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FOSRENOL 1000 MG ORAL POWDER

Active substance(s): LANTHANUM

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PACKAGE LEAFLET: INFORMATION FOR THE USER

750 mg oral powder
1000 mg oral powder
lanthanum
Read this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the
same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or
pharmacist

In this leaflet:
1. What Fosrenol is and what it is used for
2. Before you take Fosrenol
3. How to take Fosrenol
4. Possible side effects
5. How to store Fosrenol
6. Further information
1. What FOSRENOL is and what it is used for
Fosrenol is used to lower the phosphate level in the blood of
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 medicine 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.
2. Before you take FOSRENOL
Do not take Fosrenol
• if you are allergic (hypersensitive) to lanthanum carbonate
hydrate or any of the other ingredients of Fosrenol.
• if you have too little phosphate in your blood
(hypophosphataemia).
Take special care with Fosrenol
If you know that you have or have had any of the following
conditions, you should discuss this with your doctor before using
Fosrenol:
• 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.
If you have been told by your doctor that you have an intolerance
to some sugars, contact your doctor before taking this medicinal
product.
Taking other medicines
Fosrenol can affect how certain medicines 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 thyroidstimulating hormone (TSH) in your blood more closely.
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines obtained
without a prescription.
Taking Fosrenol with food and drink
Fosrenol should be taken with or immediately after food.
Fosrenol oral powder is intended to be mixed with soft food (e.g.
applesauce or other similar food product) and then swallowed.
Additional fluid is not necessary.
Pregnancy and breast-feeding
Fosrenol should not be taken during pregnancy. If you are, or
could be pregnant, talk to your doctor before taking Fosrenol.
As it is not known whether the medicine 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.
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.
3. How to take FOSRENOL
Always take Fosrenol exactly as your doctor has told you. You
should check with your doctor or pharmacist if you are not sure.
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You should take Fosrenol with or immediately after food. Fosrenol
oral powder is intended to be mixed with soft food (e.g.
applesauce or other similar food product) and then swallowed.
Additional fluid is not necessary.
Do not open the sachet until ready to use. Mix all of the contents
of the sachet into 1-2 spoonfuls of soft food, taking care to see
that the entire dose is mixed with the food. Ensure that the oral
powder/food mixture is eaten immediately (within 15 minutes).
Never store any oral powder/food mixture for use at a later time.
Your doctor will tell you how many sachets of oral powder you
must take with each meal (your daily dose will be divided
between meals). The number of sachets that you take will
depend on:
• Your diet (the amount of phosphate in the food you eat)
• Your blood phosphate level
Before starting on Fosrenol oral powder, your doctor may have
used Fosrenol chewable tablets to find the correct dose. Fosrenol
chewable tablets are available in a number of strengths allowing for
smaller increases in dose. The starting dose of chewable tablets is
usually 250mg, three times a day with meals. Your dose of oral
powder is likely to be 750 or 1000mg, three times a day with meals.
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 and regularly thereafter.
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 much Fosrenol contact your doctor to assess the
risk and obtain advice. Symptoms of overdose may be nausea
and headaches.

sweating; taste disturbance and increased white blood cell
count.
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.
5. How to store FOSRENOL
Keep out of the reach and sight of children.
This medicinal product does not require any special storage
conditions.
Do not use Fosrenol after the expiry date which is stated on the
carton and the sachets after EXP. 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 dispose of medicines no
longer required. These measures will help to protect the
environment
6. Further Information
What Fosrenol contains
• Each sachet contains 750mg lanthanum (as lanthanum
carbonate hydrate).
• Each sachet 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
This medicinal product is presented as a white to off-white oral
powder in a sachet.

If you forget to take Fosrenol
It is important to take Fosrenol with every meal.

The sachets are supplied in a carton of 90 sachets. (Outer carton
contains 9 cartons of 10 sachets).

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 individual doses.

Marketing Authorisation Holder and Manufacturer
The marketing authorisation holder is:
Shire Pharmaceutical Contracts Ltd., Hampshire International
Business Park, Chineham, Basingstoke, Hampshire RG24 8EP,
UK.

4. Possible side effects
Like all medicines, Fosrenol 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 (affects more than 1 user in 10):
• Nausea, vomiting, diarrhoea, stomach pain, headache,
itching, rash
Common side effects (affects 1 to 10 users in 100):
• 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 (affects 1 to 10 users in 1000):
• 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

The manufacturer is:
Catalent Pharma Solutions, Steinbeisstrasse 2, D-73614
Schorndorf, Germany
Shire Pharmaceutical Contracts Ltd., Hampshire International
Business Park, Chineham, Basingstoke, Hampshire RG24 8EP,
UK.
For any information about this medicine, please contact the local
representative of the Marketing Authorisation Holder.
Shire Pharmaceutical Contracts Ltd., Hampshire International
Business Park, Chineham, Basingstoke, Hampshire RG24 8EP, UK.
Tel: 0800 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,
Luxembourg, Malta, Netherlands, Norway, Poland,
Portugal, Romania, Slovak Republic, Slovenia,
Spain, Sweden, UK

Fosrenol

Ireland, Italy

Foznol

This leaflet was last approved in: 03/2012

6619 V2
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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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