Viks Active Symptomax (Vicks Active SymptoMax)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceParacetamol + PhenylephrineParacetamol + Phenylephrine
Dosage form: & nbspPowder for solution for oral administration
Composition:

For one sachet:

Active substances - paracetamol 1000 mg, phenylephrine hydrochloride 12,20 mg.

Excipients in powder blackcurrant: ascorbic acid 100 mg, sucrose 2351 mg, citric acid 812 mg, sodium citrate 501 mg, aspartame 53 mg, acesulfame potassium 51 mg, black currant flavor S-133747 56 mg, black currant flavor 1007348 60 mg, blackcurrant dye 6 mg.

Excipients in powdered lemon: ascorbic acid 100 mg, sucrose 1936 mg, citric acid 812 mg, sodium citrate 501 mg, aspartame 25 mg, acesulfame potassium 65 mg, dye quinoline yellow 1 mg, flavoring lemon F / 29088 30 mg, flavoring lemon F / 29089 240 mg, lemon flavor F / 28151 240 mg, lemon flavor F / 501 476 / AP0504 40 mg.

Description:

Black-currant powder: a fine crystalline powder of light purple color, with a characteristic smell of black currant.

Powder of lemon: a fine crystalline powder of light yellow color, with a characteristic smell of lemon.

A solution of blackcurrant powder: red-violet, with a characteristic smell of black currant.

A solution of lemon powder: yellow, with a characteristic smell of lemon, with opalescence.

Pharmacotherapeutic group:ARI and "colds" of symptoms remedy (analgesic non-narcotic remedy + alpha-adrenomimetic)
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 of which is due to the composition of its components.

Paracetamol has an analgesic and antipyretic effect, these effects are due to the inhibition of the synthesis of prostaglandins in the central nervous system.

Phenylephrine - postsynaptic alpha-adrenoreceptor agonist with low cardioselective affinity for beta receptors. Decongestant, narrows vessels, eliminates puffiness and flushing of the mucous membrane of the nasal cavity.

Pharmacokinetics:

Paracetamol quickly and completely absorbed in the small intestine. The maximum concentration in the blood is observed 15-20 minutes after ingestion. Systemic bioavailability is determined by presystemic metabolism and, depending on the dose, ranges from 70% to 90%. Paracetamol fast pspreads across all tissues and has a half-life of about 2 hours. Metabolised in the liver and is excreted in the urine in the form of glucuronides and sulfate compounds (> 80%).

Phenylephrine quickly absorbed from the gastrointestinal tract. The level of primary metabolism is quite high (60%), so the oral use of phenylephrine reduces its bioavailability (40%). The maximum concentration in the blood plasma is observed after 1-2 hours, and the half-life period varies from 2 to 3 hours. It is excreted in the urine in the form of sulfate compounds. Oral reception of phenylephrine as decongestant should be carried out with an interval of 4-6 hours.

Indications:Symptoms of "colds" and flu: headache, sore throat, other types of pain, nasal congestion, fever.
Contraindications:

- Hypersensitivity to paracetamol or other components of the drug;

- arterial hypertension;

- cardiac ischemia;

- a violation of liver function and expresseda violation of kidney function;

- hyperthyroidism;

- diabetes;

- phenylketonuria (because the drug contains aspartame);

- aboutsimultaneous administration of tricyclic antidepressants, monoamine oxidase (MAO) inhibitors or beta-blockers, or their administration during the last 2 weeks;

- bVariability and the period of breastfeeding;

- gyipperprostatic gland prostate;

- glaucoma;

- atozrast to 18 years;

- dsugar content / isomaltase;

- Mr.fructose intolerance;

glucose-galactose malabsorption.

Carefully:

Long-term use of the drug is not recommended. It is necessary to avoid simultaneous administration of other anti-cold and / or paracetamol-containing drugs. Do not take the drug while taking alcohol.

Bronchial asthma, COPD (chronic obstructive pulmonary disease), glucose-6-phosphate dehydrogenase deficiency, blood diseases, congenital hyperbilirubinemia (Gilbert syndrome, Dubin-Johnson syndrome, Rotor), hyperoxaluria, pheochromocytoma.

Pregnancy and lactation:

Do not use the drug during pregnancy and during breastfeeding.

Dosing and Administration:

Dissolve the contents of one sachet in hot, but not boiling water (250 ml). Allow to cool to an acceptable temperature and drink.

Adults and children over 18 years of age one sachet. If necessary, repeat the reception every 4-6 hours, but not more than 4 doses (sachets) per day.

The drug is not recommended for more than 5 days as an anesthetic and 3 days as an antipyretic agent without consulting a doctor.

If symptoms persist, consult a physician.

Side effects:

Paracetamol

Allergic reactions

Rarely: skin rash, hives, anaphylaxis, angioedema.

From the central nervous system

Rarely: dizziness.

From the skin

Rarely: Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), acute generalized exanthematous pustulosis.

On the part of the hematopoiesis system

Rarely: aplastic anemia, methemoglobinemia, increased blood pressure.

Rarely: pathological changes in the blood, such as thrombocytopenia, agranulocytosis, hemolytic anemia, neutropenia, leukopenia, pancytopenia.

On the part of the respiratory system

Rarely: bronchospasm or exacerbation of bronchial asthma, including in patients susceptible to acetylsalicylic acid or other NSAIDs.

From the digestive system

Rarely: nausea, vomiting, dryness of the oral mucosa, hepatotoxic effect.

From the urinary system

Rarely: retention of urine, nephrotoxicity (papillary necrosis).

Other

Rarely: paresis of accommodation, increased intraocular pressure, mydriasis.

Phenylephrine

From the side of the cardiovascular system

Rarely: tachycardia, increased blood pressure.

From the nervous system

Rarely: insomnia, nervousness, tremor, anxiety, increased excitability, confusion, irritability and headache.

From the digestive system

Often: anorexia, nausea and vomiting.

From the immune system and skin

Rarely: allergic reactions, including skin rash, hives, anaphylaxis and bronchospasm.

Overdose:

Paracetamol

Liver involvement is possible in adults who take 10 or more grams of paracetamol. Taking 5 or more grams of paracetamol can cause liver damage if there are risk factors: prolonged treatment with carbamazepine, phenobarbital, phenytoin, primidon, rifampicin, or other drugs that induce liver enzymes, alcohol abuse, glutathione deficiency (eg, malnutrition), cystic fibrosis, HIV -infection, starvation, cachexia.

Symptoms of paracetamol overdose in the first 24 hours: pallor, nausea, vomiting, anorexia and pain in the abdomen. Liver damage can occur between 12 and 48 hours after application of the drug. There may also be signs of hypokalemia and metabolic acidosis (including lactic acidosis).

Frequent clinical manifestations after 3-5 days in conditions of chronic overdose with paracetamol are jaundice, fever, liver odor from the mouth, hemorrhagic diathesis, hypoglycemia, hepatic insufficiency.

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.

In case of an overdose of paracetamol, despite the absence of primary symptoms of an overdose, it is necessary to seek qualified help in medical institutions. To prevent serious consequences of overdose, it is necessary to take the necessary measures in time.

Symptoms may manifest only partially as nausea or vomiting, and may not reflect the actual degree of overdose or the risk of organ damage.

In severe overdose - liver failure with progressive encephalopathy, coma, death: acute renal failure with tubular necrosis (including in the absence of severe liver damage); arrhythmia, pancreatitis.

Phenylephrine

Symptoms of an overdose of phenylephrine include irritability, headache, increased blood pressure. In case of the above symptoms of an overdose, it is necessary to consult a doctor.

Treatment: introduction of donators SH-groups and precursors of glutathione-methionine synthesis for 8-9 hours after an overdose and acetylcysteine ​​- for 8 hours. The need for additional therapeutic measures (further introduction of methionine,intravenous injection of acetylcysteine) is determined depending on the concentration of paracetamol in the blood, as well as on the time elapsed after its administration.

Interaction:

Paracetamol

Stimulatemicrosomallyth oxidation in the liver (phenytoin, ethanol, barbiturates, flumecinol, rifampicin, phenylbutazone, tricyclic antidepressants) increase the production of hydroxylated active metabolites, hthen the possibility development of severe intoxication.

Paracetamol increases the effect of anticoagulants of indirect action and reduces effectiveness of uricosuric medicines.

Suction speedof paracetamol is increased by metoclopramide or domperidone and decreases by the action of kostiramamine.

The anticoagulant effect of warfarin and other coumarin derivatives is enhanced with prolonged use of paracetamol.

The drug enhances the effects of MAO inhibitors, sedatives, ethanol.

Phenylephrine

When simultaneous application of phenylephrine with an antidepressantantiparkinsonian, antipsychotic drugs, phenothiazine derivatives may delay urine,dryness of the oral mucosa, constipation.

When used with glucocorticosteroids, the risk of developing glaucoma increases.

Tricyclic antidepressants increase the adrenomimetic effect of phenylephrine, the simultaneous administration of halothane increases the risk of ventricular arrhythmia.

Special instructions:

The drug should not be combined with taking ethanol.

During the treatment period it is necessary to refrain from taking sleeping pills, anxiolytic drugs, as well as other drugs containing paracetamol.

The drug distorts the results of laboratory tests evaluating the concentration of glucose and uric acid in the plasma.

Contains sucrose. The drug is contraindicated in patients with a rare congenital intolerance to fructose, with impaired absorption of glucose-galactose or with a deficiency of sucrose-isomaltase.

Contains aspartame (E951), a source of phenylalanine. May be toxic to patients with phenylketonuria.

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

When driving vehicles and engaging in other potentially hazardous activities, it is necessary to take into account that the drug can cause such side effects,Like dizziness and confusion.

Form release / dosage:Powder for solution for oral administration [blackcurrant, lemon].
Packaging:

5.0 g of powder in a laminated bag.

For 5 or 10 bags together with the instructions for use are placed in a cardboard box.

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 expiry date.

Terms of leave from pharmacies:Without recipe
Registration number:LP-000098
Date of registration:22.12.2010 / 25.02.2016
Expiration Date:Unlimited
The owner of the registration certificate:Procter and Gamble Distributing Company, LLC Procter and Gamble Distributing Company, LLC Russia
Manufacturer: & nbsp
Information update date: & nbsp11.03.2017
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