Decoldax (Powder) Instructions for Use

Marketing Authorization Holder

Ivanovo Pharmaceutical Factory PJSC (Russia)

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 Forms

	Decoldax	Powder for preparation of oral solution (with black currant flavor) 750 mg+10 mg+60 mg: sachets 5 g 3, 5, 10, 12, 20, 25 or 30 pcs.
		Powder for preparation of oral solution (with lemon flavor) 750 mg+10 mg+60 mg: sachets 5 g 3, 5, 10, 12, 20, 25 or 30 pcs.

Dosage Form, Packaging, and Composition

Powder for preparation of oral solution (with black currant flavor) from white to white with a yellowish tint, with a black currant odor; the presence of lumps that easily crumble when pressed with a glass rod is allowed; the prepared solution is transparent or opalescent, from colorless to light yellow, with a black currant odor.

Excipients: sodium citrate pentasesquihydrate, citric acid monohydrate, sodium saccharinate dihydrate, black currant flavor, sucrose (sugar).

5 g – heat-sealed sachets (3) – cardboard packs.
5 g – heat-sealed sachets (5) – cardboard packs.
5 g – heat-sealed sachets (10) – cardboard packs.
5 g – heat-sealed sachets (12) – cardboard packs.
5 g – heat-sealed sachets (20) – cardboard packs.
5 g – heat-sealed sachets (25) – cardboard packs.
5 g – heat-sealed sachets (30) – cardboard packs.

Powder for preparation of oral solution (with lemon flavor) from white to white with a yellowish tint, with a lemon odor; the presence of lumps that easily crumble when pressed with a glass rod is allowed; the prepared solution is transparent or opalescent, from colorless to light yellow, with a lemon odor.

Excipients: sodium citrate pentasesquihydrate, citric acid monohydrate, sodium saccharinate dihydrate, lemon flavor, sucrose (sugar).

5 g – heat-sealed sachets (3) – cardboard packs.
5 g – heat-sealed sachets (5) – cardboard packs.
5 g – heat-sealed sachets (10) – cardboard packs.
5 g – heat-sealed sachets (12) – cardboard packs.
5 g – heat-sealed sachets (20) – cardboard packs.
5 g – heat-sealed sachets (25) – cardboard packs.
5 g – heat-sealed sachets (30) – cardboard packs.

Clinical-Pharmacological Group

Drug for symptomatic therapy of acute respiratory diseases

Pharmacotherapeutic Group

Acute respiratory diseases and “common cold” symptoms elimination agent (non-narcotic analgesic+alpha-adrenomimetic+vitamin)

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 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 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. Penetrates 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.

Ascorbic acid is rapidly and completely absorbed from the gastrointestinal tract. Binding to plasma proteins is 25%. It is excreted as 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 solution immediately before use by emptying the contents of one sachet into a glass and adding 200 ml of warm or cold water; stir until completely dissolved.

Administer orally. The interval between doses must be at least 4 hours. Do not exceed the maximum daily dose.

For adults and children aged 12 years and older, administer one sachet up to 4 times in 24 hours.

The maximum single dose of paracetamol is 1000 mg. The maximum daily dose of paracetamol is 4000 mg.

For patients with chronic or compensated active liver disease, chronic alcoholism, dehydration, or chronic malnutrition, reduce the daily dose of paracetamol or increase the interval between doses.

Limit the duration of use to 3 days for fever and 5 days for pain. Discontinue use and consult a physician if symptoms persist or worsen.

Do not use for more than 5 days as an analgesic or for more than 3 days as an antipyretic unless directed by a physician.

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 central nervous system 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 drugs; 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 liver failure.

Use in Renal Impairment

Contraindication – severe renal failure.

Pediatric Use

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

Special Precautions

If the symptoms of the disease persist after 5 days of using this remedy, you should stop taking it and consult a doctor.

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, anticonvulsants, 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, sedatives, 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 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.

When used simultaneously with iron preparations, Ascorbic acid, due to its reducing properties, converts ferric iron to ferrous iron, which helps improve its absorption.

When used simultaneously 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.

When used simultaneously 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.