AeroBec Forte Autohaler.

Each actuation delivers beclometasone dipropionate 250μg (as propellant solvate) into the mouthpiece of the adapter.

Pressurised aerosol for inhalation therapy.

AeroBec Forte Autohaler is indicated for the prophylactic treatment of chronic reversible obstructive airways disease in those patients who require high doses of beclometasone to control their symptoms.

The dose should be titrated to the lowest dose at which effective control of asthma is maintained.

ADULTS: for maintenance: 2 inhalations (500 μg), twice daily or 1 inhalations (250 μg), four times daily, may be increased to 2 inhalations four times daily if necessary.

In patients receiving doses of 1500 µg or more daily, adrenal suppression may occur. The degree of suppression may not always be clinically significant but it is advisable to provide such patients with a supply of oral steroid to use in stressful situations. The risk of adrenal suppression occurring should be balanced against the therapeutic advantages.

CHILDREN: AeroBec Forte Autohaler is not recommended for use in children.

ELDERLY: No special dosage recommendations are made for elderly patients.

Hypersensitivity to beclometasone is a contra-indication. Caution should be observed in patients with pulmonary tuberculosis.

Patients should be instructed on the proper use of the inhaler. They should be made aware of the prophylactic nature of Aerobec Autohaler therapy and that it should be used regularly at the intervals recommended and not when immediate relief is required.

In patients who have been transferred to inhalation therapy, systemic steroid therapy may need to be re-instated rapidly during periods of stress or where airways obstruction or mucus prevents absorption from the inhalation.

Systemic effects of inhaled corticosteroids may occur, particularly at high doses prescribed for prolonged periods. These effects are much less likely to occur than with oral corticosteroids. Possible systemic effects include adrenal suppression, growth retardation in adolescents, decrease in bone mineral density, cataract and glaucoma. It is important therefore that the dose of inhaled steroid is titrated to the lowest dose at which effective control of asthma is maintained.

It is recommended that the height of adolescents receiving prolonged treatment with inhaled corticosteroids is regularly monitored. If growth is slowed, therapy should be reviewed with the aim of reducing the dose of inhaled corticosteroid, if possible, to the lowest dose at which effective control of asthma is maintained.

Prolonged treatment with high doses of inhaled corticosteroids, particularly higher than the recommended doses, may result in clinically significant adrenal suppression. Additional systemic corticosteroid cover should be considered during periods of stress or elective surgery.

Patients who have received systemic steroids for long periods of time or at high doses, or both, need special care and subsequent management when transferred to beclometasone therapy. Recovery from impaired adrenocortical function, caused by prolonged systemic steroid therapy, is slow. The patient should be in a reasonably stable state before being given AeroBec Autohaler in addition to his usual maintenance dose of systemic steroid. Withdrawal of the systemic steroid should be gradual, starting after about seven days by reducing the daily oral dose by 1 mg prednisolone, or equivalent, at intervals not less than one week. Adrenocortical function should be monitored regularly.

Most patients can be successfully transferred to AeroBec Autohaler with maintenance of good respiratory function, but special care is necessary for the first months after the transfer until the hypothalamic-pituitary-adrenal (HPA) system has sufficiently recovered to enable the patient to cope with emergencies such as trauma, surgery or infections.

Patients who have been transferred to inhalation therapy should carry a warning card indicating that systemic steroid therapy may need to be re-instated without delay during periods of stress. It may be advisable to provide such patients with a supply of oral steroid to use in emergency, for example when the asthma worsens as a result of a chest infection. The dose of AeroBec Autohaler should be increased at this time and then gradually reduced to the maintenance level after the systemic steroid has been discontinued.

Discontinuation of systemic steroids may cause exacerbation of allergic diseases such as atopic eczema and rhinitis. These should be treated as required with antihistamine and topical therapy.

None known

There is inadequate evidence of safety in human pregnancy. In animals, systemic administration of relatively high doses can cause abnormalities of foetal development including growth retardation and cleft palate. There may therefore be a very small risk of such effects in the human foetus. However, inhalation of beclometasone dipropionate into the lungs avoids the high level of exposure that occurs with administration by systemic routes.

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

It is probable that beclometasone is excreted in milk. However, given the relatively low doses used by the inhalation route, the levels are likely to be low. In mothers breast feeding their baby the therapeutic benefits of the drug should be weighed against the potential hazards to mother and baby.

None.

Candidiasis of the throat and mouth may develop in some patients, but this can be treated without discontinuation of beclometasone therapy. Hoarseness may also occur.

As with other inhaled therapy, paradoxical bronchospasm with wheezing may occur immediately after dosing. Immediate treatment with an inhaled short-acting bronchodilator is required. Aerobec Forte Autohaler should be discontinued immediately and alternative prophylactic therapy introduced.

Systemic effects of inhaled corticosteroids may occur particularly at high doses prescribed for prolonged periods. These may include adrenal suppression, growth retardation in adolescents, decrease in bone mineral density, cataract and glaucoma.

Hypersensitivity reactions including rashes, urticaria, pruritus and erythema and oedema of the eye, face, lips and throat (angioedema) have been reported

If grossly excessive doses of beclometasone dipropionate were taken over a prolonged period a degree of atrophy of the adrenal cortex could occur in addition to HPA suppression. In this event the patient should be treated as steroid-dependent and transferred to a suitable maintenance dose of a systemic steroid such as prednisolone. Once the condition is stabilised the patient should be returned to AeroBec Forte Autohaler by the method recommended above. To guard against unexpected occurrence of adrenal suppression regular tests of adrenal function are advised.

Inhaled beclometasone dipropionate is now well established in the management of asthma. It is a synthetic glucocorticoid and exerts a topical, anti-inflammatory effect on the lungs, without significant systemic activity.

The beclometasone dipropionate absorbed directly from the lungs is converted to less active metabolites during its passage through the liver. Peak plasma concentrations are reached 3-5 hours following ingestion. Excretion is via the urine.

Not applicable.

Sorbitan trioleate Ph Eur

Trichlorofluoromethane (Propellant 11) BP (1988)

Dichlorodifluoromethane (Propellant 12) BP (1988)

Dichlorotetrafluoroethane (Propellant 114) BP (1988)

None known

3 years

Do not store above30ºC. Avoid storage in direct sunlight or heat. Protect from frost.

10ml Aluminium vial closed with a 50μl metering valve containing 200 doses.

Pressurised vial. Do not puncture. Do not burn, even when empty.

Meda Pharmaceuticals Ltd

249 West George Street

Glasgow

G2 4RB

Trading as:

Meda Pharmaceuticals Ltd

Skyway House

Parsonage Road

Takeley

Bishop's Stortford

CM22 6PU

PL 15142/0043

October 1991/25 July 2002

10^th November 2009