Nurofen 200 mg + 30 mg flu and colds - decongestant analgesic - 12 tablets

Product Description

Flu and Cold Tablets

Composition

One tablet contains: Ibuprofen 200 mg, Pseudoephedrine hydrochloride 30 mg. For excipients: see section 6.1.

Excipients

Tricalcium phosphate, sodium carboxymethylcellulose, microcrystalline cellulose, povidone, methylhydroxypropylcellulose, magnesium stearate, talc, colorants: E 104, E 110, E 171.

Therapeutic indications

Treatment of cold and flu symptoms such as nasal and sinus congestion, aches, fever, sore throat, headache.

Contraindications

Hypersensitivity to the active substances or to any of the excipients. Patients with peptic ulcer. History of gastrointestinal bleeding or perforation related to previous active treatments or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding). Subjects with hypersensitivity to acetylsalicylic acid or other analgesics, antipyretics, nonsteroidal anti-inflammatory drugs (NSAIDs), particularly when hypersensitivity is associated with nasal polyps and asthma. Severe renal or hepatic insufficiency. Severe cardiac insufficiency. Patients with serious cardiovascular disease, tachycardia, hypertension, angina pectoris, hyperthyroidism, diabetes, pheochromocytoma, glaucoma, prostatic syndrome. Pregnancy. Breastfeeding (see section 4.6). Children under 12 years.

Dosage

Adults and children over 12 years: initial dose 1-2 tablets, then, if necessary, 1-2 tablets every 4 hours. Do not exceed the dose of 6 tablets in 24 hours. No changes to the recommended dosage are required in the elderly, except in patients with renal or hepatic impairment, for whom the dosage must be individually adjusted.

Warnings and precautions

The use of NUROFEN FLU AND COLD should be avoided in conjunction with NSAIDs, including selective COX-2 inhibitors. Avoid the simultaneous use of two or more analgesics, antipyretics, and non-steroidal anti-inflammatory drugs, as this increases the risk of side effects. The use of NSAIDs should be carefully evaluated in patients with coagulation disorders, as reduced coagulability is possible. The same applies to patients being treated with oral anticoagulants, due to the possibility of enhanced anticoagulant effect (see also section 4.5). As with all anti-inflammatory drugs, the drug should not be used if the patient suffers from ulcers or gastric disorders. Gastrointestinal bleeding, ulceration and perforation: Gastrointestinal bleeding, ulceration and perforation, which can be fatal, have been reported with all NSAIDs at any time during treatment, with or without warning symptoms or a previous history of serious gastrointestinal events. In the elderly and in patients with a history of ulcers, particularly if complicated with haemorrhage or perforation (see section 4.3), the risk of gastrointestinal bleeding, ulceration or perforation is higher with increased NSAID doses. These patients should start treatment on the lowest available dose. Concomitant use of protective agents (misoprostol or proton pump inhibitors) should be considered for these patients, and also for patients taking low-dose aspirin or other drugs that may increase the risk of gastrointestinal events (see below and section 4.5). Patients with a history of gastrointestinal toxicity, particularly when elderly, should report any unusual gastrointestinal symptoms (especially gastrointestinal bleeding), particularly in the initial stages of treatment. Caution should be exercised in patients taking concomitant medications which could increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors, or antiplatelet agents such as aspirin (see section 4.5). If gastrointestinal bleeding or ulceration occurs in patients taking NUROFEN FLU AND COLD, the treatment should be discontinued. NSAIDs should be administered with caution to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease), as these conditions may be exacerbated (see section 4.8). Caution is advised (discuss with your doctor or pharmacist) before initiating treatment in patients with a history of hypertension and/or heart failure, as fluid retention, hypertension, and edema have been reported in association with NSAID treatment. Clinical trial and epidemiological data suggest that use of ibuprofen, particularly at high doses (2400 mg/day) and in long-term treatment, may be associated with a small increased risk of arterial thrombotic events (e.g., myocardial infarction or stroke). Overall, epidemiological studies do not suggest that low doses of ibuprofen (e.g., <2400 mg/day) or <2400 mg/day) may increase the risk of arterial thrombotic events (e.g., myocardial infarction or stroke).