AgiCold^® Plus (Ointment) Instructions for Use

Marketing Authorization Holder

Agio Pharmaceuticals, Ltd. (India)

ATC Code

R05X (Other remedies for the treatment of colds)

Dosage Form

AgiCold® Plus

Ointment for external use and inhalation: jar 20 g

Dosage Form, Packaging, and Composition

Ointment for external use and inhalation white or almost white in color with a possible yellowish tint, homogeneous, with a characteristic odor.

Excipients: turpentine oil, white beeswax, butylated hydroxyanisole, butylated hydroxytoluene, white soft paraffin, Ceylon cinnamon bark oil.

20 g – polypropylene jars (1) – cardboard packs.

Clinical-Pharmacological Group

A drug with counterirritant action, used for colds, back pain, headache

Pharmacotherapeutic Group

Local irritant of plant origin

Pharmacological Action

A combined herbal preparation with local irritant, local anesthetic (counterirritant), antiseptic, and anti-inflammatory action.

Pharmacokinetics

Due to low systemic absorption, pharmacokinetic data for the drug are not available.

Indications

Used in the complex therapy of

• Infectious and inflammatory diseases (including colds) of the upper and lower respiratory tract, accompanied by cough, runny nose, feeling of nasal congestion;
• Muscle pain;
• Neuralgia.

ICD codes

Dosage Regimen

Externally.

For infectious and inflammatory diseases of the upper and lower respiratory tract apply a small amount of the ointment twice a day to the upper part of the chest, neck, and back and rub in vigorously. After rubbing, it is necessary to stay warm.

Muscle pain, neuralgia apply a small amount of the ointment twice a day to the skin over the painful areas and rub in vigorously. After rubbing, it is necessary to stay warm.

For rhinitis (runny nose) it is necessary to dissolve 1 teaspoon of the ointment in 200 ml (1 glass) of very hot water and inhale twice a day. Do not heat during inhalation. Do not reuse the prepared inhalation solution.

Adverse Reactions

The Menthol and essential oils included in the drug can lead to the development of hypersensitivity reactions, including contact dermatitis.

If the drug is accidentally taken orally, the following side effects may develop: nausea, vomiting, abdominal pain, diarrhea, drowsiness.

If the above symptoms occur, it is recommended to consult a doctor.

Contraindications

• Tendency to bronchospasm;
• History of seizures;
• Skin lesions in the area of intended application of the drug;
• Children under 2 years of age;
• Hypersensitivity to the components of the drug.

With caution: pregnancy and lactation period, children aged 2 to 3 years.

Use in Pregnancy and Lactation

Use with caution during pregnancy and lactation.

Pediatric Use

Contraindicated in children under 2 years of age.

Use with caution in children aged 2 to 3 years.

Special Precautions

It is strictly forbidden to apply the ointment to mucous membranes (especially the nose and oral cavity), to burn surfaces or damaged skin. Avoid getting the drug into the eyes.

If the drug accidentally gets into the eyes or on the mucous membranes of the nose and mouth, rinse with cold water.

Overdose

No cases of overdose have been reported with external use.

Symptoms of accidental ingestion nausea, vomiting, spasmodic abdominal pain, headache, severe dizziness, facial redness, difficulty breathing, delirium, convulsions, CNS depression and coma.

Treatment administration of activated charcoal, saline laxative and gastric lavage. Convulsions can be controlled by slow intravenous administration of diazepam or, if necessary, short-acting barbiturates.

Drug Interactions

There is no information on the interaction of the drug with other medicinal products.

Storage Conditions

Store in a place inaccessible to children at a temperature not exceeding 25°C (77°F).

Shelf Life

The shelf life is 3 years.

Dispensing Status

By prescription.

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.