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 taking FOSRENOL?
FOSRENOL contains the active ingredient lanthanum carbonate hydrate. FOSRENOL is used
to lower the phosphate level in the blood of adult patients with chronic kidney disease.
2. What should I know before I take FOSRENOL?
Do not use if you have ever had an allergic reaction to FOSRENOL 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 FOSRENOL and affect how it works.
4. How do I take FOSRENOL?
Always take this medicine exactly as your doctor or pharmacist has told you
FOSRENOL tablets must be chewed completely and not swallowed whole. Patients who have
chewing difficulty, the tablets can be crushed.
FOSRENOL should be taken with or immediately after food.
5. What should I know while taking FOSRENOL?
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Things you should do
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Remind any doctor, dentist, or pharmacist you visit or any new medicines you are about
to start, that you are using FOSRENOL.
If you need to have an X-ray or an endoscopy, please inform your doctor that you are
taking FOSRENOL, as it may affect the results.
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Things you should not do
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Do not use any other medicines while taking FOSRENOL unless you have discussed this
with your doctor or pharmacist.
FOSRENOL tablets must be chewed completely and not swallowed whole.
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Driving or using machines
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Dizziness, nausea, and vertigo are uncommon side effects of FOSRENOL; which may affect
your ability to drive or operate machinery.
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Looking after your medicine
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Keep your medicine in a cool, dry place where the temperature stays below 25°C
Keep FOSRENOL where children cannot reach it.
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6. Are there any side effects?
The common side effects include nausea, vomiting, diarrhoea, headache, stomach pain,
constipation, itching, skin rash, low calcium (hypocalcaemia), blockage in the intestine.
Active ingredient: lanthanum carbonate hydrate
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using FOSRENOL. 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 FOSRENOL.
Where to find information in this leaflet:
1. Why am I taking FOSRENOL?
FOSRENOL contains the active ingredient lanthanum carbonate hydrate.
Phosphorous is found in your body as "phosphate" and is needed for building strong
teeth and bones as well as keeping other parts of your body healthy. When your kidneys
fail to work properly, phosphate can build up in the blood. This buildup of excess
phosphate is called hyperphosphataemia.
FOSRENOL is a phosphate binder and is used to lower the amount of phosphate in your
body. It prevents the body from absorbing the phosphate from the food you eat.
The phosphate in the food binds to FOSRENOL and is carried through the digestive tract
to be eliminated in your stool.
2. What should I know before I use FOSRENOL?
FOSRENOL chewable tablets are not suitable for everyone.
Do not use FOSRENOL if:
you are allergic to lanthanum carbonate, or any of the ingredients listed at the end
of this leaflet
always check the ingredients to make sure you can use this medicine
you have bowel blockage (obstruction), no movement in your bowels (ileus), or you
are unable to defecate due to faecal impaction
you have too little phosphate in your blood (hypophosphataemia).
Check with your doctor if you have:
reduced liver function. It is possible that your liver will not be able to 'clean'
FOSRENOL from your body adequately
a disease involving the gastrointestinal tract
inflammatory bowel disease including ulcerative colitis or Crohn's disease
a history of stomach ulcer
a history of blockage of the bowel
previously had abdominal surgery, or infection or inflammation of the abdomen/bowel
(peritonitis)
reduced kidney function
taken 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.
Some medicines can have harmful effects on the breast-fed baby. FOSRENOL may be passed
into breast milk and therefore is not recommended for mothers who breast feed their
babies.
Warnings
It is very important to chew completely FOSRENOL tablets and not to swallow them whole
or incompletely chewed. This will reduce the risk of adverse gastrointestinal complications
like rupture in the intestinal wall, blockage in the intestine, constipation (see
also section 6).
If you need to have an x-ray, please inform your doctor that you are taking FOSRENOL
as it may affect the results.
If you need to have a gastrointestinal endoscopy, please inform your doctor that you
are taking FOSRENOL it might detect lanthanum deposits in the digestive tract.
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 FOSRENOL and affect how it works.
FOSRENOL can affect the uptake of certain medicines from the gut.
Such medicines should be taken at least 2 hours before or 2 hours after taking FOSRENOL.
The following drugs are affected:
chloroquine (against rheumatism and malaria)
ketoconazole (against fungal infections)
certain antibiotics (tetracycline, doxycycline)
thyroxine (used for deficiency of thyroid hormone).
Quinolone antibiotics such as ciprofloxacin and norfloxacin should be taken at least
2 hours before or four hours after FOSRENOL.
4. How do I take FOSRENOL?
How much to take
Always take FOSRENOL exactly as your doctor has instructed you.
Your doctor will tell you how many tablets you must take with each meal (your daily
dose will be divided between three meals). The number of tablets that you take will
depend on:
your diet (the amount of phosphate in the food you eat)
your blood phosphate level.
To start with, the daily dose of FOSRENOL will usually be 1 tablet with each meal
(3 tablets per day). Your doctor will then check the level of phosphate in your blood
and may then increase this dose to a level that is correct for you.
When to take FOSRENOL
FOSRENOL works by binding phosphate from the food in your gut. It is very important to take FOSRENOL during or immediately after every meal.
If you eat extra meals, or eat between meals, you may need to take extra FOSRENOL.
Your doctor will tell you what to do in this case.
How to take FOSRENOL
FOSRENOL tablets must be chewed completely and not swallowed whole.
For those patients who have dentures or those who have difficulty chewing you can
crush the tablets.
If you forget to take FOSRENOL
It is important to take FOSRENOL with every meal.
If you forget to take your FOSRENOL, then take the next dose with your next meal.
Do not take a double dose to make up for the dose you missed.
If you took too much FOSRENOL
If you think that you have taken too much FOSRENOL, 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.
Symptoms of overdose may include nausea, vomiting and headaches. You should do this even if there are no signs of discomfort or poisoning.
5. What should I know while taking FOSRENOL?
Things you should do
Keep all your doctor's appointments so your progress can be checked.
Tell all doctors, dentists and pharmacists who are treating you that you are having
treatment with FOSRENOL.
Remind them if any new medicines are about to be started, or if you are about to have
a medical or dental procedure.
If you need to have an x-ray of your stomach or abdomen, please tell your doctor that
you are taking FOSRENOL as it may affect the results of the x-ray.
If you need to have a gastrointestinal endoscopy, please inform your doctor that you
are taking FOSRENOL because the endoscopist might detect lanthanum deposits in the
digestive tract.
Like most medicines FOSRENOL is not recommended during pregnancy or while breastfeeding.
It is uncertain whether FOSRENOL can affect the unborn child. If it is necessary for
you to receive this medicine, your doctor will discuss the risks and benefits of taking
FOSRENOL.
If pregnancy occurs during your treatment, you must immediately inform your doctor.
Things you should not do
Do not stop using this medicine suddenly. Your doctor will decide how long to continue
your treatment with FOSRENOL.
Do not use any other medicines while taking FOSRENOL unless you have discussed this
with your doctor or pharmacist.
This includes medicines you can buy without a prescription from a pharmacy, supermarket,
or health food shop.
Do not use FOSRENOL to treat any complaint other than directed by your doctor. It
may not be safe to use FOSRENOL for another complaint.
FOSRENOL should only be used by the person for whom it was prescribed.
Do not administer FOSRENOL to someone else even if they have the same condition as
you. It may not be safe for another person to use FOSRENOL.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how FOSRENOL
affects you.
Dizziness and vertigo (a feeling of dizziness or "spinning") are uncommon side effects
reported by some patients taking FOSRENOL. If you experience these side effects it
may affect your ability to drive or operate machinery.
Looking after your medicine
Keep your medicine in the original pack until it is time to take it. Keep your medicine
in a cool, dry place where the temperature stays below 25°C.
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.
Do not take FOSRENOL after the expiry date stated on the bottle label.
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.
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 FOSRENOL contains
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Active ingredient
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500 mg, 750 mg, or 1000 mg of lanthanum as lanthanum carbonate hydrate.
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Other ingredients
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Dextrates, silicon dioxide, magnesium stearate
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Do not take this medicine if you are allergic to any of these ingredients.
What FOSRENOL looks like
FOSRENOL chewable tablets are available in the following strengths and pack sizes:
FOSRENOL 500 mg: White, round, bevel-edged flat tablets debossed with 'S405/500' on
one side (45 tablets per bottle; 2 bottles per carton).
FOSRENOL 750 mg: White to off-white round, flat bevelled edge tablets debossed on
one side with 'S405' above '750' (15 tablets per bottle; 6 bottles per carton).
FOSRENOL 1000 mg: White to off-white round, flat bevelled edge tablets debossed on
one side with 'S405' above '1000' (15 tablets per bottle; 6 bottles per carton).
Australian Registration Numbers
AUST R 106960 (FOSRENOL 500 mg)
AUST R 106962 (FOSRENOL 750 mg)
AUST R 106964 (FOSRENOL 1000 mg)
Not all pack sizes may be supplied.
Who distributes FOSRENOL
Takeda Pharmaceuticals Australia Pty Ltd
Level 39
225 George Street
Sydney, NSW 2000
Australia
Phone: 1800 012 612
This leaflet was prepared in April 2023.
FOSRENOL
®
and the FOSRENOL Logo
®
are registered trademarks of Shire International Licensing BV.
TAKEDA
®
and the TAKEDA Logo
®
are registered trademarks of Takeda Pharmaceutical Company Limited.