Advil CS Tablet

ADvil COLD and SINUS is indicated for the relief of symptoms associated with the common cold, sinusitis, or flu, including nasal congestion, headache, fever, body aches and pain.

ADvil COLD and SINUS is contra-indicated in:

• patients sensitive to ibuprofen or any other nonsteroidal anti-inflammatory agent (NSAID)
• patients sensitive to pseudoephedrine hydrochloride or any other sympathomimetic agent.
• patients sensitive to any other component of this product
• persons under treatment with monoamine oxidase inhibitors, or within 14 days of stopping such treatment
• cardiovascular disease, heart failure, hypertension, diabetes mellitus, hyperthyroidism, hyperexcitability, prostatic hypertrophy, phaeochromocytoma and close-angle glaucoma
• patients who have had a severe allergic reaction to aspirin - asthma, swelling, shock or hives, because even though Advil COLD and SINUS contains no aspirin, or salicylates, cross-reactions may occur in patients allergic to aspirin
• patients with impaired renal and liver functions
• patients with a history of gastrointestinal bleeding or perforation related to previous NSAIDs
• patients with active or history of recurrent ulcer, haemorrhage or perforations
• patients with bleeding disorders, haematological disorders
• pregnancy and lactation See u201c PREGNANCY AND LACTATION u201d.

Caution is advised to those patients who are receiving coumarin anticoagulants. Advil COLD and SINUS should not be combined with other non-prescription pain relievers or any other ibuprofen-containing product. Caution is required in patients with a history of hypertension and/or heart failure as fluid retention and oedema have been reported in association with non-steroidal anti-inflammatory therapy, including Advil COLD and SINUS. In view of the inherent potential of Advil COLD and SINUS to cause fluid retention, heart failure may be precipitated in some compromised patients. Advil COLD and SINUS should be given with caution to patients with a history of gastrointestinal disease (e.g. ulcerative colitis, Crohnu2019s disease, hiatus hernia, gastro-oesophageal reflux disease, angiodysplasia) as the condition may be exacerbated. The elderly have an increased frequency of adverse reactions to NSAIDs, such as Advil COLD and SINUS especially gastrointestinal bleeding and perforation, which may be fatal. The risk of gastrointestinal bleeding or ulceration is higher with increasing doses, in patients with a history of ulcers and the elderly. When gastrointestinal bleeding or ulceration occurs in patients receiving Advil COLD and SINUS, treatment should be stopped. Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis have been reported in association with non-steroidal anti-inflammatory therapy. Discontinue treatment at the first appearance of rash, mucosal lesions, or any other sign of hypersensitivity.

Special Precautions:

Ibuprofen: Ibuprofen should be discontinued in patients who experience blurred or diminished vision or changes in colour vision. Aseptic meningitis has occurred in patients with systemic lupus erythematosus who were receiving ibuprofen.

Pseudoephedrine hydrochloride: To minimise the possibility of insomnia, the last dose for each day should be administered a few hours before bedtime.

Ibuprofen: Interactions involving NSAIDs include possible enhancement of the effects of oral anticoagulants (such as warfarin) and increased plasma concentrations of lithium, methotrexate and digoxin. The risk of nephrotoxicity may be increased if Advil COLD and SINUS is given with angiotensin-converting enzyme inhibitors, cyclosporine, tacrolimus or diuretics. There may also be an increased risk of hyperkalaemia with angiotensin-converting enzyme inhibitors and potassium-sparing diuretics. The antihypertensive effects of some antihypertensive agents including angiotensin-converting enzyme inhibitors, beta blockers, and diuretics may be reduced. Convulsions may occur due to an interaction with quinolones. Advil COLD and SINUS may enhance the effects of phenytoin, oral antidiabetic agents and insulin. The risk of gastrointestinal bleeding and ulceration associated with Advil COLD and SINUS is increased when used with corticosteroids, selective serotonin reuptake inhibitors, the antiplatelets clopidogrel and ticlopidine, or, possibly alcohol, bisphosphonates, or oxpentifylline (pentoxifylline). The concomitant use of more than one NSAID (including aspirin) should be avoided because of the increased risk of adverse effects. There may be an increased risk of haemotoxicity during concomitant use of zidovudine and Advil COLD and SINUS.

Pseudoephedrine hydrochloride: Pseudoephedrine hydrochloride should be given with caution to patients receiving halothane or other halogenated anaesthetics. An increased risk of dysrythmias may occur if pseudoephedrine hydrochloride is given to patients receiving digoxin, quinidine or tricyclic antidepressants and there is an increased risk of vasoconstrictor or pressor effects in patients receiving ergot alkaloids or oxytocin. Pseudoephedrine hydrochloride may reverse the action of many antihypertensive agents and therefore special care is advisable in patients receiving antihypertensive therapy. Pseudoephedrine may cause a hypertensive crisis in patients receiving a monoamine oxidase inhibitor (MAOI). See u201cCONTRA - INDICATIONSu201d. Concurrent use with beta-adrenergic blocking agents may inhibit the therapeutic effect of these agents, with a risk of hypertension and excessive bradycardia and possible heart block. Concurrent use with citrates may inhibit urinary excretion and prolong the duration of action of pseudoephedrine. Concurrent use with central nervous system (CNS) stimulation-producing medications may result in additive CNS stimulation to excessive levels. The use of levodopa with pseudoephedrine may increase the possibility of cardiac dysrythmias. Concurrent use of nitrates with pseudoephedrine may reduce the anti-anginal effects of these medications. The use of thyroid hormones and pseudoephedrine concurrently may increase the effects of either these medications or pseudoephedrine. In addition to possibly increasing CNS stimulation, concurrent use with other sympathomimetics may increase the cardiovascular effects and the potential for side-effects.

ADvil COLD and SINUS is not recommended for use in pregnant or lactating women.

Ibuprofen: Regular use of non-steroidal anti-inflammatory drugs during the third trimester of pregnancy, may result in premature closure of the foetal ductus arteriosus in utero, and possibly, in persistent pulmonary hypertension of the new-born. The onset of labour may be delayed and its duration increased.

Pseudoephedrine hydrochloride: Pseudoephedrine studies on birth defects have not been done in humans. However, studies in animals have shown pseudoephedrine causes a reduction in average weight, length and rate of bone formation in the animal foetus. Pseudoephedrine passes into breast milk and may cause unwanted effects in nursing babies.

Ibuprofen: Blood and the lymphatic system disorders: Less frequent: Agranulocytosis, anaemia, aplastic anaemia, eosinophilia, leukopenia, neutropenia, thrombocytopenia, haemolytic anaemia. Frequency unknown: Ecchymosis. Immune system disorders: Less frequent: Anaphylaxis or anaphylactoid reactions, angiitis, angioedema; bronchospastic allergic reactions, allergic rhinitis, serum sickness-like reaction, systemic lupus erythematosus-like syndrome, hepatotoxicity and aseptic meningitis, which may occur rarely, may also be hypersensitivity reactions. Nervous System Disorders: Frequent: Dizziness Less frequent: Mild to moderate headache, nervousness or irritability, confusion, hallucinations, aseptic meningitis, mental depression, peripheral neuropathy, drowsiness, trouble in sleeping. Frequency unknown: Convulsions, mood or mental changes. Eye disorders: Less frequent: Amblyopia (toxic), blurred or double vision or change in vision, conjunctivitis; dry, irritated or swollen eyes. Ear and labyrinth disorders: Less frequent: Ringing or buzzing in ears; decrease or change in hearing. Cardiac disorders: Many of the cardiovascular effects may occur secondary to NSAID-induced renal function impairment. Less frequent: Oedema, hypertension, unexplained nose bleeds; cardiac dysrhythmias; congestive heart failure or exacerbation of; fast or pounding heartbeat; flushing. Frequency unknown: Angina pectoris or exacerbation of; pulmonary oedema. Gastrointestinal disorders: Frequent: Mild to moderate abdominal cramps; pain or discomfort; epigastric pain or discomfort; heartburn, nausea. Less frequent: Flatulence, constipation, decreased appetite or loss of appetite; diarrhoea, indigestion, vomiting, gastritis, gastrointestinal bleeding or haemorrhage; melaena, haematemesis, gastrointestinal perforation, gastrointestinal ulceration, irritation, dryness or soreness of mouth. Gingival ulceration or aphthous stomatitis. Frequency unknown: Colitis or exacerbation of; enterocolitis, oesophagitis, ulcerative stomatitis, exacerbation of Crohnu2019s disease. Hepato-biliary disorders: Less frequent: Pancreatitis, hepatitis or jaundice (toxic). Frequency unknown: Abnormalities in liver function tests. Skin and subcutaneous tissue disorders: Frequent: Skin rash. Less frequent: Itching, bullous eruption, hives, Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme. Frequency unknown: Eczema, exfoliative dermatitis, photosensitivity reactions. Respiratory, thoracic and mediastinal disorders: See also u201cImmune system disordersu201d Less frequent: Alveolitis, pulmonary eosinophilia, pulmonary oedema. Renal and urinary disorders: Less frequent: Fluid retention; oedema. unexplained vaginal bleeding, blood in urine; cystitis; renal impairment or failure; polyuria, renal papillary or tubular necrosis. Frequency unknown: Renal calculi or ureteral obstruction; interstitial nephritis, nephrotic syndrome.

Pseudoephedrine hydrochloride: Endocrine disorders: Frequency unknown: Altered metabolism, including disturbances of glucose metabolism. Nervous System disorders: Frequent: Nervousness, restlessness, insomnia. Less frequent: Giddiness, headache, sweating, muscular weakness, tremor, hallucinations, convulsions. Frequency unknown: Fear, confusion, irritability, psychotic states, tolerance with dependence may occur. Cardiac disorders: Less frequent: Tachycardia. Frequency unknown: Precordial pain, palpitations, hypertension and ventricular dysrhythmias may occur. Respiratory, thoracic and mediastinal disorders: Less frequent: Shortness of breath or troubled breathing. Frequency unknown: Dyspnoea. Gastrointestinal disorders: Less frequent: Nausea or vomiting. Frequency unknown: Reduced appetite, thirst, ischaemic colitis. Skin and subcutaneous tissue disorders: Frequency unknown: Skin rashes. Renal and urinary disorders: Less frequent: Difficult or painful urination. Frequency unknown: Urinary retention.

See u201c SIDE EFFECTS u201d. Treatment is symptomatic and supportive. The latest information regarding the treatment of overdosage can be obtained from the nearest poison control centre.