Allen & Hanburys Ltd

Beconase Aqueous 50 micrograms per metered dose Nasal Spray Suspension

Each 100mg spray contains beclomethasone dipropionate monohydrate equivalent to 50 micrograms of beclomethasone dipropionate.

Excipients: Each 100mg spray contains 20 micrograms of benzalkonium chloride

For a full list of excipients, see section 6.1.

Nasal spray, suspension (Nasal Spray).

An aqueous, white, opaque suspension.

For the prophylaxis and treatment of perennial and seasonal allergic and vasomotor rhinitis.

Beconase can significantly delay the recurrence of nasal polyps after nasal polypectomy. Where polyps do recur, Beconase can suppress their increase in size.

Beconase is for administration by the intranasal route only.

Adults and Children over 6 years of age:

Two applications to each nostril twice daily. In some patients a single application into each nostril three or four times daily may be preferred.

The total daily dose should not usually exceed 400 micrograms (8 sprays).

Children under 6 years:

There is insufficient clinical data to recommend use.

Beconase Aqueous Nasal Spray has a dust cap which protects the nozzle and keeps it clean. Remember to take this off before using the spray. Replace the dust cap after use.

A new spray, or one which has not been used for a few days, may not work the first time. You may need to 'prime' the bottle by pumping the spray a few times until a fine mist is produced. To do this, hold the bottle as shown. Put your forefinger and middle finger either side of the nozzle and your thumb underneath the bottle. Keeping your thumb still, press down with your fingers to pump the spray.

Hold the nozzle pointing away from you while you are doing this.

If the spray still doesn't work and you think it may be blocked, clean it as follows. NEVER try to unblock it or enlarge the tiny spray hole with a pin or other sharp object because this will destroy the spray mechanism.

To clean the spray:

1. Take the dust cap off.

2. Press upwards on the white collar to release the nozzle.

3. Soak the nozzle and dust cap in warm water for a few minutes and then rinse under a running tap.

4. Shake off the excess water and allow to dry in a warm, NOT HOT place.

5. Re-fit the nozzle.

6. 'Prime' the bottle if necessary by pumping the spray a few times until the fine mist is produced.

Your nasal spray should be cleaned at least once a week or more if it gets blocked.

Using the spray:

1. Shake the bottle and remove the dust cap.

2. Blow your nose gently.

3. Close one nostril as shown and put the nozzle in the other nostril. Tilt your head forward slightly and keep the bottle upright. Hold the bottle as shown.

4. Start to breathe in slowly through your nose. WHILE YOU ARE BREATHING IN squirt a spray of fine mist into your nostril by pressing down firmly with your fingers.

5. Breathe out through your mouth. Repeat step 4 to take a second spray in the same nostril.

6. Remove the nozzle from this nostril and breathe out through your mouth.

7. Repeat steps 3 to 6 for the other nostril.

After using the spray:

Wipe the nozzle carefully with a clean tissue or handkerchief, and replace the dust cap.

Beconase Aqueous Nasal Spray is contraindicated in patients with a hypersensitivity to any of its components.

The use of beclomethasone dipropionate locally in the nasopharynx may result in the development of local monilial infections.

The use of the preparation should be avoided in the presence of untreated infections.

If patients are on systemic corticosteroid therapy, great care should be taken during the transfer of the patient to small beclomethasone therapy in case there is impairment of adrenal function.

Occasionally sneezing attacks may follow use.

Infections of the nasal passages and paranasal sinuses should be appropriately treated but do not constitute a specific contra-indication to treatment with Beconase Aqueous Nasal Spray.

If recommended doses of intranasal beclomethasone are exceeded or if individuals are particularly sensitive or predisposed by virtue of recent systemic steroid therapies, systemic effects may occur, including reduction in growth velocity.

Although Beconase Aqueous Nasal Spray will control seasonal allergic rhinitis in most cases, an abnormally heavy challenge of summer allergens may in certain instances necessitate appropriate additional therapy particularly to control eye symptoms.

For full therapeutic benefit, regular usage is essential.

Particular care should be taken to minimise use of topical corticosteroids in patients with immunosuppression.

Experience of the safety of long-term use of topical corticosteroids is not yet established.

Particular caution is required in patients with a history of, or existent tuberculosis.

Cataracts have been associated with systemic steroid therapy. There have been rare reports of cataracts developing in patients who have been using intranasal or inhaled corticosteroids for prolonged periods, although together causes, including exposure to systemic steroids, cannot be excluded.

This product contains benzalkonium chloride which may cause nasal irritation.

Not applicable.

Administration of drugs during pregnancy should only be considered if the expected benefit to the mother is greater than any possible risk to the foetus.

There is inadequate evidence of safety of beclomethasone dipropionate 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.

Lactation:

No specific studies examining the transference of beclomethasone dipropionate into the milk of lactating animals have been performed.

It is reasonable to assume that beclomethasone dipropionate is secreted in milk but at the dosages used for direct intranasal application, there is low potential for significant levels in breast milk. The use of beclomethasone dipropionate in mothers breast-feeding their babies require that the therapeutic benefits of the drug be weighed against the potential hazards to the mother and baby.

Not applicable.

Adverse events are listed below by system organ class and frequency. Frequencies are defined as: very common (1/10), common (1/100 and <1/10), uncommon (1/1000 and <1/100), rare (1/10,000 and <1/1000) and very rare (<1/10,000) including isolated reports. Very common, common and uncommon events were generally determined from clinical trial data. Rare and very rare events were generally determined from spontaneous data. In assigning adverse event frequencies, the background rates in placebo groups were not taken into account, since these rates were generally comparable to those in the active treatment group.

Immune system disorders

Very rare: Hypersensitivity reactions including rashes, urticaria, pruritis, erythema and oedema of the eyes, face, lips and throat, anaphylactoid/anaphylactic reactions, bronchospasm.

Nervous system disorders

Common: Unpleasant taste, unpleasant smell.

As with other nasal sprays, unpleasant taste and smell have been reported.

Eye disorders

Very rare: Glaucoma, raised intraocular pressure, cataract.

Respiratory, thoracic and mediastinal disorders

Common: Epistaxis, nasal dryness, nasal irritation, throat dryness, throat irritation.

Very rare: Nasal septal perforation.

As with other nasal sprays, dryness and irritation of the nose and throat, and epistaxis have been reported. Nasal septal perforation has also been reported following the use of intranasal corticosteroids.

The only harmful effect that follows inhalation of larger amounts of the drug over a short period is suppression of hypothalamic-pituitary-adrenal (HPA) function. No specific emergency action need be taken. Treatment with Beconase Aqueous Nasal Spray should be continued at the recommended dose. HPA function recovers in a day or two.

Following topical administration beclomethasone 17, 21-dipropionate (BDP) produces potent anti-inflammatory and vaso-constrictor effects.

BDP is a pro-drug with weak glucocorticoid receptor binding affinity. It is hydrolysed via esterase enzymes to the active metabolite beclomethasone-17-monopropionate (B-17-MP), which has high topical anti-inflammatory activity.

Beclomethasone dipropionate offers a preventative background treatment for hayfever when taken prior to allergen challenge. After which with regular use, BDP can continue to prevent allergy symptoms from re-appearing by reducing the sensitivity of nasal membranes.

Absorption

Following intranasal administration of BDP the systemic absorption was assessed by measuring the plasma concentrations of its active metabolite B-17-MP, for which the absolute bioavailability following intranasal administration is 44%.

Following oral administration of BDP the systemic absorption was also assessed by measuring the plasma concentrations of its active metabolite B-17-MP, for which the absolute bioavailability following oral administration is 41%.

Metabolism

BDP is cleared very rapidly from the circulation and plasma concentrations are undetectable (< 50 pg/ml) following oral or intranasal dosing. Metabolism is mediated via esterase enzymes found in most tissues. The main product of metabolism is the active metabolite (B-17-MP). Minor inactive metabolites, beclomethasone-21-monopropionate (B-21-MP) and beclomethasone (BOH), are also formed but these contribute little to systemic exposure.

Distribution

Elimination

There is no additional information of relevance to the prescriber.

Microcrystalline cellulose & sodium carboxymethylcellulose (Avicel RC591).

Glucose (Anhydrous)

Benzalkonium chloride (added as Benzalkonium chloride solution)

Phenylethyl alcohol

Polysorbate 80

Dilute hydrochloric acid

Purified water

Not applicable.

2 years.

Discard 3 months after first using spray.

Do not store above 30°C. Do not refrigerate. Keep the bottle in the outer carton in order to protect from light.

A 30ml Type 1 plastic bottle fitted with a metering atomising pump (Valois VP3/93 18PH). Combined nasal adaptor/actuator covered with a dust cap is fitted on the pump. Each bottle delivers 200 sprays.

Shake gently before use

GlaxoSmithKline (Ireland) Limited

Stonemasons Way,

Rathfarnham,

Dublin 16

Trading as:

Allen & Hanburys

PA 1077/41/1

15^th October 1990/15^th October 2010

February 2011