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LANTHANUM 750 MG CHEWABLE TABLETS

Active substance(s): LANTHANUM

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Fosrenol® 750 mg chewable
tablets

2811
20.05.16[2]

(lanthanum carbonate)
PATIENT INFORMATION LEAFLET
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.
This medicine is available using the above name but will be referred to as
Fosrenol throughout the following leaflet. Also available in other strengths.
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
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 has bonded
to Fosrenol cannot be absorbed through the intestinal wall.
2. WHAT YOU NEED TO KNOW BEFOREYOU TAKE FOSRENOL
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 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.

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.
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.
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 Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
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.
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
The active substance is 750 mg lanthanum (as lanthanum carbonate
hydrate).
Each tablet contains 750 mg of 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 ‘S405/750’ on one side of the tablet.
The tablets are supplied in plastic bottles –
a multipack containing 90 (6 packs of 15) chewable tablets.
MANUFACTURER AND PRODUCT LICENCE NUMBER
Manufactured by
Hamol Limited, Thane Road, Nottingham, Nottinghamshire NG90 2DB, UK.
Wasdell Packaging Limited, Units 6, 7, 8, Euro Way Industrial Estate,
Blagrove, Swindon, SN5 8YW, UK.
Procured from within the EU by Product Licence holder
Star Pharmaceuticals Ltd., 5 Sandridge Close, Harrow, Middlesex HA1 1XD.
Repackaged by Servipharm Ltd.
POM

PL 20636/2811

Leaflet revision and issue date (Ref) 20.06.16[2]
Fosrenol is a trademark of Shire International Licensing BV.

Lanthanum 750 mg chewable
tablets

2811
20.05.16[2]

(lanthanum carbonate)
PATIENT INFORMATION LEAFLET
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.
This medicine is available using the above name but will be referred to as
Lanthanum throughout the following leaflet. Also available in other
strengths.
What is in this leaflet:
1. What Lanthanum is and what it is used for
2. What you need to know before you take Lanthanum
3. How to take Lanthanum
4. Possible side effects
5. How to store Lanthanum
6. Contents of the pack and other information
1. WHAT LANTHANUM IS AND WHAT IT IS USED FOR
Lanthanum 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).
Lanthanum 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 Lanthanum cannot be absorbed through the intestinal wall.
2. WHAT YOU NEED TO KNOW BEFOREYOU TAKE LANTHANUM
Do not take Lanthanum
- 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 Lanthanum 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.

Pregnancy and breast-feeding
Lanthanum 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 Lanthanum. If you are breastfeeding, 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 Lanthanum. If you experience these
side effects it may affect your ability to drive or operate machinery.
Lanthanum 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 LANTHANUM
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 Lanthanum 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 Lanthanum 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.
Lanthanum works by binding phosphate from the food in your gut. It is very
important to take Lanthanum at every meal. If you change your diet, contact
your doctor as you may need to take extra Lanthanum. Your doctor will tell
you what to do in this case.
If you take more Lanthanum 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 Lanthanum
It is important to take Lanthanum with every meal.
If you forget to take your Lanthanum 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.

If you have previously had abdominal surgery, or infection or inflammation of
the abdomen/bowel (peritonitis) inform your doctor.

Side effects such as nausea and vomiting are more likely if you take
Lanthanum before your meal. You should always take it during or
immediately after your food.

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

Very Common side effects (may affect more than 1 in 10 people):
- Nausea, vomiting, diarrhoea, stomach pain, headache, itching, rash.

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

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.

Lanthanum 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 Lanthanum.
It is not recommended that you take oral floxacin antibiotics (including
ciprofloxacin) within 2 hours before or 4 hours after taking Lanthanum.
If you are taking levothyroxine (for an underactive thyroid) it should not be
taken within 2 hours before or after taking Lanthanum. Your doctor may
want to monitor the levels of thyroid-stimulating hormone (TSH) in your
blood more closely.
Lanthanum with food and drink
Lanthanum should be taken with, or immediately after food. See section 3
for instructions on how to take Lanthanum.

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 Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the
safety of this medicine.
5. HOW TO STORE LANTHANUM
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.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Lanthanum contains
The active substance is 750 mg lanthanum (as lanthanum carbonate
hydrate).
Each tablet contains 750 mg of lanthanum (as lanthanum carbonate
hydrate).
The other ingredients are dextrates (hydrated), colloidal anhydrous silica
and magnesium stearate.
What Lanthanum looks like and contents of the pack
Lanthanum is a white, round, bevelled-edged flat chewable tablet debossed
with ‘S405/750’ on one side of the tablet.
The tablets are supplied in plastic bottles –
a multipack containing 90 (6 packs of 15) chewable tablets.
MANUFACTURER AND PRODUCT LICENCE NUMBER
Manufactured by
Hamol Limited, Thane Road, Nottingham, Nottinghamshire NG90 2DB, UK.
Wasdell Packaging Limited, Units 6, 7, 8, Euro Way Industrial Estate,
Blagrove, Swindon, SN5 8YW, UK.
Procured from within the EU by Product Licence holder
Star Pharmaceuticals Ltd., 5 Sandridge Close, Harrow, Middlesex HA1 1XD.
Repackaged by Servipharm Ltd.
POM

PL 20636/2811

Leaflet revision and issue date (Ref) 20.06.16[2]

Expand view ⇕

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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