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Logo BUDEFLAM AQUANASE

SCHEDULING STATUS:
S3

PROPRIETARY NAME
(and dosage form):

BUDEFLAM AQUANASE
(Aqueous Nasal Spray)

COMPOSITION:
BUDEFLAM AQUANASE contains
budesonide 100 micrograms per metered dose.
Contains 0.12% potassium sorbate as a preservative.

PHARMACOLOGICAL CLASSIFICATION:
A 21.5.1 Corticosteroids and analogues.

PHARMACOLOGICAL ACTION:
BUDEFLAM AQUANASE contains budesonide, a non-halogenated corticosteroid, that has local anti-inflammatory properties. Budesonide is rapidly inactivated by the liver.

INDICATIONS:
BUDEFLAM AQUANASE nasal spray is used for the prophylaxis of seasonal allergic rhinitis.

CONTRA-INDICATIONS:
Hypersensitivity to budesonide. BUDEFLAM AQUANASE is contra-indicated in patients with active or quiescent pulmonary tuberculosis. Fungal or viral infections of the nose.
Safety and efficacy in children has not been established. The safety in pregnancy and lactation has not been established.

DOSAGE AND DIRECTIONS FOR USE:
One spray of 100 micrograms into each nostril twice (2x) daily, morning and evening. Or, two sprays of 100 micrograms into each nostril once a day.
Maintenance dosage: One spray in each nostril once daily.
Directions for use:
{illustrated}
Shake the bottle and
Pump several times (5-10 times) into the air.
A uniform mist is thus obtained (see illustration). The loading effect will remain for about 24 hours. After twenty four hours, the pump must be loaded again before the next dose is taken. This time only one (1) pump into the air will be sufficient.
1. Blow your nose, then shake the bottle and remove the cap.
2. Hold the bottle as shown in the illustration.
3. Insert the tip of the bottle into the nostril and administer the number of pumps prescribed.
  Repeat for the other nostril.
4. Replace the cap and store the bottle in an upright position.
5. Do not use BUDEFLAM AQUANASE more often than prescribed.
6. Clean the nasal applicator regularly:
  Remove the cap and lift off the nasal applicator.
  Wash the nasal applicator in warm water.
  Air dry the nasal applicator completely before replacing.
Note: The full effect of BUDEFLAM AQUANASE will only be achieved after a few days. To counteract potential eye symptoms caused by the allergy, concomitant use of an antihistamine may be necessary.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Sneezing attacks may occur immediately after use of the nasal spray. Cases of sore throat, dry nose, crust formation and headache have been reported. A slight haemorrhagic secretion may occur. Treatment with intranasal steroids should not be stopped abruptly.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Adrenal suppression may occur. Discontinue the treatment. Appropriate measures should be taken to protect the patient from stressful situations.

IDENTIFICATION !
A white homogeneous, re-dispersible suspension.

PRESENTATION:
7.5 mL in an amber glass vial with crimped nasal spray assembly.

STORAGE INSTRUCTIONS:
Store below 30°C. Protect from light. KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
33/21.5.1/0045.

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Cipla Life Sciences (Pty) Ltd.
Rosen Heights, Pasita Street,
Rosen Park, BELLVILLE,
7530 RSA

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
FEB. 2000

Cipla Life Sciences logo
7900B

New addition to this site: February 2004
Source: Community Pharmacy

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