Vicks Flu Triple Action 500mg/200mg/10mg 10 sachets powder for oral solution

In compliance with article 118 "authorization of advertising to the public" of the legislative decree of 24 April 2006, number 219

INDICATIONS

Short-term symptomatic treatment of mild to moderate pain, fever, nasal congestion with expectorant effect in case of wet cough, associated with colds, chills and flu.

CONTRAINDICATIONS

Hypersensitivity to paracetamol, guaifenesin, phenylephrine hydrochloride or to any of the excipients. Severe hepatic or renal impairment Hypertension Hyperthyroidism Diabetes Heart disease. Angle-closure glaucoma Porphyria Use in patients who are taking tricyclic antidepressants Use in patients who are taking, or who have taken in the previous 2 weeks, monoamine oxidase inhibitors (MAOIs). Use in patients who are taking beta-blocking drugs. Use in patients who are taking other sympathomimetic drugs. Children under 12 years of age.

WARNINGS AND PRECAUTIONS FOR USE

Prolonged use of the product is not recommended. Patients should be advised not to take other products containing paracetamol or containing the same active ingredients as this preparation. Patients should also be advised to avoid the concomitant use of alcohol, other decongestant products or cough or cold products. The doctor or pharmacist is required to verify that preparations containing sympathomimetics are not administered simultaneously through multiple routes, i.e. orally and topically (nasal, auricular and ocular preparations). This medicine should only be recommended in the presence of all symptoms (pain and/or fever, nasal congestion and bronchial cough). The risks related to overdose are greater in patients with non-cirrhotic alcoholic liver disease. Use with caution in patients taking digitalis, beta-adrenergic blockers, methyldopa or other antihypertensive agents (see section 4.5). Use with caution in patients with prostatic hypertrophy as they are potentially subject to urinary retention. Products containing sympathomimetics should be used with great care in patients taking phenothiazines. Use in patients with Raynaud's phenomenon. Consult your doctor before use in case of persistent or chronic cough such as that manifested by smoking, asthma, chronic bronchitis or emphysema. Contains sucrose. Patients suffering from rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrasisomaltase insufficiency should not take this medicine. Contains 157 mg sodium per dose. To be taken into consideration in people with reduced kidney function or who follow a low sodium diet. Contains aspartame (E951). This medicine contains a source of phenylalanine. It may be harmful to you if you suffer from phenylketonuria.

INTERACTIONS

The hepatotoxicity of paracetamol can be potentiated by excessive alcohol intake. The rate of absorption of paracetamol can be increased with metoclopramide or domperidone and the absorption reduced with cholestyramine. Substances that induce hepatic microsomal enzymes, such as alcohol, barbiturates, monoamine oxidase inhibitors and tricyclic antidepressants, may increase the hepatotoxicity of paracetamol, particularly following overdosage. Isoniazid reduces the elimination of paracetamol, with possible enhancement of its activity and/or toxicity, through the inhibition of its metabolism in the liver. Probenecid causes a halving of the elimination of paracetamol, inhibiting its binding with glucuronic acid. A reduction in paracetamol should be considered if probenecid is being taken. Regular use of paracetamol may reduce the metabolism of Zidovudine (increasing the risk of neutropenia). Interactions between sympathomimetic amines, such as phenylephrine, and monoamine oxidase inhibitors cause hypertensive effects. Phenylephrine may interact negatively with sympathomimetic agents and may reduce the effectiveness of beta-blocking drugs, methyldopa and other antihypertensive drugs (see section 4.4). The conditions in which these drugs are taken constitute contraindications to the use of the product. The anticoagulant effect of warfarin and other coumarin drugs can be enhanced by regular and prolonged intake of paracetamol, with an increased risk of bleeding; doses taken occasionally have no significant effects. Drug interactions have been reported between acetaminophen and several other drugs. Such interactions are considered unlikely to be clinically significant in temporary use and in accordance with the suggested dosing regimen. Salicylates/aspirin can prolong the elimination (t ½) of paracetamol. Paracetamol may decrease the bioequivalence of lamotrigine, with a possible decrease in its effect, due to a possible increase in its metabolism in the liver. It is possible that digitalis may sensitize the myocardium to sympathomimetic-like effects. Paracetamol can alter the uric acid phosphotungstate test and the blood sugar test.

SIDE EFFECTS

The incidence of side effects is usually classified as follows: Very common (>10) Common (>1/100 to <1/10) Uncommon (>1/1000 to <1/100) Rare (>1/10,000 to <1/1000) Very rare (<1/10,000) Not known (the incidence cannot be classified from the available data) Cardiac disorders: Phenylephrine may be rarely associated with tachycardia (≥1/10,000 to ≤1 in 1000). Blood and lymphatic system disorders: very rarely (<1 in 10,000) blood dyscrasias such as thrombocytopenia, agranulocytosis, hemolytic anemia, neutropenia, leukopenia and pancytopenia have been reported following the intake of paracetamol, although there may not be a causal relationship. Nervous system disorders: As with other sympathomimetic amines, insomnia, nervousness, tremor, anxiety, restlessness, confusion, irritability and headache may occur rarely (≥1/10,000 to ≤1 in 1000). It is also known that guaifenesin can rarely (≥1/10,000 to ≤1 in 1000) cause headache and dizziness. Gastrointestinal disorders: Anorexia, nausea and vomiting are common with sympathomimetics (≥1 in 100 to ≤1 in 10) and may occur with phenylephrine. Gastrointestinal disorders, nausea, vomiting, and diarrhea are the most common side effects associated with guaifenesin, but occur rarely (≥1/10,000 to ≤1 in 1000). The gastrointestinal effects of paracetamol are very rare but cases of acute pancreatitis have been reported following ingestion of higher than normal doses. Renal and urinary disorders: Interstitial nephritis has been reported randomly after prolonged use of high doses of paracetamol. Skin and subcutaneous tissue disorders: hypersensitivity, including skin rash, and urticaria may rarely occur following the intake of paracetamol (from ≥1/10,000 to ≤1 in 1000). Vascular disorders: following the intake of phenylephrine, increased blood pressure associated with headache, vomiting and palpitations may rarely occur (from ≥1/10,000 to ≤1 in 1000). Immune system disorders: Rare cases (≥1/10,000 to ≤1 in 1000) of allergic or hypersensitivity reactions have been reported following intake of both phenylephrine and paracetamol, including skin rashes, urticaria, anaphylaxis and bronchospasm. Hepatobiliary disorders: rarely (≥ 1/10,000 to ≤ 1/1000), abnormalities in liver function tests (increased liver transaminases).