Consumer medicine information

1. Why am I using BUDAMAX?

BUDAMAX contains the active ingredient Budesonide. BUDAMAX is used to prevent and treat allergic rhinitis. This is an inflammation or swelling of the nose lining which may cause blockage, runny nose, itching and/or sneezing. It is often caused by allergy.
For more information, see Section 1. Why am I using BUDAMAX? in the full CMI.

2. What should I know before I use BUDAMAX?

Do not use if you have ever had an allergic reaction to Budesonide or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use BUDAMAX? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with BUDAMAX and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use BUDAMAX?

• TWO sprays into EACH nostril in the morning; or ONE spray into EACH nostril twice a day (in the morning and evening).

• It may take a few days (in rare cases after 2 weeks) of using Budamax before you notice any improvement in your symptoms.

• Do not exceed the recommended dose.

• More instructions can be found in Section 4. How do I use BUDAMAX? in the full CMI.

5. What should I know while using BUDAMAX?

6. Are there any side effects?

Side effects are usually mild and only last a short time. Corticosteroids taken through the nose for long periods may affect how children grow. In rare cases, some children may be sensitive to the growth effects of corticosteroids, so the doctor may monitor a child's height.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

1 Name of Medicine

Budesonide.

2 Qualitative and Quantitative Composition

Budamax contains 32 microgram (not available in Australia) or 64 microgram budesonide per actuation.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Spray suspension.
White to off-white, viscous thixotropic suspension.

4 Clinical Particulars

4.9 Overdose

Acute overdosage with Budamax, even in excessive doses, is not expected to be a clinical problem.
In the unlikely event of prolonged excessive use of Budamax which could possibly lead to adrenal suppression, treatment should be discontinued. Overdosage may give rise to signs of Cushing's syndrome, such as increased bodyweight, lethargy, hypertension, hirsutism, cutaneous striae, personality change, ecchymosis, oedema, polyuria and polydipsia. In severe cases, the dosage of the corticosteroid should be gradually withdrawn to prevent the possibility of adrenal failure.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).
Keep out of reach of children. In the event of overdose, seek medical attention immediately.

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. The mutagenic potential of budesonide was evaluated in 6 different test systems. No mutagenic or clastogenic effects of budesonide were found.
Carcinogenicity. The carcinogenic potential of budesonide has been evaluated in mouse and rat at oral doses up to 200 and 50 microgram/kg/day, respectively. No oncogenic effect was noted in the mouse. One study indicated an increased incidence of brain gliomas in male Sprague-Dawley rats given budesonide, however the results were considered equivocal.
Further studies performed in male Sprague-Dawley and Fischer rats showed that the incidence of gliomas in the budesonide treated rats was low and did not differ from that in the reference glucocorticoid groups or the controls. It was concluded that treatment with budesonide does not increase the incidence of brain tumours in the rat.
In male rats dosed with 10, 25 and 50 microgram/kg/day, those receiving 25 and 50 microgram/kg/day showed an increased incidence of primary hepatocellular tumours. This was observed in all three steroid groups (budesonide, prednisolone, triamcinolone acetonide) in a repeat study in male Sprague-Dawley rats thus indicating a class effect of corticosteroids.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

The active ingredient, budesonide, is a non-halogenated glucocorticoid structurally related to 16α hydroxyprednisolone. Budesonide is a white to off-white powder, freely soluble in chloroform, sparingly soluble in ethanol and practically insoluble in water and heptane. Budesonide melts between 224°C and 231.5°C with decomposition.
Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSBUDESO.gif Chemical Name: 16α, 17α-22 R, S-propylmethylenedioxypregna-1, 4-diene-11β, 21-diol-3, 20-dione; MW: 430.5.
CAS number. 51333-22-3.

7 Medicine Schedule (Poisons Standard)

Prescription only medicine (Schedule 4).

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/BUDAMAST.gif