Physiodosa (Solution) Instructions for Use

Marketing Authorization Holder

Laboratoires Gilbert (France)

ATC Code

R01AX10 (Other drugs)

Active Substance

Sodium chloride (Ph.Eur. European Pharmacopoeia)

Dosage Form

Physiodosa

Solution for topical application 0.9%: 5 ml dropper bottle 6, 12, 15, 18, 30 or 36 pcs.

Dosage Form, Packaging, and Composition

5 ml – plastic dropper bottles (6) – cardboard packs.
5 ml – plastic dropper bottles (12) – cardboard packs.
5 ml – plastic dropper bottles (15) – cardboard packs.
5 ml – plastic dropper bottles (18) – cardboard packs.
5 ml – plastic dropper bottles (30) – cardboard packs.
5 ml – plastic dropper bottles (36) – cardboard packs.

Clinical-Pharmacological Group

Drug for moisturizing, cleansing, and protecting the nasal mucosa

Pharmacotherapeutic Group

Remedy for nasal conditions

Pharmacological Action

It effectively moisturizes the nasal mucosa, thins thick mucus, softens dry crusts in the nose and facilitates their easy removal.

The solution’s pH is close to the pH of the natural secretory fluid of the nasal mucosa.

Indications

• Administer for hygienic care of the nasal cavity in infants.
• Use in children and adults for cleansing the nasal cavity of mucus and crusts in cases of dryness of the nasal mucosa.
• Apply as part of the management of rhinitis of various etiologies.

ICD codes

Dosage Regimen

Apply intranasally into each nostril. Use 3-4 times per day or as needed for symptom relief.

For a course of prevention and treatment, the typical duration is 2 to 4 weeks.

Ensure the use of an age-appropriate dosage form for young children to guarantee safe and effective administration.

Adverse Reactions

Allergic reactions are possible, including localized skin or mucosal irritation.

Discontinue use immediately and consult a healthcare professional if any signs of hypersensitivity, such as rash, itching, or swelling, occur.

Drug Interactions

No clinically significant drug interactions have been reported. The solution can be used concomitantly with other intranasal medications.

When used as part of complex therapy, administer other intranasal medicinal products 10-15 minutes after application to allow for proper nasal cavity cleansing and to avoid potential dilution of other drugs.

Contraindications

• Avoid use in patients with known hypersensitivity to sodium chloride or any of the excipients in the formulation.

Overdose

Overdose is unlikely due to the topical route of administration and the nature of the active substance.

Excessive intranasal use may lead to local irritation or discomfort. No specific antidote exists; manage symptoms supportively and discontinue use if adverse effects occur.

Use in Pregnancy and Lactation

Can be used during pregnancy and breastfeeding.

Use in Hepatic Impairment

The drug is approved for use in patients with hepatic impairment.

Use in Renal Impairment

The drug is approved for use in patients with renal impairment.

Pediatric Use

The drug is approved for use in children and adolescents under 18 years of age.

Geriatric Use

The drug is approved for use in elderly patients.

Special Precautions

When used as part of complex therapy, other medicinal products should be administered intranasally after cleansing the nasal cavity – 10-15 minutes after the spray applications.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

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.