Antigrippin-ORVI neo-instructions for use, dose, side effects, contraindications

Excipients: citric acid - 998 mg. sodium bicarbonate - 874 mg, sorbitol - 730 mg, macrogol-6000 - 95 mg, sodium carbonate - 93 mg, sodium saccharinate - 40 mg, flavoring orange - 40 mg, flavoring lemon - 20 mg.

One tablet [forest berries] contains:

active substances: paracetamol - 500 mg. ascorbic acid - 100 mg, phenylephrine hydrochloride - 10 mg;

Excipients: citric acid - 998 mg, sodium hydrogen carbonate - 874 mg, sorbitol - 650 mg, macrogol-6000 - 95 mg, sodium carbonate - 93 mg, sodium saccharinate - 40 mg, flavoring forest berries - 140 mg.

Description:

Round flat cylindrical tablets of pink color with white and dark pink inclusions with a specific smell of forest berries with a bevel (forest berries) or white with a yellowish tint of color with a specific smell of orange-lemon with chamfer (orange and lemon).

Pharmacotherapeutic group:ARI and "colds" of symptoms remedy (analgesic non-narcotic agent + alpha-adrenomimetic + vitamin)

ATX: & nbsp

N.02.B.E Anilides

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

Pharmacodynamics:

Combined drug. The effect is due to the constituents of the preparation.

Paracetamol has an analgesic and antipyretic effect, which is associated with the effect of the drug on the center of thermoregulation in the hypothalamus and the ability to inhibit the synthesis of prostaglandins.

Ascorbic acid plays an important role in the regulation of oxidation-reduction processes, carbohydrate metabolism, blood coagulability, tissue regeneration. Reduces the permeability of the vascular wall, stimulates the formation of steroid hormones, regulates immunological reactions (activates the synthesis of antibodies, C3-component of complement, interferon), promotes phagocytosis, increases the body's resistance to infections.

Phenylephrine hydrochloride - alpha1-adrenomimetic (stimulates postsynaptic alpha 1-adrenergic receptors). In doses up to 10 mg does not raise blood pressure (BP) and has no central stimulating effect.Has vasoconstrictive effect, reduces edema and hyperemia of the mucous membranes of the upper respiratory tract and sinuses, reducing the sense of nasal congestion and facilitating breathing.

Pharmacokinetics:

Paracetamol well absorbed in the intestine, time to reach the maximum concentration of T_mOh - 0.5-2 h: communication with plasma proteins - 15%. Metabolised in the liver with the formation of both active and inactive metabolites. The half-life of T1 / 2 is 1-4 hours. It is mainly excreted by the kidneys in the form of metabolites - glucuronides and sulfates, 3% - unchanged.

Phenylephrine after intake is poorly absorbed from the gastrointestinal tract (GIT). Metabolized with the participation of monoamine oxidase (MAO) in the intestinal wall and "first pass" through the liver. Bioavailability of phenylephrine is low. Ascorbic acid absorbed in the digestive tract (mainly in the jejunum). T_mOh after ingestion - 4 hours. Connection with plasma proteins 25%. The concentration of ascorbic acid is higher in leukocytes and platelets, compared with erythrocytes and plasma. Penetrates through the placenta and enters the breast milk. Metabolised mainly in the liver in desoxyascorbic and then in oxaloacetic acid and ascorbate-2-sulfate.It is excreted by the kidneys in the unmodified form and in the form of metabolites.

Indications:

Symptomatic treatment of influenza and other acute respiratory viral infections (ARVI), accompanied by the following symptoms: fever, chills, nasal congestion, sore throat and nasal sinuses, headache, joint pain and muscle pain.

Contraindications:

- Hypersensitivity to paracetamol, phenylephrine, ascorbic acid or any of the components of the drug;

- intolerance to fructose;

- severe renal and hepatic insufficiency;

hyperthyroidism (thyroid gland hyperfunction);

- diseases of the cardiovascular system (severe aortic stenosis, acute myocardial infarction, tachyarrhythmia);

- arterial hypertension;

benign prostatic hyperplasia;

- an angle-closure glaucoma;

- simultaneous reception of tricyclic antidepressants, beta-blockers, monoamine oxidase inhibitors (including within 14 days after their cancellation), other paracetamol-containing drugs;

- diabetes mellitus and hereditary disorders of glucose absorption;

- Children's age (up to 12 years).

Carefully:

Be wary of benign hyperbilirubinemia (hereditary diseases: Gilbert syndrome, Dubin-Johnson syndrome, Rotor), deficiency of glucose-6-dehydrogenase fosfatdegidro- (hereditary disease), erosive-ulcerous lesions of the gastrointestinal tract (exacerbation), pheochromocytoma. occlusive vascular disease (Raynaud's phenomenon), glaucoma (excluding closure glaucoma), cardiac disease, liver disorders, kidney mild to moderate severity, pregnancy and lactation.

Pregnancy and lactation:Possible use during pregnancy and during breastfeeding, if the expected effect of therapy exceeds the potential risk to the fetus and the baby, but only after consulting a doctor.

Dosing and Administration:

Inside, between meals. The tablet is dissolved in a glass (200 ml) of water at room temperature and the resulting solution is immediately drunk.

Adults - I tablet every 4-6 hours, but not more than 4 tablets in 24 hours and children over 12 years - 1 tablet every 6 hours but not more than 3 tablets over 24 hours The course of therapy -.. 3-5 days , until the symptoms disappear.

Duration of admission withoutconsultation with a doctor for no more than 5 days when used as an anesthetic and 3 days as an antipyretic.

Side effects:

Paracetamol

On the part of the organs of hematopoiesis: thrombocytopenia, leukopenia, agranulocytosis.

From the respiratory system: bronchospasm in patients susceptible to acetylsalicylic acid (ASA) and other non-steroidal anti-inflammatory drugs (NSAIDs).

From the liver and biliary tract: abnormal liver function.

From the urinary system: with prolonged use with excess of the recommended dose, nephrotoxic effect can be observed.

Allergic reactions: anaphylactic shock, skin rash, urticaria, angioedema (acute swelling of the skin, subcutaneous tissue and mucous membranes), Stevens-Johnson syndrome).

Phenylephrine

From the nervous system: nervousness, headache, dizziness, insomnia.

From the side of the cardiovascular system: increased blood pressure, palpitations, tachycardia.

From the digestive system: nausea, vomiting.

From the sense organs: mydriasis, acute attack of glaucoma.

From the urinary system: dysuria, urinary retention in patients with obstruction of the bladder outlet with prostatic hypertrophy.

From the skin: allergic reactions (skin rash, hives, allergic dermatitis).

Ascorbic acid

From the digestive system: pain in epigastrium (due to irritation of the mucosa of the gastrointestinal tract).

On the part of the organs of hematopoiesis: Thrombocytosis, hyperprothrombinemia, erythropenia, neutrophilic leukocytosis, giocaemia.

From the urinary system: when taking ascorbic acid more than 600 mg / day, moderate pollakiuria is possible.

From the skin: allergic reactions (skin rash, skin hyperemia).

Overdose:

The drug should be taken only at recommended doses. If the recommended dose is exceeded, you should seek medical help, even in the absence of overdose symptoms, because there is a risk of delayed serious liver damage. Overdose is caused, as a rule, by paracetamol.

Liver involvement in adults is possible with 10 or more grams of paracetamol.Taking 5 or more grams of paracetamol can lead to liver damage in patients who have the following risk factors: prolonged treatment with carbamazepine, phenobarbital, phenytoin, primidon, rifampicin, St. John's wort preparations, or other drugs that stimulate liver enzymes; regular use of alcohol in excess quantities; Deficiency of glutathione (due to malnutrition, cystic fibrosis, HIV infection, starvation, exhaustion).

Symptoms (due to paracetamol): Within 24 hours are possible: pallor of the skin, anorexia, nausea, vomiting, abdominal pain. During 12-48 hours, signs of a liver function disorder may appear. There may be signs of impaired glucose metabolism and metabolic acidosis. In case of severe poisoning, severe hepatic insufficiency may develop, including hepatic encephalopathy, coma, and death. Acute renal failure with acute tubular necrosis, which is diagnosed by severe pain in the lumbar region, hematuria and proteinuria, can develop without a serious impairment of liver function.There are reports of cardiac arrhythmias and pancreatitis in case of an overdose of paracetamol. At the first signs of an overdose, it is urgent to see a doctor, even if there are no distinct symptoms of poisoning. In the early period, the symptomatology can be limited only by nausea and vomiting and may not reflect the severity of the overdose or the risk of injury to the internal organs.

Treatment: During the first hour after the proposed overdose, it is advisable to assign the activated carbon inside. Four or more hours after the alleged overdose, a determination of the paracetamol concentration in the plasma is required (an earlier determination of the paracetamol concentration may be unreliable). LeAcetylcysteine can be administered up to 24 hours after paracetamol administration. however, the maximum hepatoprotective effect can be obtained in the first 8 hours after an overdose. After that, the effectiveness of the antidote drops sharply. If necessary acetylcysteine can be administered intravenously. In the absence of vomiting, an alternative option (in the absence of the possibility of rapid receipt of inpatient care) is the use of methionine inside.Treatment of patients with severe impairment of liver function 24 hours after taking paracetamol should be done in conjunction with specialists from the toxicology center or specialized department of liver diseases.

Symptoms (due to phenylephrine): irritability, headache, dizziness. insomnia, increased blood pressure, nausea, vomiting, increased excitability, reflex bradycardia. In severe cases of overdose, it is possible to develop hallucinations, confusion, convulsions, arrhythmias.

Treatment: symptomatic therapy, with severe arterial hypertension, the use of alpha-adrenoblockers, such as phentolamine.

Symptoms (due to ascorbic acid): when using more than 1000 mg - headache, increased excitability of the central nervous system, insomnia, nausea, vomiting, diarrhea, hyperacid gastritis, damage to the mucous membrane of the gastrointestinal tract, suppression of the function of the insulin pancreas apparatus (hyperglycemia, glucosuria), hyperoxaluria, nephrolithiasis (calcium oxalate ), damage to the glomerular apparatus of the kidneys, decreased permeability of capillaries (possibly deterioration of tissue trophism, increased blood pressure, hypercoagulability, development of microangiopathies).High doses of ascorbic acid (more than 3000 mg) can cause temporary osmotic diarrhea and gastrointestinal disturbances. such as nausea, discomfort in the stomach.

Treatment: symptomatic therapy, forced diuresis.

Interaction:

Paracetamol

Paracetamol, when taken for a long time, enhances the effect of indirect anticoagulants (warfarin and other coumarins). which increases the risk of bleeding. Episodic intake of a single dose of the drug has no significant effect on the effect of indirect anticoagulants.

Inductors of isoenzymes of microsomal oxidation in the liver (barbiturates, diphenin, carbamazepine, rifamnicin, zidovudine, fenitoia, ethanol, flumecinol, phenylbutazone and tricyclic antidepressants) increase the risk of hepatotoxic effects during overdoses and simultaneous administration with paracetamol.

Inhibitors of microsomal oxidation (cimetidine) reduce the risk of hepatotoxic effects of paracetamol.

Paracetamol decreases the effectiveness of diuretic drugs.

Metoclopramide and domperidone increase, and colestramine reduces the rate of absorption of paracetamol.

Paracetamol increases the effects of MAO inhibitors. sedatives, ethanol. Diflunisal increases the plasma concentration of paracetamol by 50%, increasing the risk of hepatotoxicity.

Paracetamol reduces the effectiveness of uricosuric (sulfinpyrazone, etc.) drugs.

Phenylephrine

Phenylephrine when taken with MAO inhibitors can lead to increased blood pressure.

Phenylephrine reduces the effectiveness of beta-blockers and antihypertensive drugs, increases the risk of developing hypertension and cardiovascular disorders.

Simultaneous use of phenylephrine with sympathomimetic amines can increase the risk of side effects from the cardiovascular system. Tricyclic antidepressants enhance the sympathomimetic effect of phenylephrine, may increase the risk of developing side effects of the cardiovascular system.

The simultaneous use of halothane with phenylephrine increases the risk of ventricular arrhythmia.

Phenylephrine reduces the hypotensive effect of guanethidine, nitrates, methyldopa. Guanethidine increases the alpha-adrenostimulating activity of phenylephrine.

With the simultaneous use of phenylephrine with antidepressants, antiparkinsonian, antipsychotic drugs (phenothiazine derivatives), urinary retention, dry mouth, constipation is possible.

The combined use of phenylephrine with glucocorticosteroids increases the risk of developing glaucoma.

The combined use of phenylephrine with digoxin or other cardiac glycosides increases the risk of cardiac rhythm and myocardial infarction.

Ascorbic acid

Ascorbic acid increases the concentration in the blood of benzylpenicillin and tetracyclines.

Ascorbic acid improves absorption in the intestine of iron preparations (converts trivalent iron into bivalent); can increase the excretion of iron with simultaneous application with deferoxamine.

Ascorbic acid reduces the effectiveness of heparin and indirect anticoagulants. ASA, oral contraceptives, fresh juices and alkaline drink reduce the absorption and absorption of ascorbic acid.

With simultaneous application with ASA, urinary excretion of ascorbic acid increases and the excretion of ASA decreases. ASA reduces the absorption of ascorbic acid by about 30%.

Ascorbic acid increases the risk of developing crystalluria in the treatment of short-acting salicylates and sulfonamides, slows the excretion of acids by the kidneys, increases the excretion of drugs that have an alkaline reaction (including alkaloids), and decreases the concentration of oral contraceptives in the blood.

Ascorbic acid increases the overall clearance of ethanol, which in turn reduces the concentration of ascorbic acid in the body.

Tetracycline, as well as barbiturates (primidon) increase the excretion of ascorbic acid with urine.

Ascorbic acid reduces the therapeutic effect of antipsychotic drugs (neuroleptics) - derivatives of fepotiazine, tubular reabsorption of amphetamine and tricyclic antidepressants.

Simultaneous use with ethanol promotes the development of acute pancreatitis. Myelotoxic drugs increase the manifestation of hematotoxicity of the drug.

Special instructions:

The drug should not be taken concurrently with other paracetamol-containing drugs. as well as other non-narcotic analgesics. NSAIDs (metamizol sodium, ASA, ibuprofen and the like), drugs for relief of symptoms "cold", sympathomimetics such as dekongestaty, drugs that regulate appetite, amfetaminpodobnymi stimulants, barbiturates, antiepileptic drugs, rifampicin, chloramphenicol.

To avoid toxic liver damage, the drug should not be combined with ethanol-containing drugs and refrain from drinking alcohol.

The preparation may distort the results of laboratory tests that measure the concentration of uric acid, glucose, bilirubin, activity "liver" transaminases and laktagdegidrogenazy.

Before applying Antigrippin SARS drug neo consult e physician in the event of reception: metoclopramide, domperidone (used to eliminate nausea and vomiting), cholestyramine used for reducing the concentration of cholesterol in blood, warfarin or other anticoagulants, digoxin and other cardiac glycosides to treat heart failure, antihypertensive drugs (eg, beta-blockers), drugs for depression (tricyclic antidepressants - amitriptyline); when it is necessary to observe a hyponatrial diet (each tablet contains 0.28 g of sodium).

Do not apply the drug without consulting a doctor for more than 3 days as an antipyretic and for more than 5 days as an anesthetic.

Effect on the ability to drive transp. cf. and fur:

Has no effect (when used in recommended doses). When there is dizziness to drive vehicles and engage in other potentially dangerous activities that require increased concentration and speed of psychomotor reactions is not recommended.

Form release / dosage:

Tablets effervescent [orange and lemon, forest berries] 500 mg + 10 mg + 100 mg.

Packaging:

For 12 tablets in a polypropylene box, sealed with a polyethylene plug with silica gel.

2 tablets per contour non-jawed package of combined material (strip).

Each pencil case, 2, 3, 4, 5 or 6 strips together with instructions for use are placed in a cardboard pack.

Storage conditions:

In the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years. He apply at the expiration date indicated on the package.

Terms of leave from pharmacies:Without recipe

Registration number:LP-003035

Date of registration:15.06.2015 / 06.03.2017

Expiration Date:15.06.2020

The owner of the registration certificate:VALENTA PHARM, PAO VALENTA PHARM, PAO Russia

Manufacturer: & nbsp

VITALE-XD, Ltd. Estonia

Information update date: & nbsp06.09.2017

Illustrated instructions

Instructions

Antigrippin-ORVI neo (Antigrippin-ORVI neo)