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FOSRENOL 250MG CHEWABLE TABLETS

Active substance(s): LANTHANUM (III) CARBONATE HYDRATE

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Package Leaflet: Information for the Patient
FOSRENOL 250 mg chewable tablets
FOSRENOL 500 mg chewable tablets
FOSRENOL 750 mg chewable tablets
FOSRENOL 1000 mg chewable tablets
lanthanum

Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.
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Keep this leaflet. You may need to read it again.

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If you have any further questions, ask your doctor or pharmacist.

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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.

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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.

What is in this leaflet:
1.
2.
3.
4.
5.
6.

What Fosrenol is and what it is used for
What you need to know before you take Fosrenol
How to take Fosrenol
Possible side effects
How to store Fosrenol
Contents of the pack and other information

1.

What Fosrenol is and what it is used for

Fosrenol is used to lower the phosphate level in the blood of adult patients with chronic kidney
disease.
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 have bonded to Fosrenol cannot be absorbed through the
intestinal wall.
2.

What you need to know before you take Fosrenol

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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)

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 conditions:






stomach ulcer;
ulcerative colitis;
Crohn’s disease;
blockage of the bowel;
reduced liver or kidney function.

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 have previously had abdominal surgery, or infection or inflammation of the abdomen/bowel
(peritonitis) inform your doctor.
If you need to have an x-ray, please inform your doctor that you are taking Fosrenol as it may affect
the results.
Other medicines and Fosrenol
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines.
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.
It is not recommended that you take oral floxacin antibiotics (including ciprofloxacin) within 2 hours
before or 4 hours after taking Fosrenol.
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.

Fosrenol with food and drink
Fosrenol should be taken with, or immediately after food. See Section 3 for instructions on how to take
Fosrenol.
Pregnancy and breast-feeding

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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 breast-milk, you should not breastfeed whilst taking Fosrenol. If you are breast-feeding, ask your doctor or pharmacist for advice before
taking any medicines.
Driving and using machines
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.
Fosrenol contains Glucose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor
before taking this medicinal product.
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. The tablets must be chewed completely
and not swallowed whole. To aid with chewing the tablets may be crushed. Additional fluid is not
necessary.
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:



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 take more Fosrenol than you should
If you take too many tablets contact your doctor to assess the risk and obtain advice. Symptoms of
overdose may be nausea and headaches.
If you forget to take Fosrenol
It is important to take Fosrenol with every meal.
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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.
4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects such as nausea and vomiting are more likely if you take Fosrenol before your meal. You
should always take it during or immediately after your food.
Very Common side effects (may affect more than 1 in 10 people):


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

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


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.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed
in this leaflet.
You can also report side effects directly via the national reporting system (to be completed nationally).
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.

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This medicinal product does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the carton and the bottle label. The
expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These measures will help protect the environment
6.

Contents of the pack and other information

What Fosrenol contains
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The active substance is 250 mg, 500 mg 750 mg or 1000 mg lanthanum (as lanthanum
carbonate hydrate).

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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 ‘S405/250’ (250
mg), ‘S405/500’ (500 mg), ‘S405/750’ (750 mg) or ‘S405/1000’ (1000 mg) on one side of the tablet.
The tablets are supplied in plastic bottles of 40, 90, 200, or 400 tablets (250 mg); 20, 45, 100, 200
tablets, or a multipack containing 90 (2 packs of 45) chewable tablets (500 mg); 15, 30, 45, 75,r 150
tablets, or a multipack containing 90 (6 packs of 15) chewable tablets (750 mg); and 10, 15, 30, 50, ,
100 tablets, or a multipack containing 90 (6 packs of 15) chewable tablets (1000 mg).
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
The marketing authorisation holder is:
Shire Pharmaceutical Contracts Ltd., Hampshire International Business Park, Chineham, Basingstoke,
Hampshire RG24 8EP, UK.
The manufacturer is:
Hamol Limited, Thane Road, Nottingham, Nottinghamshire NG90 2DB, UK
Wasdell Packaging Limited, Units 1-8, Euro Way Industrial Estate, Blagrove, Swindon, SN5 8YW,
UK
For any information about this medicine, please contact the local representative of the Marketing
Authorisation Holder.

This medicinal product is authorised in the Member States of the EEA under the following names:

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Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Iceland, Latvia, Lithuania, Luxembourg,
Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovak Republic,
Slovenia, Spain, Sweden, UK

Fosrenol

Ireland, Italy

Foznol

This leaflet was last revised in 5 December 2014

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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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