Fervex - instructions for use, dose, side effects, contraindications

* - Aromatizer lemon-rum - maltodextrin, acacia gum, α-pinene, β-pinene, limonene, γ-terpinene, linalol, neral, α-terpineol, geranium, dextrose, silicon dioxide, butylhydroxyanisole.

[crimson with sugar] - sucrose 1 1.555 g, citric acid 0.200 g, acacia gum 0.100 g, sodium saccharinate dihydrate 0.020 g, raspberry flavor 0.150 g **

** A flavourful crimson - ethyl acetate, isoamyl acetate, acetic acid, benzyl alcohol, triacetin, vanillin, p-hydroxybenzylacetone, maltodextrin, E 1450 modified corn starch, E 129 dye red charming, E 133 dye diamond blue, E 110 dye sunset yellow, permastable 505528 RI, raspberry 054428 A.

Description:

Fervex lemon: Powder of light beige color with a characteristic smell. Inclusions are brown.

Appearance of the prepared solution: a solution of gray-beige color, opalescent, with a characteristic lemon scent.

Fervex crimson: Powder from light pink to light beige. Blotches of dark pink are allowed.

Appearance of the prepared solution: pink solution, lightly opalescent, with a characteristic crimson smell.

Pharmacotherapeutic group:means for eliminating the symptoms of acute respiratory infections (ARI) and "colds" (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:

Fervex® is a combined preparation that contains 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.

Phenyramin - blocker H1-histamine 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 is a cofactor of some hydroxylation and amidation reactions - transfers electrons to enzymes, providing them with a replacement equivalent. Participates in the reactions of hydroxylation of proline and lysine residues of procollagen with the formation of hydroxyproline and hydroxylizine (post-translational modification of collagen), the oxidation of the side chains of lysine in proteins with the formation of hydroxytrimethyllysine (during the synthesis of carnitine), the oxidation of folic acid to folinic, the metabolism of drugs in liver microsomes and hydroxylation dopamine with the formation of norepinephrine.Increases the activity of amidating enzymes involved in the synthesis of oxytocin, adrenocorticotropic hormone and holitsistokinina. Participates in steroidogenesis in the adrenal glands.

Pharmacokinetics:

Paracetamol

Absorption is high. The time required to reach the maximum concentration (TCMah) - 0.5-2 hours; maximum concentration (Сmah) - 5-20 mcg / ml. Connection with plasma proteins - 15%. Penetrates through the blood-brain barrier (BBB).

Metabolised in the liver in three main ways: conjugation with glucuronides, conjugation with sulfates, oxidation with microsomal enzymes of the liver. In the latter case, toxic intermediate metabolites are formed, which are subsequently conjugated to glutathione, and then to cysteine and mercapturic acid. The main isoenzymes of cytochrome P450 for this pathway of metabolism are isoenzyme CYP2E1 (predominantly), CYP1A2 and CYP3A4 (a secondary role). With a deficiency of glutathione, these metabolites can cause damage and necrosis of hepatocytes.

Additional ways of metabolism are hydroxylation to 3-hydroxyparacetamol and methoxylation to 3-methoxyparacetamol, which are subsequently conjugated to glucuronides or sulfates.

Conjugated metabolites of paracetamol (glucuronides, sulfates and conjugates with glutathione) have low pharmacological (including toxic) activity.

The half-life (T1 / 2) is 1-4 hours. It is excreted by the kidneys in the form of metabolites, mainly conjugates, only 3% in unchanged form. In elderly patients the clearance of the drug decreases and T1 / 2 increases.

Pheniramine:

Well absorbed in the digestive tract. The half-life of plasma is from one to one and a half hours.

It is excreted primarily through the kidneys.

Ascorbic acid:

Well absorbed in the digestive tract. Time to create the maximum therapeutic concentration (TC_m_ax) after ingestion - 4 hours Metabolised mainly in the liver. It is excreted by the kidneys, through the intestine, with sweat, in unchanged form and in the form of metabolites.

Connection with plasma proteins - 25%. Easily penetrates into leukocytes, platelets, and then into all tissues; the greatest concentration is achieved in glandular organs, leukocytes, liver and lens of the eye; penetrates the placenta. The concentration of ascorbic acid in leukocytes and platelets is higher,than in erythrocytes and in plasma. In deficient states, the concentration in leukocytes decreases later and more slowly and is considered as the best criterion for estimating the deficit than concentration in plasma.

Metabolised mainly in the liver in desoxyascorbic and then in oxaloacetic acid and ascorbate-2-sulfate.

It is excreted by the kidneys, through the intestines, with sweat, breast milk in unchanged form and in the form of metabolites. It is in hemodialysis.

Indications:

It is used as a symptomatic therapy for acute respiratory viral infections to alleviate the following symptoms:

- rhinorrhea, nasal congestion;

- headache;

- increased body temperature;

- lacrimation;

- sneezing.

Contraindications:

- Hypersensitivity to paracetamol, ascorbic acid, phenyramin or any other component of the drug;

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

- Liver failure;

- Closed-angle glaucoma;

- Urinary retention associated with prostate disease and urinary disorders;

- Portal hypertension;

- Alcoholism;

- Phenylketonuria;

- Glucose-galactose malabsorption;

- Children's age (up to 15 years);

- Pregnancy and lactation (safety not studied).

Carefully:renal failure, congenital hyperbilirubinemia (Gilbert syndrome, Dubin-Johnson and Rotor syndrome), viral hepatitis, alcoholic hepatitis, advanced age, diabetes mellitus.

Pregnancy and lactation:

Adequate and well-controlled studies of the drug Ferveks® in pregnant women have not been conducted, therefore, the use of the drug in this group of patients is not recommended.

It is not known whether the active substances of the drug penetrate into breast milk. The drug should not be used during lactation.

Dosing and Administration:

Inside - 1 packet 2-3 times a day. Before use, the contents of the sachet must be dissolved in a glass (200 ml) of warm water. The maximum duration of treatment is 5 days. The maximum daily dose of paracetamol is 4 g (8 packets of the Fervex® preparation) 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.

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.

There are dry mouth, nausea, vomiting, abdominal pain, disturbance of micturition, constipation, allergic reaction (erythema, skin rash, pruritus, urticaria, angioedema, anaphylactic shock), drowsiness, ccomodation, palpitations, orthostatic hypotension, dizziness, incoordination, tremors, confusion, hallucinations, attention span disorder (most often - in elderly patients), anemia, leukopenia, agranulocytosis, thrombocytopenia, agitation, nervousness, insomnia.

If any side effects occur, stop taking the medication and consult a doctor.

Overdose:

Symptoms caused by paracetamol: pallor of the skin, decreased appetite, nausea, vomiting; hepatonecrosis (the severity of necrosis due to intoxication directly depends on the degree of overdose).Toxic effect in adults is possible after taking more than 10-15 g of paracetamol: increased activity of "liver" transaminases, an increase in prothrombin time (12-48 hours after administration); a detailed clinical picture of liver damage manifests itself after 1-6 days. Rarely, liver failure develops at a lightning speed and can be complicated by renal insufficiency (tubular necrosis).

Treatment: Discontinue use immediately and consult a doctor. In the first 6 hours after an overdose - gastric lavage, the introduction of donators SH-groups and precursors of glutathione-methionine synthesis 8-9 hours after an overdose and N-acetylcysteine after 12 h. The need for additional therapeutic measures (further introduction of methionine, iv administration N- acetylcysteine) is determined by the concentration of paracetamol in the blood, as well as by the time that has passed since it was taken.

Symptoms caused by ascorbic acid: nausea, diarrhea, irritation mucous membrane of the gastrointestinal tract, flatulence, abdominal pain of a spastic nature, frequent urination, nephrolithiasis, insomnia, irritability, hypoglycemia.

Treatment: Discontinue use immediately and consult a doctor.Treatment is symptomatic, forced diuresis.

Symptoms caused by phenyramine: convulsions, impaired consciousness, coma. Treatment: Discontinue use immediately and consult a doctor. Recommended gastric lavage, intake of enterosorbents (Activated carbon, hydrolysis lignin), Intravenous or oral administration acetylcysteine antidote (if possible, during the first 10 hours after the overdose), symptomatic treatment.

Interaction:

Ethanol enhances the sedative effect of antihistamines (phenyramine), therefore, it should be avoided during the treatment with the drug Fervex®. Besides, ethanol with simultaneous use with phenyramine promotes the development of acute pancreatitis.

Phenyramin enhances the action of sedatives: morphine derivatives, barbiturates, benzodiazepine and other tranquilizers, neuroleptics (meprobamate, phenothiazine derivatives), antidepressants (amitriptyline, mirtazapine, mianserin), antihypertensive drugs of central action, sedatives, belonging to the group H1-blockers, baclofen; while not only increases the sedative effect, but also increases the risk of side effects of the drug (urine retention, dry mouth, constipation).

The possibility of strengthening central m-cholinoblocking effects when used in combination with other drugs possessing m-cholin-blocking activity (other H1-histamine receptor blockers, tricyclic antidepressants, phenothiazine-type antipsychotics, antisparkinsonics with m-cholinoblocking activity, disopyramide) should be considered.

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

Glucocorticosteroids with simultaneous application increase the risk of developing glaucoma.

Admission simultaneously with salicylates increases the risk of nephrotoxic action.

With the simultaneous use with chloramphenicol (levomitsetinom) toxicity of the latter increases.

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

Ascorbic acid increases the concentration of benzylpenicillin and tetracyclines in the blood; in a dose of 1 g / day increases the bioavailability of ethinyl estradiol (including those included in oral contraceptives).

Improves absorption in the intestines of iron preparations (converts trivalent iron into bivalent); can increase the excretion of iron with simultaneous use with deferoxamine.

Reduces the effectiveness of heparin and indirect anticoagulants.

With simultaneous use with acetylsalicylic acid (ASA), urinary excretion of ascorbic acid increases and the excretion of ASA decreases. ASA reduces the absorption of ascorbic acid by about 30%. Increases the risk of developing crystalluria in the treatment of salicylates and sulfonamides short-acting, slows the excretion of kidney acids, increases the excretion of drugs that have an alkaline reaction (including alkaloids), reduces the concentration of oral contraceptives in the blood.

Increases the total clearance of ethanol, which in turn reduces the concentration of ascorbic acid in the body.

The drugs of quinoline series, calcium chloride, salicylates, glucocorticosteroids with prolonged use deplete the stores of ascorbic acid. With simultaneous application ascorbic acid reduces the chronotropic effect of isoprenaline. With prolonged use or use in high doses, it can interfere with the interaction of disulfiram and ethanol. In high doses increases the excretion of mexiletine by the kidneys.

Barbiturates and primidon increase the excretion of ascorbic acid in the urine.

Reduces the therapeutic effect of neuroleptics - phenothiazine derivatives, tubular reabsorption of amphetamine and tricyclic antidepressants.

Special instructions:

Fervex® should not be used concomitantly with other medicines containing paracetamol.

To avoid toxic damage to the liver paracetamol should not be combined with the reception of alcoholic beverages, but also to people prone to chronic alcohol consumption.

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

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.

Ascorbic acid as a reducing agent can distort the results of various laboratory tests (blood and urine content of glucose, bilirubin, activity of "liver" transaminases and LDH).

In case of taking the drug by patients with diabetes mellitus or on a diet with a low sugar content, it should be taken into account that each packet contains 11.555 g of sucrose, which corresponds to 0.9 XE.

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

Considering the possibility of developing such undesirable effects as drowsiness and dizziness, during the period of drug treatment it is recommended to refrain from driving and mechanisms.

Form release / dosage:Powder for solution for oral administration.

Packaging:

Powder for solution for ingestion, [lemon with sugar].

For 13.1 grams in a bag of paper / aluminum / polyethylene. For 8 bags together with instructions for use in a pack of cardboard.

Powder for solution for oral administration, [raspberry with sugar].

For 12.75 grams in a bag of paper / aluminum / polyethylene. For 8 bags together with instructions for use in a pack of cardboard.

Storage conditions:

In a dry place at a temperature of 15 to 25 ° C.

Keep out of the reach of children!

Shelf life:

3 years.

Do not use the product after the expiry date printed on the package.

Terms of leave from pharmacies:Without recipe

Registration number:P N 015947/01

Date of registration:25.08.2009

The owner of the registration certificate:Bristol-Myers SquibbBristol-Myers Squibb France

Manufacturer: & nbsp

BRISTOL-MYERS SQUIBB, S.r.L. Italy

Representation: & nbspBRISTOL-Majers SKVIBB, LLCBRISTOL-Majers SKVIBB, LLCRussia

Information update date: & nbsp02.05.2012

Illustrated instructions

Instructions

Fervex® (Fervex®)