BECLATE Nasal spray Ref.[50453] Active ingredients: Beclometasone

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2022  Publisher: CIPLA MEDPRO (PTY) LTD., Rosen Heights, Pasita Street, Rosen Park, Bellville, 7530. RSA

4.1. Therapeutic indications

BECLATE AQUANASE is indicated for the treatment of the symptoms of seasonal allergic rhinitis, including hay fever.

4.2. Posology and method of administration

Posology

Adults and children over 12 years of age

One metered dose (50 μg) in each nostril, two to four times a day. Alternatively, a dosage of two metered doses (100 μg) into each nostril twice daily can be used. The total daily recommended dose is 200 μg/nostril/day.

Method of administration

BECLATE AQUANASE aqueous nasal spray is for administration through the nasal route only.

4.9. Overdose

The use of large amounts of BECLATE AQUANASE over a short time period may lead to suppression of hypothalamic-pituitary-adrenal (HPA) function. Treatment is symptomatic and supportive.

Symptoms of chronic overdosing include acneform lesions; Cushing’s syndrome (fullness or rounding of face) and menstrual changes.

Withdraw BECLATE AQUANASE gradually to avoid precipitation of acute adrenal insufficiency. Treatment should be symptomatic and supportive

6.3. Shelf life

36 months.

6.4. Special precautions for storage

BECLATE AQUANASE should be stored at or below 25°C, and should not be refrigerated. Protect from light.

6.5. Nature and contents of container

10 ml amber glass vial fitted with a metering atomising pump and nasal adaptor.

Each vial contains 7,5 ml of nasal spray (150 doses).

6.6. Special precautions for disposal and other handling

No special requirements.

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