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?
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?
|
Things you should do
|
Remind any doctor, dentist or pharmacist you visit that you are using JORVEZA tablets.
If you become pregnant while using this medicine, tell your doctor immediately.
|
|
Things you should not do
|
Do not take JORVEZA tablets to treat any other complaints unless your doctor tells
you to.
Do not give your medicine to anyone else, even if they have the same condition as
you.
Do not stop using JORVEZA or change the dosage without checking with your doctor.
|
|
Driving or using machines
|
This medicine is not expected to affect your ability to drive a car or operate machinery.
|
|
Looking after your medicine
|
Keep JORVEZA in their original packaging until it is time to take them.
Keep your tablets in a cool dry place where the temperature stays below 25°C. Protect
from light and moisture.
Keep it where children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place
to store medicines.
|
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).
Active ingredient:
budesonide
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using JORVEZA tablets. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using JORVEZA.
Where to find information in this leaflet:
1. Why am I taking JORVEZA?
JORVEZA tablets contain the active ingredient, budesonide. Budesonide belongs to a
group of medications called corticosteroids.
JORVEZA tablets are used to treat
eosinophilic oesophagitis (EoE) which is an inflammatory condition of the gullet (food
pipe) that causes problems with swallowing food.
2. What should I know before I take JORVEZA?
Warnings
Do not take JORVEZA if:
you are allergic to budesonide, or any of the ingredients listed at the end of this
leaflet.
Always check the ingredients to make sure you can take this medicine.
Do not take this medicine if you have uncontrolled infections or active tuberculosis.
Do not take this medicine after the expiry date printed on the pack or if the packaging
is torn or shows signs of tampering.
Check with your doctor if you:
have any other conditions especially the following:
liver disease or kidney disease
lung disease (e.g. tuberculosis)
high blood pressure
diabetes, when the level of sugar in the blood is too high
disease which causes bones to become less dense, gradually making them weaker, more
brittle and likely to break (osteoporosis)
ulcer in stomach or duodenum
glaucoma (high pressure in the eye)
cataracts (cloudy area in your eye)
family history of diabetes or glaucoma
any infection
recent or planned surgery
other stresses
any other disease where use of corticosteroids may have unwanted effects
are on other corticosteroid treatments.
get fungal infections in the mouth, throat (symptoms can be white spots) or in the
gullet or if you think you have any infection during treatment with JORVEZA. The symptoms
of some infections can be unusual or less pronounced when taking JORVEZA.
have been exposed to chicken pox, measles and shingles infections. These illnesses
may become more severe when you take JORVEZA.
have not yet had measles.
know that you need to be vaccinated, please speak to your doctor first.
know that you are due to have an operation, please tell your doctor that you are taking
JORVEZA.
have been treated with a stronger corticosteroid preparation before starting treatment
with JORVEZA, your symptoms may reappear when the medicine is changed. If this happens,
contact your doctor.
experience blurred vision or other visual disturbances.
Keep away from people who have chicken pox, measles or herpes zoster (shingles), if
you have never had them.
If you develop swelling of your face, particularly around your mouth (lips, tongue
or throat) and/or difficulties to breathe or swallow, stop taking JORVEZA and seek
urgent medical attention. These may be signs of an allergic reaction, which may also
include rash and itching.
JORVEZA 0.5 mg and 1 mg contains 26 mg of sodium (the main component of cooking/table
salt) in each tablet. Therefore, the maximum daily dose of sodium from either strength
when taken as advised (2 x 1 mg or 2 x 0.5 mg tablets) is 52 mg per day. This is equivalent
to approximately 2.6% of the recommended maximum daily dietary intake of sodium for
an adult.
JORVEZA could affect the results of adrenal function tests (ACTH stimulation test)
ordered by your doctor or in hospital. Tell your doctors that you are taking JORVEZA
before you have any tests.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
Your doctor will discuss the risks and benefits of taking JORVEZA if you are pregnant
or breastfeeding.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Some medicines may interfere with JORVEZA and affect how it works.
cardiac glycosides such as digoxin (medicines used to treat heart conditions)
diuretics (medicines used to treat excess fluid in your body)
ketoconazole and itraconazole (medicines used to treat fungal infections)
antibiotics such as clarithromycin and erythromycin (medicines used to treat infections)
ritonavir and cobicistat (medicines used to treat HIV infections)
oestrogens (contraceptive pill)
These medicines may be affected by JORVEZA or they may affect how well JORVEZA works.
You may need different doses of your medicine(s) or you may need to take different
medicines. Your doctor or pharmacist will advise you if this is required.
Avoid drinking grapefruit juice. Grapefruit juice contains some components that influence the metabolism (break-down)
of JORVEZA. This can worsen its side effects.
Your doctor or pharmacist have more information on medicines to be careful with or
to avoid while taking JORVEZA.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect JORVEZA.
4. How do I take JORVEZA tablets?
Follow all directions given to you by your doctor or pharmacist carefully.
How much to take
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.
Speak to your doctor if you want to interrupt or end your JORVEZA treatment early.
It is important that you do not stop taking JORVEZA without talking to your doctor.
Keep taking JORVEZA until your doctor tells you to stop, even if you feel better.
When to take JORVEZA
Take your medicine twice a day (once in the morning and once at night) after a meal.
Take your medicine at about the same time each day.
Taking it at the same time each day will have the best effect. It will also help you
remember when to take it.
How to take JORVEZA
Take the JORVEZA tablet immediately once removed from the blister package.
Take JORVEZA after a meal.
Place the tablet on the tip of your tongue and close your mouth. Press it gently against
the roof of your mouth with your tongue until it has disintegrated completely (this
takes between 2 and 5 minutes on average but may take up to 10 minutes or longer in
some patients). Saliva will be produced while the JORVEZA tablet is disintegrating.
Swallow the disintegrated material slowly, as the tablet breaks up.
Do NOT take any liquid or food with the tablet.
Do not chew or swallow the tablet if not disintegrated.
Do not eat, drink, brush your teeth or rinse your mouth for at least 30 minutes after
you have taken the tablet. Do not use any oral solutions, sprays or chewable tablets
for at least 30 minutes before or after administration of the tablet. This will ensure
that your medicine works properly.
For Australian patients, an ‘Instructions for Use’ video is available by scanning
the QR code, which covers the same dosing procedure detailed above.
How long to take JORVEZA
Initially, your treatment should last about 6 to 12 weeks.
After this initial treatment, your doctor will decide for how long and which dose
(1 mg/day or 2 mg/day) you should continue to take, depending on your condition and
your response to the treatment.
Continue taking JORVEZA for as long as your doctor tells you.
If you forget to take JORVEZA
Take your dose as soon as you remember and continue to take it as you would normally.
If it is almost time for your next dose, skip the dose you missed and take your next
dose when you are meant to.
Do not take a double dose to make up for the dose that you missed. This may increase the chance of getting an unwanted side effect.
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering when to take your medicine, ask your pharmacist for
some hints.
If you take too much JORVEZA
If you think that you have taken too much JORVEZA no emergency medical treatment is
required. If you have any concerns, you should:
contact your doctor, or
phone the Poisons Information Centre (by calling 13 11 26)
5. What should I know while taking JORVEZA?
Things you should do
If you are about to be started on any new medicine, remind your doctor and pharmacist
that you are taking JORVEZA.
Tell any other doctors, dentists, and pharmacists who treat you that you are taking
JORVEZA.
If you are going to have surgery, tell the surgeon or anaesthetist that you are taking
JORVEZA.
It may affect other medicines used during surgery.
If you become pregnant while taking JORVEZA, tell your doctor immediately.
Things you should not do
Do not stop taking JORVEZA or change the dosage without checking with your doctor.
Do not take JORVEZA to treat any other complaints unless your doctor tells you to.
Do not give your JORVEZA to anyone else, even if they have the same condition as you.
Driving or using machines
This medicine is not expected to affect your ability to drive a car or operate machinery.
Looking after your medicine
Keep JORVEZA in the original packaging until it is time to take them. If you take
out of the packaging before you plan to dose, they may not keep well.
Store below 25°C.
Follow the instructions on the carton on how to take care of your medicine properly.
Store JORVEZA in a cool dry place away from moisture, heat or sunlight, for example,
do not store it:
in the bathroom or near a sink; or
in the car or on window sills.
Keep it where children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place
to store medicines.
Getting rid of any unwanted medicine
If you no longer need to take this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not take this medicine after the expiry date.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, speak to your doctor or pharmacist
if you have any further questions about side effects.
Less serious side effects
Serious side effects
The following side effects have been reported with medicines which are in the same
class as JORVEZA tablets (corticosteroids). These side effects are typical for systemically acting preparations. As JORVEZA tablets
act locally, the risk of these class effects occurring with this medicine are generally
expected to be lower than with systemically acting corticosteroids.
Possible class effects of systemically acting corticosteroids are:
Cushing Syndrome: roundness of the face, weight gain, acne, increased risk of high
blood sugar, fluid retention (e.g. swollen legs)
slowed growth in children
increased risk of infection
irregular periods in women, male hair growth patterns in women
impotence
mood changes such as depression, irritation or euphoria
restlessness with increased physical activity and aggression
blurred vision (e.g. glaucoma and cataract)
increased risk of blood clotting, disease of the blood vessels (associated with stopping
corticosteroid use after long term therapy)
ulcers in the small intestine, pancreatitis and constipation
muscle and joint pain, muscle weakness, muscle twitching
bone weakness (osteoporosis), bone damage due to poor circulation of blood (osteonecrosis)
rash from hypersensitivity reactions (allergic exanthema), formation of red stripes
(striations) and bleeding in the skin, delayed wound healing, bruising
general feeling of being ill
increased brain pressure with possible additional swelling of the optic disk in adolescents.
These side effects are typical for systemic corticosteroids, such as prednisolone.
Due to the local action of JORVEZA tablets, the risk of systemic adverse reactions
is generally lower than when taking systemically acting corticosteroids.
Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What JORVEZA tablets contains
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Active ingredient
(main ingredient)
|
Budesonide 1 mg or 0.5 mg
|
|
Other ingredients
(inactive ingredients)
|
magnesium stearate
sodium acid citrate
sodium dihydrogen citrate
docusate sodium
sucralose
sodium bicarbonate
mannitol
macrogol 6000
povidone
|
|
Potential allergen
|
sucralose
|
Do not take this medicine if you are allergic to any of these ingredients.
What JORVEZA tablets looks like
JORVEZA 1 mg orally disintegrating tablets: white or almost white, round tablets with a smooth
surface and facet.
They are available in blisters of 20, 30, 60 and 90 tablets*.
* Not all pack sizes may be marketed
JORVEZA 0.5 mg orally disintegrating tablets: white, round tablets debossed with “0.5” on one side
and smooth on the other side.
They are available in blisters of 20, 60, 100 and 200 tablets*.
* Not all pack sizes may be marketed.
Australian Registration Number:
JORVEZA 1 mg orally disintegrating tablets:
AUST R 322645
JORVEZA 0.5 mg orally disintegrating tablets:
AUST R 350996
Who distributes JORVEZA tablets
JORVEZA® is supplied in Australia by:
Dr Falk Pharma Australia Pty Ltd
9 Help Street
Chatswood, NSW 2067
Australia
Phone: 1800 DRFALK (373 255)
JORVEZA® is supplied in New Zealand by:
Dr Falk Pharma New Zealand Ltd
29 Northcroft Street
Takapuna, Auckland 0622
New Zealand
Phone: 0800 44 88 69
JORVEZA® is a registered trademark of Dr. Falk Pharma GmbH, Germany.
This leaflet was prepared in January 2025.
