Azulan (Solution) Instructions for Use

Marketing Authorization Holder

Vifitech, CJSC (Russia)

ATC Code

A01AB11 (Other drugs)

Active Substances

Matricaria flowers (DAB German Pharmacopoeia)

Guaiazulene (BP British Pharmacopoeia)

Dosage Form

Azulan

Oral, topical and external solution: fl. 50 ml or 100 ml 1 pc.

Dosage Form, Packaging, and Composition

Solution for oral, topical and external use in the form of a liquid from brown with a greenish tint to dark brown with a reddish tint, with a characteristic odor; sedimentation may occur during storage.

Excipients : Tween-80 (polysorbate 80) – 4.082 g.

* Liquid chamomile extract (44 : 100) is obtained from chamomile flowers (German chamomile) – Chamomilla recutita (L.) Rausch. (Matricaria recutita L., M. chamomilla L.), family Asteraceae; extractant – ethyl alcohol 50%, ammonia solution 10% to pH (8.0-8.5), ratio of raw material : final extract – 44 : 100.

50 ml – bottles (1) – carton packs.
100 ml – bottles (1) – carton packs.

Clinical-Pharmacological Group

Herbal preparation with anti-inflammatory, antimicrobial, and spasmolytic action

Pharmacotherapeutic Group

Herbal anti-inflammatory agent

Pharmacological Action

Combined preparation. It has anti-inflammatory, spasmolytic and carminative effects, and possesses moderate antimicrobial properties.

Indications

Orally – in the complex therapy of gastritis, duodenitis, colitis, flatulence; topically – for inflammatory diseases of the oral mucosa ( stomatitis, gingivitis, periodontitis), vaginitis; externally – for inflammatory skin diseases (including cracks, insect bites).

ICD codes

Dosage Regimen

Orally. For gastrointestinal diseases, adults and children aged 12 years and older should take the solution diluted – 2.5 ml per glass (200 ml) of warm water 2-3 times/day. The course of treatment is 2-3 weeks. Repeated courses of treatment are possible on the recommendation of a doctor.

Externally for inflammatory skin diseases (dressings, washings, compresses) and topically for inflammatory diseases of the mucous membranes (in the form of microenemas of 50-100 ml, rinses, vaginal douches) the drug is used in a diluted form – 7.5 ml per 1 liter of water.

Adverse Reactions

Possible allergic reactions ( contact dermatitis, allergic conjunctivitis, bronchospasm, angioedema, anaphylactic shock).

Contraindications

Hypersensitivity to the components of the drug and plants of the Asteraceae family; for oral administration – pregnancy, lactation, children under 12 years of age.

With caution – bronchial asthma, atopic dermatitis in history; for oral administration – liver diseases, alcoholism, traumatic brain injury, brain diseases.

Use in Pregnancy and Lactation

Oral administration of the drug is contraindicated during pregnancy and lactation.

Use in Hepatic Impairment

With caution for oral administration – liver diseases.

Pediatric Use

Oral administration of the drug is contraindicated in children and adolescents under 12 years of age.

Special Precautions

Before using the drug, the patient should consult a doctor.

If symptoms of the disease persist or the condition worsens during the use of the drug within 14 days, the patient should inform the attending physician.

The ethanol content in the preparation is at least 32%. When taking the drug orally in the maximum single dose, the ethanol content is about 0.63 g, in the maximum daily dose – about 1.89 g.

Effect on the ability to drive vehicles and mechanisms

During treatment with oral administration of the drug, caution should be exercised when engaging in potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Drug Interactions

Due to the inhibitory effect of chamomile extract on liver microsomal enzymes, simultaneous use of the drug with anticoagulants (warfarin) is not recommended due to an increased risk of bleeding.

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.