1 NAME OF THE MEDICINAL PRODUCT

JML Hayfever Relief for Adults 50 micrograms / dose Nasal Spray

Pollenase Hayfever Relief for Adults 50 micrograms / dose Nasal Spray

Tesco Hayfever Relief Nasal Spray for Adults 50 micrograms / dose Nasal Spray

Superdrug Hayfever Relief For Adults 50 micrograms / dose Nasal Spray

Boots Hayfever Relief For Adults 50 micrograms / dose Nasal Spray

Numark Hayfever Relief for Adults 50 micrograms/dose Nasal Spray

Essential Waitrose Hayfever Relief For Adults 50 micrograms/dose Nasal Spray

Lloyds Pharmacy Hayfever Relief for Adults 50 micrograms/dose Nasal Spray Wilko Hayfever Relief for Adults 50 micrograms/dose Nasal Spray Asda Hayfever Relief for Adults 50 micrograms/dose Nasal Spray Careway Hayfever Relief for Adults 50 microgram/dose Nasal Spray

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each spray contains: Beclometasone Dipropionate 50 micrograms For a full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Nasal spray suspension

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

Hayfever Relief 50 micrograms / dose Nasal Spray is indicated for the treatment of seasonal allergic rhinitis (hayfever)in adults aged 18 years and over. The drug has a potent antiinflammatory effect within the respiratory tract.

4.2 Posology and method of administration

Hayfever Relief 50 micrograms / dose Nasal Spray for intranasal administration only.

The minimum effective dose according to individual response should be used at which the control of symptoms is maintained (200 to 400 micrograms/day)

The product is not recommended in children and adolescents under 18 years. The recommended dosage for adults is two sprays into each nostril twice daily. When good effect has been achieved the dosage may be reduced to one spray into each nostril twice a day.

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

For full therapeutic benefit, regular use is essential. If symptoms have not improved within 7 days a doctor should be consulted.

4.3 Contraindications

Hayfever Relief 50 micrograms / dose Nasal Spray is contra-indicated in patients with a history of hyper-sensitivity to any of the components.

4.4 Special warnings and precautions for use

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

Caution should be exercised whilst transferring patients from systemic steroid treatment to Hayfever Relief Spray if there is doubt that their adrenal function is impaired.

Hayfever Relief 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).

Growth retardation has been reported in children receiving nasal corticosteroids at licensed doses. 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.

4.5 Interaction with other medicinal products and other forms of interaction

None known.

4.6 Pregnancy and lactation

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. Such effects may include hypothalmic-pituitary-adrenal (HPA) suppression.

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

Rare cases of raised intra-ocular pressure 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.

Very rare cases of hypersensitivity reactions including rashes, urticaria, pruritus and erythema and oedema of the eyes, face, lips and throat, anaphylactoid / anaphylactic reactions, dyspnoea and / or Bronchospasm have been reported.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the

Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

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 a Hayfever Relief 50 micrograms / dose 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 it’s anti-inflammatory 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-pharnyx. It has been shown that when 4mg 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 Preclinical safety data

No data is 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 teratogenic in mice but the relevance of this in man is unknown.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Dextrose Anhydrous Polysorbate 80 Dispersible Cellulose Benzalkonium Chloride 95%

Phenylethanol Purified Water

6.2 Incompatibilities

None known

6.3 Shelf life

3 years - unopened 3 months opened

6.4    Special precautions for storage

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

6.5    Nature and contents of container

Hayfever Relief 50 micrograms / dose Nasal Spray is supplied in a white plastic (high density polyethylene) bottle fitted with a screw on pump covered by a dustcap. The bottle provides 100 sprays.

6.6    Special precautions for disposal

Not applicable

7    MARKETING AUTHORISATION HOLDER

Ayrton Saunders Ltd

9 Arkwright Road

Astmoor Industrial Estate

Runcorn

Cheshire

WA7 1NU

United Kingdom

8    MARKETING AUTHORISATION NUMBER(S)

PL 16431/0176

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

23/03/2009

10 DATE OF REVISION OF THE TEXT

17/11/2016