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FOSRENOL 750 MG CHEWABLE TABLETS

Active substance(s): LANTHANUM / LANTHANUM

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Package Leaflet: Information for the patient
®

Fosrenol 500 mg chewable tablets, Fosrenol® 750 mg chewable tablets,
Fosrenol® 1000 mg chewable tablets
(lanthanum carbonate)
This product is known by the above name, but will be referred to as
Fosrenol® throughout this leaflet.

If you are taking levothyroxine (for an under active thyroid) it should not
be taken within 2 hours before or after taking Fosrenol®. Your doctor may
want to monitor the levels of thyroid-stimulating hormone (TSH) in your
blood more closely.

Read all of this leaflet carefully before you start taking this medicine
because it contains important information for you.

Fosrenol® with food and drink

 Keep this leaflet. You may need to read it again.
 If you have any further questions, ask your doctor or pharmacist.
 This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if their signs of illness are the same as
yours.
 If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. See section
4.

Fosrenol® should be taken with, or immediately after food. See Section 3
for instructions on how to take Fosrenol®.
Pregnancy and breast-feeding
Fosrenol® should not be taken during pregnancy. If you are pregnant or
breast-feeding, think you may be pregnant, or are planning to have a
baby ask your doctor or pharmacist for advice before taking this medicine.
As it is not known whether the drug can be transferred to a child in breastmilk, you should not breast-feed whilst taking Fosrenol®. If you are breastfeeding, ask your doctor or pharmacist for advice before taking any
medicines.

What is in this leaflet:
1. What Fosrenol® is and what it is used for
2. What you need to know before you take Fosrenol®
3. How to take Fosrenol®

Driving and using machines

4. Possible side effects

Dizziness and vertigo (a feeling of dizziness or “spinning”) are uncommon
side effects reported by patients taking Fosrenol®. If you experience these
side effects, it may affect your ability to drive or operate machinery.

®

5. How to store Fosrenol

6. Contents of the pack and other information
1. WHAT FOSRENOL® IS AND WHAT IT IS USED FOR

Fosrenol® contains Glucose

®

Fosrenol is used to lower the phosphate level in the blood of adult
patients with chronic kidney disease.

If you have been told by your doctor that you have an intolerance to some
sugars, contact your doctor before taking this medicinal product.

Patients who have kidneys that do not work properly are not able to
control the level of phosphate in the blood. The amount of phosphate in
the blood then rises (your doctor may call this hyperphosphataemia).
Fosrenol® is a drug which reduces the body’s absorption of phosphate
from food by binding with it in your digestive tract. Phosphate which has
bonded to Fosrenol® cannot be absorbed through the intestinal wall.

3. HOW TO TAKE FOSRENOL®
Always take this medicine exactly as your doctor or pharmacist has told
you. Check with your doctor or pharmacist if you are not sure.
You should take Fosrenol® with, or immediately after food. Side effects
such as nausea and vomiting are more likely if you take Fosrenol® before
your meal.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FOSRENOL®

The tablets must be chewed completely and not swallowed whole. To aid
with chewing, the tablets may be crushed. Additional fluid is not
necessary.

Do not take Fosrenol®
 if you are allergic to lanthanum carbonate hydrate or any of the other
ingredients of this medicine (listed in section 6).
 if you have too little phosphate in your blood (hypophosphataemia).

If you find chewing the tablets difficult, talk to your doctor as an oral
powder form of this medicine is available.
Your doctor will tell you how many tablets you must take with each meal
(your daily dose will be divided between meals). The number of tablets
that you take will depend on:

Warnings and precautions
Talk to your doctor or pharmacist before taking Fosrenol® if you know that
you have, or have had, any of the following:
 stomach or intestinal cancer
 inflammatory bowel disease including ulcerative colitis or Crohn’s
disease
 abdominal surgery, or infection or inflammation of the abdomen/bowel
(peritonitis)
 stomach or intestinal ulcers
 blockage of the intestine or slow motility (movement) in the intestine
(e.g. constipation and stomach complications due to diabetes)
 reduced liver or kidney function.

 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).
Every 2-3 weeks your doctor will check the level of phosphate in your
blood and may increase your dose until the level of phosphate in your
blood is acceptable.
Fosrenol® works by binding phosphate from the food in your gut. It is very
important to take Fosrenol® at every meal. If you change your diet, contact
your doctor as you may need to take extra Fosrenol®. Your doctor will tell
you what to do in this case.

If you have reduced kidney function your doctor may decide to check the
level of calcium in your blood from time to time. If you have too little
calcium, you may then be given extra calcium.

If you take more Fosrenol® than you should

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 take too many tablets, contact your doctor to assess the risk and
obtain advice. Symptoms of overdose may be nausea and headaches.

®

Other medicines and Fosrenol

If you forget to take Fosrenol ®

Tell your doctor or pharmacist if you are taking, have recently taken, or
might take any other medicines.

It is important to take Fosrenol® with every meal.
If you forget to take your Fosrenol® tablets, then take the next dose with
your next meal. Do not take a double dose to make up for a forgotten
dose.

Fosrenol® can affect how certain drugs are absorbed from your digestive
tract. If you are taking chloroquine (for rheumatism and malaria),
ketoconazole (for fungal infections), tetracycline or doxycycline antibiotics
they should not be taken within 2 hours before or after taking Fosrenol®.

4. POSSIBLE SIDE EFFECTS

It is not recommended that you take oral floxacin antibiotics (including
ciprofloxacin) within 2 hours before or 4 hours after taking Fosrenol®.

Like all medicines, this medicine can cause side effects, although not
everybody gets them.
Some side effects could be serious. If you get any of the following
side effects, seek immediate medical attention:

1

The 1000mg tablets are supplied in plastic bottles of 10, 15, 30, 50, 100
tablets, or a multipack containing 90 (6 packs of 15) chewable tablets.

 Rupture in the intestinal wall (signs include: severe stomach pain,
chills, fever, nausea, vomiting, or a tender abdomen). This is a rare
side effect (may affect up to 1 in 1,000 people).
 Blockage in the intestine (signs include: severe bloating; abdominal
pain, swelling or cramps; severe constipation). This is an uncommon
side effect (may affect up to 1 in 100 people).

Not all pack sizes may be marketed
Manufacturers and Product Licence Holder

Other less serious side effects include the following:

Hamol Limited, Thane Road, Nottingham, Nottinghamshire, NG90 2DB,
UK.

Very Common side effects (may affect more than 1 in 10 people):

Or



Wasdell Packaging Limited, Units 6, 7, 8, Euro Way, Blagrove, Swindon,

Nausea, vomiting, diarrhoea, stomach pain, headache, itching,
rash.

SN5 8YW, UK.
Procured from within the EU and repackaged by the Product Licence
holder: Beachcourse Limited, 20 Alliance Court, London W3 0RB.

Common side effects (may affect up to 1 in 10 people):
Constipation, heartburn, flatulence.
Hypocalcaemia (too little calcium in your blood) is also a
common side effect; the symptoms of which can include tingling
in the hands and feet, muscle and abdominal cramps or spasms
of the facial and feet muscles.
Please inform your doctor if you experience constipation. This can be an
early symptom of a blockage in your intestine.



PL 16378/0585

Fosrenol® 500 mg chewable tablets

PL 16378/0586

Fosrenol® 750 mg chewable tablets

PL 16378/0587

Fosrenol® 1000 mg chewable tablets

Uncommon side effects (may affect up to 1 in 100 people):


POM

Tiredness; feeling of discomfort; chest pain; weakness; swollen
hands and feet; body pain; dizziness; vertigo; belching;
inflammation of the stomach and intestines (gastroenteritis);
indigestion; irritable bowel syndrome; dry mouth; tooth
disorders; inflammation of the gullet or mouth; loose stools;
increases in certain liver enzymes, parathyroid hormone;
aluminium, calcium and glucose in the blood; increased or
reduced phosphate level in the blood; thirst; weight decrease;
joint pain; muscle pain; weakness and thinning of the bones
(osteoporosis); lack of and increased appetite; inflammation of
the larynx; loss of hair; increased sweating; taste disturbance
and increased white blood cell count.

Revision date: 15.12.2016
Leaflet reference: FOSR500, 750, 1000

Fosrenol® is a registered trademark of Shire International Licensing BV.

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Beachcourse, Tel: 020 8896 9054

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.

for help.

By reporting side effects you can help provide more information on the
safety of this medicine.
5. HOW TO STORE FOSRENOL®
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the
carton and blister. The expiry date refers to the last day of the month.
This medicinal product does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste.
Ask your pharmacist how to throw away medicines you no longer use.
These measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Fosrenol® contains
The active substance is lanthanum carbonate hydrate.
Each 500mg tablet contains 500mg lanthanum (as lanthanum carbonate
hydrate).
Each 750mg tablet contains 750mg lanthanum (as lanthanum carbonate
hydrate).
Each 1000mg tablet contains 1000mg lanthanum (as lanthanum
carbonate hydrate).
The other ingredients are dextrates (hydrated), colloidal anhydrous silica
and magnesium stearate.
What Fosrenol® looks like and contents of the pack
Fosrenol® is a white, round, bevelled-edged flat chewable tablet debossed
with either ‘S405/500’ (500 mg), ‘S405/750’ (750 mg) or ‘S405/1000’
(1000 mg) on one side of the tablet.
The 500mg tablets are supplied in plastic bottles of 20, 45, 100, 200
tablets, or a multipack containing 90 (2 packs of 45) chewable tablets.
The 750mg tablets are supplied in plastic bottles of 15, 30, 45, 75, 150
tablets, or a multipack containing 90 (6 packs of 15) chewable tablets.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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