Nu-seals 75 mg gastro-resistant tablets

Ország: Írország

Nyelv: angol

Forrás: HPRA (Health Products Regulatory Authority)

Aktív összetevők:

Acetylsalicylic acid

Beszerezhető a:

Alliance Pharmaceuticals Ltd.

ATC-kód:

B01AC; B01AC06

INN (nemzetközi neve):

Acetylsalicylic acid

Adagolás:

75 milligram(s)

Gyógyszerészeti forma:

Gastro-resistant tablet

Recept típusa:

Product subject to prescription which may be renewed (B)

Terápiás terület:

Platelet aggregation inhibitors excl. heparin; acetylsalicylic acid

Engedélyezési státusz:

Marketed

Engedély dátuma:

1997-04-23

Betegtájékoztató

Nu-Seals 75 PIL ROI 016
PATIENT INFORMATION LEAFLET
NU-SEALS
®
75MG
GASTRO-RESISTANT TABLETS
aspirin (acetylsalicylic acid)
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. WHAT IS IN THIS LEAFLET
1.
WHAT NU-SEALS 75MG IS AND WHAT IT IS TAKEN FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NU-SEALS 75MG
3. HOW TO TAKE NU-SEALS 75MG
4. POSSIBLE SIDE EFFECTS
5.
HOW TO STORE NU-SEALS 75MG
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT NU-SEALS 75MG IS AND WHAT IT IS TAKEN FOR
Nu-Seals 75mg contains aspirin. Aspirin 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 Nu-Seals
75mg 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 ASPIRIN 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 ASPIRIN IS NOT
RELEASED
UNTIL IT HAS PASSED THROUGH THE STOMACH.
Aspirin is released slowly from these tablets, so Nu-Seals 75mg is not
suitable
for the short-term relief of pain, such as headaches or toothache.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NU-SEALS 75MG
DO NOT TAKE NU-SEALS 75MG:
Nu-Seals 75 PIL ROI 016
•
if you are allergic to aspirin or any of the other ingredients in this
medicine
(listed in section 6)
•
if you have had a cerebral haemorrhage (a type of stroke caused by
bleeding in your brain)
•
if y

Termékjellemzők

Health Products Regulatory Authority
03 December 2018
CRN008JZR
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nu-seals 75 mg gastro-resistant tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
Aspirin (Acetylsalicylic Acid) 75mg.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant tablet
Smooth, white tablets printed with ‘75’ in red.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Aspirin 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.
Nu-Seals 75 is indicated wherever 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 75
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.
Antithrombotic action: The usual dose is 75mg, daily. When rapid
absorption is
required (e.g., following acute myocardial infarction), two tablets
(150mg) should be
taken together and chewed.
The elderly: As for adults.
In general, aspirin should be used with particular caution in elderly
patients who are
more prone to adverse events.
Health Products Regulatory Authority
03 December 2018
CRN008JZR
Page 2 of 13
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).
4.3 CONTRAINDICATIONS
Hypersensitivity to aspirin (e.g.- bronchospasm, rhinitis, urticaria),
to non-s