Disprin Direct 300 mg Orodispersible Tablets

Land: Irland

Språk: engelska

Källa: HPRA (Health Products Regulatory Authority)

Aktiva substanser:

Aspirin

Tillgänglig från:

Reckitt Benckiser Ireland Ltd

ATC-kod:

N02BA; N02BA01

INN (International namn):

Aspirin

Dos:

300 milligram(s)

Läkemedelsform:

Orodispersible tablet

Receptbelagda typ:

Product not subject to medical prescription

Terapiområde:

Salicylic acid and derivatives; acetylsalicylic acid

Bemyndigande status:

Marketed

Tillstånd datum:

1983-07-26

Bipacksedel

PACKAGE LEAFLET: INFORMATION FOR THE USER
Disprin Direct 300mg Orodispersible Tablets
ASPIRIN (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 24 hours.
WHAT IS IN THIS LEAFLET
1.
What Disprin Direct is and what is it used for
2.
What you need to know before you take Disprin Direct
3.
How to take Disprin Direct
4.
Possible side-effects
5.
How to store Disprin Direct
6.
Contents of the pack and other information.
1.
WHAT DISPRIN DIRECT IS AND WHAT IT IS USED FOR
The ingredients that makes Disprin Direct work (the active ingredient)
is Aspirin. Aspirin belongs to a
group of medicines know as non-steroidal anti-inflammatory drugs
(NSAIDs). It works to relieve pain
and inflammation. Disprin Direct can be used to
•
relieve mild to moderate pain (such as headache, toothache and nerve
pain)
•
reduce temperature and inflammation, such as lower back pain.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DISPRIN DIRECT
DO NOT TAKE DISPRIN DIRECT IF YOU
•
are
ALLERGIC
to or have ever had an allergic reaction to aspirin or to other
non-steroidal anti-
inflammatory drugs or to any of the other ingredients (see section 6).
Allergic reactions may
include wheeziness, runny nose, itchy skin, rash
•
have or have ever had a
STOMACH ULCER, PERFORATION OR BLEEDING
•
have or have ever had a
BLEEDING DISORDER
•
have severe
LIVER OR KIDNEY PROBLEMS
•
are in the last
3 MONTHS OF PREGNANCY
or are
BREAST-FEEDING
•
are under
16 YEARS
of age
•
have or have ever had
SEVERE HEART FAILURE
W

Produktens egenskaper

Health Products Regulatory Authority
28 September 2022
CRN00CT1Q
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Disprin Direct 300 mg Orodispersible Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 300 mg acetylsalicylic acid.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Orodispersible tablet
A white circular flat tablet with odour and taste of lemon. On one
surface indented with ‘sword’ motif, the other plain.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the relief of mild to moderate pain such as is associated with
headache, toothache and neuralgia. Reduction of
temperature. Reduction of inflammation such as in lumbago.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The lowest effective dose should be used for the shortest duration
necessary to relieve symptoms.
POSOLOGY
Adults and children 16 years and over: One to two tablets every 4-6
hours to a maximum of twelve tablets in 24 hours.
Do not give to children and adolescents aged under 16 years, except on
medical advice, where the benefit outweighs the risk.
HEPATIC IMPAIRMENT: Patients with hepatic impairment should seek the
advice of a doctor before taking this product (see
sections 4.3 and 4.4).
RENAL IMPAIRMENT: Patients with renal impairment should seek the
advice of a doctor before taking this product (see sections
4.3 and 4.4).
ELDERLY: There is no indication that dosage need be modified in the
elderly. Non-steroidal anti-inflammatory drugs should be
used with particular caution in elderly patients who are more prone to
adverse events. The lowest dose compatible with
adequate safe clinical control should be employed. See also Section
4.4.
METHOD OF ADMINISTRATION
For oral administration.
Disperses on the tongue without water.
4.3 CONTRAINDICATIONS
Hypersensitivity to acetylsalicylic acid or to any of the excipients
listed in section 6.1.
Hypersensitivity to other non-steroidal anti-inflammatory drugs.
History of gastrointestinal bleeding or perforation related to