Baby-Sed (Granules) Instructions for Use

Marketing Authorization Holder

Homeopathic Pharmacy, LLC (Russia)

Dosage Form

Baby-Sed

Homeopathic granules: 8 g tubes or jars

Dosage Form, Packaging, and Composition

Homeopathic granules are uniform, of regular spherical shape, white with a gray or cream tint, odorless, with a sweet taste.

Excipients: sucrose pellets 100 g.

8 g – polymer tubes (1) – cardboard packs.
8 g – polymer jars (1) – cardboard packs.

Clinical-Pharmacological Group

Homeopathic preparation with sedative action

Pharmacotherapeutic Group

Homeopathic agent

Pharmacological Action

Homeopathic preparation.

Indications

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

• Manage increased excitability and irritability in children.
• Alleviate symptoms of tearfulness and emotional lability.
• Address sleep disorders, including difficulties with sleep initiation and maintenance.

Initiate therapy only in children over 7 years of age.

ICD codes

Dosage Regimen

Administer 5 granules orally once daily in the morning, approximately 15 minutes before a meal.

Allow the granules to dissolve completely in the mouth; do not swallow whole.

The standard course of treatment is 1.5 to 2 weeks.

If symptoms persist, repeat treatment courses may be initiated after a two-week interval for a total duration of up to three months.

For long-term management, transition to a maintenance therapy regimen of 1 to 2 times per week.

Adverse Reactions

Monitor patients for signs of hypersensitivity.

Allergic reactions, including skin rash, pruritus, or urticaria, may occur.

Discontinue use immediately upon the appearance of any adverse effects and consult a healthcare professional.

Report any unexpected reactions not listed in this monograph.

Contraindications

Do not administer this medication under the following conditions.

• Known hypersensitivity to any of the active ingredients (Bryonia, Chamomilla recutita, Delphinium staphisagria) or the excipient sucrose.
• Do not use in patients with hereditary fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase deficiency due to the sucrose content.

This product is contraindicated in children under 7 years of age.

Pediatric Use

Used in children over 7 years of age.

Special Precautions

When using homeopathic medicines, a temporary exacerbation of symptoms may occur. In this case, you should stop taking the drug and consult a doctor.

If there is no therapeutic effect, as well as if side effects not described in the instructions appear, you should consult a doctor.

Overdose

No specific cases of overdose have been reported to date.

Due to the homeopathic nature of the product and its composition, significant toxicity from ingestion of large quantities is not anticipated.

In the event of accidental ingestion of a very large dose, monitor for gastrointestinal discomfort due to the sucrose content.

Provide symptomatic and supportive care as required.

Drug Interactions

The use of this homeopathic preparation does not preclude treatment with other conventional medicines.

No specific pharmacodynamic or pharmacokinetic interactions with other medicinal products are known or expected.

Inform your physician about all concomitant medications, including over-the-counter products and herbal supplements.

The clinical effect of homeopathic remedies may be diminished by strong olfactory or gustatory stimuli, such as camphor or menthol.

Storage Conditions

At a temperature not exceeding 25°C (77°F) in a place protected from light. Keep out of reach of children.

Shelf Life

Shelf life – 2 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.