SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Beclometasone Hayfever Relief Nasal Spray Tesco Hayfever Relief Nasal Spray Boots Hayfever Relief Nasal Spray Pollenase Hayfever Nasal Spray Vivabec

2.    QUALITATIVE AND QUANTITATIVE COMPOSITION

Each spray contains: Beclometasone Dipropionate Ph. Eur., 50 micrograms

3.    PHARMACEUTICAL FORM

Mechanical driven (atomising) spray for nasal use.

4.    CLINICAL PARTICULARS

4.1.    Therapeutic Indications

Category POM

Beclometasone Dipropionate Aqueous Nasal Spray is indicated for the treatment and prevention of seasonal and perennial allergic rhinitis; hayfever and vasomotor rhinitis. The drug has a potent anti-inflammatory effect within the respiratory tract at doses which are not systemically active.

Category P

Beclometasone Dipropionate Aqueous Nasal Spray is indicated for the treatment of hayfever.

4.2. Posology and Method of Administration

Category POM

Beclometasone Dipropionate Aqueous Nasal Spray for intranasal administration only.

Adults and children:

There is insufficient clinical data at present to support the recommended use of this product in children under the age of six.

A dose range of 200 to 400 pg per day is recommended. The recommended dosage for adults and children is two sprays into each nostril twice daily. Once control of symptoms has been achieved a single spray into each nostril twice a day may be preferred. However, the minimum dose should be used at which effective control of symptoms is maintained.

The total daily dose should not normally exceed eight sprays (400 micrograms/day).

For full therapeutic benefit regular use is essential. Furthermore, it should be explained to the patient that maximum relief may not be obtained with the first few doses and that patients co-operation to comply with the regular dosage schedule should be sought.

Category P

Beclometasone Dipropionate Aqueous Nasal Spray is not recommended for children or adolescents under 18 years of age.

A dose range of 200 to 400 pg per day is recommended. Usually a dosing regimen of two sprays into each nostril every morning and evening is recommended. The maximum number of sprays that should be administered each day is 8. Once control of symptoms has been achieved a single spray into each nostril twice a day may be preferred. However, the minimum dose should be used at which effective control of symptoms is maintained.

If symptoms have not improved within 10 days the doctor should be consulted. This product should not be used continuously for longer than 3 months without consulting your doctor.

For full therapeutic benefit regular usage is essential.

The co-operation of the patient should be sought to comply with the regular dosage schedule and it should be explained that maximum relief may not be obtained within the first few doses.

If a dose is missed, then the next dose should be taken when it is due.

Contra-Indications

Beclometasone Dipropionate Aqueous Nasal Spray is contra-indicated in patients with a history of hypersensitivity to any of its components.

4.4. Special Warnings and Precautions for Use

Nasal passage infections and paranasal sinuses should be appropriately treated. Beclometasone Dipropionate Aqueous Nasal Spray may be used in conjunction with other medicaments if required.

Caution should be exercised whilst transferring patients from systemic steroid treatment to Beclometasone Dipropionate Aqueous Nasal Spray if there is doubt that their adrenal function is impaired.

Beclometasone Dipropionate Aqueous Nasal Spray will control seasonal allergic rhinitis in most cases. However, an abnormally heavy challenge of summer allergies may, in certain situations, necessitate appropriate additional therapy, especially to control eye symptoms.

Systemic effects of nasal corticosteroids may occur, particularly at high doses prescribed for prolonged periods. These effects are much less likely to occur than with oral corticosteroids and may vary in individual patients and between different corticosteroid preparations. Potential systemic effects may include Cushing’s syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, cataract, glaucoma and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children)..

It is recommended that the height of children receiving prolonged treatment with nasal corticosteroids is regularly monitored. If growth is slowed, therapy should be reviewed with the aim of reducing the dose of nasal corticosteroid, if possible, to the lowest dose at which effective control of symptoms is maintained. In addition, consideration should be given to referring the patient to a paediatric specialist.

Treatment with higher than recommended doses may result in clinically significant adrenal suppression. If there is evidence for higher than recommended doses being used then additional systemic corticosteroid cover should be considered during periods of stress or elective surgery.

In addition for Category P:

The Pharmacy product should not be used continuously for longer than 3 months without consulting a doctor.

Medical advice should be sought before using Beclometasone Dipropionate Aqueous Nasal Spray in the case of recent injury or surgery to the nose, or problems with ulceration of the nose.

4.5. Interaction with other Medicinal Products and other Forms of Interaction

None known.

4.6. Pregnancy and Lactation

Pregnancy:

The use of Beclometasone Dipropionate in pregnancy requires that the benefits of the drug be weighed against the possible hazards. It should be noted that the drug has been in widespread use for many years without apparent ill consequence.

Safety in pregnancy has not been established. Corticosteroid administration to pregnant animals can cause abnormalities of foetal development including cleft palate and intra-uterine growth retardation. Therefore there may be a very small risk of such effects in the human foetus.

Lactation:

The use of Beclometasone Dipropionate in mothers breast feeding their babies requires that the therapeutic benefits of the drug be weighed against the potential hazards to the mother and baby.

No specific studies examining the transference of Beclometasone Dipropionate into the milk of lactating animals have been performed. It is reasonable to assume that Beclometasone Dipropionate is secreted in milk but at the dosages used for direct intranasal administration there is low potential for significant levels in breast milk.

4.7. Effects on Ability to Drive and Use Machines

None known.

4.8. Undesirable Effects

Systemic effects of nasal corticosteroids may occur, particularly when prescribed at high doses for prolonged periods.

Systemic effects include hypothalmic-pituitary-adrenal (HPA) suppression and growth retardation in children and adolescents.

Rare cases of nasal septal perforation have been reported following the use of intranasal corticosteroids.

Rare cases of raised intra-ocular pressure, cataract or glaucoma have been reported.

As with other nasal sprays, dryness and irritation of the nose and throat, unpleasant taste and smell and epistaxis have been reported rarely.

Common hypersensitivity reactions including rashes, urticaria, pruritus and erythema, and very rare hypersensitivity reactions including oedema of the eyes, face, lips and throat, have been reported.

Very rarely dyspnoea and/or bronchospasm have been reported.

4.9. Overdose

The only harmful effect that follows inhalation of large amounts of the drug over a short time period is suppression of the hypothalmic-pituitary-adrenal (HPA) function. No special emergency action need be taken. Treatment with Beclometasone Dipropionate Aqueous Nasal Spray should be continued at the recommended dose. HPA function reverses in one or two days.

5. PHARMACOLOGICAL PROPERTIES

5.1. Pharmacodynamic Properties

Beclometasone Dipropionate is a glucocorticoid. It is a synthetic corticosteroid esterified at the 17 position and is more potent topically than systemically. This drug is currently only used topically for its antiinflammatory activity. In addition to the local anti-inflammatory action it exerts it also has immunosuppressive activity. There are a number of factors contributing to the mechanisms behind these actions. Firstly and foremost the drug inhibits the adherence of neutrophils and monocyte-macrophages to the capillary endothelial cells of the inflamed area. Secondly it obstructs the effect of macrophage migration inhibitory factor. Finally, Beclometasone Dipropionate also decreases the activation of plasminogen to plasmin and by inhibition of phospholipase A2 activity, it reduces the formation of prostaglandins and leukotrienes in the local tissue.(SPC pharmacokinetics).

5.2. Pharmacokinetic Properties

The greater part of any drug administered by inhalation is ultimately swallowed after being deposited in the mouth and oro-pharynx. It has been shown that when 4 mg Beclometasone Dipropionate was administered to man as a microfine suspension over 90% of the drug was absorbed. The rate of absorption is slow, peak serum levels being attained at about 3 to 5 hours after administration.

Beclometasone Dipropionate is widely distributed in the body tissues. It is found in the liver, in the kidney and in white blood cells. It is 87 per cent bound to human plasma protein (cortisol binds 90%).

Beclometasone Dipropionate is hydrolysed after oral administration by tissue and faecal esterases in vitro. It is, therefore, probable that the Beclometasone monopropionate and Beclometasone present in faeces after oral administration result from hydrolysis of unabsorbed drug by gut esterases, and that the polar metabolites found in human faeces probably arise from the biliary excretion of metabolites of absorbed drug.

It is thought likely that any absorbed steroid is converted to pharmacologically inactive metabolites Beclometasone-17-propionate, Beclometasone and unidentified polar metabolites during its passage through the liver (first pass effect).

Studies using tritiated Beclometasone Dipropionate show that after oral administration 10-15% of the dose was recovered in the urine as metabolites over a period of 72 to 96 hours. Faecal excretion accounted for 37% to 47% of a 4 mg dose.

5.3. Pre-clinical Safety Data

No data are available on the toxic effects of Beclometasone Dipropionate but these are likely to be similar to toxic effects reported for other halogenated topical corticosteroids. Toxic effects of corticosteroids in acute toxicity studies in mouse and rat include reduction in adrenal weight, liver changes, lung consolidation and gastrointestinal effects. These are dose related, the more potent the topical steroid the greater the effect; there is no evidence to suggest that these findings have any clinical relevance in man.

Potential carcinogenic effects have been found in mice following prolonged topical application of potent corticosteroids, but there is no evidence for carcinogenicity occurring in man. No data for Beclometasone is available.

Halogenated topical corticosteroids have been found to be teratogenetic in mice but the relevance of this in man is unknown.

PHARMACEUTICAL PARTICULARS

6.1. List of Excipients

Dextrose Anhydrous BP/Ph. Eur. Polysorbate 80 NF Dispersible Cellulose BP Benzalkonium Chloride 95% USP Phenylethanol USP Purified Water BP/USP

6.2. Incompatibilities

None known.

6.3. Shelf-Life

3 years.

3 months (after first opening).

6.4. Special Precautions for Storage

Store below 25°C. Do not refrigerate. Protect from light.

6.5. Nature and Contents of Container

Amber glass bottle, Type 1, attached to a pump valve assembly with a white winged nasal actuator and overcap.

6.6. Instructions for Use, Handling and Disposal

The lock-ring (if fitted) and dust-cap are removed and the bottle shaken gently (figure 1)

On first using the nasal spray it is prepared for use by pressing down on the white collar using both the index and middle fingers. The base is supported with the thumb (figure 2). The patient continues to depress the device until the collar stops and then allows it to return to its original position. This action is repeated until a fine spray appears. The first five attempts to produce a spray should be allowed to go to waste, after which the spray is ready to use.

To use the nasal spray, the nose is first blown gently. One nostril is closed off as shown, and the head bent forward slightly. The bottle is held upright and the applicator carefully inserted into the other nostril (figure 3).

The patient slowly begins to breathe in through the nose and whilst doing so presses down firmly on the white collar to deliver a fine spray in the nostril. The procedure is completed by breathing out through the mouth (figure 4).

Steps 3 and 4 are repeated to deliver a second spray in the same nostril.

If the pump has not been used for more than a short period of time, re-priming may be necessary (see Step 2 above).

7    MARKETING AUTHORISATION HOLDER

Generics [UK] Ltd t/a Mylan

Station Close

Potters Bar

Herts

EN6 1TL

8. MARKETING AUTHORISATION NUMBER(S)

PL 04569/0326

9. DATE OF FIRST AUTHORISATION / RENEWAL OF AUTHORISATION

05 August 1997

10 DATE OF REVISION OF THE TEXT

20/05/2011