ADVIL COLD & FLU
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
26-04-2024
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Active ingredient:
IBUPROFEN PSEUDOEPHEDRINE HYDROCHLORIDE
Available from:
Pfizer Consumer Healthcare Ltd
Dosage:
200/30 Milligram
Pharmaceutical form:
Coated Tablets
Authorization date:
1994-09-08
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Advil Cold & Flu Coated Tablets
Ibuprofen 200mg
Pseudoephedrine Hydrochloride 30mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Excipients: Each tablet contains 174.6 mg sucrose, 0.003 mg methyl parahydroxybenzoate (E218) and 0.002 mg propyl
parahydroxybenzoate (E216)
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Coated Tablet
Oval-shaped, butterscotch coloured, sugar coated tablet imprinted ‘Advil Cold and Flu’ in black ink on one face.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In the symptomatic relief of the symptoms associated with the common cold and influenza including blocked sinuses.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults, the elderly and young persons over 12 years:
1 or 2 tablets every 4-6 hours to a maximum of 6 tablets in 24 hours.
Not to be given to children under the age of 12.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substances or to any of the excipients.
Patients with allergy to aspirin or other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) or with a history of
hypersensitivity reactions (e.g. bronchospasm, rhinitis, urticaria) in response to ibuprofen, aspirin or NSAIDs.
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)
Patients with active peptic ulceration or a history of peptic ulceration.
Patients with phaeochromocytoma, closed angle glaucoma, diabetes or thyroid disease.
Patients with kidney disease.
Patients suffering from heart disease, circulatory problems, hypertension or coronary artery disease.
Patients taking other NSAIDs, pain-relievers or decongestants.
Patients receiving tricyclic
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