FlumiKolds (Powder) Instructions for Use

Marketing Authorization Holder

Veropharm, JSC (Russia)

Manufactured By

Nabros Pharma, Pvt. Ltd. (India)

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)

Phenylephrine (Rec.INN registered by WHO)

Dosage Form

FlumiKolds

Powder for preparation of oral solution 750 mg+60 mg+10 mg/5 g: pkg. 5 or 10 pcs.

Dosage Form, Packaging, and Composition

5 g – laminated paper sachets (5) – cardboard packs.
5 g – laminated paper sachets (10) – cardboard packs.

Clinical-Pharmacological Group

Drug for symptomatic therapy of acute respiratory diseases

Pharmacotherapeutic Group

Remedy for the relief of symptoms of acute respiratory infections and the "common cold" (non-narcotic analgesic agent + alpha-adrenomimetic + 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-adrenomimetic, causes vasoconstriction, eliminates swelling and hyperemia of the nasal mucosa.

Ascorbic acid is involved in the regulation of redox processes, carbohydrate metabolism, blood clotting, tissue regeneration, and the synthesis of steroid hormones; increases the body’s resistance to infections, reduces vascular permeability, reduces the need for vitamins B₁, B₂, A, E, folic acid, pantothenic acid. 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.

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.

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

Indications

Symptomatic treatment of colds and influenza, accompanied by fever, headache, chills, nasal congestion, sore throat, and sinus pain.

ICD codes

Dosage Regimen

Prepare the oral solution immediately before use by dissolving the entire contents of one 5 g sachet in a glass of warm water.

Administer orally. The interval between doses must be at least 4 hours.

For adults and children over 12 years, take one sachet up to four times within 24 hours.

Do not exceed the maximum daily dose of 4 sachets (equivalent to 3000 mg paracetamol, 240 mg ascorbic acid, and 40 mg phenylephrine hydrochloride).

The total duration of self-administered treatment without medical supervision must not exceed 5 days as an analgesic and 3 days as an antipyretic.

Consult a physician if symptoms persist beyond this period.

Adjust dosage frequency based on clinical need; the minimum effective dose for the shortest duration should be used.

For patients with hepatic impairment, renal impairment, or elderly patients, exercise caution and consider a longer dosing interval.

Avoid concomitant use with other products containing paracetamol.

Adverse Reactions

From the hematopoietic system very rarely – thrombocytopenia.

Allergic reactions rarely – skin rash, urticaria, allergic dermatitis; very rarely – anaphylaxis, hypersensitivity reactions, including angioedema, Stevens-Johnson syndrome.

From the respiratory system very rarely – bronchospasm in patients sensitive to acetylsalicylic acid and other NSAIDs.

From the digestive system very rarely – nausea, vomiting, impaired liver function.

From the CNS very rarely – dizziness, headache, insomnia.

From the sensory organs: rarely – mydriasis, acute attack of glaucoma in most cases in patients with angle-closure glaucoma.

From the cardiovascular system: rarely – tachycardia, palpitations, increased blood pressure.

From the urinary system very rarely – dysuria, urinary retention in patients with bladder outlet obstruction due to prostatic hyperplasia.

With long-term use exceeding the recommended dose, hepatotoxic and nephrotoxic effects may be observed.

Contraindications

Severe liver dysfunction; severe renal dysfunction; hyperthyroidism (including thyrotoxicosis); cardiovascular diseases (severe aortic stenosis, acute myocardial infarction, tachyarrhythmia); arterial hypertension; prostatic hyperplasia; angle-closure glaucoma; simultaneous use of tricyclic antidepressants, beta-blockers, MAO inhibitors (including within 14 days after their withdrawal), other paracetamol-containing medicinal products; children under 12 years of age (for dosage forms intended for adults); hypersensitivity to the components of the combination.

With caution

Benign hyperbilirubinemia, glucose-6-phosphate dehydrogenase deficiency, pregnancy, lactation (breastfeeding), obliterating vascular diseases (Raynaud’s syndrome), glaucoma (excluding angle-closure glaucoma).

Use in Pregnancy and Lactation

Should be used with caution during pregnancy and breastfeeding.

Use in Hepatic Impairment

Contraindication — severe hepatic insufficiency.

Use in Renal Impairment

Contraindication — severe renal insufficiency.

Pediatric Use

Contraindication – children under 12 years of age (for dosage forms intended for adults).

Special Precautions

If symptoms of the disease persist after 5 days of using this remedy, its use should be discontinued and a doctor should be consulted.

Should not be taken simultaneously with other drugs containing Paracetamol, as well as with other non-narcotic analgesics (metamizole sodium), NSAIDs (acetylsalicylic acid, ibuprofen), barbiturates, anticonvulsant drugs, rifampicin and chloramphenicol, sympathomimetics (such as decongestants, appetite suppressants, amphetamine-like psychostimulants), with other remedies for relieving cold and flu symptoms.

Effect on ability to drive vehicles and operate machinery

If dizziness occurs while using drugs containing this combination, it is not recommended to drive vehicles or operate machinery.

Drug Interactions

Inducers of microsomal oxidation in the liver (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants) increase the production of hydroxylated active metabolites of paracetamol, which may lead to the development of severe intoxication with small overdoses.

Paracetamol enhances the effects of MAO inhibitors, sedative drugs, ethanol .

Antidepressants, antiparkinsonian, antipsychotic drugs, phenothiazine derivatives – risk of urinary retention, dry mouth, constipation.

Corticosteroids – risk of developing glaucoma.

Phenylephrine reduces the hypotensive effect of guanethidine .

Guanethidine enhances the alpha-adrenostimulating effect, and tricyclic antidepressants – the sympathomimetic effects of phenylephrine.

With simultaneous use of oral contraceptives the concentration of ascorbic acid in blood plasma decreases. An increase in the concentration of ethinylestradiol in 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 to 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.