Aspirem Tablets Gastro-Resistant 75mg

Krajina: Malta

Jazyk: angličtina

Zdroj: Medicines Authority

Aktívna zložka:

ACETYLSALICYLIC ACID

Dostupné z:

Remedica Limited Limassol Industrial Estate, Aharnon Street, 3056 Limassol, Cyprus

ATC kód:

B01AC06

INN (Medzinárodný Name):

ACETYLSALICYLIC ACID 75 mg

Forma lieku:

GASTRO-RESISTANT TABLET

Zloženie:

ACETYLSALICYLIC ACID 75 mg

Typ predpisu:

OTC

Terapeutické oblasti:

ANTITHROMBOTIC AGENTS

Stav Autorizácia:

Authorised

Dátum Autorizácia:

2006-11-01

Príbalový leták

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ASPIREM 75 MG GASTRO-RESISTANT TABLETS
Acetylsalicylic acid
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.
-
You must talk to a doctor if you do not feel better or if you feel
worse after taking the
medicine.
WHAT IS IN THIS LEAFLET
1.
What Aspirem is and what it is used for
2.
What you need to know before you take Aspirem
3.
How to take Aspirem
4.
Possible side effects
5.
How to store Aspirem
6.
Contents of the pack and other information
1.
WHAT ASPIREM IS AND WHAT IT IS USED FOR
Aspirem contains the active substance acetylsalicylic acid.
Acetylsalicylic acid is used:
•
to prevent recurrence of heart attacks or strokes by thinning the
blood. If someone who
has previously had a heart attack or stroke takes Aspirem regularly,
it reduces the risk of
a blood clot occurring in the heart or brain. This can prevent further
heart attacks or
strokes.
IF YOU TAKE ACETYLSALICYLIC ACID IN HIGH DOSES OR OVER A LONG PERIOD
OF TIME, IT CAN IRRITATE
YOUR STOMACH LINING. TO PREVENT STOMACH IRRITATION, THESE TABLETS HAVE
A SPECIAL COATING
(CALLED ENTERIC) SO THAT THE ACETYLSALICYLIC ACID IS NOT RELEASED
UNTIL IT HAS PASSED THROUGH
THE STOMACH.
Acetylsalicylic acid is released slowly from these tablets, so Aspirem
is not suitable for the
short-term relief of pain, such as headaches or toothache.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ASPIREM
DO NOT TAKE ASPIREM
•
if you are allergic to acetylsalicylic acid or any of the ingredients
in this medicine (listed
in section 6).
•
if you have had a cerebral ha

Súhrn charakteristických

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SUMMARY OF PRODUCT CHARACTERISTICS
_ _
1.
NAME OF THE MEDICINAL PRODUCT
Aspirem 75 mg gastro-resistant tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gastro-resistant tablet contains 75 mg acetylsalicylic acid.
Excipient(s) with known effect
This product contains 37.1 mg lactose and 1.9 mg sucrose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Gastro-resistant tablet.
White, round, gastro-resistant tablets.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Acetylsalicylic acid has an antithrombotic action, mediated through
inhibition of platelet
activation, which has been shown to be useful in secondary prophylaxis
following myocardial
infarction and in patients with unstable angina or ischaemic stroke.
Aspirem is indicated when prolonged dosage of acetylsalicylic acid is
required. The special
coating resists dissolution in gastric juice, but will dissolve
readily in the relatively less acid
environment of the duodenum. Owing to the delay that the coating
imposes on the release of
the active ingredient, Aspirem is unsuitable for the short-term relief
of pain.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION_ _
_ _
Aspirem is for oral administration to adults only.
Posology
Antithrombotic action: The usual dose is 75 mg, daily. When rapid
absorption is required
(e.g., following acute myocardial infarction), two tablets (150 mg)
should be taken together
and chewed.
_ _
_ _
_The elderly_
: As for adults.
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In general, acetylsalicylic acid should be used with particular
caution in elderly patients who
are more prone to adverse events. Undesirable effects may be minimised
by using the lowest
effective dose for the shortest duration necessary to control symptoms
(see section 4.4).
Treatment should be reviewed at regular intervals.
_Children: _
do not give to children and adolescents aged under 16 years, except on
medical
advice, where the benefit outweighs the risk (see section 4.4).
Method of adm