Vicks flu action 200 + 30mg - treating symptoms of cold and flu 12 tablets

Product Description

Vicks

Tablets

Therapeutic Indications

Symptomatic relief of nasal/sinus congestion with headache, fever and pain associated with colds and flu. Vicks Flu Action is indicated in adults and adolescents aged 15 years and over.

Dosage

Dosage Adults and adolescents aged 15 years and over: 1 tablet (equivalent to 200 mg ibuprofen and 30 mg pseudoephedrine hydrochloride) every 4–6 hours as needed. For more severe symptoms, take 1 tablet (equivalent to 200 mg ibuprofen and 30 mg pseudoephedrine hydrochloride) every 4–6 hours as needed. For severe cases, 2 tablets (equivalent to 400 mg ibuprofen and 60 mg pseudoephedrine hydrochloride) every 6–8 hours as needed, up to the maximum total daily dose. The maximum total daily dose of 6 tablets (equivalent to 1200 mg ibuprofen and 180 mg pseudoephedrine hydrochloride) should not be exceeded. Treatment should not exceed 5 days. This combination product should be used when both the decongestant action of pseudoephedrine hydrochloride and the analgesic and/or anti-inflammatory action of ibuprofen are needed. If one symptom is predominant (nasal congestion or headache and/or fever), therapy with a single active ingredient is preferable. Consult your doctor if use of this medicine in adolescents is necessary for more than 3 days, or if symptoms worsen. In older patients, the maximum daily dose should be 180 mg. In the elderly and in patients with a history of ulcers, particularly if complicated by haemorrhage or perforation (see section 4.3), initiate therapy with the lowest possible dose because the risk of gastrointestinal bleeding, ulceration or perforation is greater with increasing NSAID doses. In these patients, or in patients taking other drugs that can increase the risk of gastrointestinal events (see below and section 4.5), concomitant use of protective agents (misoprostol or proton pump inhibitors) should be considered. In patients with renal or hepatic impairment, the dosage must be adjusted to the individual patient. The lowest effective dose should be used for the shortest duration necessary to relieve symptoms. Paediatric population Vicks Flu Action is contraindicated in children under 15 years of age (see section 4.3). Method of administration For oral use. The tablets should be swallowed with water, preferably on a full stomach. Do not break or crush the tablets.

Active Ingredients

One tablet contains 200 mg of ibuprofen and 30 mg of pseudoephedrine hydrochloride (equivalent to 24.6 mg of pseudoephedrine). Excipients with known effect: Colorants: tartrazine (E102, 0.47 mg/film-coated tablet). Sunset Yellow FCF (E110, 0.07 mg/film-coated tablet). Soya lecithin (E322, 0.37 mg/film-coated tablet). For the full list of excipients, see section 6.1.

Excipients

Tablet core Microcrystalline cellulose Pregelatinised maize starch Povidone K-30 Colloidal anhydrous silica Stearic acid 95 Croscarmellose sodium Sodium laurilsulfate Film-coating: Opadry II yellow Polyvinyl alcohol – Partially hydrolysed Talc (E553b) Titanium dioxide (E 171) Macrogol 3350 Tartrazine (E102) Soya lecithin (E322) Sunset yellow FCF (E110) Opadry fx Silver Polyvinyl alcohol – Partially. hydrolyzed Talc (E553b) Titanium dioxide (E 171) Potassium aluminium silicate (E555) Titanium dioxide (E171) Polysorbate 80 (E433)

Contraindications

– Hypersensitivity to ibuprofen, pseudoephedrine or to any of the excipients listed in section 6.1. – Patients under 15 years of age. – Pregnancy and breast-feeding (see section 4.6). – A history of hypersensitivity reactions (e.g. bronchospasm, asthma, nasal polyposis, rhinitis or urticaria) associated with aspirin, other analgesics, antipyretics or other nonsteroidal anti-inflammatory drugs (NSAIDs). – Active peptic ulcer or history of recurrent ulcer/haemorrhage (two or more distinct episodes of proven ulcer or bleeding). - History of gastrointestinal bleeding or perforation, including cases associated with NSAIDs. - Cerebrovascular or other haemorrhage. - Unexplained haematopoietic abnormalities. - Severe renal insufficiency. - Severe liver insufficiency. - Severe cardiac decompensation. - Severe cardiovascular disorder, coronary artery disease (heart disease, hypertension, angina pectoris), tachycardia, hyperthyroidism, diabetes, pheochromocytoma. - History of stroke or presence of risk factors for stroke (due to NSAID activity).