Nu-Seals 75

Land: Malta

Språk: engelsk

Kilde: Medicines Authority

Aktiv ingrediens:

ACETYLSALICYLIC ACID

Tilgjengelig fra:

Phadisco Limited Yiannou Kranidioti Avenue 185, CY-2234 Latsia, Cyprus

ATC-kode:

N02BA01

INN (International Name):

ACETYLSALICYLIC ACID 75 mg

Legemiddelform:

COATED TABLET

Sammensetning:

ACETYLSALICYLIC ACID 75 mg

Resept typen:

POM

Terapeutisk område:

ANALGESICS

Autorisasjon status:

Authorised

Autorisasjon dato:

2005-08-01

Informasjon til brukeren

Nu-Seals 75 (Aspirin)
INFORMATION FOR PATIENTS
WHAT YOU SHOULD KNOW ABOUT NU-SEALS 75 (ASPIRIN)
Please read this leaflet carefully before you start to take your
tablets. It does not contain all the
information about your tablets that you may need to know, so please
ask your doctor or
pharmacist if you have any questions. This leaflet only applies to
Nu-Seals 75.
WHAT IS IN YOUR TABLETS?
Your medicine is called Nu-Seals Aspirin. Its active ingredient is
aspirin (acetylsalicylic.acid).
Each tablet of Nu-Seals 75 contains 75mg of aspirin. The tablets also
contain the inactive
ingredients maize starch, hypromellose, talc, methacrylic acid-ethyl
acrylate (1:1) copolymer
dispersion 30 percent, polyethylene glycol 3350, propylene glycol,
benzyl alcohol, emulsion
silicone, and edible printing ink (E172 red and shellac).
Nu-Seals 75 is a white tablet, with 75 on it in red. Nu-Seals 75 comes
in boxes of 56 tablets.
Nu-Seals Aspirin is one of 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. Nu-Seals Aspirin
can help to prevent (further heart attacks (myocardial infarcts),
unstable angina (a type of chest
pain), or mini-strokes (ischaemic strokes including cerebral transient
attacks) by helping to
prevent blood clots forming.
Nu-Seals Aspirin is manufactured by Chanelle Medical Unlimited,
Loughrea, Co Galway,
Ireland.
The Μarketing Αuthorization Ηolder is Phadisco Ltd, 185 Yiannou
Kranidioti Avenue, CY-
2234 Latsia, Cyprus.
WHY NU-SEALS ASPIRIN?
Nu-Seals Aspirin helps patients with heart problems such as heart
attacks, angina or mini-
strokes.
IF YOU TAKE ASPIRIN IN HIGH DOSES OR OVER A LONG PERIOD OF TIME, IT
CAN IRRITATE THE STOMACH
LINING. TO PREVENT STOMACH IRRITATION, THESE TABLETS HAVE A SPECIAL
COATING (CALLED ENTERIC)
SO THAT THE ASPIRIN IS NOT RELEASED UNTIL IT HAS PASSED THROUGH THE
STOMACH.
Nu-Seals Aspirin is not suitable for the short-term relief of pain,
such as headaches or toothache,
because of the low relea

Preparatomtale

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
T
RADE
N
AME OF
M
EDICINAL
P
RODUCT
Nu-Seals 75
Aspirin 75mg Enteric Coated Tablets
2.
Q
UALITATIVE AND
Q
UANTITATIVE
C
OMPOSITION
Acetylsalicylic Acid 75mg
3.
P
HARMACEUTICAL
F
ORM
White, enteric coated tablets, coded “75”
4.
C
LINICAL
P
ARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the secondary prevention of thrombotic, cerebrovascular or
cardiovascular disease and
following by-pass surgery (see below).
Aspirin has an anti-thrombotic action, mediated through inhibition of
platelet activation, which
has been shown to be useful in secondary prophylaxis following
infarction and in patients with
unstable angina or ischaemic stroke including cerebral transient
attacks.
Nu-Seals 75 is indicated wherever high and prolonged dosage of aspirin
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, Nu-Seals is unsuitable for the short-term relief of
pain.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Nu-Seals 75 is for oral administration to adults only.
Patients should seek the advice of a doctor before commencing therapy
for the first time.
The usual dosage, for long term use, is 75-150mg once daily. In some
circumstances a higher dose
may be appropriate, especially in the short term, and up to 300mg a
day may be used on the advice
of a doctor.
_Antithrombotic action:_
150mg at diagnosis and 75mg once daily thereafter. Tablets taken at
diagnosis should be chewed in order to gain rapid absorption.
_ _
2
_ _
_ _
_The elderly: _
The risk-benefit ratio of the antithrombotic action of aspirin has not
been fully
established.
Children: Nu-Seals 75 is not indicated for use in children and young
people less than 16 years of
age, for example in treatment of juvenile rheumatoid arthritis. Avoid
in children up to and
including 15 years of age if feverish (see “Special Warning and
Special Precautions for Use”).