RHINOLAST Nasal spray Ref.[49937] Active ingredients: Azelastine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2022  Publisher: Mylan Products Ltd, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

4.1. Therapeutic indications

For the treatment of both seasonal allergic rhinitis (e.g. hayfever) and perennial allergic rhinitis in patients aged 6 years and over.

4.2. Posology and method of administration

Route of application is topical – nasal mucosa.

Adults

One application (0.14 ml) in each nostril twice daily (0.56 mg of azelastine hydrochloride).

Elderly

There have been no specific studies in the elderly.

Children

For children aged 6 years and older, one application (0.14 ml) in each nostril twice daily (0.56 mg of azelastine hydrochloride).

4.9. Overdose

The results of animal studies show that toxic doses can produce CNS symptoms, e.g. excitation, tremor, convulsions. Should these occur in humans, symptomatic and supportive treatment should be instigated as there is no specific antidote. Gastric lavage is recommended if the overdose is recent.

With the nasal route of administration overdosage reactions are not anticipated.

6.3. Shelf life

Three years unopened.

6.4. Special precautions for storage

Do not store below 8°C. Do not refrigerate.

6.5. Nature and contents of container

Polyethylene bottle with polypropylene cap and polyethylene seal containing either 10 ml or 20 ml.

Glass bottle with screw closure and polypropylene seal containing 10 ml, 20 ml or 22 ml.

Glass bottle with pump attached containing 10 ml, 20 ml or 22 ml.

10 ml glass bottle with pump attached, containing 5 ml aqueous solution.

10 ml polyethylene bottle with polypropylene cap and polyethylene seal, containing 5 ml aqueous solution.

6.6. Special precautions for disposal and other handling

For separate bottle and pump:

Open the bottle by unscrewing the cap. Place the spray pump nozzle in the bottle and screw the pump onto the bottle. Remove the protective cap. Before first using, squeeze down the collar several times until an even spray emerges. The Rhinolast spray is now ready to use.

For attached pump and bottle:

Remove the protective cap. Before first using, squeeze down the collar several times until an even spray emerges. The Rhinolast spray is now ready to use.

Discard product six months after first opening.

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