Fluvix (Powder) Instructions for Use

ATC Code

N02BE51 (Paracetamol in combination with other drugs, excluding psycholeptics)

Active Substances

Ascorbic acid (Rec.INN registered by WHO)

Paracetamol (Rec.INN registered by WHO)

Pheniramine (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Combination analgesic-antipyretic

Pharmacotherapeutic Group

Analgesics; other analgesics and antipyretics; anilides

Pharmacological Action

Combined medicinal product.

Paracetamol is an analgesic-antipyretic. It has analgesic, antipyretic, and weak anti-inflammatory effects. The mechanism of action is associated with the inhibition of prostaglandin synthesis, with a predominant effect on the thermoregulation center in the hypothalamus.

Pheniramine is an antiallergic agent, a histamine H₁-receptor blocker. It relieves allergic symptoms, has a moderate sedative effect, and also exhibits m-cholinolytic activity.

Ascorbic acid is involved in the regulation of redox processes, carbohydrate metabolism, blood clotting, tissue regeneration, and the synthesis of steroid hormones; it increases the body’s resistance to infections, reduces vascular permeability, and decreases the need for vitamins B₁, B₂, A, E, folic acid, and pantothenic acid. It improves the tolerability of paracetamol and prolongs its action (associated with the prolongation of T_1/2).

Pharmacokinetics

Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract. C_max in plasma is reached within 10-60 minutes after oral administration. It is distributed in most body tissues. It crosses the placental barrier and is excreted in breast milk. In therapeutic concentrations, binding to plasma proteins is insignificant but increases with increasing concentration. It undergoes primary metabolism in the liver. It is excreted mainly in the urine as glucuronides and sulfates. T_1/2 ranges from 1 to 3 hours.

C_max of pheniramine in plasma is reached in approximately 1-2.5 hours. T_1/2 of pheniramine is 16-19 hours. 70-83% of the dose is excreted from the body in the urine as metabolites or unchanged.

Ascorbic acid is rapidly and completely absorbed from the gastrointestinal tract. Binding to plasma proteins is 25%. It is excreted in the urine as metabolites. Ascorbic acid, taken in excessive amounts, is rapidly excreted unchanged in the urine.

Indications

Acute respiratory viral infections (symptomatic therapy); allergic rhinitis; rhinopharyngitis; pain syndrome (mild to moderate): arthralgia, myalgia, neuralgia, migraine, toothache and headache, dysmenorrhea; pain from injuries, burns.

ICD codes

Dosage Regimen

Prepare the powder for oral administration by dissolving the entire contents of one sachet in a glass of warm water. Stir thoroughly until completely dissolved. Consume the resulting solution immediately.

Administer a single dose 2 to 4 times per day, depending on the patient’s age and clinical presentation. Maintain a minimum interval of 4 hours between consecutive doses.

For adult patients and adolescents aged 15 years and older, the standard regimen is one sachet per dose. Do not exceed four sachets (four doses) within a 24-hour period.

In patients with chronic renal failure (CrCl 10 ml/min), extend the dosing interval to at least 8 hours between administrations. Adjust the total daily dose accordingly to prevent accumulation.

The total duration of self-administered treatment without medical supervision should not exceed 3 days for fever or 5 days for pain. Discontinue use and consult a physician if symptoms persist beyond these durations.

Avoid concurrent use with other products containing paracetamol. Adhere strictly to the recommended dosage to avoid the risk of hepatotoxicity.

Adverse Reactions

From the digestive system: nausea, pain in the epigastric region; rarely – dry mouth; with long-term use in doses significantly exceeding the recommended ones, the likelihood of impaired liver function increases.

From the hematopoietic system rarely – anemia, thrombocytopenia, methemoglobinemia.

From the urinary system rarely – urinary retention; with long-term use in doses significantly exceeding the recommended ones, the likelihood of impaired renal function increases.

Allergic reactions skin rash, itching, urticaria, angioedema.

Other rarely – accommodation paresis, drowsiness.

Contraindications

Erosive and ulcerative lesions of the gastrointestinal tract (in the acute phase); renal failure; portal hypertension; chronic alcoholism; children under 15 years of age (for dosage forms intended for adults); first and third trimesters of pregnancy; lactation period (breastfeeding); hypersensitivity to the components of the combination.

With caution

Hepatic failure, angle-closure glaucoma, prostatic hyperplasia, congenital hyperbilirubinemias (Gilbert’s, Dubin-Johnson and Rotor syndromes), viral hepatitis, alcoholic hepatitis, in elderly patients.

Use in Pregnancy and Lactation

Contraindications: first and third trimesters of pregnancy; lactation period (breastfeeding).

Use in Hepatic Impairment

The drug is contraindicated for use in impaired liver function.

Use in Renal Impairment

With caution in renal failure.

In chronic renal failure (CrCl 10 ml/min), the interval between doses is 8 hours.

Pediatric Use

Contraindication – children under 15 years of age (for dosage forms intended for adults).

Special Precautions

If hyperthermia persists for more than 3 days and pain syndrome for more than 5 days, a doctor’s consultation is required.

It distorts the indicators of laboratory tests in the quantitative determination of glucose and uric acid in plasma.

During treatment, monitoring of the peripheral blood picture and the functional state of the liver is necessary.

During the treatment period, it is necessary to refrain from consuming ethanol (the development of a hepatotoxic effect is possible).

Effect on the ability to drive vehicles and mechanisms

During the treatment period, it is necessary to refrain from driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Drug Interactions

Ethanol enhances the sedative effect of antihistamine drugs.

Antidepressants, antiparkinsonian, antipsychotic drugs (phenothiazine derivatives) increase the risk of side effects (urinary retention, dry mouth, constipation).

Corticosteroids increase the risk of developing glaucoma.

Inducers of microsomal oxidation (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants) increase the production of hydroxylated active metabolites, increasing the risk of severe intoxication with small overdoses.

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

Paracetamol reduces the effectiveness of uricosuric drugs .

With simultaneous use of oral contraceptives, the concentration of ascorbic acid in the blood plasma decreases. An increase in the concentration of ethinyl estradiol in the blood plasma is possible with its simultaneous use as part of oral contraceptives.

With simultaneous use with iron preparations, Ascorbic acid, due to its reducing properties, converts ferric iron into ferrous iron, which contributes to improved absorption.

With simultaneous use with warfarin, a decrease in the effects of warfarin is possible.

With simultaneous use, Ascorbic acid increases the excretion of iron in patients receiving deferoxamine .

With simultaneous use with tetracycline, the excretion of ascorbic acid in the urine increases.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.