Flufight^® (Powder) Instructions for Use

Marketing Authorization Holder

Remedia, LLC (Russia)

Manufactured By

Celebrity Biopharma, Ltd. (India)

ATC Code

N02BE71 (Paracetamol in combination with psycholeptics)

Dosage Forms

	Flufight®	Powder for oral solution (ginger): sachet 10 pcs.
		Powder for oral solution (honey-lemon): sachet 10 pcs.
		Powder for oral solution (lemon): sachets 10 pcs.
		Powder for oral solution (raspberry): sachets 10 pcs.

Dosage Form, Packaging, and Composition

Powder for oral solution from almost white to light yellow in color, with small dark inclusions, free-flowing; prepared solution (when dissolved in 200 ml of hot water) is light brown in color with a ginger odor.

Excipients : sodium chloride – 30 mg, anhydrous citric acid – 480 mg, anhydrous sodium citrate – 600 mg, aspartame – 80 mg, anhydrous lactose – 1800 mg, mannitol – 1162 mg, disodium edetate – 5 mg, ginger flavor – 30 mg.

5 g – sachets (10) – cardboard packs.

Powder for oral solution from almost white to light yellow in color, with small dark inclusions, free-flowing; prepared solution (when dissolved in 200 ml of hot water) has a faint brownish tint, with a honey and lemon odor.

Excipients : sodium chloride – 30 mg, anhydrous citric acid – 480 mg, anhydrous sodium citrate – 600 mg, aspartame – 80 mg, anhydrous lactose – 1800 mg, mannitol – 1162 mg, disodium edetate – 5 mg, honey flavor – 15 mg, lemon flavor – 15 mg, caramel color – 3 mg.

5 g – sachets (10) – cardboard packs.

Powder for oral solution from almost white to light yellow in color, with light orange inclusions, free-flowing; prepared solution (when dissolved in 200 ml of hot water) ranges from light yellow to orange in color, with a lemon odor.

Excipients : sodium chloride – 30 mg, anhydrous citric acid – 480 mg, anhydrous sodium citrate – 600 mg, aspartame – 80 mg, anhydrous lactose – 1800 mg, mannitol – 1162 mg, disodium edetate – 5 mg, lemon flavor – 30 mg, sunset yellow dye – 3 mg.

5 g – sachets (10) – cardboard packs.

Powder for oral solution from almost white to light pink in color, with darker pink inclusions, free-flowing; prepared solution (when dissolved in 200 ml of hot water) is pink in color, with a raspberry odor.

Excipients : sodium chloride – 30 mg, anhydrous citric acid – 480 mg, anhydrous sodium citrate – 600 mg, aspartame – 80 mg, anhydrous lactose – 1800 mg, mannitol – 1162 mg, disodium edetate – 5 mg, raspberry flavor – 30 mg, ponceau 4R dye – 3 mg.

5 g – sachets (10) – cardboard packs.

Clinical-Pharmacological Group

Drug for symptomatic therapy of acute respiratory diseases

Pharmacotherapeutic Group

Remedy for the relief of acute respiratory disease and "common cold" symptoms (non-narcotic analgesic + decongestant + vitamin)

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 inhibition of prostaglandin synthesis, with a predominant effect on the thermoregulation center in the hypothalamus.

Phenylephrine is an alpha₁-adrenergic agonist, causes vasoconstriction, eliminates swelling and hyperemia of the nasal mucosa.

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

Caffeine stimulates the psychomotor centers of the brain, has an analeptic effect, enhances the effect of analgesics, eliminates drowsiness and fatigue, increases physical and mental performance.

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.

Phenylephrine is absorbed from the gastrointestinal tract. It is metabolized during the “first pass” through the intestinal wall and in the liver, so when taken orally, Phenylephrine Hydrochloride is characterized by limited bioavailability. C_max in plasma is reached within the interval from 45 minutes to 2 hours. It is excreted by the kidneys almost completely in the form of sulfate compounds. T_1/2 is 2-3 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.

Caffeine is rapidly absorbed from the gastrointestinal tract and distributed throughout the body. Caffeine is almost completely metabolized in the liver by oxidation and demethylation into metabolites, which are excreted in the urine. T_1/2 is 4-9 hours.

Indications

Symptomatic treatment of infectious and inflammatory diseases (ARVI, including influenza), accompanied by high fever, chills, body aches, headache and muscle pain, runny nose, nasal congestion, sneezing.

ICD codes

Dosage Regimen

Administer orally. Dissolve the contents of one sachet completely in 200 ml of hot water. Stir thoroughly before consumption.

Adults and adolescents 12 years of age and older: take one prepared solution every 4 to 6 hours.

Do not exceed three doses within 24 hours. Maintain a minimum interval of 4 hours between doses.

The maximum duration of use without medical supervision is 5 days for pain relief and 3 days for fever reduction.

Do not use for more than 5 consecutive days. Cease use and consult a physician if symptoms persist or worsen.

Avoid concurrent use with other products containing paracetamol.

Adverse Reactions

Allergic reactions skin rash, itching, urticaria, angioedema.

From the nervous system dizziness, sleep onset disturbance, increased excitability.

From the cardiovascular system increased blood pressure, tachycardia.

From the digestive system nausea, vomiting, pain in the epigastric region, dry mouth, hepatotoxic effect.

From the sensory organs mydriasis, accommodation paresis, increased intraocular pressure.

From the hematopoietic organs thrombocytopenia, agranulocytosis.

Other bronchospasm, urinary retention.

Contraindications

Severe cardiovascular diseases; arterial hypertension; portal hypertension; diabetes mellitus; hyperthyroidism; angle-closure glaucoma; pheochromocytoma; alcoholism; simultaneous or within the preceding 2 weeks use of MAO inhibitors; simultaneous use of tricyclic antidepressants, beta-blockers, other sympathomimetics; pregnancy; lactation period (breastfeeding); children under 12 years of age; hypersensitivity to the components of the combined medicinal product.

With caution

Severe atherosclerosis of the coronary arteries, cardiovascular diseases, acute hepatitis, hemolytic anemia, bronchial asthma, severe liver or kidney diseases, prostatic hyperplasia, difficulty urinating due to prostatic hypertrophy, blood diseases, congenital hyperbilirubinemia (Gilbert, Dubin-Johnson and Rotor syndromes), in exhaustion, dehydration, pyloroduodenal obstruction, stenosing gastric and/or duodenal ulcer, epilepsy, with simultaneous use of drugs that can adversely affect the liver (for example, inducers of liver microsomal enzymes); in patients with recurrent formation of urate stones in the kidneys.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and lactation (breastfeeding).

Pediatric Use

Contraindicated for use in children under 12 years of age.

Geriatric Use

The drug is approved for use in elderly patients.

Special Precautions

Consultation with a doctor is necessary if patients have bronchial asthma, emphysema or chronic bronchitis; symptoms do not go away within 5 days or are accompanied by severe fever lasting for 3 days, rash or persistent headache.

To avoid toxic liver damage, the combined product should not be combined with the consumption of alcoholic beverages.

Effect on ability to drive vehicles and machinery

The combined medicinal product may cause drowsiness, therefore, during treatment, it is not recommended to drive vehicles or engage in other activities requiring concentration and high speed of psychomotor reactions.

Drug Interactions

Paracetamol

It enhances the effects of MAO inhibitors, sedatives, ethanol.

The risk of hepatotoxic action of paracetamol increases with simultaneous use of barbiturates, phenytoin, phenobarbital, carbamazepine, rifampicin, isoniazid, zidovudine and other inducers of liver microsomal enzymes.

With long-term regular use of paracetamol, the anticoagulant effect of warfarin and other coumarins may be enhanced, thereby increasing the risk of bleeding. A single use of paracetamol does not have a significant effect.

Metoclopramide increases the absorption rate of paracetamol and reduces the time to reach its C_max in blood plasma. Similarly, domperidone may lead to an increase in the absorption rate of paracetamol.

Paracetamol may lead to an increase in the T_1/2 of chloramphenicol.

Paracetamol may reduce the bioavailability of lamotrigine, and a decrease in the effectiveness of lamotrigine is possible due to induction of its metabolism in the liver.

The absorption of paracetamol may be reduced when used simultaneously with cholestyramine, but the reduction in absorption is insignificant if cholestyramine is taken one hour later.

Regular use of paracetamol simultaneously with zidovudine may cause neutropenia and increase the risk of liver damage.

Probenecid affects the metabolism of paracetamol. In patients simultaneously using probenecid, the dose of paracetamol should be reduced.

The hepatotoxicity of paracetamol is enhanced by long-term excessive consumption of ethanol (alcohol).

Paracetamol may affect the results of the uric acid test using the precipitating reagent phosphotungstate.

Pheniramine

Enhancement of the influence of other substances on the central nervous system (for example, MAO inhibitors, tricyclic antidepressants, alcohol, antiparkinsonian drugs, barbiturates, tranquilizers and narcotics) is possible. Pheniramine may inhibit the action of anticoagulants.

Phenylephrine

Phenylephrine may potentiate the action of MAO inhibitors and cause a hypertensive crisis.

Simultaneous use of phenylephrine with other sympathomimetic drugs or tricyclic antidepressants (for example, amitriptyline) may lead to an increased risk of adverse reactions from the cardiovascular system.

Phenylephrine may reduce the effectiveness of beta-blockers and other antihypertensive drugs (for example, debrisoquine, guanethidine, reserpine, methyldopa). An increase in the risk of arterial hypertension and other side effects from the cardiovascular system is possible.

Simultaneous use of phenylephrine with digoxin and cardiac glycosides may increase the risk of cardiac arrhythmia or myocardial infarction.

Simultaneous use of phenylephrine with ergot alkaloids (ergotamine and methysergide) may increase the risk of ergotism.

When used simultaneously with barbiturates, primidone, the excretion of ascorbic acid in the urine increases.

Caffeine

Caffeine accelerates the absorption of ergotamine.

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.