OTRIVINE ADULT Nasal spray, solution Ref.[49999] Active ingredients: Xylometazoline

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: GlaxoSmithKline Consumer Healthcare (UK) Trading Limited, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom

4.1. Therapeutic indications

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

4.2. Posology and method of administration

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

Adults, children over 12 years

One application in each nostril up to 3 times daily. Do not exceed 3 applications daily into each nostril.

Route of administration

Nasal use.

The recommended dose should not be exceeded, especially in children and the elderly.

4.9. Overdose

Symptoms and Signs

Excessive administration of topical xylometazoline hydrochloride or accidental ingestion 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.

Treatment

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 would include observation of the individual for several hours.

6.3. Shelf life

Unopened: 24 months.

After the container is opened for the first time: 28 days.

6.4. Special precautions for storage

Do not store above 25°C.

6.5. Nature and contents of container

Bottle: Low density polyethylene

Cap: High density polyethylene

Spray valve and capillary: Low density polyethylene

Carton: Cardboard

Pack size: 10 ml.

6.6. Special precautions for disposal and other handling

Keep all medicines out of the reach of children

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