Dorosan (Aerosol) Instructions for Use

Marketing Authorization Holder

Rottapharm S.r.l. (Italy)

ATC Code

M02AA15 (Diclofenac)

Active Substance

Diclofenac (Rec.INN registered by WHO)

Dosage Form

Dorosan

External use aerosol 1%: 50 ml canisters

Dosage Form, Packaging, and Composition

50 ml – aluminum aerosol cans (1) – cardboard packs.

Clinical-Pharmacological Group

NSAIDs for external use

Pharmacotherapeutic Group

NSAID

Pharmacological Action

The active component Diclofenac is a non-steroidal anti-inflammatory drug with pronounced analgesic and anti-inflammatory properties.

By non-selectively inhibiting cyclooxygenase types 1 and 2, it disrupts the metabolism of arachidonic acid and the synthesis of prostaglandins, which are the main link in the development of inflammation.

Dorosan is used to eliminate pain and reduce swelling associated with the inflammatory process.

Indications

• Post-traumatic inflammation of soft tissues and joints, for example, due to sprains, strains, and contusions;
• Rheumatic diseases of soft tissues (tenosynovitis, bursitis, damage to periarticular tissues);
• Pain and swelling associated with diseases of muscles and joints (rheumatoid arthritis, osteoarthritis, radiculitis, lumbago, sciatica).

ICD codes

Dosage Regimen

Remove the protective cap from the container, apply the foam to the painful area by pressing the special button, and close the container with the cap.

Depending on the size of the affected area, the foam is applied 3-4 times/day to the painful areas by pressing the special button for 1-2 seconds, and light massage promotes the absorption of the drug.

The duration of treatment depends on the indications and the observed effect. After 2 weeks of using the drug, a doctor should be consulted.

Adverse Reactions

Local reactions eczema, photosensitivity, contact dermatitis (itching, redness, swelling of the treated skin area, papules, vesicles, peeling).

Systemic reactions generalized skin rash, allergic reactions (urticaria, angioedema, bronchospastic reactions), photosensitivity.

Contraindications

• “aspirin” asthma;
• Pregnancy (III trimester);
• Lactation period;
• Children under 12 years of age;
• Impaired skin integrity;
• Hypersensitivity to diclofenac, or other components of the drug, acetylsalicylic acid or other NSAIDs.

With caution hepatic porphyria (exacerbation), erosive and ulcerative lesions of the gastrointestinal tract, severe impairment of liver and kidney function, chronic heart failure, bronchial asthma, elderly age, pregnancy I and II trimester.

Use in Pregnancy and Lactation

The drug should not be used in the III trimester of pregnancy. Use in the I and II trimesters is possible only after consultation with a doctor.

Use in Hepatic Impairment

With caution hepatic porphyria (exacerbation), severe liver dysfunction.

Use in Renal Impairment

With caution renal impairment.

Pediatric Use

Contraindicated in children under 12 years of age.

Geriatric Use

Use with caution in the elderly.

Special Precautions

Dorosan should be applied only to intact skin, avoiding contact with open wounds. After application, an occlusive dressing should not be applied. Avoid contact of the drug with eyes and mucous membranes.

The container is under pressure, do not puncture or burn the container even after use, do not expose to direct sunlight, do not freeze, do not heat above 50°C (122°F).

Overdose

Extremely low systemic absorption of the active components of the drug with external use makes overdose practically impossible.

Drug Interactions

Dorosan may enhance the effect of drugs that cause photosensitivity. Clinically significant interaction with other drugs has not been described.

Storage Conditions

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

Shelf Life

Shelf life – 3 years.

Dispensing Status

The drug is dispensed 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.