NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.
FOSRENOL® TABLETS CMI V2.0
500 mg, 750 mg, 1000 mg Chewable Tablets
Lanthanum carbonate hydrate
Consumer Medicine Information
What is in this leaflet
Please read this leaflet before you start taking FOSRENOL.
This leaflet answers some common questions about FOSRENOL chewable tablets. It does not contain all of the available information.
This information is not intended to replace the advice of your health care professional.
All medicines have risks and benefits. Your doctor has weighed the risks of you taking FOSRENOL against the benefits they expect it will have for you.
If you have any concerns about taking FOSRENOL, ask your doctor or pharmacist.
Keep this leaflet with the medicine.
You may need to read it again.
What FOSRENOL is used for
Phosphorus 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 build up 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.
FOSRENOL tablets are not addictive.
FOSRENOL tablets are only available on a doctor’s prescription.
Before you take FOSRENOL
FOSRENOL chewable tablets are not suitable for everyone.
When you must not take FOSRENOL
Do not take FOSRENOL if:
you are hypersensitive (allergic) to lanthanum carbonate hydrate or any of the other ingredients of FOSRENOL listed at the end of this leaflet
you have too little phosphate in your blood (hypophosphataemia).
Before you start to take FOSRENOL
You must tell 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
you have a disease involving the gastrointestinal tract
you have Crohn’s disease
you have ulcerative colitis
you have or have had a stomach ulcer
you have or have had a blockage of the bowel
you have previously had abdominal surgery, or infection or inflammation of the abdomen/bowel (peritonitis)
you are pregnant or plan to become pregnant
you are breast-feeding
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.
If you have not told your doctor about any of the above, tell them before you start taking FOSRENOL.
Taking other medicines
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, even any that you buy without a prescription from your pharmacy, supermarket or health food shop.
FOSRENOL and some medicines may interfere with each other.
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)
thyroxine (used for deficiency of thyroid hormone)
certain antibiotics (tetracycline, doxycycline).
Quinolone antibiotics such as ciprofloxacin and norfloxacin should be taken at least two hours before or four hours after FOSRENOL.
How to take FOSRENOL
Always take FOSRENOL exactly as your doctor has instructed you.
You should check with your doctor or pharmacist if you are unsure as to how you should take FOSRENOL.
How much to take
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.
How to take it
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.
When to take it
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 long to take it
Your doctor will decide how long to continue your treatment with FOSRENOL.
If you forget to take it
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 forgotten doses.
If you take too much (Overdose)
Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have taken too much FOSRENOL.
Do this even if there are no signs of discomfort or poisoning.
Symptoms of overdose may include nausea, vomiting and headaches.
While you are taking FOSRENOL
Things you must do
Keep all of 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.
Like most medicines FOSRENOL is not recommended during pregnancy or while breastfeeding. It is uncertain whether or not 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 must not do
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.
Things to be careful of
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.
Side effects
Tell your doctor or pharmacist as soon as possible if you do not feel well whilst you are taking FOSRENOL.
Like all medicines, FOSRENOL can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.
Do not be alarmed by the following list of side effects. You may not experience any of them.
Tell your doctor if you notice any of the following and they worry you:
nausea
vomiting
diarrhoea
headache
stomach pain
constipation
bronchitis and rhinitis
dizziness (from low blood pressure)
The above list includes the more common side effects of FOSRENOL. They are usually mild. Stomach effects are more likely if you take FOSRENOL before your meal.
You should always take FOSRENOL during or immediately after your food.
Some people get other less common side effects whilst taking FOSRENOL. These may include:
tiredness
chest pain
weakness
dry mouth
weight decrease
thinning of the bones (osteoporosis)
joint pain
loss of hair
itching; rash
increase sweating
taste disturbance
Some side effects could be serious. Tell your doctor immediately, if you notice any of the following:
Blockage in the intestine (signs include: severe bloating, severe abdominal pain, swelling or cramps; severe constipation). This is a less common side effect.
Hypocalcaemia (too little calcium in your blood): symptoms include tingling in the hands and feet, muscle and abdominal cramps or spasms of the facial and feet muscles. This is a common side effect.
Tell your doctor if you notice anything else that is making you feel unwell.
Other side effects not listed above may also occur in some people.
After using FOSRENOL
Storage
Keep your medicine in the original pack until it is time to take it.
Keep FOSRENOL 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.
Keep your medicine in a cool, dry place where the temperature stays below 25°C.
Do not store FOSRENOL or any other medicine in the bathroom or near a sink. Do not leave it on a window sill or in the car.
Heat and dampness can destroy some medicines.
Do not take FOSRENOL after the expiry date stated on the bottle label.
Disposal
Ask your pharmacist what to do with any unwanted medicine that is left over or if the expiry date has passed.
Product description
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).
Ingredients
FOSRENOL contains 500 mg, 750 mg or 1000 mg lanthanum as the active substance in form of lanthanum carbonate hydrate.
The other ingredients are:
dextrates
silicon dioxide
magnesium stearate
Supplier
Takeda Pharmaceuticals Australia Pty Ltd
Level 39
225 George Street
Sydney, NSW 2000
Australia
www.takeda.com/en-au
Phone: 1800 012 612
This leaflet was prepared in November 2020.
Australian Registration Numbers:
FOSRENOL 500 mg, 2 bottles of 45 tablets
AUST R 106960
FOSRENOL 750 mg, 6 bottles of 15 tablets
AUST R 106962
FOSRENOL 1000 mg, 6 bottles of 15 tablets
AUST R 106964
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.
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