Fervex for it is put. time. for shouted. solution of sachet No. 8

Pharmacological properties

Pharmacological effects caused by the components which are a part of medicine fervex:

— pheniramine a maleate — the blocker of N ₁ - receptors, provides the desensibilizing action which is shown reduction of expressiveness of inflammatory reaction of mucous membranes of the upper airways (nasal breath improves, the rhinorrhea, sneezing and dacryagogue decrease);

— paracetamol has the febrifugal and anesthetizing effect, the pains facilitating expressiveness and fevers (a headache, myalgia);

— ascorbic acid compensates the needs of an organism for vitamin C.

in a digestive tract. The C _max paracetamol in blood plasma is reached in 30–60 min. after reception. Paracetamol is quickly distributed in all fabrics. Concentration in blood, saliva and blood plasma are similar. Linking with proteins of blood plasma weak. Paracetamol is metabolized in a liver with formation of connections with glucuronic acid and sulfates. The minor metabolic way which is catalyzed by P 450 cytochrome leads to formation of intermediate reagent (N-atsetilbenzokhinonimina) which under normal conditions applications is quickly neutralized by the restored glutathione and is removed with urine after conjugation with cysteine and mercapturic acid. However at a serious poisoning the quantity of this toxic metabolite increases.

It is removed with urine, generally in the form of metabolites. 90% of the accepted dose are allocated with kidneys during 24 h, mainly in the form of conjugates with glucuronic acid (60–80%), sulphatic conjugates (20–30%).

In not changed look removes about 5% of the accepted dose. The t _½ makes about 2 h

maleate well is soaked up in a digestive tract. It is allocated mainly with kidneys. T _½ —

in a digestive tract. It is removed mainly with urine.

Indication

Fervex for adults: symptomatic treatment of catarrhal diseases, rhinitis, nasopharyngitis, the grippopodobny states which are shown a rhinorrhea, dacryagogue, sneezing, fever and/or a headache.

Fervex for children: symptomatic treatment of catarrhal diseases, a nasopharyngitis at children (aged from 6 years) and the states which are shown a rhinorrhea, dacryagogue, sneezing, fever and/or a headache.

Use

Fervex for adults. inside to adults and children 15 years medicine are aged more senior to appoint 1 sachet 2–3 times a day. to dissolve the maintenance of a sachet in enough cold or warm water. to accept solution right after preparation. with symptoms of a catarrhal disease it is better for patients to accept warm solution of medicine in the evening. the interval between receptions has to be not less than 4 h the maximum duration of treatment makes 5 days.

For patients with renal failures (clearance of creatinine of 10 ml/min.) the interval between receptions has to make not less than 8 h

If symptoms of a disease do not disappear or worsen, consultation of the doctor is necessary.

Fervex for children. For oral administration. The maintenance of a sachet is dissolved in enough cold or warm water.

for use only at children (aged from 6 years):

6-10 years — on 1 sachet 2 times a day;

10-12 years — on 1 sachet 3 times a day;

12-15 years — on 1 sachet 4 times a day.

Interval between receptions has to make not less than 4 h. The maximum duration of treatment — 3 days.

For patients with renal failures (clearance of creatinine of 10 ml/min.) the interval between receptions has to make not less than 8 h.

If symptoms of a disease do not disappear or worsen, consultation of the doctor is necessary.

Contraindication

Fervex for adults. hypersensitivity to components of medicine or antihistamines, heavy abnormal liver functions and/or kidneys, a congenital hyperbilirubinemia, deficiency glyukozo-6-fosfatdegidrogenazy, alcoholism, blood diseases, the expressed anemia, a leukopenia, heavy ag, unstable stenocardia, heavy violations of warm conductivity, an acute period of a myocardial infarction, heavy atherosclerosis, dekompensirovanny heart failure, a hyperthyroidism, a sharp ischuria at a prostatauxe, obstruction of a neck of a bladder, piloroduodenalny obstruction, ulcer of stomach and duodenum in an aggravation stage, closed-angle glaucoma, thrombosis, thrombophlebitis, severe forms of diabetes, epilepsy, advanced age; intolerance of fructose, a sprue of a glucose/galactose or insufficiency of sucrose-isomaltose, because of sucrose content.

together with MAO inhibitors and during 2 weeks after the termination of intake of MAO inhibitors. Fervex for adults it is contraindicated to patients who accept tricyclic antidepressants or blockers of β-adrenoceptors at an urolithiasis — provided that ascorbic acid gets to an organism in a dose of 1 g/days

Fervex for children. Hypersensitivity to components of medicine or antihistamines, heavy abnormal liver functions and/or kidneys, phenylketonuria, a congenital hyperbilirubinemia, deficiency glyukozo-6-fosfatdegidrogenazy, alcoholism, blood diseases, the expressed anemia, a leukopenia, heavy AG, unstable stenocardia heavy violations of warm conductivity, an acute period of a myocardial infarction, heavy atherosclerosis, dekompensirovanny heart failure, a hyperthyroidism, a sharp ischuria at a prostatauxe, obstruction of a neck of a bladder, piloroduodenalny obstruction, ulcer of stomach and duodenum in an aggravation stage, closed-angle glaucoma, thrombosis, thrombophlebitis, severe forms of diabetes, epilepsy. Not to apply together with MAO inhibitors and during 2 weeks after the termination of intake of MAO inhibitors. Contraindicated to the patients accepting tricyclic antidepressants or blockers of β-adrenoceptors. An urolithiasis — provided that ascorbic acid gets to an organism in a dose of 1 g/days

Children's age to 6 years; intolerance of fructose, a sprue of glucose galactose or insufficiency of sucrose-isomaltose, because of sucrose content.

Side effects

from the haematogenic and lymphatic system: anemia, a sulfhemoglobinemia and a methemoglobinemia (cyanosis, short wind, pain in heart), hemolytic anemia, thrombosis, a giperprotrombinemiya, an erythrocytopenia, thrombocytopenia, the Agranulocytosis, a neutrophylic leukocytosis, purple, a leukopenia.

from the immune system: an anaphylaxis, an acute anaphylaxis, skin reactions of hypersensitivity, including an itch, rashes on skin and mucous membranes (usually erythematic, a small tortoiseshell), a Quincke's disease, a multiformny erythema (Stephens's syndrome — Johnson), a toxic epidermal necrolysis (Lyell's disease).

from a respiratory system: a bronchospasm at the patients sensitive to acetylsalicylic acid and other NPVP.

from a digestive tract: dryness in a mouth, nausea, heartburn, vomiting, a lock, pain in epigastriums, diarrhea, an abnormal liver function, increase in activity of liver enzymes, as a rule, without development of jaundice, gepatonekroz (dose-dependent effect).

from an endocrine system: a hypoglycemia up to a hypoglycemic coma.

from nervous system: seldom — a headache, dizziness, a sleep disorder, insomnia, drowsiness, confusion of consciousness, a hallucination, nervousness, a shiver; in some cases — a coma, spasms, dyskinesia, changes of behavior, hyperexcitability; violation of balance and memory, absent-mindedness, especially at patients of advanced age.

from a cardiovascular system: in isolated cases — tachycardia, myocardium dystrophy (dose-dependent effect at prolonged use), orthostatic hypotension.

from a metabolism: violation of exchange of zinc, copper.

from an urinary system: ischuria and difficulty of urination, aseptic pyuria, renal colic.

from skin: eczema.

from an organ of sight: xerophthalmus, mydriasis, accommodation violation.

At prolonged use in high doses: damage of the glomerular device of kidneys, crystalluria, formation of uratny, tsistinovy and/or oxalic concrements to kidneys and urinary tract; damages of the insulyarny device of a pancreas (hyperglycemia, a glucosuria) and violation of synthesis of a glycogen before development of diabetes.

Special instructions

in case of the high temperature of a body or long fever remaining within 5 days against the background of use of medicine or at emergence of signs of superinfection should see a doctor for determination of expediency of further use of medicine.

sick diabetes with caution.

Alcohol strengthens sedative effect of pheniramine of a maleate, paracetamol hepatotoxicity.

results of laboratory tests (glucose, bilirubin of blood, activity of Transaminases).

Risk of mainly mental dependence appears when exceeding the recommended doses and at long-term treatment.

For prevention of overdose should check and exclude all medicines containing paracetamol.

For adults with the body weight of 50 kg the general dose of paracetamol should not exceed 4 g/days

Maximum recommended medicine Fervex doses for children:

· children with the body weight of 37 kg: the general dose of paracetamol should not exceed 80 mg/kg of body weight a day;

· children with the body weight of 38-50 kg: the general dose of paracetamol should not exceed 3 g/days;

· children with the body weight of 50 kg: the general dose of paracetamol should not exceed 4 g/days

Precautionary measure. Consumption of alcoholic beverages or use of sedatives (especially barbiturates) increase sedation of pheniramine of a maleate, therefore, it is necessary to avoid the use of these substances during treatment.

Each sachet of Fervex for adults and Fervex for adults with crimson taste contains 11.5 g of sucrose that should be considered sick diabetes and to the patients who are on a diet with the reduced content of sugar.

Each sachet of Fervex for children contains 2.4 g of sucrose that should be considered sick diabetes and to the patients who are on a diet with the reduced content of sugar.

Use during pregnancy and feeding by a breast. As influence of medicine on a course of pregnancy or feeding by a breast is insufficiently studied, it is not necessary to appoint it during these periods.

Children. Fervex not to apply to adults at children aged up to 15 years.

Fervex to children is applied at children aged from 6 up to 15 years.

Ability to influence speed of response at control of vehicles or work with other mechanisms. Drug can cause drowsiness therefore during its reception it is necessary to refrain from control of vehicles or work with other mechanisms.

Interaction

Undesirable combinations. because of availability of pheniramine ethanol increases sedation of blockers of n1-receptors therefore it is necessary to refrain from control of vehicles or work with other mechanisms. during treatment it is necessary to avoid consumption of alcoholic beverages and use of the medicines containing alcohol.

Combination to which it is necessary to pay attention. Because of availability of pheniramine other sedatives can cause oppression of central nervous system, these are such medicines as morphine derivatives (analgetics, the means suppressing cough and replacement therapy), neuroleptics, barbiturates, benzodiazepines, anxiolytics, not benzodiazepines (for example meprobamate), sleeping medicines, sedative antidepressants (amitriptyline, docsepin, mianserin, mirtazapin, trimipramin), sedative blockers of N ₁ - receptors, antihypertensive medicaments of the central action, Baclofenum and thalidomide.

Because of availability of pheniramine the medicines having atropinopodobny effect, such as imipraminovy antidepressants, the majority of atropinic blockers of N ₁ - receptors, anticholinergic, protivoparkinsonichesky means, atropinic spasmolysants, dizopramid, fenotiazinovy neuroleptics and clozapine can add undesirable atropinic effects, for example an ischuria, a lock and dryness in a mouth.

At a concomitant use with oral anticoagulants the risk of their strengthened action and the increased risk of bleeding at intake of paracetamol in the maximum doses (4 g/days) within not less than 4 days exists. It is necessary to carry out control of MNO regularly. If necessary the dose of intake of anticoagulant can be adjusted at intake of paracetamol and after the treatment termination by paracetamol.

Intake of paracetamol can affect results of definition of glucose in blood by a glucose oxydas-peroxidase method with abnormally high concentrations.

Intake of paracetamol can affect results of definition of urea in blood by method of phosphatotungstic acid.

Speed of absorption of paracetamol can increase because of simultaneous application with Metoclopramidum and domperidony and decrease because of application with Colestyraminum. Barbiturates reduce expressiveness of febrifugal effect of paracetamol.

Anticonvulsant medicines (including Phenytoinum, barbiturates, carbamazepine) which stimulate activity of microsomal enzymes of a liver, can strengthen toxic impact of paracetamol on a liver owing to increase in extent of transformation of medicine into hepatotoxic metabolites. At simultaneous use of paracetamol with an isoniazid the risk of development of a hepatotoxic syndrome increases. Paracetamol reduces efficiency of diuretics.

along with alcohol.

Ascorbic acid increases absorption of iron in intestines, the level of ethinylestradiol, penicillin, tetracycline; reduces the level of antipsychotic medicines, fenotiazinovy derivatives in blood. GKS reduce reserves of ascorbic acid. The concomitant use of ascorbic acid and Deferoxaminum increases fabric toxicity of iron, especially in a cardiac muscle that can lead to a blood circulatory system decompensation. It can be applied only in 2 h after Deferoxaminum injection. High doses of ascorbic acid reduce efficiency of tricyclic antidepressants. Absorption of ascorbic acid decreases at simultaneous application of oral contraceptives, the use of fruit or vegetable juice, alkaline drink.

Overdose

Svyazanaya with pheniramine. the overdose of pheniramine can cause spasms (especially in children), consciousness violation, a coma.

Svyazanaya with paracetamol. There is a risk of developing intoxication at elderly people and especially at small children (cases of therapeutic overdose and accidental poisoning note quite often).

Overdose of paracetamol can be lethal.

Symptoms. Nausea, vomiting, anorexia, pallor, the increased sweating, abdominal pain, usually develop during the first 24 h

Overdose more than 10 g of paracetamol for 1 reception at adults and 150 mg/kg of body weight for 1 reception causes a hepatic cytolysis in children that can lead to full and irreversible necrosis, hepatocellular insufficiency, a metabolic acidosis, encephalopathy that, in turn, can cause a coma and a lethal outcome.

are noted At the same time by the increased levels of hepatic Transaminases, LDG and bilirubin against the background of the increased prothrombin level that can be shown in 12–48 h after application.

Urgent actions:

— immediate hospitalization;

— determination of initial level of paracetamol in blood plasma;

— immediate removal of the applied medicine by gastric lavage;

— usual treatment of overdose includes use of antidote of N-Acetylcysteinum in/in or orally. Antidote should be applied as soon as possible, it is desirable during 10 h after overdose;

— methionine as symptomatic therapy.

Storage conditions

At a temperature up to 25 °C.