Flixonase Allergy Relief Nasal Spray

Reduction in shelf life from 3 years to 2 years.

Section 7

Marketing Authorisation Holder address updated to:

12 Riverwalk,

Citywest Business Campus,

Dublin 24,

Ireland

4. Present:

2            Posology and method of administration

Flixonase Allergy Relief is for administration by the intranasal route only.

Adults 18 years and over:  for the prophylaxis and treatment of allergic rhinitis:

Two sprays into each nostril once a day, preferably in the morning.  Once control is achieved the dose should be titrated down to the lowest effective dose of one spray in each nostril once a day (100 micrograms per day).

In some cases two sprays into each nostril twice daily may be required for short periods to achieve control of symptoms, after which the dose should be titrated down to the lowest effective dose (see above).

The maximum daily dose should not exceed four sprays into each nostril.

Elderly patients:

The normal adult dosage is applicable.

Children and adolescents under 18 years of age:

Do not use in those under 18 years of age.

Onset of action in the treatment of allergic rhinitis has been observed in some patients as early as 2-4 hours after use, with most users achieving symptomatic relief within 12 hours of treatment.

Prophylaxis of allergic rhinitis requires treatment before contact with allergen.

For full therapeutic benefit regular usage is recommended.

Maximum benefit may require 3-4 days of continuous treatment in some people (see section 5.1 Pharmacodynamic Properties).

When Flixonase Allergy Relief is discontinued, it may be several days before symptoms recur.

Proposed:

4.2            Posology and method of administration

Flixonase Allergy Relief is for administration by the intranasal route only.

Adults 18 years and over:  for the prophylaxis and treatment of allergic rhinitis:

Two sprays into each nostril once a day, preferably in the morning.  Once control is achieved the dose should be titrated down to the lowest effective dose of one spray in each nostril once a day (100 micrograms per day).

In some cases two sprays into each nostril twice daily may be required for short periods to achieve control of symptoms, after which the dose should be titrated down to the lowest effective dose (see above).

The maximum daily dose should not exceed four sprays into each nostril.

Elderly patients:

The normal adult dosage is applicable.

Children and adolescents under 18 years of age:

Do not use in those under 18 years of age.

Onset of action in the treatment of allergic rhinitis has been observed in some patients as early as 2-4 hours after use, with most users achieving symptomatic relief within 12 hours of treatment.

Prophylaxis of allergic rhinitis requires treatment before contact with allergen.

For full therapeutic benefit regular usage is recommended.

Maximum benefit may require 3-4 days of continuous treatment in some people (see section 5.1 Pharmacodynamic Properties).

When Flixonase Allergy Relief is discontinued, it may be several days before symptoms recur.

4.4            Special warnings and precautions for use

The full benefit of fluticasone propionate aqueous nasal spray may not be achieved until treatment has been administered for several days.

4.4            Special warnings and precautions for use

The full benefit of fluticasone propionate aqueous nasal spray may not be achieved until treatment has been administered for several days.

4.6            Pregnancy and lactation

Pregnancy:  There is inadequate evidence of safety in human pregnancy.  In animal reproduction studies adverse effects typical of potent corticosteroid are only seen at high systemic exposure levels; direct intranasal application ensures minimal systemic exposure.

The use of Fluticasone Propionate Allergy Relief during human pregnancy should be avoided unless thought essential by the doctor. Consumers should be advised to seek a medical opinion before using Flixonase Allergy Relief if they are pregnant or breast-feeding.

As with other drugs, the use of intranasal fluticasone propionate during pregnancy and lactation requires that the benefits be weighed against possible risks associated

with the product or with any alternative therapy.

Proposed:

6            Pregnancy and lactation

Pregnancy

There is inadequate evidence of the safety of fluticasone propionate in human pregnancy. In animal reproduction studies, adverse effects typical of potent corticosteroids are only seen at high systemic exposure levels; direct intranasal application ensures minimal systemic exposure. The use of Flixonase Allergy Relief should be avoided during pregnancy unless thought essential by the doctor. Medical advice should be sought before use if pregnant.

Lactation

Medical advice should be sought before use if breast-feeding.

The excretion of fluticasone propionate into human breast milk has not been investigated. When measurable plasma levels were obtained in lactating laboratory rats following subcutaneous administration, there was evidence of fluticasone

propionate in the breast milk. However, plasma levels in patients following intranasal application of fluticasone propionate at recommended doses are likely to be very low.

Present:

4.9            Overdose

There is no data available on the effects of acute or chronic overdosage with Flixonase Allergy Relief.  Intranasal administration of fluticasone propionate at 20 times the recommended dose in adults (2mg twice daily) for seven days to healthy human volunteers had no effect on hypothalamic-pituitary-adrenal axis function. 

Proposed:

4.9            Overdose

Administration of doses higher than those recommended over a long period of time may lead to temporary suppression of adrenal function.

There is no data available on the effects of acute or chronic overdosage with Flixonase Allergy Relief.  Intranasal administration of fluticasone propionate at 20 times the recommended dose in adults (2mg twice daily) for seven days to healthy human volunteers had no effect on hypothalamic-pituitary-adrenal axis function. 

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4.

Section 1    Flixonase Allergy Relief 50 micrograms per dose Nasal Spray

Section 2    Each actuation delivers 100mg of suspension containing 50 micrograms of fluticaasone propionate

                    Excipients: also includes 20 micrograms of Benzalkonium Chloride per spray

                    For a full list of excipients, see section 6.1

(Changes are in bold)