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FOSRENOL 1000MG CHEWABLE TABLETS

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

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1335 V5
3003400

1335v5
Fosrenol GB/MT PIL Multistrength 14020604502656: RB
50
469349A11
14-0014
7

Package Leaflet: Information for the Patient

210 x 297mm

®

500 mg chewable tablets

®

750 mg chewable tablets

®

1000 mg chewable tablets

13-04-15

P279

P2603

P2748

Technical Info

Profile

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Lanthanum

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GFW-045 00

Fonts used:
Futura Std-Book
Goudy Oldstyle Std-Bold

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

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
4. Possible side effects
5. How to store Fosrenol
6. Contents of the pack and other information

NimbusSanLOT-Bold
NimbusSanLOT-Regular
NimbusSanLOTBla-Regular

1. What Fosrenol is and what it is used for

Smallest point sized used:

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

7.0 pt
Average Text Size (Body Text):
8.0 pt

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).

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 underactive 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.

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.

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.

2. What you need to know before you take Fosrenol

As it is not known whether the drug can be transferred to a child in breast-milk,
you should not breast-feed whilst taking Fosrenol. If you are breast-feeding,
ask your doctor or pharmacist for advice before taking any medicines.

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.

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.

1335v5
Fosrenol GB/MT PIL Multistrength 14020604502656: RB
50
469349A11
14-0014
7
210 x 297mm
13-04-15

P279

P2603

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.

P2748

Technical Info

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Profile

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.
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.

GFW-045 00

Fonts used:
Futura Std-Book
Goudy Oldstyle Std-Bold
NimbusSanLOT-Bold
NimbusSanLOT-Regular
NimbusSanLOTBla-Regular
Smallest point sized used:
7.0 pt
Average Text Size (Body Text):
8.0 pt

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.

6. Contents of the pack and other information
What Fosrenol contains
The active substance is 500 mg, 750 mg or 1000 mg
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 tablets are supplied in plastic bottles of 20, 45 tablets, or a multipack
containing 90 (2 packs of 45) chewable tablets (500 mg); 15, 45 tablets,
or a multipack containing 90 (6 packs of 15) chewable tablets (750 mg);
and 10, 15 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 Limited, 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 1,2,3,5,6,7 & 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:
Shire Pharmaceuticals Limited, Hampshire International Business Park,
Chineham, Basingstoke, RG24 8EP, UK. Tel: +44 (0) 800 055 6614
This medicinal product is authorised in the Member States of the EEA
under the following names:
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
Ireland , Italy

Fosrenol

Foznol

This leaflet was last revised in

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 (see details below). By reporting
side effects you can help provide more information on the safety of this
medicine.
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Malta
ADR Reporting
The Medicines Authority
Post-Licensing Directorate
203 Level 3, Rue D’Argens
GŻR-1368 Gżira
Website: www.medicinesauthority.gov.mt
e-mail: postlicensing.medicinesauthority@gov.mt
5. How to store Fosrenol
Keep this medicine out of the sight and reach of children.
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.

1335 V5
3003400

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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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