DysheFLU^® (Powder kit) Instructions for Use

Marketing Authorization Holder

Akvion, JSC (Russia)

Manufactured By

AmantisMed, LLC (Republic of Belarus)

ATC Code

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

Dosage Form

DysheFLU®

Powder set for solution for oral administration

Dosage Form, Packaging, and Composition

Powder set for solution for oral administration

Powder “Day”

Powder “Night”

5 g – sachets (12 pcs.) – cardboard packs /in a set: 9 “Day” sachets and 3 “Night” sachets/ – Over-the-Counter
5 g – sachets (4 pcs.) – cardboard packs /in a set: 3 “Day” sachets and 1 “Night” sachet/ – Over-the-Counter
5 g – sachets (8 pcs.) – cardboard packs /in a set: 6 “Day” sachets and 2 “Night” sachets/ – Over-the-Counter

Clinical-Pharmacological Group

Drug for the relief of symptoms of acute respiratory infections and colds

Pharmacotherapeutic Group

Analgesics and antipyretics; paracetamol in combination with other drugs (excluding psycholeptics)

Pharmacological Action

Combined drug.

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.

Phenylephrine is an alpha₁-adrenergic agonist; it 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 m-anticholinergic activity.

Caffeine stimulates the psychomotor centers of the brain, has an analeptic effect, enhances the effect of analgesics, eliminates drowsiness and fatigue, and 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 is 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 in 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 entire contents of one sachet in a glass of hot water. Stir until completely dissolved. Allow the solution to cool to a drinkable temperature before consumption.

Use the “Day” sachet during waking hours. Use the “Night” sachet in the evening before bedtime.

Adults and children over 12 years: take one sachet as a single dose. Maintain an interval of at least 4-6 hours between doses.

Do not exceed three sachets within 24 hours. The maximum daily dose of paracetamol is 1000 mg.

Limit the duration of use to no more than 5 days for pain relief and no more than 3 days for fever reduction without medical supervision.

Discontinue use and consult a physician if symptoms persist, worsen, or new symptoms appear. Avoid concurrent use with other paracetamol-containing products.

Adverse Reactions

Allergic reactions skin rash, itching, urticaria, angioedema.

From the nervous system dizziness, sleep onset disorder, 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; closed-angle 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 drug.

With caution

Severe atherosclerosis of the coronary arteries, cardiovascular diseases, acute hepatitis, hemolytic anemia, bronchial asthma, severe liver or kidney diseases, prostate hyperplasia, difficulty urinating due to prostate hypertrophy, blood diseases, congenital hyperbilirubinemia (Gilbert’s, 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 agent should not be combined with the consumption of alcoholic beverages.

Effect on the ability to drive vehicles and mechanisms

The combined drug 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 rate of absorption 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 can reduce the bioavailability of lamotrigine, while a decrease in the effectiveness of lamotrigine is possible due to the induction of its metabolism in the liver.

The absorption of paracetamol may be reduced with simultaneous use 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 heart rhythm disturbances or myocardial infarction.

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

With simultaneous use 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.