Aspirin 300mg Effervescent tablets
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
29-07-2021
Summary of Product characteristics
(SPC)
10-01-2024
Active ingredient:
Aspirin
Available from:
Bayer Limited
ATC code:
N02BA; N02BA01
INN (International Name):
Aspirin
Dosage:
300 milligram(s)
Pharmaceutical form:
Effervescent tablet
Prescription type:
Product not subject to medical prescription
Therapeutic area:
Salicylic acid and derivatives; acetylsalicylic acid
Authorization status:
Not marketed
Authorization date:
1976-06-08
Patient Information leaflet
BCH20056
Package Leaflet: Information for the user
ASPIRIN 300MG EFFERVESCENT TABLETS
Acetylsalicylic acid (Aspirin)
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 3 days.
WHAT IS IN THIS LEAFLET:
1. What Aspirin is and what it is used for
2. What you need to know before you take Aspirin
3. How to take Aspirin
4. Possible side effects
5. How to store Aspirin
6. Contents of the pack and other information
1.
WHAT ASPIRIN IS AND WHAT IT IS USED FOR
Each effervescent tablet contains aspirin (acetylsalicylic acid). They
dissolve in water to
form a sparkling, lemon-tasting solution which is absorbed quickly
into the bloodstream.
Aspirin belongs to a group of medicines known as non-steroidal
anti-inflammatory drugs
(NSAIDS). It is used for the treatment of pain and reduction of fever
and also has anti-
inflammatory properties.
Aspirin can be used for the:
Treatment of mild to moderate pain including headache, migraine,
toothache, period
pains, sore throat, nerve pain (neuralgia), aches and pains.
Symptomatic relief of influenza, feverishness, colds, backache
(lumbago), sciatica,
fibrositis, rheumatic pain (arthritis), muscular aches and pains.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ASPIRIN
DO NOT TAKE ASPIRIN IF YOU:
Are allergic to aspirin or any of the other ingredients of this
medicine_ (listed in section _
_6)_.
Are allergic to any other pain relieving or anti-inflammatory
medicines (e.g. NSAIDS
or salicylates). _For more information see Section 4_, ‘_Possible
Side Eff
Read the complete document
Summary of Product characteristics
Health Products Regulatory Authority
10 January 2024
CRN00DTQC
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Aspirin 300mg Effervescent tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Acetylsalicylic Acid (aspirin) 300.00 mg.
Excipients with known effect:
Sodium 150 mg (6.5 mmol) per tablet.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Effervescent Tablet
White, circular tablets, with a scoreline on one face (to allow
breaking for ease of swallowing) and the other side plain.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
The symptomatic relief of influenza, feverishness, feverish colds, and
of lumbago, sciatica, fibrositis, rheumatic pains, muscular
aches and pains.
The relief of mild to moderate pain including headache, migraine,
toothache, period pains, sore throat, neuralgia, aches and
pains.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults:
2 tablets in half a glass of water every 4 hours as required. Do not
exceed 13 tablets in 24 hours unless directed by a doctor.
Aspirin must not be taken for longer than 3-5 days without consulting
your doctor. If symptoms persist consult your doctor.
Medicines should not be taken in pregnancy without consulting your
doctor.
Elderly:
As for adults.
_Paediatric population_
Do not give to children and adolescents aged under 16 years, except on
medical advice, where the benefit outweighs the risk.
In case of accidental administration or use in children, see section
"Special warning and precautions for use".
Method of administration
Oral.
Tablets must be dissolved in water. The tablets should preferably be
taken after meals.
4.3 CONTRAINDICATIONS
Aspirin must not be used in the following cases:
Health Products Regulatory Authority
10 January 2024
CRN00DTQC
Page 2 of 9
hypersensitivity to acetylsalicylic acid or other salicylates, or to
any of the excipients listed in section 6.1
a history of asthma induced by the administration of salicylates or
substances with a similar a
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