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Logo BECLATE 50 metered dose inhaler
BECLATE 100 metered dose inhaler
BECLATE 200 metered dose inhaler

SCHEDULING STATUS:
S3

PROPRIETARY NAME
(and dosage form):

BECLATE 50 metered dose inhaler
BECLATE 100 metered dose inhaler
BECLATE 200 metered dose inhaler

COMPOSITION:
Beclate 50 is a metered dose inhaler, delivering 50 micrograms
beclomethasone dipropionate per actuation into the mouthpiece of the actuator.
Beclate 100 is a metered dose inhaler, delivering 100 micrograms beclomethasone dipropionate per actuation into the mouthpiece of the actuator.
Beclate 200 is a metered dose inhaler, delivering 200 micrograms beclomethasone dipropionate per actuation into the mouthpiece of the actuator.

PHARMACOLOGICAL CLASSIFICATION:
Category A. 21.5.1. Corticosteroids and analogues.

PHARMACOLOGICAL ACTION:
Beclomethasone dipropionate is a synthetic glucocorticoid with anti-inflammatory action within the respiratory tract.

INDICATIONS:
Beclate Inhalers are indicated for the treatment of bronchospasm, in the following groups of patients with asthma.
1. Patients who are expected to be on long term steroid maintenance therapy.
2. Asthmatic patients poorly controlled by bronchodilators. In these patients Beclate may facilitate the control of the asthma and may reduce the need for bronchodilators.
3. Patients who are inadequately controlled by sodium cromogylcate in addition to bronchodilators.
4. Patients with severe asthma who are dependent on systemic corticosteroids, or adrenocorticotrophic hormone (ACTH) or its synthetic equivalent, or for patients who have received intermittent courses of steroids.
5. Inhaled beclomethasone dipropionate is particularly important for managing asthma in children because effective control can be achieved without the retardation of growth commonly associated with systemic administration of steroids.

CONTRAINDICATIONS:
Hypersensitivity to any of the ingredients of this preparation.
Acute status asthmaticus.
Special care is necessary in patients with active or quiescent pulmonary tuberculosis. Safety of Beclate in pregnancy has not been established.

WARNINGS:
Patients should be instructed in the proper use of the inhaler to ensure that the inhaled beclomethasone reaches the target area within the lungs. They should also be made aware of the prophylactic nature of therapy with inhaled Beclomethasone dipropionate, and that it should be taken regularly even when they are asymptomatic. 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 airway obstruction or mucus prevents absorption from the inhalation.
The potential for paradoxical bronchospasm should be kept in mind. If it occurs, the preparation should be discontinued immediately and alternative therapy instituted.
Adrenal suppression may occur at standard doses of Beclate. In such patients, precautions should be taken to provide systemic cortisteroid cover in situations of prolonged stress.
Patients being treated with oral corticosteroids should be in a stable state before having Beclate added to their current therapy.
The transfer of patients who have received systemic steroids for long periods of time or at high doses, or both, to beclomethasone therapy and their subsequent management needs special care. Recovery from impaired adrenocortical function, caused by prolonged systemic steroid therapy, is slow. The patient should be in a reasonable stable state before being given Beclate in addition to his usual maintenance dose of systemic steroid. Withdrawal of the systemic steroid should be gradual, starting after about 7 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 Beclate with maintenance of good respiratory function, but special care is necessary for the first months after the transfer until the hypothalamic-pituitary-adrenal system has sufficiently recovered to enable the patient to cope with emergencies such as trauma, surgery and infections.
Patients who have been transferred to Inhalation therapy should carry a warning card indicating that systemic steroid therapy may need to be reinstated 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 chest infection. The dose of Beclate 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 symptomatically as required.

DOSAGE AND DIRECTIONS. FOR USE:
Do not exceed the recommended dose.
Adults: The usual dose is 200 ug twice daily. In more severe cases the dosage may be started at or increased to 600-800 ug per day and subsequently reduced when the patients asthma has stabilised.
The totaly daily dose may be administered as two, three or four divided doses. In patients with severe asthma, or those showing only partial response to standard inhalation doses, high dose inhalation therapy may be considered, and doses or up to 1 mg daily, in divided doses, may be used.
Children: 50-100 ug should be given two, three or four times daily according to the age and response. Alternatively, 100 ug or 200 ug twice daily may be administered.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Intolerance to adrenocorticoids.
Hoarseness of the voice, as well as a reduction of plasma cortisol levels, has been reported.
Special care is necessary in patients with active or quiscent pulmonary tubercolosis and the therapeutic advantages should be weighed against possible undesirable effects.
Candidiasis of the mouth and throat (thrush) occurs in some patients, the incidence of which is increased with doses greater than 400 ug per day. Patients with high blood levels of Candida precipitins, indicating a previous infection, are most likely to develop this complication. Some patients may find it helpful to rinse their mouth thoroughly with water after inhalation. The water should not be swallowed.
If respiratory infection occurs during treatment with Beclate, antibacterial treatment should be commenced, and the administration of oral steroids may have to be considered.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
The only harmful effect that follows inhalation of large amounts of the drug over a short time-period is suppression of hypothalamic-pituitary-adrenal (HPA) function. No special emergency action need be taken. Treatment should be continued at the recommended dose. HPA function recovers in a day or two. In the event of excessive intake of beclomethasone for a long period of time a degree of adrenal suppression could occur in addition to suppression of HPA function.
The patient should be treated as steroid dependent and transferred to a suitable maintenance dose of systemic steroid.

IDENTIFICATION:
Milky white homogenous suspension filled in aluminium container in propellant gases with suitable surface active agent. The aluminium container is filled with a metering valve and fitted in a plastic oral adaptor. Each canister is clearly labelled Beclate 50, Beclate 100 or Beclate 200.

PRESENTATION:
BECLATE 50: A pressurised aluminium canister fitted with a metered valve and a plastic oral adaptor, providing 200 metered doses.
BECLATE 100: A pressurised aluminium canister fitted with a metered valve and a plastic oral adaptor, providing 200 metered doses.
BECLATE 200: A pressurised aluminium canister fitted with a metered valve and a plastic oral adaptor providing 200 metered doses.

STORAGE INSTRUCTIONS:
Beclate Inhaler should be stored below 30°C, and should not be refrigerated.
Avoid storage in direct sunlight or heat.
The product should be kept out of reach of children.
The metal canister of Beclate Inhaler is pressurised. It should not be broken, punctured or burnt, even when apparently empty.

REGISTRATION NUMBER:
Beclate-50
REG. No 30/21.5.1/0080
Beclate-100
REG. No 30/21.5.1/0081
Beclate-200
REG. No 30/21.5.1/0147

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Cipla-Medpro (Pty) Ltd.
Rosen Park, South Africa 7530

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
NOVEMBER 1995

1481 G

PATIENT INFORMATION:

Before using your inhaler read this leaflet carefully and follow the instructions

Beclomethasone Inhaler
BECLATE-50
BECLATE-100
BECLATE-200
Metered Dose Inhaler

Cipla-Medpro (Pty) Ltd.
Rosen Park, South Africa 7530

HOW TO USE YOUR INHALER CORRECTLY
{illustrated}
Important:
Follow instructions carefully.

Testing your inhaler
Before using your inhaler for the first time, or if it has not been used for a week or more, "test fire" it, i.e. release one puff into the air.

1. Remove the mouthpiece cover, and check the mouthpiece thoroughly to see that it is clean. Shake the inhaler vigorously.
2. Hold the inhaler as shown between index finger and thumb. Breathe out gently through your mouth and immediately place the mouthpiece in your mouth between your teeth (Do not bite it).
3. Grip the mouthpiece firmly with your lips. Tilt your head slightly backwards. Start breathing in slowly through your mouth. At the same time press the canister as shown, to release one dose while continuing to breathe in steadily and deeply.
4. Remove the inhaler from your mouth. Hold your breath for at least 10 seconds, or as long as is comfortable. Breathe out slowly.
5. If another dose is required, wait for at least one minute and repeat steps 1 to 4. After use, replace the mouthpiece cover.
NOTE
Do not rush stages 2 and 3. It is important to breathe in slowly through your mouth just before pressing the canister.
To be sure of using your inhaler properly, you may initially practice these steps in front of a mirror.
For children
Young children may need help. To help the child, parents must first learn the technique
correctly themselves, then properly guide the child to use the inhaler.
Cleansing
Clean your inhaler at least once a week.
1. Gently pull the metal canister out of the adaptor of the inhaler. Remove the mouthpiece cover.
2. Rinse the adaptor and the mouthpiece cover in warm water. But do not put the metal canister into water.
3. Leave to dry in a warm place. Avoid excessive heat.
4. Replace the canister and the mouthpiece cover correctly.

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