Rinicold HotMix (Powder) Instructions for Use

Marketing Authorization Holder

Shreya Life Sciences, Pvt.Ltd. (India)

ATC Code

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

Dosage Forms

	Rinicold HotMix	Powder for oral solution (orange): 1, 5, 10 or 50 pcs.
		Powder for oral solution (lemon): 1, 5, 10 or 50 pcs.
		Powder for oral solution (pineapple): 1, 5, 10 or 50 pcs.

Dosage Form, Packaging, and Composition

Powder for oral solution (pineapple) light yellow in color with white specks, free-flowing; prepared solution (when dissolved in 200 ml of hot water) – greenish-yellow in color with a pineapple odor.

Excipients : sodium chloride, anhydrous citric acid, anhydrous sodium citrate, aspartame, anhydrous lactose, mannitol, disodium edetate, quinoline yellow dye, pineapple flavor.

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

Powder for oral solution (orange) almost white with a pinkish tint, with white specks, free-flowing; prepared solution (when dissolved in 200 ml of hot water) – orange in color with an orange odor.

Excipients : sodium chloride, anhydrous citric acid, anhydrous sodium citrate, aspartame, anhydrous lactose, mannitol, disodium edetate, orange flavor, sunset yellow dye.

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

Powder for oral solution (lemon) almost white with a yellowish tint, with white specks, free-flowing; prepared solution (when dissolved in 200 ml of hot water) – yellow in color with a slight greenish tint and opalescence, with a lemon odor.

Excipients : sodium chloride, anhydrous citric acid, anhydrous sodium citrate, aspartame, anhydrous lactose, mannitol, disodium edetate, lime flavor, quinoline yellow dye.

5 g – sachets (5) – cardboard packs.
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 drug. Paracetamol has antipyretic and analgesic effects: it reduces pain syndrome observed in colds – sore throat, headache, muscle and joint pain, and reduces high temperature.

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

Pheniramine has an antiallergic effect: eliminates itching of the eyes, nose and throat, swelling and hyperemia of the mucous membranes of the nasal cavity, nasopharynx and paranasal sinuses, and reduces exudative manifestations.

Caffeine has a stimulating effect on the central nervous system, which leads to a reduction in fatigue and drowsiness, and an increase in mental and physical performance.

Indications

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

ICD codes

Dosage Regimen

Pour the contents of 1 sachet into a glass, add hot water, stir until completely dissolved and drink (sugar or honey can be added if desired). The drug should be taken with plenty of liquid, 1-2 hours after a meal.

Adults and children over 15 years old should take one sachet 3-4 times/day with intervals between doses of 4-6 hours. The maximum daily dose is 4 sachets.

The drug is not recommended for use for more than 5 days as an analgesic and for more than 3 days as an antipyretic without a doctor’s prescription and supervision.

Increasing the daily dose of the drug or the duration of treatment is possible only under medical supervision. Do not exceed the indicated dose. In case of overdose, consult a doctor immediately, even if you feel well.

Adverse Reactions

Allergic reactions skin rash, itching, urticaria, angioedema.

Nervous system disorders dizziness, sleep onset disturbance, increased excitability.

Cardiovascular system disorders increased blood pressure, tachycardia.

Digestive system disorders nausea, vomiting, epigastric pain, dry mouth, hepatotoxic effect.

Sensory organ disorders mydriasis, accommodation paresis, increased intraocular pressure.

Hematopoietic system disorders thrombocytopenia, agranulocytosis.

Other bronchospasm, urinary retention.

Contraindications

• Use of other medicines containing substances that are part of the drug;
• Concomitant use of tricyclic antidepressants, beta-blockers, MAO inhibitors, including within 14 days after their discontinuation;
• Pregnancy, lactation period;
• Childhood (under 15 years).
• Hypersensitivity to paracetamol and other components of the drug.

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

Use in Hepatic Impairment

With caution – hepatic failure.

Use in Renal Impairment

With caution – renal failure.

Pediatric Use

Contraindication: childhood (under 15 years).

Special Precautions

Consultation with a doctor is necessary before taking the drug in case of taking metoclopramide, domperidone, cholestyramine, anticoagulants (warfarin).

During treatment, one should refrain from drinking alcohol, hypnotics and anxiolytic (tranquilizers) medicines.

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.

To avoid toxic liver damage, Paracetamol should not be combined with the intake of alcoholic beverages, and should not be taken by persons prone to chronic alcohol consumption.

Effect on ability to drive vehicles and operate machinery

Caution should be exercised when performing work requiring concentration of attention and increased speed of motor and mental reactions.

Overdose

It is usually caused by paracetamol and manifests after taking more than 10-15 g of paracetamol.

Symptoms pale skin, anorexia, nausea, vomiting; increased activity of liver transaminases, increased prothrombin time. In case of overdose symptoms, it is necessary to consult a doctor urgently.

Treatment 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.

Glucocorticoids increase the risk of glaucoma.

Paracetamol reduces the effectiveness of uricosuric drugs.

Chlorpheniramine simultaneously with MAO inhibitors, furazolidone can lead to hypertensive crisis, agitation, hyperpyrexia.

Concomitant administration of halothane increases the risk of ventricular arrhythmia.

Phenylephrine reduces the hypotensive effect of guanethidine.

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

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

Storage Conditions

Store in a dry place, out of reach of children, at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 3 years. Do not use after the expiration date printed on the package.

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.