NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.
MEZAVANT® CMI V2.0
Consumer Medicine Information (CMI) summary
The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.
Why am I using MEZAVANT?
MEZAVANT contains the active ingredient mesalazine. MEZAVANT is used for the treatment of ulcerative colitis.
For more information, see Section 1. Why am I using MEZAVANT? in the full CMI.
What should I know before I use MEZAVANT?
Do not use if you have ever had an allergic reaction to MEZAVANT 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 MEZAVANT? in the full CMI.
What if I am taking other medicines?
Some medicines may interfere with MEZAVANT 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.
How do I use MEZAVANT?
Your doctor will tell you what dose to take each day.
Take your tablets with or without food at the same time each day. The tablets must be swallowed whole and must not be crushed or chewed. Follow all directions given to you by your pharmacist or doctor carefully.
More instructions can be found in Section 4. How do I use MEZAVANT? in the full CMI.
What should I know while using MEZAVANT?
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Things you should do
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Remind any doctor or dentist you visit that you are using MEZAVANT. If you are pregnant or intend to become pregnant while using this medicine, tell the doctor immediately.
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Things you should not do
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Do not stop using this medicine suddenly or change the dosage without checking with your doctor.
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Driving or using machines
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MEZAVANT is unlikely to have any effect on your ability to drive or use machines.
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Looking after your medicine
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Store MEZAVANT in a cool dry place where the temperature is below 25°C.
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For more information, see Section 5. What should I know while using MEZAVANT? in the full CMI.
Are there any side effects?
Common side effects include headache, tiredness, indigestion, mild stomach pains, excessive gas in the stomach or bowel, increased number of bowel motions, nausea, vomiting, rash or itchy skin, fever, loss of strength, muscle or joint or back pain.
Serious side effects include: Acute intolerance syndrome symptoms such as cramping, severe stomach pain, bloody and excessive stools (diarrhoea), fever, headache or rash. Unexplained bruising, rash, anaemia, sore throat, unusual bleeding. Allergic reaction. Severe pain in the back, side or stomach. Trouble urinating, pain or burning during urination. Increased blood pressure.
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.
Active ingredient(s): mesalazine
Consumer Medicine Information (CMI)
This leaflet provides important information about using MEZAVANT. It does not take the place of talking to your doctor or pharmacist. You should also speak to your doctor or pharmacist if you would like further informationor if you have any concerns or questions about using MEZAVANT. The information in this leaflet was last updated on the date listed on the final page. More recent information on the medicine may be available. You should ensure that you speak to your pharmacist or doctor to obtain the most up to date information on this medicine. You can also download the most up to date leaflet from www.takeda.com/en-au . Those updates may contain important information about the medicine and its use of which you should be aware.
Where to find information in this leaflet:
1. Why am I using MEZAVANT?
2. What should I know before I use MEZAVANT?
3. What if I am taking other medicines?
4. How do I use MEZAVANT?
5. What should I know while using MEZAVANT?
6. Are there any side effects?
7. Product details
Why am I using MEZAVANT?
MEZAVANT contains the active ingredient mesalazine (also called 5-aminosalicylic acidor 5-ASA).
MEZAVANT is an anti-inflammatory drug used for the treatment of ulcerative colitis. When MEZAVANT is taken for a flare up of ulcerative colitis, it acts through the entire colon and rectum to treat the inflammation and reduce symptoms. MEZAVANT can also be taken to help prevent re-occurrence of ulcerative colitis.
What should I know before I use MEZAVANT?
Warnings
Do not use MEZAVANT if:
1. you are allergic to mesalazine, or any of the ingredients listed at the end of this leaflet.
2. you are allergic to a family of drugs known as salicylates (which include aspirin).
3. Always check the ingredients to make sure you can use this medicine.
Check with your doctor if you:
have any kidney problems
have previously had inflammation of the heart (which may be the result of an infection in the heart)
have had a previous allergic reaction to MEZAVANT or other medicines containing mesalazine or sulphasalazine (other medicines taken for treatment of ulcerative colitis)
have narrowing or blockage of the stomach or the gut
have skin conditions such as atopic dermatitis or atopic eczema
have any other medical conditions or take any medicines for any other condition
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.
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 MEZAVANT and affect how it works.
These include:
mesalazine or sulphasalazine (taken for treatment of ulcerative colitis)
non-steroidal anti-inflammatory drugs (for example medicines containing aspirin, ibuprofen or diclofenac)
azathioprine or 6-mercaptopurine (known as ‘immunosuppressant’ medicines).
warfarin (taken to prevent blood clots) or other coumarin-type anticoagulants
Check with your doctor or pharmacist if you are not sure about what medicines, vitaminsor supplements you are taking and if these affect MEZAVANT.
How do I use MEZAVANT?
How much to take
Adults and the elderly:
The usual daily dose for adults and the elderly is 2.4g to 4.8g (two to four tablets) taken once a day for an acute episode of ulcerative colitis. If you are taking the highest daily dose of 4.8g/day, you should be evaluated after 8 weeks of treatment. Once your symptoms have cleared and to help prevent re-occurrence of another episode, your doctor may direct you to take 2.4g (two tablets) once a day.
The usual daily dose for adults and the elderly is 2.4g to 4.8g (two to four tablets) taken once a day for an acute episode of ulcerative colitis. If you are taking the highest daily dose of 4.8g/day, you should be evaluated after 8 weeks of treatment. Once your symptoms have cleared and to help prevent re-occurrence of another episode, your doctor may direct you to take 2.4g (two tablets) once a day.
Children and Adolescents:
MEZAVANT is not recommended to be given to children under 18 years of age due to lack of data on safety and efficacy.
Follow the instructions provided and use MEZAVANT until your doctor tells you to stop.
When to take MEZAVANT
Take MEZAVANT at the same time each day. It is important to take MEZAVANT every day for as long as your doctor tells you to, even when you don’t have any symptoms of ulcerative colitis.
How to take MEZAVANT
MEZAVANT can be taken with or without food. The tablets must be swallowed whole and must not be crushed or chewed.
If you forget to use MEZAVANT
MEZAVANT should be used regularly at the same time each day. If you miss your dose at the usual time, then take them as usual the next day.
Do not take a double dose to make up for the dose you missed.
If you use too much MEZAVANT
If you think that you have used too much MEZAVANT, you may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(by calling 13 11 26), or
(by calling 13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
What should I know while using MEZAVANT?
Things you should do
make sure that all of your doctors, dentists, and pharmacists know you are taking MEZAVANT. Remind them if any new medicines are about to be started.
ensure adequate fluid intake during treatment.
Things you should not do
do not stop using this medicine suddenly or change the dosage without checking with your doctor.
do not give to children under 18 years of age. MEZAVANT is not suitable for children under 18 years of age as there is not enough information on its effects in children.
do not give MEZAVANT to anyone else, even if they have the same condition as you. It may not be safe for another person to take MEZAVANT.
do not take MEZAVANT to treat any other complaints unless your doctor tells you to. It may not be safe to use MEZAVANT for another complaint.
Driving or using machines
MEZAVANT is unlikely to have any effect on your ability to drive or use machines.
Looking after your medicine
Keep MEZAVANT tablets in the pack until it is time to take them. Store MEZAVANT in a cool dry place where the temperature stays below 25°C.
Do not store it in the bathroom or near a sink, or in the car or on windowsill.
Do not use this medicine after the expiry date.
Keep it where young children cannot reach it.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.
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, ask your doctor or pharmacist if you have any further questions about side effects.
Less serious side effects
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Less serious side effects
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What to do
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headache
tiredness
indigestion
mild stomach pains
bloating or passing wind
excessive gas in the stomach or bowel
increased number of bowel motions
nausea
vomiting
rash or itchy skin
fever
loss of strength
muscle, joint or back pain
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Speak to your doctor if you have any of these less serious side effects and they worryyou.
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Serious side effects
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Serious side effects
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What to do
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if you experience symptoms such as cramping, severe stomach pain, bloody and excessive stools (diarrhoea), fever, headache or rash. These symptoms could be a sign of Acute Intolerance Syndrome which can happen during an acute episode of ulcerative colitis. This is a serious condition which occurs rarely, but means your treatment would have to be stopped immediately
if you develop unexplained bruising (without injury), rash, anaemia (feeling tired, weak and looking pale, especially on lips, nails and inside of eyelids), fever (high temperature), sore throat or unusual bleeding (e.g. nose bleeds)
if you develop allergic swelling of face, eyes, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing.
widespread rash with blistering of the skin, particularly around the mouth, eyes and genitals
allergic skin rash with fever
severe pain in the back, side or stomach. Trouble urinating, pain or burning during urination. These could be symptoms of kidney stones
increased blood pressure
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Call your doctor straight away, or go straight to the Emergency Department at yournearest hospital if you notice any of these serious side effects.
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Tell your doctor or pharmacist if you notice anything else that may be making youfeel 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 stoptaking any of your medicines.
Product details
This medicine is only available with a doctor’s prescription.
What MEZAVANT contains
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Active ingredient
(main ingredient)
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Mesalazine
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Other ingredients
(inactive ingredients)
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Carmellose sodium, carnauba wax, stearic acid, silicon dioxide, sodium starch glycollate, talc-purified, magnesium stearate, methacrylic acid copolymer, triethyl citrate, titanium dioxide (E171), iron oxide red (CI77491), Macrogol 6000
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Do not take this medicine if you are allergic to any of these ingredients.
What MEZAVANT looks like
MEZAVANT 1.2 g tablet (AUST R 155172): Oval shaped red-brown tablets which are stamped with S476.
MEZAVANT is supplied as a 60 tablets pack size.
Who distributes MEZAVANT
Takeda Pharmaceuticals Australia Pty Ltd
Level 39, 225 George Street
Sydney NSW 2000
Australia
Phone: 1800 012 612
www.takeda.com/en-au
This leaflet was prepared in October 2020.
MEZAVANT® and the MEZAVANT Logo® are registered trademarks used under license from Nogra Pharma Limited.
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