Shalun (Granules) Instructions for Use

Marketing Authorization Holder

Materia Medica Holding NPF, LLC (Russia)

Dosage Form

Shalun

Homeopathic granules: 10 g sachets

Dosage Form, Packaging, and Composition

Homeopathic granules are homogeneous, spherical in shape, from white to white with a creamy or white with a grayish tint, without a foreign odor.

Excipients: sucrose granules 100 g.

10 g – Sachets made of combined material “Multifol” (1) – cardboard packs.

Clinical-Pharmacological Group

Homeopathic preparation with sedative action

Pharmacotherapeutic Group

Homeopathic agent

Pharmacological Action

Homeopathic preparation with sedative action.

Indications

Use the preparation for the management of specific behavioral and sleep-related symptoms in the pediatric population.

• Administer to children over 5 years of age for the relief of symptoms associated with increased nervous excitability.
• Employ for the management of pronounced irritability and emotional lability.
• Utilize to address difficulties with sleep onset disturbance and to facilitate the process of falling asleep.

ICD codes

Dosage Regimen

Administer 5 granules per single dose, holding them in the mouth until they are completely dissolved.

Take the dose orally in the evening as part of the bedtime routine. Continue this regimen for a duration of 1 month to complete the initial therapeutic course.

If symptoms persist or reoccur, a repeat course is permissible. Initiate any subsequent course no earlier than after a 1-2 month interval has passed since the completion of the previous treatment cycle.

Adverse Reactions

During post-marketing surveillance, no adverse reactions have been formally reported in association with the use of this preparation.

Remain vigilant for the potential development of hypersensitivity reactions in susceptible individuals, as this is a possibility with any active or inactive component.

Discontinue use immediately and consult a healthcare professional if any signs of an allergic response or intolerance are observed following administration.

Contraindications

Do not administer this preparation under any circumstances to individuals with a known hypersensitivity to its components.

• Strictly contraindicated in patients with a confirmed or suspected increased individual sensitivity to any of the homeopathic active ingredients: Staphisagria, Levant wormseed (Cina), or German chamomile (Chamomilla).
• Also contraindicated in cases of hypersensitivity to the excipient, sucrose, due to the composition of the granules.

Pediatric Use

It is prescribed for children over 5 years of age.

The drug should be used with caution in children suffering from disorders of carbohydrate metabolism (diabetes mellitus, etc.)

Special Precautions

Does not cause daytime drowsiness.

The drug should be used with caution in children suffering from disorders of carbohydrate metabolism (diabetes mellitus, etc.)

Drug Interactions

No specific pharmacokinetic or pharmacodynamic drug interactions have been identified for this homeopathic preparation.

Concomitant use with other medicinal products is generally considered acceptable. There are no known incompatibilities that would preclude combination therapy.

When administering multiple treatments, monitor the patient’s overall clinical response. Inform the prescribing physician about all concurrently used medications for comprehensive care management.

Overdose

No cases of overdose have been reported, and due to the nature and dilution of the active components, toxic effects are not expected from ingestion of quantities exceeding the recommended dose.

In the event of accidental ingestion of a significantly large quantity, monitor for potential effects related to the excipient, primarily gastrointestinal discomfort due to high sucrose intake.

Provide symptomatic and supportive care as required. There is no specific antidote; management should be directed at relieving any presenting symptoms.

Storage Conditions

In a dry, light-protected place, out of reach of children, at a temperature not exceeding 25°C (77°F).

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.