Orvis Flu Powder for preparation of lemon-ginger solution 500mg+25mg+200mg, 10pcs

Composition

of 1 pack. : Paracetamol 500 Mgpheniramine maleate 25 Mgascorbic acid 200 mgsupport substances: Maltodextrin – 3507.25 mg Aspartame 24.75 mg Sodium citrate – 247.5 mg Citric acid anhydrous – 49.5 concentrate lemon powder (lemon juice, maltodextrin, citric acid) – 247.5 mg of Ginger dry extract (extract of ginger root, starch, maltodextrin, silica colloidal anhydrous) – 49.5 mg natural lemon Flavor, Lemon (aromatic composition, an aromatic component, maltodextrin, gumarabic) – 99 mg.

Pharmacological properties

Pharmacotherapeutic group:

remedy for symptoms of acute respiratory diseases (ARD) and “cold” (non-narcotic analgesic tool + H1-histamine receptor blocker + vitamin).

ATX code: N02BE51

Pharmacological properties

Pharmacodynamics

A combination drug containing paracetamol, phenyramine and ascorbic acid.

Paracetamol is a non-narcotic analgesic that blocks cyclooxygenase, mainly in the central nervous system, affecting the centers of pain and thermoregulation; it has analgesic and antipyretic effects.

Phenyramine is a blocker of H1-histamine receptors, reduces rhinorrhea and lacrimation, eliminates spastic phenomena, swelling and hyperemia of the nasal mucosa, nasopharynx and paranasal sinuses.

Ascorbic acid is involved in the regulation of redox processes, carbohydrate metabolism, blood clotting, tissue regeneration, in the synthesis of steroid hormones; reduces vascular permeability, reduces the need for vitamins B 1, B 2, A, E, folic acid, pantothenic acid.

Improves the tolerance of paracetamol and prolongs its action (due to the prolongation of the half-life (T 1/2)).

Pharmacokinetics

Paracetamol

After oral use, it is rapidly absorbed from the gastrointestinal tract: the maximum concentration of the drug in blood plasma is reached in 10-60 minutes.

It is rapidly distributed throughout the body’s tissues, penetrates through the blood-brain barrier.

The association with plasma proteins is insignificant and has no therapeutic significance, but increases as the dose increases.

Metabolism occurs in the liver,80% of the dose is conjugated with glucuronic acid and sulfates to form inactive metabolites; 17% is hydroxylated to form 8 active metabolites, which are conjugated with glutathione to form already inactive metabolites.

One of the hydroxylated intermediates of metabolism exhibits a hepatotoxic effect.

This metabolite is neutralized by conjugation with glutathione, but it can accumulate and cause hepatocyte necrosis with an overdose of paracetamol (150 mg of paracetamol/kg or 10 g of paracetamol by mouth).

It is excreted by the kidneys in the form of metabolites, mainly in the form of conjugates. Less than 5% of the dose is excreted unchanged. T 1/2 is from 1 to 3 hours.

Phenyramine

It is almost completely absorbed in the digestive tract. T 1/2 from the blood plasma is from 1 to 1.5 hours. It is excreted from the body mainly through the kidneys.

Ascorbic acid

It is absorbed in the small intestine. Bioavailability is approximately 70%. The time to reach the maximum therapeutic concentration after oral use is

4 hours. It is mainly metabolized in the liver. It is excreted by the kidneys, through the intestines, with sweat, in unchanged form and in the form of metabolites.

Indications

It is used for: – acute respiratory infections— acute respiratory viral infections (ARVI) – nasopharyngitis (runny nose) — Flu to relieve the following symptoms: – increased body temperature — – chills;— headache; – nasal congestion — – rhinorrhea;- lacrimation — – sneezing;- muscle and joint pain.

Use during pregnancy and lactation

Due to the lack of animal studies and clinical studies of the use of a combination of paracetamol, ascorbic acid and phenyramine during pregnancy, taking the drug in this group of patients is not recommended. It is not known whether the active ingredients of the drug penetrate into breast milk. Taking the drug ORVIS Flu during breastfeeding is not recommended. If necessary, breast-feeding should be discontinued.

Recommendations for use

Inside 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 °C). 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 going to bed, at night. The maximum daily dose of paracetamol is 4 g (8 sachets) for a body weight of more than 50 kg. The interval between doses of the drug should be at least 4 hours. In patients with impaired renal function (creatinine clearance), the maximum duration of treatment is 5 days. If there is no relief of symptoms within 5 days after starting the drug, if the body temperature remains elevated, or if it suddenly rises again after the initial decrease, you should consult a doctor.

Contraindications

Hypersensitivity to paracetamol, ascorbic acid, phenyramine or any of the excipients. Pregnancy and breast-feeding 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.

Side effects

The drug is well tolerated in the recommended doses. Possible: Dryness of the oral mucosa. Nausea, vomiting, abdominal pain, constipation. Violation of urination. Allergic reactions (erythema, skin rash, pruritus, urticaria, angioedema, anaphylactic shock). Bronchospasm. Drowsiness, accommodation disorders, palpitations, orthostatic hypotension, dizziness, coordination disorders, 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 any adverse reactions occur, stop taking the drug and consult your doctor.

Interaction

Ethanol increases the sedative effect of antihistamines (phenyramine), so it should be avoided during treatment.

In addition, ethanol, when used concomitantly with phenyramine, contributes to the development of acute pancreatitis.

Phenyramine enhances the effect of sedatives:  

derivatives of morphine, barbiturates, benzodiazepines and other tranquilizers, neuroleptics (meprobamate, phenothiazines), antidepressants (amitriptyline, mirtazapine, mianserin), antihypertensive medications Central action, sedatives, belonging to the group H 1-histamine antagonists, baclofen;

this not only increases sedative effect, but also increases the risk of side effects (urinary retention, dry mucous membranes of the mouth, constipation).

Consideration should be given to the possibility of enhancing central atropine-like effects when used in combination with other substances with anticholinergic properties (other antihistamines, imipramine group antidepressants, phenothiazine-type neuroleptics, m-holinoblocking antiparkinsonian agents, 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 hepatotoxic action (due to the paracetamol included in the composition) significantly increases.

Concomitant use of glucocorticosteroids increases the risk of glaucoma.

Concomitant use with salicylates increases the risk of nephrotoxic effects.

When used concomitantly with levomycetin (chloramphenicol), the toxicity of the latter increases.

Paracetamol contained in the preparation enhances the effect of indirect anticoagulants and reduces the effectiveness of uricosuric drugs.

Overdose

Signs of acute paracetamol poisoning include anorexia, nausea, vomiting, epigastric pain, increased sweating, pallor of the skin, drowsiness, and metabolic acidosis (including lactic acidosis). The overdose threshold can be lowered in elderly patients and children, in patients taking certain medications (for example, inducers of microsomal liver enzymes), alcohol, or suffering from exhaustion. After 1-2 days, signs of impaired liver function appear. In severe cases, liver failure, hepatonecrosis, encephalopathy and coma develop, which can lead to death. Signs of phenyramine poisoning include seizures, impaired consciousness, and coma. If symptoms of poisoning occur, you should immediately stop using the drug and consult a doctor. Gastric lavage, use of enterosorbents (activated charcoal), use of the antidote acetylcysteine intravenously or orally (if possible, in the first 10 hours after overdose), and symptomatic treatment are recommended.

Special instructions

The drug does not contain sugar and can be used by patients with diabetes mellitus.The drug should not be used simultaneously with other medications containing paracetamol. In order to avoid toxic liver damage, paracetamol should not be combined with the intake of alcoholic beverages, as well as taken in patients prone to alcohol abuse. The risk of developing liver damage increases in patients with alcoholic hepatitis. If the recommended doses are exceeded and prolonged use occurs, mental dependence on the drug may occur. To avoid an overdose of paracetamol, make sure that the total daily dose of paracetamol contained in all medications taken by the patient does not exceed 4 g.

Form of production

Powder for preparation of oral solution [lemon-ginger],500 mg+25 mg+200 mg.

4.95 g of powder in a bag made of a combined film based on polymer films and aluminum foil (PET/F/PE).

4,6,10,20 sachets together with the instructions for use in a pack of cardboard.

Storage conditions

At a temperature not exceeding 25 °C. Keep out of reach of children.

Shelf life

3 years

Active ingredient

Paracetamol, Phenyramine, Ascorbic acid

Purpose

Pregnant women only in the second trimester as prescribed by a doctor, For adults, Children over 15 years of age

Indications

Respiratory Tract Infections, Pharyngitis, Cold, Flu, Runny Nose