AgiCold^® Hotmix (Powder) Instructions for Use

Marketing Authorization Holder

Agio Pharmaceuticals, 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

AgiCold® Hotmix

Powder for oral solution (orange) 750 mg+10 mg+60 mg/5 g: sachets 5, 10 or 50 pcs.

Dosage Form, Packaging, and Composition

Powder for the preparation of an oral solution (orange).

5 g – sachets (5) – cardboard packs.
5 g – sachets (10) – cardboard packs.
5 g – sachets (50) – 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

A combined drug. Paracetamol has antipyretic and analgesic effects: it reduces pain syndrome observed in cold conditions – sore throat, headache, muscle and joint pain, and reduces high temperature.

Phenylephrine has a vasoconstrictive effect – it reduces swelling and hyperemia of the mucous membranes of the upper respiratory tract and paranasal sinuses.

Ascorbic acid (vitamin C) replenishes the increased need for vitamin C in colds and influenza, especially in the early stages of the disease. It increases the body’s resistance to infectious diseases.

Indications

• Symptomatic treatment of colds, influenza, acute respiratory viral infections (febrile syndrome, pain syndrome, rhinorrhea).

ICD codes

Dosage Regimen

Pour the contents of 1 sachet into a glass, add hot water, stir until completely dissolved and drink. The drug should be taken with plenty of fluid, 1-2 hours after a meal.

Adults and children over 12 years old should take 1 sachet 3-4 times a day with intervals between doses of 4-6 hours.

The maximum daily dose is 4 sachets. The course of treatment is no more than 5 days.

Adverse Reactions

Allergic reactions (including skin rash, itching, urticaria, angioedema), dizziness, sleep onset disturbance, increased excitability, mydriasis; increased blood pressure, tachycardia; nausea, vomiting, epigastric pain; dry mouth; urinary retention, accommodation paresis, increased intraocular pressure; anemia, thrombocytopenia, agranulocytosis, hemolytic anemia, aplastic anemia, methemoglobinemia, pancytopenia; hepatotoxic effect, nephrotoxicity (papillary necrosis); bronchial obstruction.

Contraindications

• Use of other drugs containing substances that are part of AgiCold Hotmix;
• Concomitant use of tricyclic antidepressants, MAO inhibitors, beta-blockers;
• Pregnancy, lactation period;
• Children under 12 years of age;
• Hypersensitivity to paracetamol and other components of the drug.

With caution in severe coronary artery atherosclerosis, arterial hypertension, thyrotoxicosis, pheochromocytoma, diabetes mellitus, bronchial asthma, chronic obstructive pulmonary disease, glucose-6-phosphate dehydrogenase deficiency, blood diseases, congenital hyperbilirubinemias (Gilbert’s, Dubin-Johnson and Rotor syndromes), hepatic and/or renal failure, angle-closure glaucoma, prostatic hyperplasia.

Use in Pregnancy and Lactation

Contraindicated during pregnancy and lactation.

Use in Hepatic Impairment

With caution: hepatic insufficiency.

Use in Renal Impairment

With caution: renal insufficiency.

Pediatric Use

Contraindicated in children under 12 years of age.

Special Precautions

During treatment, one should refrain from consuming alcohol, hypnotics and anxiolytic (tranquilizers) drugs. Do not take together with other medicines containing Paracetamol. If the symptoms of the disease do not disappear within 3-5 days, consult a doctor.

Overdose

Usually caused by paracetamol, it manifests after taking more than 10-15 g of the latter.

Possible symptoms include pale skin, anorexia, nausea, vomiting; hepatonecrosis; increased activity of "liver" transaminases, increased prothrombin time. In case of overdose symptoms, consult a doctor immediately.

Treatment includes gastric lavage followed by the administration of activated charcoal; symptomatic therapy, administration of methionine 8-9 hours after overdose and N-acetylcysteine – after 12 hours.

Drug Interactions

It enhances the effects of MAO inhibitors, sedative drugs, ethanol. Antidepressants, antiparkinsonian drugs, antipsychotic drugs, phenothiazine derivatives – increase the risk of urinary retention, dry mouth, constipation. Glucocorticosteroids increase the risk of glaucoma. Paracetamol reduces the effectiveness of uricosuric drugs. Tricyclic antidepressants enhance the adrenomimetic effect of phenylephrine, simultaneous administration of halothane increases the risk of ventricular arrhythmia.

When AgiCold Hotmix is prescribed simultaneously with barbiturates, diphenin, carbamazepine, rifampicin and other inducers of liver microsomal enzymes, the risk of hepatotoxic action of paracetamol increases.

Storage Conditions

In a dry and light-protected place at a temperature not exceeding 25°C (77°F).

Keep out of reach of children.

Shelf Life

Shelf life – 3 years.

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.