Anadin Extra Film-coated TabletsAspirin 300mgParacetamol 200mgCaffeine 45mg

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Acetylsalicylic acid; Caffeine; Paracetamol

Available from:

Pfizer Healthcare Ireland

ATC code:

N02BA; N02BA51

INN (International Name):

Acetylsalicylic acid; Caffeine; Paracetamol

Dosage:

300/200/45 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product not subject to medical prescription

Therapeutic area:

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

Authorization status:

Not marketed

Authorization date:

1984-02-28

Patient Information leaflet

Anadin Extra PA 822/166/1
1661_PIL text_19_114_v3
Patient Information Leaflet
ANADIN EXTRA FILM-COATED TABLETS
ASPIRIN 300 MG
PARACETAMOL 200 MG
CAFFEINE 45 MG
The full name of this medicine as listed above has been abbreviated
throughout the leaflet for ease of
reference to ‘Anadin Extra.’
PACKAGE LEAFLET: INFORMATION FOR THE USER.
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 Anadin Extra is and what it is used for
2. What you need to know before you take Anadin Extra
3. How to take Anadin Extra
4. Possible side effects
5. How to store Anadin Extra
6. Content of the pack and other information
1. WHAT ANADIN EXTRA IS AND WHAT IT IS USED FOR
Each film-coated tablet contains aspirin (acetylsalicyclic acid)
300mg, paracetamol 200mg and
caffeine 45mg.
A
spirin and paracetamol work by relieving pain and reducing high
temperature and
fever. Aspirin belongs to a group of medicines called Non-Steroidal
anti-inflammatory Drugs
(NSAIDs) and has anti-inflammatory properties. In addition, the
tablets contain caffeine, which
increases the pain relieving effect of the product.
Anadin Extra is for the treatment of mild to moderate pain including,
headache, period pain,
toothache, sore throat, symptoms of influenza, joint swelling &
stiffness, feverishness and colds,
muscular aches and pains, rheumatic pain, and neuralgia.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
ANADIN EXTRA
Please read the following information. There is a possible association
with aspirin and Reye’s
syndrome when

Summary of Product characteristics

Health Products Regulatory Authority
10 February 2020
CRN0095X7
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Anadin Extra Film-coated Tablets Aspirin 300mg Paracetamol 200mg
Caffeine 45mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredients
mg/tablet
Acetylsalicylic acid
300.0 mg
Paracetamol
200.0 mg
Caffeine
45.0 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film coated tablet (tablet)
A capsule-shaped white tablet with a break bar on one side and with
“A” and “E” debossed on the other side.
The scoreline is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the relief of pain of:

Headache

Neuralgia

Myalgia

Rheumatism

Toothache

Dysmenorrhoea

Symptoms of the common cold or influenza
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
ADULTS AND ADOLESCENTS OVER 16 YEARS:
1-2 tablets every 4 hours with a maximum of 6 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.
THE ELDERLY
Dosage is as above.
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
Treatment should be reviewed at regular intervals and discontinued if
no benefit is seen or intolerance occurs.
Health Products Regulatory Authority
10 February 2020
CRN0095X7
Page 2 of 11
Method of Administration: Oral.
4.3 CONTRAINDICATIONS

Hypersensitivity to the active ingredients or any of the excipients
listed in section 6.1. Patients with a history of
hypersensitivity reactions (e.g. bronchospasm, rhinitis, urticaria) in
response to Anadin Extra, aspirin or other
non-steroidal anti-inflammatory drugs or any of the other
constituents.

Bleeding disorders, concurrent anti-coagulant t