OTRIVIN ADULT Menthol Nasal spray, solution Ref.[50845] Active ingredients: Xylometazoline

Source: Health Products Regulatory Authority (IE)  Revision Year: 2021  Publisher: GlaxoSmithKline Consumer Healthcare (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

4.1. Therapeutic indications

For the symptomatic relief of nasal congestion, perennial and allergic rhinitis (including hay fever), sinusitis.

4.2. Posology and method of administration

Otrivine should not be used for more than seven consecutive days (see section 4.4). The recommended dose should not be exceeded, especially in children and the elderly.

Adults (including the elderly) and adolescents over 12 years of age

1 to 2 sprays into each nostril, up to 3 times daily as needed. Do not exceed 3 applications daily into each nostril. It is recommended to make the last application shortly before retiring to bed.

Paediatric population

Otrivine Adult Menthol Nasal Spray should not be used in children aged less than 12 years old.

Route of administration

Nasal use.

  1. To produce a fine spray, the nebuliser should be held upright with the nozzle pointing upwards. Be careful not to spray in the eyes.
  2. Blow your nose gently.
  3. Remove protective cap.
  4. Lean forward slightly and insert the nozzle into a nostril.
  5. Squeeze the bottle once and breathe in gently at the same time.
  6. Remove the nozzle before releasing the pressure on the bottle.
  7. Repeat with the other nostril.
  8. Clean and dry the nozzle before replacing back the cap right after use.

4.9. Overdose

Overdose of oral or excessive administration of topical xylometazoline hydrochloride may cause severe dizziness, perspiration, severely lowered body temperature, headache, bradycardia, hypertension, respiratory depression, coma and convulsions. Hypertension may be followed by hypotension. Small children are more sensitive to toxicity than adults.

Appropriate supportive measures should be initiated in all individuals suspected of an overdose, and urgent symptomatic treatment under medical supervision is indicated when warranted. This may include observation of the individual for at least several hours.

6.3. Shelf life

Unopened: 30 months.
Opened: 28 days.

6.4. Special precautions for storage

Do not store above 25°C.

6.5. Nature and contents of container

Squeeze bottle of high density polyethylene and polypropylene, with polyethylene nose piece.

Pack size: 10ml.

6.6. Special precautions for disposal and other handling

No special requirements.

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