Patient leaflet - Lanthanum 1000 mg chewable tablets
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 medicine 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 before you take Lanthanum
Do not take Lanthanum:
if you are allergic to Lanthanum or any of the
other ingredients of this medicine (listed in section 6).
if you have too little phosphate in your blood
(hypophosphataemia).
if you have blockage of the bowel (bowel
obstruction).
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 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.
Reduced 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.
Reduced liver function
If you have impaired liver function your doctor should monitor your liver function tests carefully.
If you need to have an X-ray, please inform your doctor that you are taking Lanthanum as it may affect the results.
If you need to have a gastrointestinal endoscopy, please inform your doctor that you are taking Lanthanum because the endoscopist might detect lanthanum deposits in the digestive tract.
It is very important to chew completely Lanthanum tablets and not to swallow them whole or incompletely chewed. This will reduce the risk of adverse gastrointestinal complications like rupture in the intestine wall, blockage in the intestine, constipation (see section 4).
Other medicines and Lanthanum
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
This medicine 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 Lanthanum.
It is not recommended that you take oral floxacin antibiotics (including ciprofloxacin) within 2 hours before or 4 hours after taking this medicine.
If you are taking levothyroxine (for an under active 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
This medicine should be taken with, or immediately after food. See section 3 for instructions on how to take Lanthanum.
Pregnancy and breast-feeding
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.
Pregnancy
Lanthanum should not be taken during pregnancy.
Breast-feeding
As it is not known whether the medicine can be transferred to a child in breast-milk, you should not breast-feed whilst taking Lanthanum. 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 Lanthanum. If you experience these side effects, it may affect your ability to drive or operate machines.
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 food or immediately after food.
Side effects such as nausea and vomiting are more likely if you take this medicine before your meal.
The tablets must be chewed completely and not swallowed whole. To aid with chewing the tablets may be crushed. Additional fluid is not necessary. If you find chewing the tablets difficult, talk to your doctor as other dosage forms are available in the market.
Date / Remarks
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03.02.2025 - KLD SHARED (Manual Pack)
Date / Remarks
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dd / mm / yy dd / mm / yy 1 of 2
100%
04/02/25 13:00 ART-706-06
ART-706-06
ART-706-04
NA
PL 04569/1780, PL 04569/1781,
PL 04569/1782
400538777, 400538779,
400538778
Mylan Laboratories Ltd ( Nashik IN)
NA
NA
1
NA
NA
Myriad Pro
NA
12 pt
Safety Updates
NA
NA
Adobe InDesign 2023
United Kingdom (GB)
LIT. (BOT.) LANTHANUM CHEWABLE TABS (COMMON) GB V5
75108284
75104398
Printed Literature
1
Folded size - 48 x 80 mm
NA
NA
NA
60 gsm Century Maplitho Paper
Supply Leaflet in Folded Form as Proposed Size (with Tape)
your diet (the amount of phosphate in the food
you eat),
- your blood phosphate level.
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 this medicine 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.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
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 (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 (uncommon side effect - may affect up to 1 in 100 people).
Contact your doctor if you experience new or
severe constipation, it could be an early sign of a blockage in your intestine. Constipation is a common side effect (may affect 1 in 10 people).
Other side effects include the following:
Very common (may affect more than 1 in 10 people):
- feeling sick (nausea),
- being sick (vomiting),
- diarrhoea,
- stomach pain,
- headache,
- itching,
- hives (urticaria)
rash (a noticeable change in the texture or
colour of your skin).
Common (may affect up to 1 in 10 people):
- heartburn,
wind (flatulence),
hypocalcaemia (too little calcium in your
blood). The symptoms of which can include tingling in the hands and feet, muscle and abdominal cramps or spasms of the facial and feet muscles.
Uncommon (may affect up to 1 in 100 people):
- tiredness,
- feeling of discomfort,
- chest pain,
- weakness,
- swollen hands and feet,
- body pain,
- dizziness
vertigo (sensation that you, or the environment
around you, is moving or spinning.),
belching (expelling air from the stomach
through the mouth),
gastroenteritis (inflammation of the stomach
and intestines),
- indigestion
irritable bowel syndrome (common, long-term
condition of the digestive system. It can cause bouts of stomach cramps, bloating, diarrhoea and/or constipation),
- 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,
osteoporosis (weakness and thinning of the
bones),
- lack of and increased appetite,
- inflammation of the larynx,
- loss of hair,
- increased sweating,
- taste disturbance,
- increased white blood cell count.
Unknown (frequency cannot be estimated from the available data):
- product residue present in digestive tract
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme. Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. 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.
Do not use this medicine after the expiry date which is stated on the carton and bottle after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special temperature storage conditions. Store in the original package in order to protect from light.
Do not throw away any medicines 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 lanthanum (as
Lanthanum octahydrate). Each chewable tablet contains lanthanum carbonate octahydrate corresponding to 500 mg, 750 mg or 1000 mg of lanthanum.
- The other ingredients are hypromellose, cellulose microcrystalline & guar gum, cellulose microcrystalline, hydroxypropylcellulose, silica colloidal anhydrous, acesulfame potassium and magnesium stearate.
What Lanthanum looks like and contents of the pack
500 mg chewable tablets
The chewable tablets of Lanthanum 500 mg are white to off-white, round, flat-faced, bevelled-edge, debossed with ‘M on one side of the tablet and ‘LC’ over ‘500’on the other side.
Pack sizes: This medicine is available in bottle packs containing 1 bottle with 45 tablets or 2 bottles with 45 tablets each (90 tablets).
750 mg chewable tablets
The chewable tablets of Lanthanum 750 mg are white to off-white, round, flat-faced, bevelled-edge, debossed with ‘M on one side of the tablet and ‘LC’ over ‘750’on the other side.
Pack sizes: This medicine is available in bottle packs containing 1 bottle with 15 tablets or 6 bottles with 15 tablets each (90 tablets).
1000 mg chewable tablets
The chewable tablets of Lanthanum 1000 mg are white to off-white, round, flat-faced, bevelled-edge, debossed with ‘M on one side of the tablet and ‘LC’ over ‘1000’on the other side. Pack sizes: This medicine is available in bottle packs containing 1 bottle with 15 tablets or 6 bottles with 15 tablets each (90 tablets).
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Mylan,
Potters Bar,
EN6 1TL,
UK.
Manufacturers
Mylan Hungary Kft,
H-2900 Komarom,
Mylan utca 1,
Hungary
This leaflet was last revised in 02/2025
ART-706-06 75108284
Date / Remarks
Date / Remarks
Date / Remarks
Date / Remarks
Date / Remarks
Date / Remarks
Date / Remarks
Date / Remarks
03.02.2025 - KLD SHARED (Manual Pack)
Date / Remarks
Date / Remarks
dd / mm / yy dd / mm / yy 2 of 2
100%
04/02/25 13:00 ART-706-06
ART-706-06
ART-706-04
NA
PL 04569/1780, PL 04569/1781,
PL 04569/1782
400538777, 400538779,
400538778
Mylan Laboratories Ltd ( Nashik IN)
NA
NA
1
NA
NA
Myriad Pro
NA
12 pt
Safety Updates
NA
NA
Adobe InDesign 2023
United Kingdom (GB)
LIT. (BOT.) LANTHANUM CHEWABLE TABS (COMMON) GB V5
75108284
75104398
Printed Literature
1
Folded size - 48 x 80 mm
NA
NA
NA
60 gsm Century Maplitho Paper
Supply Leaflet in Folded Form as Proposed Size (with Tape)