedel (PIL)
19-04-2018
Produktens egenskaper Produktens egenskaper (SPC)
19-04-2018

Aktiva substanser:

acetylsalicylsyra

Tillgänglig från:

Hexal A/S

ATC-kod:

B01AC06

INN (International namn):

acetylsalicylic acid

Dos:

100 mg

Läkemedelsform:

Enterotablett

Sammansättning:

acetylsalicylsyra 100 mg Aktiv substans; natriumlaurilsulfat Hjälpämne

Klass:

Apotek

Receptbelagda typ:

Receptbelagt

Terapiområde:

Acetylsalicylsyra

Produktsammanfattning:

Förpacknings: Blister, 100 x 1 tabletter; Blister, 30 x 1 tabletter; Blister, 50 x 1 tabletter; Blister, 50 tabletter; Blister, 100 tabletter; Blister, 30 tabletter

Bemyndigande status:

Avregistrerad

Tillstånd datum:

2011-09-23

Bipacksedel

                                PACKAGE LEAFLET: INFORMATION FOR THE USER
ACETYLSALICYLSYRA HEXAL 100 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 YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always take this medicine exactly as described in this leaflet or as
your doctor or pharmacist has 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. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Acetylsalicylsyra Hexal is and what it is used for
2.
What you need to know before you take Acetylsalicylsyra Hexal
3.
How to take Acetylsalicylsyra Hexal
4.
Possible side effects
5.
How to store Acetylsalicylsyra Hexal
6.
Contents of the pack and other information
1.
WHAT ACETYLSALICYLSYRA HEXAL IS AND WHAT IT IS USED FOR
Acetylsalicylsyra Hexal 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 artery
it stops the blood flowing and
cuts off the oxygen supply. When this happens in the heart it can
cause a heart attack or angina; in the
brain it can cause a stroke.
                                
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Produktens egenskaper

                                Produktinformationen för Acetylsalicylsyra Hexal 100 mg
enterotablett, MTnr 46234, gäller vid det
tillfälle då läkemedlet godkändes. Informationen kommer inte att
uppdateras eftersom läkemedlet inte
marknadsförs i Sverige. Av samma anledning finns inte någon svensk
produktinformation.
Den engelska produktinformationen kommer dock att uppdateras för de
produkter där Sverige är
referensland.
Om läkemedelsnamnet i följande produktinformation inte stämmer med
namnet på dokumentet, beror
det på att läkemedlet i Sverige är godkänt under ett annat namn.
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Acetylsalicylsyra Hexal 100 mg gastro-resistant tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gastro-resistant tablet contains 100 mg acetylsalicylic acid.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Gastro-resistant tablet.
100 mg: Round, white, biconvex film-coated tablets, with a diameter of
7.2 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
-
Secondary prevention of myocardial infarction.
-
Prevention of cardiovascular morbidity in patients suffering from
stable angina pectoris.
-
History of unstable angina pectoris, except during the acute phase.
-
Prevention of graft occlusion after Coronary Artery Bypass Grafting
(CABG).
-
Coronary angioplasty, except during the acute phase.
-
Secondary prevention of transient ischaemic attacks (TIA) and
ischaemic cerebrovascular
accidents (CVA), provided intracerebral haemorrhages have been ruled
out.
Acetylsalicylsyra Hexal is not recommended in emergency situations. It
is restricted to secondary
prevention with chronic treatment.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults
_Secondary prevention of myocardial infarction:_
The recommended dose is 100 mg once daily.
_Prevention of cardiovascular morbidity in patients suffering from
stable angina pectoris:_
The recommended dose is 100 mg once daily.
_History of unstable angina pectoris, except during the acute phase:_
The recommended
                                
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