BECLATE AQUANASE
SCHEDULING STATUS
S2
PROPRIETARY NAME
(and dosage form)
BECLATE AQUANASE
(aqueous nasal spray)
COMPOSITION
Beclate Aquanase is an aqueous nasal spray, delivering 50mcg beclomethasone dipropionate per metered actuation.
Preservative: Benzalkonium Chloride 0,02%v/v and Phenyl Ethyl Alcohol 0,25%v/v.
PHARMACOLOGICAL CLASSIFICATION
Category A. 21.5.1. Corticosteroids and analogues.
PHARMACOLOGICAL ACTION
Beclomethasone dipropionate is a synthetic glucocorticoid with local anti-inflammatory action within the respiratory tract.
INDICATIONS
Beclate Aquanase is indicated for the prophylaxis and treatment of seasonal and perennial allergic rhinitis.
CONTRA-INDICATIONS
Hypersensitivity to any of the ingredients of this preparation. Untreated fungal, bacterial or viral infections, tuberculosis, ocular herpes simplex, unhealed nasal wounds. Bleeding tendencies or a history of recurrent nasal bleeding. Children under the age of 6years. Safety of beclomethasone dipropionate in pregnancy has not been established.
WARNINGS:
Infections of the nasal passages and paranasal sinuses should be appropriately treated but do not constitute a specific contra-indication.
DOSAGE AND DIRECTIONS FOR USE
Beclate Aquanase aqueous nasal spray is for administration through the nasal route only.
Adults and children over the age of 12years:
One metered dose (50mcg) in each nostril, two to four times a day. Alternately a dosage of two metered doses (100mcg) into each nostril twice daily, can also be used. The total daily recommended dose is 200-400mcg/day
SIDE-EFFECTS AND SPECIAL PRECAUTIONS
Intolerance to adrenocorticoids
Nasal discomfort, sneezing, epistaxis impaired wound healing and increased intra ocular pressure.
Dryness and irritation of the nose and throat unpleasant taste and smell and epistaxis have been reported.
Caution is needed when transferring patients from systemic steroids to Beclate Aquanase if there is any reason to suppose that their adrenal function has been impaired. Patients using Beclate Aquanase over several months or longer should be examined periodically due to possible changes in the nasal mucosa. If localised infection of the nose and pharynx develops, appropriate treatment must be instituted or treatment be discontinued.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
The use of large amounts of the medicine over a short time period may lead to suppression of hypothalamic-pituitary-adrenal (HPA) function. Treatment is symptomatic and supportive.
IDENTIFICATION
A white homogenous, redispersable suspension.
PRESENTATION
10mL Amber glass vial fitted with a metering atomising pump and nasal adaptor.
STORAGE INSTRUCTIONS
Beclate Aquanase should be stored below 30°C, and should not be refrigerated.
Protect from light. The product should be kept out of reach of children.
REGISTRATION NUMBER:
30/21.5.1/0079
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
3386F
Please read this leaflet carefully before you start using your Beclate Aquanase nasal Spray
Rx
Beclomethasone
Aqueous Nasal Spray
Beclate Aquanase
150 METERED DOSES
PATIENT INFORMATION
Parts of Beclate Aquanase Nasal Spray
{Illustrated}
Bottle with Metered-Dose Atomising pump Nozzle Dust cap
IMPORTANT
|
1. |
Use your Beclate Aquanase Nasal Spray as directed by your physician. Do not exceed the recommended dose. |
|
2. |
It takes a few days for this medication to work hence it is very important that you use it regularly. Do not stop treatment even if you feel better unless told to do so by your doctor. |
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3. |
This medicine has been specially recommended by your doctor for you. Do not allow any other person to use it. |
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4. |
Keep your Beclate Aquanase Nasal Spray out of the reach of children. |
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5. |
Protect your Beclate Aquanase Nasal Spray from light. Store below 30°C but do not refrigerate. |
HOW TO USE YOUR BECLATE AQUANASE NASAL SPRAY
Before using {Illustrated}
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1. |
Shake the bottle gently, then remove the dust cap. |
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2. |
Hold the bottle as shown with your forefinger and middle finger on either side of the nozzle and your thumb underneath the bottle. |
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3. |
Before using your Beclate Aquanase Nasal Spray for the first time, or if you have not used it for a period of time follow the instructions given below. |
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With the nozzle pointing away from you, press several times as shown until a fine uniform mist comes out of the nozzle. |
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4. |
Blow your nose gently. |
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5. |
Close one nostril and put the nozzle in the other nostril as shown. Tilt your head slightly forward keeping the nozzle in the upright position. |
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6. |
Start to breathe in through your nose and while breathing in press down your fingers once to release a spray. |
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7. |
Breathe out through your mouth. Repeat steps 6 and 7 to inhale a second spray. |
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8. |
Repeat steps 5, 6 and 7 for the other nostril |
After use
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9. |
Wipe the nozzle with a clean cloth and replace the dust cap. |
NOTE
The first time you use Beclate Aquanase Nasal Spray, you may sneeze a few times. This is because the lining of your nose is very sensitive. This is not likely to happen after the first few doses.
This medication can, at times cause a few side-effects in certain hypersensitive individuals. If you notice any bleeding from your nose or experience any other discomfort, please inform your doctor.
Cleansing
Your Beclate Aquanase Nasal Spray should be cleaned at least once a week.
To do this:
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1. |
Push the nozzle upwards to detach from the bottle |
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2. |
Wash the nozzle and dust cap in warm water. Shake off excess water and leave to dry in a warm place. Avoid excessive heat. |
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3. |
Replace the nozzle and dust cap |
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4. |
If the nozzle becomes blocked remove as above and soak in warm water. Rinse under a cold tap. Allow to dry and refit. Do not use a pin or other sharp object to unblock the nozzle. |
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