Leaflet AZELASTINA MISOM 0.5mg / ml ophthalmic drops solution


Indicated for: allergic rhinitis; urticaria

Route of administration: ophthalmic

Substance: azelastine (antihistamine)

ATC: S01GX07 (Sensory organs | Decongestants and antiallergics | Other antiallergics)

Azelastine is a second-generation antihistamine used in the treatment of seasonal and perennial allergic rhinitis as well as allergic conjunctivitis. It works by blocking H1 histamine receptors, reducing allergic symptoms such as sneezing, itching, nasal discharge, and congestion.

Azelastine is available as a nasal spray and eye drops, administered locally to provide rapid and targeted relief. It is indicated for patients with mild to moderate allergies and can be used long-term as needed.

Common side effects include local irritation, bitter taste, nasal dryness, and occasionally drowsiness. In rare cases, severe allergic reactions or persistent eye irritation may occur. It is important for patients to follow usage instructions to minimize the risk of adverse effects.

Azelastine is an effective and well-tolerated therapeutic option for managing allergic symptoms, contributing to improved quality of life for allergy sufferers.

General data about AZELASTINA MISOM 0.5mg / ml

  • Substance: azelastine
  • Date of last drug list: 01-01-2026
  • Commercial code: W71539001
  • Concentration: 0.5mg / ml
  • Pharmaceutical form: ophthalmic drops solution
  • Quantity: 1
  • Product type: generic
  • Prescription restrictions: P-6L - Medicines prescription that isn't retained in the pharmacy (can be renewed); the prescription can be used for 6 months from the moment of release.

Marketing authorisation

  • Manufacturer: EUROFINS BIOPHARMA PRODUCT TESTING BUDAPEST KFT. - UNGARIA
  • Holder: BROWN & BURK IR LIMITED - IRLANDA
  • Number: 16039/2025/01
  • Shelf life: 2 years-after packing for marketing;after first opening the bottle:nu mai mult de 28 days

Pharmaceutical forms available for azelastine

Concentrations available for azelastine

  • 0.1%
  • 0.5mg/ml
  • 1.5mg/ml
  • 1mg/ml

Combinations with other substances