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.
1. Why am I using Renagel?
Renagel contains the active ingredient sevelamer hydrochloride. Renagel is used to
treat hyperphosphataemia, a condition caused by too much dietary phosphorus being
retained in your body due to a diseased kidney.
2. What should I know before I use Renagel?
Do not use if you have ever had an allergic reaction to Renagel 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.
3. What if I am taking other medicines?
Some medicines may interfere with Renagel and affect how it works.
4. How do I use Renagel?
Your treating doctor will tell you how many tablets to take each day. The initial
dose is usually 1 - 2 tablets three times a day with meals. Your doctor may adjust
your dosage depending on your blood test results.
Renagel tablets should be swallowed whole with a glass of water during mealtimes.
Do not chew, crush, or break the tablets into pieces before taking them.
5. What should I know while using Renagel?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are using Renagel.
Keep your doctor's appointments so your progress can be checked. Your doctor will
check your progress and monitor your phosphate levels from time to time.
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Things you should not do
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Give Renagel to anyone else, even if they have the same condition as you.
Use Renagel to treat any other complaints unless your treating doctor tells you to.
Stop taking Renagel or change the dosage without checking with your treating doctor.
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Driving or using machines
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Be careful while you drive or use any machines or tools until you know how Renagel
affects you.
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Drinking alcohol
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Tell your doctor if you drink alcohol.
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Looking after your medicine
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Keep your tablets in the bottle until it is time to take them.
Keep Renagel in a cool dry place where the temperature stays below 25°C with the lid
tightly closed.
Do not put Renagel in the refrigerator, in the bathroom, near a sink, in the car or
on windowsills.
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6. Are there any side effects?
Common side effects: vomiting, nausea, constipation, heartburn, diarrhoea, abdominal
pain, flatulence, headache.
Active ingredient:
Sevelamer hydrochloride
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using Renagel. 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 Renagel.
Where to find information in this leaflet:
1. Why am I using Renagel?
Renagel contains the active ingredient sevelamer hydrochloride. Renagel belongs to a class of medicines that are called ion exchange resins.
Renagel helps to remove excess phosphorus that has built up in your body by binding
the phosphorus that is in the food that you eat.
Renagel is used to treat hyperphosphataemia, a condition caused by too much dietary
phosphorus being retained in your body due to a diseased kidney.
2. What should I know before I use Renagel?
Warnings
Do not use Renagel if:
you are allergic to sevelamer hydrochloride, or any of the ingredients listed at the
end of this leaflet.
you have hypophosphatemia, a condition where you do not have enough phosphorus in
your body.
you have a bowel obstruction.
the packaging is torn or shows sign of tampering.
the expiry date (EXP) printed on the pack has passed.
Check with your doctor if you have:
allergies to any other medicines or substances such as foods, preservatives, or dyes.
swallowing problems.
severe constipation.
problems with movement in your stomach and bowel.
active inflammation of the bowel.
undergone major surgery on your stomach or bowel.
any other medical conditions.
take any medicines for any other conditions.
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.
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 be affected by Renagel or may affect how well it works. You may
need different amounts of your medicine, or you may need to take different medicines.
Your treating doctor will advise you.
Medicines that may be affected by Renagel include:
ciclosporin
mycophenolate mofetil
tacrolimus
ciprofloxacin
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect Renagel.
4. How do I use Renagel?
How much to take?
Follow the instructions provided by your treating doctor and pharmacist carefully.
These directions may differ from the information contained within this leaflet.
Your treating doctor may initially prescribe 1 - 2 Renagel 800mg tablets three times
a day with meals. Your doctor may adjust your dosage during treatment depending on
your blood test results.
When to take Renagel?
Renagel tablets should be taken with meals.
The tablets should be swallowed whole with a glass of water. Do not chew, crush, or
break the tablets into pieces before taking them.
When the contents of Renagel tablets are exposed to water, they expand making them
hard to swallow.
If you are having difficulty swallowing Renagel tablets, speak to your healthcare
professional.
How long to take Renagel for?
Renagel helps lower your body's retention of dietary phosphate. It does not cure your
condition. Therefore, you must continue to take it for as long as your treating doctor
directs you to.
You may have to take Renagel for the rest of your life. If you stop taking Renagel,
your phosphate levels may rise again. It is important to keep taking Renagel even
if you feel well.
If you forget to use Renagel
Renagel should be taken at the same times each day. If you miss your dose at the usual
time, do not take an extra dose to make up for the one you missed.
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 you missed.
If you have trouble remembering to take your tablets, ask your pharmacist for some
hints.
If you take too much Renagel
If you think that you have taken too much Renagel, you may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(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.
5. What should I know while using Renagel?
Things you must do
Call your doctor straight away if you:
become pregnant while you are taking Renagel.
start to feel unwell or have any problems while you are taking Renagel, even if you
do not think the problems are related to Renagel or are not listed in this leaflet.
Remind any doctor, dentist, or pharmacist you visit that you are using Renagel.
Things you must not do:
give Renagel to anyone else, even if they have the same condition as you.
use Renagel to treat any other complaints unless your treating doctor tells you to.
stop taking Renagel or change the dosage without checking with your treating doctor.
Things you should do:
keep your doctor's appointments so your progress can be checked. Your doctor will
check your progress and monitor your phosphate levels from time to time. This helps
to ensure you are getting the correct dose of Renagel.
Driving or using machines
Be careful while you drive or use any machines or tools until you know how Renagel
affects you.
Drinking alcohol
Tell your doctor if you drink alcohol.
Looking after your medicine
Keep your tablets in the bottle until it is time to take them. If your take the tablets
out of the bottle, they may not keep well.
Keep Renagel in a cool dry place where the temperature stays below 25°C with the lid
tightly closed. Do not put Renagel in the refrigerator.
Follow the instructions in the carton on how to take care of your medicine properly.
Store it 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 windowsills.
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.
Do not use 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, ask your doctor or pharmacist if you
have any further questions about side effects.
Less serious side effects
Serious side effects
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 Renagel contains
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Active ingredient
(main ingredient)
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Each tablet contains 800mg of sevelamer hydrochloride
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Other ingredients
(inactive ingredients)
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Colloidal anhydrous silica
Stearic acid
OPADRY complete film coating system 06A29064 Clear
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Potential allergens
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Renagel does not contain gluten, lactose, sucrose, tartrazine or any other azo dyes.
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Do not take this medicine if you are allergic to any of these ingredients.
What Renagel looks like
Renagel 800mg tablets are oval off-white film coated tablets with "RG800" engraved
on one side and blank on the other side. (AUST R 101553).
Who distributes Renagel
Distributed by:
sanofi-aventis australia pty ltd
12-24 Talavera Road
Macquarie Park NSW 2113
Freecall: 1800 818 806
Email:
[email protected]
This leaflet was prepared in June 2024.
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