500, 750, 1 000 mg chewable tablet is
lanthanum
What Lanthanum Mylan is and what it is used for
Lanthanum Mylan is used to lower the level of phosphate in the blood of adult patients with chronic kidney disease.
In patients whose kidneys do not function normally, the kidneys cannot regulate blood phosphate levels. This causes the amount of phosphate in the blood to rise (doctors may call this hyperphosphatemia ).
Lanthanum Mylan is a drug that lowers the body’s uptake of phosphate from food by binding to it in the gastrointestinal tract. Phosphate bound to lanthanum cannot be absorbed through the intestinal wall.
The lanthanum contained in Lanthanum Mylan may also be approved for the treatment of other diseases not mentioned in this product information. Ask your doctor, pharmacist or other healthcare professional if you have any
further questions and always follow their instructions.
What you need to know before using Lanthanum Mylan
Do not take Lanthanum Mylan:
– 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 ( hypophosphatemia ).
Warnings and cautions
If you know you have or have had any of the following conditions, talk to your doctor or pharmacist before taking Lanthanum Mylan:
- cancer of the stomach or intestines,
- inflammatory bowel disease including ulcerative colitis or Crohn’s disease ,
- abdominal surgery or infection or inflammation of the abdomen / intestine (peritonitis),
- gastric or intestinal ulcers
- blockage in the intestine or slow motility (motility) in the intestine (eg constipation and stomach complications due to diabetes ),
- impaired liver or kidney function.
Impaired renal function
If you have impaired kidney function, your doctor may want to check the calcium level in your blood from time to time. If you have too little calcium , you may be given extra calcium .
Hepatic impairment
If you have impaired liver function, your doctor should closely monitor your liver function values.
If you need x-rays, you should tell your doctor that you are taking Lanthanum Mylan as it may affect the results.
It is very important to chew the Lanthanum Mylan tablets completely and not to swallow them whole or incompletely chewed. This reduces the risk of side effects in the gastrointestinal tract such as rupture of the intestinal wall, blockage in the intestine or constipation (see section 4).
Other medicines and Lanthanum Mylan
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
This medicine may affect the way some medicines are taken up from the gastrointestinal tract. If you are taking chloroquine (for rheumatism and malaria ), ketoconazole (for fungal infections) or antibiotics containing tetracycline or doxycycline , these medicines should not be taken within 2 hours before or after taking Lanthanum Mylan.
You should not take oral antibiotics containing floxacin (including ciprofloxacin ) within 2 hours before or 4 hours after taking this medicine.
If you are taking levothyroxine (due to an underactive thyroid gland ) it should not be taken within 2 hours before or after taking Lanthanum Mylan. Your doctor may want to check your thyroid- stimulating hormone ( TSH ) levels more closely.
Lanthanum Mylan with food and drink
The tablets should be taken with or immediately after food. See section 3 for instructions on how to take Lanthanum Mylan.
Pregnancy and breastfeeding
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 Mylan should not be used during pregnancy.
Breast-feeding
As it is not known if the medicine can be transmitted to the baby via breast milk, you should not breast-feed while taking Lanthanum Mylan. If you are breast-feeding, talk to your doctor or pharmacist before taking any medicine.
Driving and using machines
Dizziness and dizziness (a feeling of dizziness or that it “spins”) are less common side effects reported by patients taking lanthanum. If you experience these side effects , it may affect your ability to drive or use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and / or side effects . Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
How to use Lanthanum Mylan
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
You should take Lanthanum Mylan with food or immediately after food.
If you take this medicine before a meal, you are more likely to get side effects such as nausea and vomiting.
The tablets must be chewed completely and must not be swallowed whole. To facilitate chewing, the tablets can be crushed. Fluid is not needed. Talk to your doctor if you find it difficult to chew the tablets. Other forms of medicine are available on the market.
Your doctor will tell you how many tablets to take with each meal (your daily dose is divided between the meals). The number of tablets to take depends on:
- what you eat (the amount of phosphate in the food you eat),
- the level of phosphate in your blood.
You should take the medicine immediately after a meal.
Your doctor will check the level of phosphate in your blood every 2-3 weeks and may increase your dose until the level of phosphate in your blood is acceptable.
Lanthanum Mylan binds phosphate in the food in your gut. Therefore, it is important that you take Lanthanum Mylan at every meal. If you change your diet, consult your doctor as you may need to take extra Lanthanum Mylan. In that case, your doctor will tell you what to do.
If you forget to take Lanthanum Mylan
It is important to take this medicine with every meal.
If you forget to take your Lanthanum Mylan tablets, take the next dose with the 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 product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects , although not everybody gets them.
Some side effects can be serious. Contact a doctor immediately if you get any of the following side effects:
- Rupture of the intestinal wall. Symptoms of this are severe abdominal pain, chills, fever, nausea, vomiting or abdominal pain (rare side effect – may affect up to 1 in 1,000 people).
- Blockage in the intestine. Symptoms of this are 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 may be an early sign of bowel obstruction. Constipation is a common side effect (may affect up to 1 in 10 people).
Other side effects include the following:
Very common (may affect more than 1 user in 10):
- nausea,
- vomiting,
- diarrhea,
- abdominal pain,
- headache,
- itching ,
- hives
- rash (a noticeable change in the texture or color of the skin).
Common (may affect up to 1 in 10 people):
- heartburn,
- gas formation,
- hypocalcaemia (too little calcium in the blood). Symptoms of hypocalcaemia may include tingling in the hands and feet, cramps in the muscles and abdomen or spasms in the muscles of the face and feet.
Uncommon (may affect up to 1 in 100 people):
- fatigue,
- feeling uncomfortable,
- chest pain,
- weakness,
- swollen hands and feet,
- pains in the body,
- dizziness
- dizziness (the feeling that you or the surroundings are moving or spinning),
- belching (releasing air from the stomach through the mouth),
- gastroenteritis ( inflammation of the stomach and intestines),
- indigestion,
- irritable bowel syndrome (common, prolonged condition of the gastrointestinal tract. May cause seizures, bloating, diarrhea and / or constipation),
- dry mouth ,
- dental diseases,
- inflammation of the esophagus or mouth,
- loose stools,
- elevated levels of certain liver enzymes, parathyroid hormone, aluminum, calcium and glucose in the blood,
- elevated or decreased phosphate levels in the blood,
- thirst,
- weight loss,
- joint pain,
- muscle pain,
- osteoporosis (weakening and decalcification of the skeleton),
- decreased appetite and increased appetite,
- inflammation of the larynx,
- hair loss,
- increased sweating,
- taste changes,
- increased white blood cell count .
How to store Lanthanum Mylan
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 can after EXP. The expiration date is the last day of the specified month.
No special temperature instructions. Store in the original package. Sensitive to light.
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.
Contents of the pack and other information
Content declaration
- The active substance is lanthanum (as lanthanum carbonate octahydrate). Each chewable tablet contains 500 mg, 750 mg or 1,000 mg of lanthanum (as lanthanum carbonate octahydrate).
- The other ingredients are hypromellose, microcrystalline cellulose and guar gum, microcrystalline cellulose, hydroxypropylcellulose, colloidal anhydrous silica, acesulfame potassium and magnesium stearate.
What the medicine looks like and contents of the pack
500 mg chewable tablet is
The chewable tablets Lanthanum Mylan 500 mg are white to off-white, round, flat, oblique, marked with “M” on one side and “ LC ” over “ 500 ” on the other side.
Pack sizes: This medicine is available in packs containing 1 can of 45 tablets or 2 cans of 45 tablets each (90 tablets).
750 mg chewable tablet is
The chewing tablets Lanthanum Mylan 750 mg are white to off-white, round, flat, oblique, embossed with “M” on one side and ” LC ” over ” 750 ” on the other side.
Pack sizes: This medicine is available in packs containing 1 can of 15 tablets or 6 cans of 15 tablets each (90 tablets).
1,000 mg chewable tablet is
The chewing tablets Lanthanum Mylan 1,000 mg are white to off-white, round, flat, oblique, embossed with “M” on one side and “ LC ” over “ 1000 ” on the other side.
Pack sizes: This medicine is available in packs containing 1 can of 15 tablets or 6 cans of 15 tablets each (90 tablets).
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Manufacturer
McDermott Laboratories Ltd representing the brand Gerard Laboratories
35/36 Baldoyle Industrial Estate
Grange Road,
Dublin 13
Ireland
Mylan Hungary Kft,
H-2900 Komarom,
Mylan utca 1,
Hungary
Mylan Germany GmbH
Branch drop bath
Homburg Benzstrasse 1,
Bad Homburg vd Höhe,
61352, Germany