Orvis Flue instructions for use
Contraindications Hypersensitivity to paracetamol, ascorbic acid, pheniramine or any of the excipients. Pregnancy and breastfeeding period. Erosive and ulcerative lesions of the gastrointestinal tract (in the acute phase). Liver failure. Angle-closure glaucoma. Urinary retention associated with prostate diseases and urinary disorders. Portal hypertension. Alcoholism. Phenylketonuria. Deficiency of the enzyme glucose-6-phosphate dehydrogenase. Age up to 15 years. With caution: Renal failure (creatinine clearance <10 ml/min), congenital hyperbilirubinemia (Gilbert, Dubin-Johnson and Rotor syndromes), viral hepatitis, alcoholic hepatitis, old age. Concomitant use of monoamine oxidase inhibitors (MAO) and tricyclic antidepressants or within the previous 2 weeks. Concomitant use of drugs that can adversely affect the liver; in patients with bronchial asthma, chronic bronchitis, recurrent formation of urate kidney stones. Use during pregnancy and breastfeeding Due to the lack of animal studies and clinical studies of the use of a combination of paracetamol, ascorbic acid and pheniramine during pregnancy, taking the drug in this group of patients is not recommended. It is not known whether the active ingredients of the drug pass into breast milk. Taking ORVIS® Flue during breastfeeding is not recommended. If use is necessary, breastfeeding should be discontinued.
Method of administration and dosage: Orally, 1 sachet 2-3 times a day. Before use, dissolve the contents of one sachet in a glass (200 ml) of hot water (50-60 ºС). Add sugar if necessary. The drug ORVIS® Flu can be taken at any time of the day, but the best effect comes from taking the drug before bed, at night. The maximum daily dose of paracetamol is 4 g (8 sachets) for body weight over 50 kg. The interval between doses of the drug should be at least 4 hours. In patients with impaired renal function (creatinine clearance <10 ml/min), the interval between doses of the drug should be at least 8 hours. The maximum duration of treatment is 5 days. If there is no relief of symptoms within 5 days after starting to take the drug, the body temperature remains elevated, or after an initial decrease it suddenly rises again, you should consult a doctor.
Side effects The drug is well tolerated in recommended doses. Possible: Dryness of the oral mucosa. Nausea, vomiting, abdominal pain, constipation. Urinary dysfunction. Allergic reactions (erythema, skin rash, itching, urticaria, Quincke's edema, anaphylactic shock). Bronchospasm. Drowsiness, disturbance of accommodation, palpitations, orthostatic hypotension, dizziness, loss of coordination, tremor. Agitation, nervousness, insomnia, confusion, hallucinations, impaired concentration (more often in elderly patients), mydriasis. Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), acute generalized exanthematous pustulosis. Hepatotoxic effect, nephrotoxicity. Anemia, leukopenia, agranulocytosis, thrombocytopenia. If adverse reactions occur, stop taking the drug and consult a doctor.
Overdose Signs of acute paracetamol poisoning are anorexia, nausea, vomiting, epigastric pain, increased sweating, pale skin, drowsiness, metabolic acidosis (including lactic acidosis). The threshold for overdose may be lowered in elderly patients and children, in patients taking certain medications (eg, liver microsomal enzyme inducers), alcohol, or who are malnourished. After 1-2 days, signs of liver dysfunction appear. In severe cases, liver failure, hepatonecrosis, encephalopathy and coma develop, which can be fatal. Signs of pheniramine poisoning include convulsions, impaired consciousness, and coma. If symptoms of poisoning appear, you should immediately stop using the drug and consult a doctor. It is recommended to lavage the stomach, take enterosorbents (activated carbon, hydrolytic lignin), prescribe the antidote acetylcysteine intravenously or orally (if possible, in the first 10 hours after an overdose), and symptomatic treatment.
Interaction with other drugs Ethanol enhances the sedative effect of antihistamines (pheniramine), so its use should be avoided during treatment. In addition, ethanol, when used simultaneously with pheniramine, contributes to the development of acute pancreatitis. Pheniramine enhances the effect of sedatives: morphine derivatives, barbiturates, benzodiazepine derivatives and other tranquilizers, neuroleptics (meprobamate, phenothiazine derivatives), antidepressants (amitriptyline, mirtazapine, mianserin), centrally acting antihypertensive drugs, sedatives belonging to the group of H1-histamine blockers, baclofen ; this not only increases the sedative effect, but also increases the risk of developing side effects of the drug (urinary retention, dry oral mucosa, constipation). The possibility of enhancing central atropine-like effects should be taken into account when used in combination with other substances with anticholinergic properties (other antihistamines, imipramine antidepressants, phenothiazine neuroleptics, m-anticholinergic antiparkinsonian drugs, atropine-like antispasmodics, disopyramide). When using the drug together with inducers of microsomal oxidation: barbiturates, tricyclic antidepressants, anticonvulsants (phenytoin), flumecinol, phenylbutazone, rifampicin and ethanol, the risk of hepatotoxicity (due to paracetamol included in the composition) significantly increases. Glucocorticosteroids, when used simultaneously, increase the risk of developing glaucoma. Concomitant use with salicylates increases the risk of nephrotoxicity. When used simultaneously with chloramphenicol (chloramphenicol), the toxicity of the latter increases. Paracetamol contained in the drug enhances the effect of indirect anticoagulants and reduces the effectiveness of uricosuric drugs.
Special instructions The drug does not contain sugar and can be used by patients with diabetes. The drug should not be used simultaneously with other medications containing paracetamol. To avoid toxic liver damage, paracetamol should not be combined with alcoholic beverages, or taken by patients prone to alcohol abuse. The risk of developing liver damage increases in patients with alcoholic hepatitis. If the recommended doses are exceeded and with prolonged use, mental dependence on the drug may appear. To avoid an overdose of paracetamol, you should ensure that the total daily dose of paracetamol contained in all medications taken by the patient does not exceed 4 g.
Effect on the ability to drive vehicles and machinery Considering the possibility of developing such undesirable effects as drowsiness and dizziness, during the period of treatment with the drug it is recommended to refrain from performing potentially hazardous activities that require increased concentration and speed of psychomotor reactions (driving a car and other vehicles, working with moving mechanisms, work of a dispatcher, operator, etc.).
Release form Powder for the preparation of solution for oral administration [lemon-ginger], 500 mg + 25 mg + 200 mg. 4.95 g of powder per bag made of a film combined based on polymer films and aluminum foil (PET/F/PE). 4, 6, 10, 20 sachets along with instructions for use in a cardboard pack.
Storage conditions At a temperature not exceeding 25 ºС. Keep out of the reach of children.
Shelf life: 3 years. Do not use after the expiration date.
Dispensing conditions Without a prescription.
