Consumer medicine information

1. Why am I taking JORVEZA?

JORVEZA tablets contain the active ingredient, budesonide. JORVEZA tablets are used in adult patients to treat eosinophilic oesophagitis (EoE) which is an inflammatory condition of the gullet (food pipe) that causes problems with swallowing food.
For more information, see Section 1. Why am I taking JORVEZA? in the full CMI.

2. What should I know before I take JORVEZA?

Do not take if you have ever had an allergic reaction to JORVEZA tablets 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 take JORVEZA? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with JORVEZA tablets 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 take JORVEZA?

• Adults: The recommended dose for treatment of acute episodes is two 1 mg tablets per day. Take one 1 mg tablet in the morning and one in the evening.

• The recommended dose for prevention of further episodes is two 0.5 mg tablets (1 mg budesonide) per day or two 1 mg tablets (2 mg budesonide) per day, depending on your response to the treatment. Take one tablet in the morning and one tablet in the evening. Your doctor will decide which dose is best for you.

5. What should I know while taking JORVEZA?

6. Are there any side effects?

• All medicines can have side effects. If they do occur, they are usually minor and temporary. The most common side effects of taking JORVEZA are: fungal infections in the gullet (food pipe), mouth and throat, headache, feeling sick (nausea), heartburn, indigestion, tingling or numbness in your mouth, dry mouth, taste disorder, burning tongue, upper abdominal (belly) pain, tiredness, decreased amount of the hormone cortisol in your blood, dry eyes, difficulty in sleeping, problems with tongue and cold sore (oral herpes).

1 Name of Medicine

Budesonide.

2 Qualitative and Quantitative Composition

Each orally disintegrating tablet contains either 0.5 mg or 1 mg of budesonide.
Each budesonide orally disintegrating tablet also contains sucralose and sodium.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Orally disintegrating tablet.
Jorveza 0.5 mg tablet. White or almost white, round, biplane orally disintegrating tablet with '0.5' debossed on one side.
Jorveza 1 mg tablet. White or almost white, round, biplane orally disintegrating tablet.

4 Clinical Particulars

4.9 Overdose

For information on the management of overdose, contact the Poison Information Centre on 131126 (Australia).
In case of short-term overdose, no emergency medical treatment is required. There is no specific antidote. Subsequent treatment should be symptomatic and supportive.

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Budesonide had no mutagenic effects in a number of in vitro and in vivo tests.
Carcinogenicity. The carcinogenic potential of budesonide has been assessed in mice and rats at respective oral doses of up to 200 and 50 microgram/kg/day. No oncogenic effect was noted in mice. One study showed an increased incidence of malignant gliomas in male Sprague-Dawley rats given budesonide 50 microgram/kg/day. As this was not confirmed in further studies in male Sprague-Dawley and Fischer rats, it was concluded that budesonide does not increase the incidence of brain tumours in rats. In male rats dosed with 10, 25 and 50 microgram/kg/day of budesonide, those receiving 25 and 50 microgram/kg/day regimens showed an increased incidence of primary hepatocellular tumours. However, this was also observed in rats treated with prednisolone and triamcinolone acetonide, thus indicating a class effect of glucocorticoids in rats.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSBUDESO.gif Chemical name: 16α,17α-butylidene dioxy-11β,21-dihydroxy-1,4-pregnadiene-3,20-dione.
Molecular formula: C₂₅H₃₄O₆.
Molecular mass: 430.5.
CAS number. 51333-22-3.
Physicochemical properties: Budesonide is a white or almost-white crystalline powder, with a pKa of 12.85 ± 0.10.
Budesonide is practically insoluble in water, freely soluble in methylene chloride, sparingly soluble in ethanol (96%).

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription Only Medicine.

Summary Table of Changes

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