Acetylsalicylsyra Hexal 75 mg Enterotablett

Država: Švedska

Jezik: švedščina

Source: Läkemedelsverket (Medical Products Agency)

Aktivna sestavina:

acetylsalicylsyra

Dostopno od:

Hexal A/S

Koda artikla:

B01AC06

INN (mednarodno ime):

acetylsalicylic acid

Odmerek:

75 mg

Farmacevtska oblika:

Enterotablett

Sestava:

acetylsalicylsyra 75 mg Aktiv substans; natriumlaurilsulfat Hjälpämne

Razred:

Apotek

Tip zastaranja:

Receptbelagt

Terapevtsko območje:

Acetylsalicylsyra

Povzetek izdelek:

Förpacknings: Blister, 10 x1 tabletter; Blister, 20 x 1 tabletter; Blister, 28 x 1 tabletter; Blister, 30 x 1 tabletter; Blister, 50 x 1 tabletter; Blister, 56 x 1 tabletter; Blister, 60 x 1 tabletter; Blister, 90 x 1 tabletter; Blister, 10 tabletter; Blister, 28 tabletter; Blister, 100 tabletter; Blister, 50 tabletter; Blister, 30 tabletter; Blister, 56 tabletter; Blister, 90 tabletter; Blister, 60 tabletter; Blister, 20 tabletter

Status dovoljenje:

Avregistrerad

Datum dovoljenje:

2011-09-23

Navodilo za uporabo

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ACETYLSALICYLSYRA HEXAL 75 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 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. 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

Lastnosti izdelka

Produktinformationen för Acetylsalicylsyra Hexal 75 mg enterotablett,
MTnr 46233, 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 75 mg gastro-resistant tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gastro-resistant tablet contains 75 mg acetylsalicylic acid.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Gastro-resistant tablet.
75 mg: Oval, white, biconvex film-coated tablet, 9.2 x 5.2 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Acetylsalicylsyra Hexal is restricted to secondary prevention with
chronic treatment:
-
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.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults_
_Secondary prevention of myocardial infarction:_
The recommended dose is 75-150 mg once daily.
_Prevention of cardiovascular morbidity in patients suffering from
stable angina pectoris:_
The recommended dose is 75-150 mg once daily.
_History of unstable angina pectoris, except during the acute phase:_
The r