ORVIS Flue - instructions for use, dose, side effects, contraindications

Excipients: maltodextrin - 3507.25 mg; aspartame - 24.75 mg; sodium citrate - 247.50 mg; citric acid anhydrous - 49,50 mg; concentrate lemon powder [lemon juice, maltodextrin, citric acid] - 247.50 mg; ginger extract dry [extract of ginger root, starch, maltodextrin, silicon dioxide colloid] - 49,50 mg; flavoring natural "Lemon" [aromatic composition, natural aromatic component, maltodextrin, gum arabic] - 99,00 mg.

Description:

Granular powder from light pink with a yellowish tint to a light brown color with a characteristic smell of lemon and ginger.Blotches of white, gray and brown are allowed. The presence of easily disintegrating lumps is allowed.

The solution is light yellow with a pinkish or brownish tint, cloudy, with a characteristic smell of lemon and ginger. The presence of undissolved particles from yellowish to brown is allowed.

Pharmacotherapeutic group:ARI and "colds" of symptoms remedy (analgesic non-narcotic means + H1-histamine receptor blocker + vitamin)

ATX: & nbsp

N.02.B.E Anilides

N.02.B.E.51 Paracetamol in combination with other drugs, excluding psycholeptics

Pharmacodynamics:

A combined preparation containing paracetamol, phenyramine and ascorbic acid.

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

Pheniramine - blocker H₁-gistaminovyh receptors, reduces rhinorrhea and lacrimation, eliminates spastic phenomena, swelling and flushing of the mucous membrane of the nasal cavity, nasopharynx and paranasal sinuses.

Ascorbic acid participates in the regulation of oxidation-reduction processes, carbohydrate metabolism, blood coagulability, tissue regeneration, in the synthesis of steroid hormones; reduces vascular permeability, reduces the need for vitamins B₁, AT₂, A, E, folic acid, pantothenic acid. Improves tolerability of paracetamol and lengthens its action (associated with an elongation of the half-life (T_1/2)).

Pharmacokinetics:

Paracetamol

After oral administration, it is quickly absorbed from the gastrointestinal tract: maximum plasma concentrations of the drug are reached after 10-60 minutes. Quickly distributed to the tissues of the body, it penetrates the blood-brain barrier. The connection with blood plasma proteins is insignificant and has no therapeutic value, but increases with the increase in dose. Metabolism occurs in the liver, 80% of the accepted dose enters into conjugation reactions with glucuronic acid and sulfates with the formation of inactive metabolites; 17th% is subjected to hydroxylation with the formation of 8 active metabolites, which are conjugated with glutathione with the formation of already inactive metabolites.One of the hydroxylated intermediates of the metabolism shows a hepatotoxic effect. This metabolite is neutralized by conjugation with glutathione, but it can be cumulated and, in case of an overdose of paracetamol (150 mg of paracetamol / kg or 10 g of paracetamol inside), cause necrosis of hepatocytes. It is excreted by the kidneys in the form of metabolites, mainly in the form of conjugates. In an unchanged form, less than 5% of the dose taken is excreted. T_1/2is from 1 to 3 hours.

Pheniramine

Almost completely absorbed in the digestive tract. T_1/2from the blood plasma is from 1 to 1.5 hours. It is excreted primarily 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 ingestion is 4 hours. Metabolized mainly in the liver. It is excreted by the kidneys, through the intestine, 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;

- pain in the muscles and joints.

Contraindications:

- Hypersensitivity to paracetamol, ascorbic acid, phenyramin or any of the excipients;

- pregnancy and the period of breastfeeding;

- erosive and ulcerative lesions of the gastrointestinal tract (in the phase of exacerbation);

- liver failure;

- an angle-closure glaucoma;

- retention of urine associated with prostate diseases and urinary dysfunction;

- portal hypertension;

- Alcoholism;

- phenylketonuria;

- deficiency of the enzyme glucose-6-phosphate dehydrogenase;

- age up to 15 years.

Carefully:

Renal failure (creatinine clearance <10 ml / min), congenital hyperbilirubinemia (Gilbert syndrome, Dubin-Johnson syndrome and Rotor), viral hepatitis, alcoholic hepatitis, elderly age.

Simultaneous or during the previous 2 weeks of taking monoamine oxidase (MAO) inhibitors, tricyclic antidepressants.

Simultaneous reception of drugs that can adversely affect the liver.

In patients with bronchial asthma, chronic bronchitis, recurrent formation of urate stones in the kidneys.

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 this medication in this group of patients is not recommended.

It is not known whether the active ingredients of the drug penetrate into breast milk. Taking OVVIS® Flea during breast-feeding is not recommended. If necessary, breastfeeding should be discontinued.

Dosing and Administration:

Inside for 1 packet 2-3 times a day.

Before use, the contents of one sachet should be dissolved in a glass (200 ml) of hot water (50-60 ° C). Add sugar if necessary.

The drug ORVIS^®The flu can be taken at any time of the day, but the best effect is taken by taking the drug before going to bed, at night.

The maximum daily dose of paracetamol is 4 g (8 sachets) with a body weight of more than 50 kg.

The interval between doses should be at least 4 hours.

In patients with impaired renal function (creatinine clearance <10 ml / min), the interval between doses 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 receiving the drug, there remains elevated body temperature or after initial drop it suddenly rises again, you must consult your doctor.

Side effects:

The drug is well tolerated at recommended doses. Possible:

Dryness of the oral mucosa.

Nausea, vomiting, abdominal pain, constipation.

Violation of urination.

Allergic reactions (erythema, skin rash, itching, urticaria, Quincke's edema, anaphylactic shock).

Bronchospasm.

Drowsiness, disruption of accommodation, palpitations, orthostatic hypotension, dizziness, impaired 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 any side effects occur, discontinue use and consult a doctor.

Overdose:

Signs of acute paracetamol poisoning are anorexia, nausea, vomiting, pain in the epigastric region, increased sweating, pale skin, drowsiness, metabolic acidosis (including lactic acidosis). The overdose threshold can be reduced in elderly patients and children, in patients taking certain medicines (eg, inducers of microsomal liver enzymes), alcohol or suffering from malnutrition. After 1-2 days, there are signs of impaired liver function. In severe cases, hepatic failure, hepatonecrosis, encephalopathy and coma develop, which can lead to death.

Signs of poisoning with peniramine are convulsions, impaired consciousness, coma. If symptoms of poisoning appear, discontinue use immediately and consult a doctor. Recommended gastric lavage, reception of enterosorbents (Activated carbon, hydrolysis lignin), administration of an antidote of acetylcysteine intravenously or orally (if possible, within the first 10 hours after an overdose), symptomatic treatment.

Interaction:

Ethanol enhances the sedative effect of antihistamines (phenyramine), so you should avoid taking it during the treatment period.

Besides, ethanol with simultaneous use with phenyramine promotes 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), antihypertensive drugs of central action, sedatives related to group H₁-gistaminoblockers, baclofen; This not only increases the sedative effect, but also increases the risk of side effects of the drug (urinary retention, dryness of the oral mucosa, constipation).

The possibility of strengthening central atropine-like effects when used in combination with other substances with anticholinergic properties (other antihistamines, antidepressants of the imipramine group, phenothiazine-type antipsychotics, m-holinoblocking antiparkinsonics, atropine-like antispasmodics, disopyramide) should be considered.

When the drug is used together with inducers of microsomal oxidation: barbiturates, tricyclic antidepressants, anticonvulsants (phenytoin), flumecinol, phenylbutazone, rifampicin and ethanol, the risk of hepatotoxic effects (due to the paracetamol constituent) is significantly increased.

Glucocorticosteroids with simultaneous application increase the risk of developing glaucoma.

Admission simultaneously with salicylates increases the risk of nephrotoxic action.

When used simultaneously with levomitsetinom (chloramphenicol), the toxicity of the latter increases.

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

Special instructions:

The drug does not contain sugar and can be used by patients with diabetes mellitus.

The drug should not be used concomitantly with other medicines containing paracetamol.

To avoid toxic damage to the liver paracetamol It should not be combined with the reception of alcoholic beverages, and also take patients prone to alcohol abuse.

The risk of liver damage increases in patients with alcoholic hepatitis.

When exceeding the recommended doses and with prolonged use, there may be a psychic dependence on the drug.

To avoid overdose of paracetamol, it should be ensured 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 transp. cf. and fur:

Taking into account the possibility of development of such undesirable effects as drowsiness and dizziness, during the treatment with the drug it is recommended to refrain from performing potentially dangerous activities requiring increased concentration of attention and speed of psychomotor reactions (driving and other vehicles, working with moving mechanisms, dispatcher, operator etc.).

Form release / dosage:

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

Packaging:

4.95 grams of powder in a bag of film combined on the basis of polymer films and aluminum foil (PET / F / PE).

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

Storage conditions:

At a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiration date.

Terms of leave from pharmacies:Without recipe

Registration number:LP-003945

Date of registration:08.11.2016

Expiration Date:08.11.2021

The owner of the registration certificate:EVALAR, CJSC EVALAR, CJSC Russia

Manufacturer: & nbsp

EVALAR, CJSC Russia

Representation: & nbspEVALAR CJSC EVALAR CJSC Russia

Information update date: & nbsp10.06.2017

Illustrated instructions

Instructions

ORVIS® Flou (Orvis® Flu)