Disprin Original 300 mg Dispersible Tablets

Šalis: Airija

kalba: anglų

Šaltinis: HPRA (Health Products Regulatory Authority)

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Parsisiųsti Pakuotės lapelis (PIL)
28-09-2022
Parsisiųsti Prekės savybės (SPC)
28-09-2022

Veiklioji medžiaga:

Acetylsalicylic acid

Prieinama:

Reckitt Benckiser Ireland Ltd

ATC kodas:

N02BA; N02BA01

INN (Tarptautinis Pavadinimas):

Acetylsalicylic acid

Dozė:

300 milligram(s)

Vaisto forma:

Dispersible tablet

Recepto tipas:

Product not subject to medical prescription

Gydymo sritis:

Salicylic acid and derivatives; acetylsalicylic acid

Autorizacija statusas:

Marketed

Leidimo data:

1978-04-01

Pakuotės lapelis

                                PACKAGE LEAFLET: INFORMATION FOR THE USER
Disprin Original 300mg Dispersible 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 Original is and what is it used for
2.
What you need to know before you take Disprin Original
3.
How to take Disprin Original
4.
Possible side-effects
5.
How to store Disprin Original
6.
Contents of the pack and other information.
1.
WHAT DISPRIN ORIGINAL IS AND WHAT IT IS USED FOR
The ingredients that makes Disprin Original 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 Original 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.
•
relief in upper respiratory tract infections
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DISPRIN ORIGINAL
DO NOT TAKE DISPRIN ORIGINAL 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
                                
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Prekės savybės

                                Health Products Regulatory Authority
28 September 2022
CRN00CT1Q
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Disprin Original 300 mg Dispersible Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 300 mg of acetylsalicylic acid.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Dispersible tablet.
White, flat, circular, bevel-edged dispersible tablets with the
‘Sword’ motif and the word ‘Disprin’ engraved on one face,
plain
on reverse.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the relief of mild to moderate pain, such as is associated with
headache, toothache, neuralgia and period pains.
Symptomatic relief in upper respiratory tract infections (such as
feverishness, cold and flu, sore throat).
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 aged 16 and over:
One to two tablets every 4-6 hours to a maximum of 12 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: 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
Oral administration after dissolution in 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.
Health Products Regulatory A
                                
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