Nu-Seals 300 mg Gastro-resistant Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Acetylsalicylic acid

Available from:

Alliance Pharma (Ireland) Limited

ATC code:

N02BA; N02BA01

INN (International Name):

Acetylsalicylic acid

Dosage:

300 milligram(s)

Pharmaceutical form:

Gastro-resistant tablet

Therapeutic area:

Salicylic acid and derivatives; acetylsalicylic acid

Authorization status:

Marketed

Authorization date:

1998-04-01

Patient Information leaflet

Nu-Seals 300 PIL ROI 015
PATIENT INFORMATION LEAFLET
NU-SEALS
® 300MG
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 300MG IS AND WHAT IT IS TAKEN FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NU-SEALS 300MG
3. HOW TO TAKE NU-SEALS 300MG
4. POSSIBLE SIDE EFFECTS
5.
HOW TO STORE NU-SEALS 300MG
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT NU-SEALS 300MG IS AND WHAT IT IS TAKEN FOR
Nu-Seals 300mg contains aspirin. Aspirin is used:

as an anti-inflammatory analgesic which can relieve pain and swelling

to bring down high body temperatures

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
300mg 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 300mg is
not
suitable for the short-term relief of pain, such as headaches or
toothache.
Nu-Seals 300 PIL ROI 015
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NU-SEALS 300MG
DO NOT TAKE NU-SEALS 300MG:

if you are allergic to aspirin or any of the other ingredients in this
medici

Summary of Product characteristics

Health Products Regulatory Authority
07 February 2020
CRN009LFK
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nu-Seals 300 mg Gastro-resistant Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
Acetylsalicylic Acid Ph. Eur. (Aspirin) 300 mg.
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant tablet.
Gastro-resistant tablets, white in colour, printed with ‘300’ in
red.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Aspirin has analgesic, antipyretic and anti-inflammatory actions. It
also has an anti-thrombotic 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 300 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 300
is unsuitable for the short-term relief of pain.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Nu-Seals 300 is for oral administration to adults only.
_Analgesic, antipyretic and anti-inflammatory actions_: The usual dose
of aspirin is 300-900mg repeated three to four times daily
according to clinical needs. In acute rheumatic disorders the dose is
in the range of 4-8 g daily, taken in divided doses.
_Antithrombotic action_: For its antithrombotic effect following
myocardial infarction, ischaemic stroke and in patients with
unstable angina, the recommended dose is 300mg daily.
_The Elderly:_ As for adults. Aspirin 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