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FOSRENOL 750 MG ORAL POWDER

Active substance(s): LANTHANUM / LANTHANUM / LANTHANUM

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Package Leaflet: Information for the Patient

750 mg oral powder
1000 mg oral powder
lanthanum
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

If you need to have an x-ray, please inform your doctor that you
are taking Fosrenol as it may affect the results.

1. What Fosrenol is and what it is used for

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

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

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 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.

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).

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 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.

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

2. What you need to know before you take Fosrenol
Do not take Fosrenol


if you are allergic to lanthanum carbonate hydrate or any of
the other ingredients of this medicine (listed is 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:


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.

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.

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 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.
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. Side
effects such as nausea and vomiting are more likely if you take
Fosrenol before your meal.
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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.

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



Your diet (the amount of phosphate in the food you eat)

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 (see below). By reporting side effects you can help
provide more information on the safety of this medicine.



Your blood phosphate level

United Kingdom

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:

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 250 mg, three times a day with meals. Your dose
of oral powder is likely to be 750 or 1000 mg, 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.
If you forget to take Fosrenol
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 a forgotten dose.
4. Possible side effects
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:




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).

Yellow Card Scheme
Website: http://www.mhra.gov.uk/yellowcard
Malta
ADR Reporting
Website: www.medicinesauthority.gov.mt/adrportal
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 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 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
-

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.
The sachets are supplied in a carton of 90 sachets. (Outer carton
contains 9 cartons of 10 sachets).
Marketing Authorisation Holder and Manufacturer
The marketing authorisation holder is:

Other less serious side effects include the following:

Shire Pharmaceutical Contracts Ltd., Hampshire International
Business Park, Chineham, Basingstoke, Hampshire RG24 8EP, UK.

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

The manufacturer is:



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

Common side effects (may affect up to 1 to 10 users in 100):

Catalent Pharma Solutions, Steinbeisstrasse 2,
D-73614 Schorndorf, Germany



Constipation, heartburn, flatulence

For any information about this medicine, please contact the local
representative of the Marketing Authorisation Holder.



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.

Shire Pharmaceuticals Limited, Hampshire International
Business Park, Chineham, Basingstoke, Hampshire, RG24 8EP,
UK. Tel: +44 (0) 800 055 6614.

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 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

This medicinal product is authorised in the Member States of
the EEA under the following names:
Austria, Belgium, Bulgaria, Cyprus, Czech Republic,
Fosrenol
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
This leaflet was last revised in 06/2016.

Foznol

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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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