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BECLATE AQUANASE (aqueous nasal spray) SCHEDULING STATUS: S2
COMPOSITION Beclate Aquanase is an aqueous nasal spray, delivering 50 mcg 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.
NDICATIONS 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 6 years. 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 12 years: One metered dose (50 mcg) in each nostril, two to four times a day. Alternately a dosage of two metered doses (100 mcg) into each nostril twice daily, can also be used. The total daily recommended dose is 200-400 mcg/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.
PRESENTATION 10 mL 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. PATIENT INFORMATION Parts of Beclate Aquanase Nasal Spray Bottle with Metered-Dose Atomising pump Nozzle Dust cap
|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.|
|3.||This medicine has been specially recommended by your doctor for you. Do not allow any other person to use it.|
|4.||Keep your Beclate Aquanase Nasal Spray out of the reach of children.|
|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
|1.||Shake the bottle gently, then remove the dust cap.|
|2.||Hold the bottle as shown with your forefinger and middle finger on either side of the nozzle and your thumb underneath the bottle.|
|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.|
|With the nozzle pointing away from you, press several times as shown until a fine uniform mist comes out of the nozzle.|
|4.||Blow your nose gently.|
|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.|
|6.||Start to breathe in through your nose and while breathing in press down your fingers once to release a spray.|
|7.||Breathe out through your mouth. Repeat steps 6 and 7 to inhale a second spray.|
|8.||Repeat steps 5, 6 and 7 for the other nostril|
|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:
|1.||Push the nozzle upwards to detach from the bottle|
|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.|
|3.||Replace the nozzle and dust cap|
|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.|