Anadin Analgesic Film-coated Tablets Aspirin 325mg Caffeine 15mg

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Aspirin; Caffeine

Available from:

GlaxoSmithKline Consumer Healthcare (Ireland) Limited

ATC code:

N02BA; N02BA51

INN (International Name):

Aspirin; Caffeine

Dosage:

325/15 milligram(s)

Pharmaceutical form:

Film-coated tablet

Therapeutic area:

Salicylic acid and derivatives; acetylsalicylic acid, combinations excl. psycholeptics

Authorization status:

Marketed

Authorization date:

1983-01-10

Patient Information leaflet

28.3401
202427
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Ireland
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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 the leaflet or as
your doctor or pharmacist 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, PHARMACIST OR NURSE. THIS INCLUDES ANY POSSIBLE SIDE
EFFECTS NOT LISTED IN THIS LEAFLET. SEE SECTION 4.
YOU MUST SEE A DOCTOR IF YOUR SYMPTOMS WORSEN OR DO NOT IMPROVE AFTER
3 DAYS.
IN THIS LEAFLET:
1. What your medicine is and what it is used for
2. What you need to know before you take your medicine
3. How to take your medicine
4. Possible side effects
5. How to store your medicine
6. Contents of the pack and other information
1. WHAT YOUR MEDICINE IS AND WHAT IT IS USED FOR
Each Film-coated tablet contains 325 mg of Aspirin (Acetylsalicylic
Acid), and 15 mg of Caffeine.
Aspirin belongs to a group of medicines called non-steroidal
anti-inflammatory drugs (NSAIDs).
These products relieve pain and inflammation and reduce fever. In
addition, your medicine contains caffeine,
which increases the pain-relieving effect

Summary of Product characteristics

Health Products Regulatory Authority
15 May 2023
CRN00DKCP
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Anadin Analgesic Film-coated Tablets Aspirin 325mg Caffeine 15mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
Acetylsalicylic acid (aspirin)
325.0 mg
Caffeine
15.0 mg
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
White capsule shaped, film coated tablets.
The tablets have '325/15' engraved on both sides.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the relief of pain of headache, neuralgia, rheumatic pain, period
pain, dental pain, toothache, and the relief of symptoms of
the common cold.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Oral
ADULTS AND ADOLESCENTS OVER 16 YEARS: Take 2 tablets every 4 hours if
necessary. Do not exceed 12 tablets in any 24 hour
period.
Do not give to children and adolescents aged under 16 years, except on
medical advice, where the benefit outweighs the risk.
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.
4.3 CONTRAINDICATIONS
Patients with a history of hypersensitivity reactions (e.g.
bronchospasm, rhinitis, urticaria) in response to Anadin Analgesic
Film-coated Tablets, aspirin or other non-steroidal anti-inflammatory
drugs or any of the other constituents.
Children and adolescents under 16 years.
Breast-feeding.
Last-trimester of pregnancy.
Concurrent anti-coagulant therapy.
Patients with severe renal failure.
Intake of more than 15mg methotrexate per week.
Health Products Regulatory Authority
15 May 2023
CRN00DKCP
Page 2 of 8
History of gastrointestinal bleeding or perforation, related to
previous NSAIDs therapy. Active or history of recurrent peptic
ulcer/haemorrhage (two or more distinct episodes of proven ulceration
or bleeding).
Use in patients with severe heart failure.
Use in patients with bl