Викс Aktiv Simptomaks

General characteristics. Structure:

Active agents - paracetamol of 1000 mg, Phenylephrinum a hydrochloride of 12,20 mg.
Excipients in powder blackcurrant - ascorbic acid, sucrose, citric acid, sodium citrate, aspartame, to potassium atsesulfa, fragrance blackcurrant S-133747, fragrance blackcurrant 1007348, dye blackcurrant.
Excipients in powder lemon - ascorbic acid, sucrose, citric acid, sodium citrate, aspartame, to potassium atsesulfa, dye quinolinic yellow, fragrance lemon F/29088, fragrance lemon F/29089, fragrance lemon F/28151, fragrance lemon F/501.476/AP0504.

Description
Powder blackcurrant: fine-crystalline powder of light-violet color with a characteristic smell of blackcurrant.
Powder lemon: fine-crystalline powder of light yellow color with a characteristic smell of a lemon.
Solution of powder blackcurrant: red-violet color with a characteristic smell of blackcurrant.
Solution of powder lemon: yellow color with a characteristic smell of a lemon, with opalescence.

Pharmacological properties:

Pharmacodynamics. The combined drug which effect is caused by structure of the components entering it.
Paracetamol possesses anesthetic and febrifugal action, these effects are caused by inhibition of synthesis of prostaglandins in the central nervous system.
Phenylephrinum - a postsynaptic agonist of alpha adrenoceptors with low cardioselective affinity to beta receptors. Decongestant, narrows vessels, eliminates puffiness and a hyperemia of a mucous membrane of a nasal cavity.

Pharmacokinetics. Paracetamol is quickly and completely soaked up in a small intestine. The maximum concentration in blood is observed in 15-20 minutes after intake. System bioavailability is defined by presistemny metabolism and, depending on a dose, fluctuates ranging from 70% to 90%. Paracetamol quickly spreads on all body tissues and has an elimination half-life about 2 hours. It is metabolized in a liver and removed with urine in the form of glucuronides and sulphatic connections (> 80%).
Phenylephrinum is quickly soaked up from digestive tract. Level of primary metabolism is rather high (≅60%) therefore oral administration of Phenylephrinum reduces its bioavailability (≅40%). The maximum concentration in a blood plasma is observed in 1-2 hours, and the elimination half-life varies from 2 to 3 hours. It is removed with urine in the form of sulphatic connections. Oral administration of Phenylephrinum as decongestant has to be carried out at an interval of 4-6 hours.

Indications to use:

Symptoms of "catarrhal" diseases and flu: a headache, a pharyngalgia, other types of pain, a nose congestion, the increased body temperature.

Route of administration and doses:

To dissolve contents of one bag in the hot, but not boiling water (250 ml). To allow to cool down up to the acceptable temperature and to drink.
To adults and children 18 years - one bag are more senior. If necessary to repeat reception each 4-6 hours, but no more than 4 doses (bags) a day.
More than 5 days as anesthetic and as an antipyretic without consultation with the doctor are not recommended to use 3 days drug.
If symptoms remain, it is necessary to see a doctor.

Features of use:

Drug should not be combined with ethanol reception.
During treatment it is necessary to refrain from reception of somnolent, anxiolytic medicines, and also other drugs containing paracetamol.
Drug distorts results of the laboratory tests estimating concentration of glucose and uric acid in plasma.
Contains sucrose. Drug is contraindicated to patients with rare inborn intolerance of fructose, with disturbance of absorption of glucose galactose or with deficit of invertase-isomaltase.
Contains aspartame (E951), a phenylalanine source. Can be toxic for patients with a fenilketonuriya.
At control of vehicles and occupation other potentially dangerous types of activity it is necessary to take into account that drug can cause such side effects as dizziness and confusion of consciousness.

Side effects:

Paracetamol
Allergic reactions Seldom: skin rash, small tortoiseshell, anaphylaxis, bronchospasm, Quincke's disease.
From the central nervous system Seldom: dizziness.
From system of a hemopoiesis it is rare: aplastic anemia, methemoglobinemia, increase in arterial pressure. Very seldom: pathological changes of blood, such as thrombocytopenia, agranulocytosis, hemolitic anemia, neutropenia, leukopenia, pancytopenia.
From the alimentary system Seldom: nausea, vomiting, dryness of a mucous membrane of an oral cavity, hepatotoxic action.
From an urinary system Seldom: ischuria, nephrotoxicity (papillary necrosis).
Others it is rare: accommodation paresis, increase in intraocular pressure, mydriasis.
Phenylephrinum
From cardiovascular system Seldom: tachycardia, increase in arterial pressure.
From a nervous system Seldom: sleeplessness, nervousness, tremor, alarm, hypererethism, confusion of consciousness, irritability and headache.
From the alimentary system Often: anorexia, nausea and vomiting.
From immune system and integuments Seldom: allergic reactions, including skin rash, a small tortoiseshell, an anaphylaxis and a bronchospasm.

Interaction with other medicines:

Paracetamol
Stimulators of a microsomal oxidation in a liver (Phenytoinum, ethanol, barbiturates, флумецинол, rifampicin, phenylbutazone, tricyclic antidepressants) increase products of hydroxylated active metabolites that causes a possibility of development of heavy intoxications.
Paracetamol strengthens effect of anticoagulants of indirect action and reduces efficiency of uricosuric medicines.
Speed of absorption of paracetamol increases under the influence of Metoclopramidum or a domperidon, and decreases under the influence of Colestyraminum.
Anticoagulating effect of warfarin and other derivative coumarins amplifies at prolonged use of paracetamol.
Drug strengthens effects of MAO inhibitors, sedative drugs, ethanol.
Phenylephrinum
At simultaneous use of Phenylephrinum with antidepressants, protivoparkinsonichesky, antipsychotic means, fenotiazinovy derivatives the ischuria, dryness of a mucous membrane of an oral cavity, a lock is possible.
At use with glucocorticosteroid the risk of development of glaucoma increases.
Tricyclic antidepressants increase adrenomimetichesky action of Phenylephrinum, co-administration of a halothane increases risk of development of ventricular arrhythmia.

Contraindications:

• Hypersensitivity to paracetamol or other components of drug;
• Arterial hypertension;
• Coronary heart disease;
• An abnormal liver function and the expressed renal failure;
• Hyperthyroidism;
• Diabetes mellitus;
• Fenilketonuriya (since drug contains aspartame);
• A concomitant use of tricyclic antidepressants, monoamine oxidase inhibitors (MAO) or beta adrenoblockers or their reception within 2 last weeks;
• Pregnancy and period of feeding by a breast;
• Prostate hyperplasia;
• Glaucoma;
• Age up to 18 years;
• Deficit of invertase/isomaltase;
• Intolerance of fructose;
• Glyukozo-galaktozny malabsorption.
With care
Prolonged use of drug is not recommended. It is necessary to avoid a concomitant use of others anti-cold and/or paracetamol - the containing drugs. Not to accept drug along with alcohol intake.
Bronchial asthma, HOBL (chronic obstructive pulmonary disease) deficit glyukozo-6-fosfatdegidrogenazy, blood diseases, inborn hyperbilirubinemias (Gilbert's syndromes, Cudgel Johnson and, Rotor), hyperoxaluria.

Use at pregnancy and during breastfeeding
It is not necessary to use drug at pregnancy and during breastfeeding.

Overdose:

Paracetamol
Damage of a liver is possible at the adults who accepted 10 and more than a grams of paracetamol. Reception of 5 or more grams of paracetamol can cause damage of a liver if there are risk factors: long treatment by carbamazepine, phenobarbital, Phenytoinum, Primidonum, rifampicin or other drugs inducing liver enzymes, an alcohol abuse, a lack of a glyutanion (for example, improper feeding), a mucoviscidosis, HIV infection, starvation, a cachexia.
Overdose symptoms paracetamol in the first 24 hours: blanching, nausea, vomiting, anorexia and pain in a stomach.
Damage of a liver can be shown during from 12 to 48 hours after drug use. In case of paracetamol overdose, despite the lack of primary symptoms of overdose, it is necessary to ask for the qualified help in medical institutions. It is necessary to take necessary measures for prevention of serious consequences of overdose timely.
Symptoms can be shown only partially in the form of nausea or vomiting, and can not reflect real extent of overdose or risk of damage of bodies.
At heavy overdose - a liver failure with the progressing encephalopathy, a coma, death; an acute renal failure with a tubular necrosis (including in the absence of severe damage of a liver); arrhythmia, pancreatitis.
Phenylephrinum
Symptoms of overdose of Phenylephrinum include irritability, a headache, increase in arterial pressure.
In case of the symptoms of overdose stated above it is necessary will see a doctor.
Treatment: introduction of donators of SH-group and predecessors of synthesis of glutathione - methionine within 8-9 hours after overdose and Acetylcysteinum - within 8 hours. Need for holding additional therapeutic actions (further administration of methionine, intravenous administration of Acetylcysteinum) is defined depending on concentration of paracetamol in blood, and also from time which passed after its reception.

Storage conditions:

At a temperature not above 25 °C. To store in the places unavailable to children. Period of validity 3 years. Not to use after a period of validity.

Issue conditions:

Without recipe

Packaging:

Powder for preparation of solution for intake [blackcurrant, lemon].
5,0 g of powder in the laminated bag.
On 5 or 10 bags together with the application instruction place in a cardboard pack.