800 mg film-coated tablets
sevelamer carbonate
What Sevelamer Mylan is and what it is used for
Sevelamer Mylan contains sevelamer carbonate as the active substance. It binds phosphate from the food in the digestive tract and thus lowers the serum levels of phosphorus in the blood.
Sevelamer Mylan is used to control hyperphosphatemia (high levels of phosphate in the blood) in:
- adult patients receiving dialysis (a blood purification technique). It can be used to treat patients who receive hemodialysis (through a blood filtration machine) or peritoneal dialysis (where fluid is pumped into the abdominal cavity and an internal membrane in the body filters the blood);
- patients with chronic (long-term) kidney disease with serum phosphorus levels (in the blood) greater than or equal to 1.78 mmol / l, who do not receive dialysis.
Sevelamer Mylan should be used with other treatment methods such as calcium supplements and vitamin D to prevent the development of skeletal disease.
Elevated levels of serum phosphorus can lead to hard deposits in the body which are called calcifications. These deposits can make the blood vessels stiff so that it becomes more difficult to pump the blood into the body. Elevated levels of serum phosphorus can also lead to itchy skin, red eyes, skeletal pain, and fractures.
Sevelamer carbonate contained in Sevelamer Mylan may also be approved for the treatment of other diseases not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you take Sevelamer Mylan
Do not take Sevelamer Mylan
- if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).if you have low levels of phosphate in your blood (your doctor will check this for you)
- if you have an intestinal obstruction (blockage or obstruction in the intestine)
Warnings and cautions
Talk to your doctor before taking Sevelamer Mylan if any of the following apply to you:
- if you have swallowing problems. Your doctor may prescribe powder for oral suspension instead.
- if you have problems with motility (mobility) in the stomach and intestines
- if you vomit often
- if you have an active intestinal inflammation
- if you have had major surgery on your stomach or intestines.
- if you have a severe inflammatory bowel disease.
Talk to your doctor during treatment with Sevelamer Mylan:
- if you experience severe abdominal pain, gastrointestinal upset, or blood in the stool ( gastrointestinal bleeding). These symptoms may be due to sevelamer crystals in the intestine. Contact your doctor who will decide whether to continue treatment or not.
Additional treatments:
Due to either your kidney condition or your dialysis treatment, you can:
- develop low or high calcium levels in the blood. As this medicine does not contain calcium, your doctor may prescribe extra calcium tablets.
- have a low amount of vitamin D in the blood. Therefore, your doctor may check the levels of vitamin D in your blood and prescribe more vitamin D if needed. If you do not take any multivitamin supplements, you may also get low levels of vitamins A, E, K, and folic acid in your blood therefore your doctor may check these levels and prescribe vitamin supplements if needed.
- get abnormal levels of bicarbonate in the blood and increased acidity in the blood and other body tissues. Your doctor should check the levels of bicarbonate in your blood.
Important to consider for patients receiving peritoneal dialysis :
You may develop peritonitis (peritonitis) in connection with peritoneal dialysis. This risk can be reduced if you carefully follow the sterile methods during bag changes. You should tell your doctor immediately if you get new signs or symptoms of abdominal discomfort, abdominal swelling, abdominal pain, abdominal pain or hard/stiff abdomen, constipation, fever, chills, nausea, or vomiting.
Children
Safety and efficacy in children (under 6 years of age) have not been studied. Therefore, Sevelamer Mylan is not recommended for use in children below 6 years of age.
Other medicines and Sevelamer Mylan
Tell your doctor or pharmacist if you have recently taken, or might take any other medicines.
You should not take Sevelamer Mylan at the same time as ciprofloxacin (an antibiotic ).
If you are taking medicines for heart rhythm problems or epilepsy, you should consult your doctor when taking Sevelamer Mylan.
Sevelamer Mylan may reduce the effects of medicines such as ciclosporin, mycophenolate mofetil, and tacrolimus ( medicines used to inhibit the immune system ). Your doctor will advise you if you are taking these medicines.
Thyroid hormone deficiency can be less common in some people taking levothyroxine (used to treat low levels of thyroid hormone) and Sevelamer Mylan. Therefore, your doctor may check the levels of thyroid-stimulating hormone in your blood more closely.
Drugs to treat heartburn and acid reflux from your stomach or esophagus, such as omeprazole, pantoprazole, or lansoprazole, so-called “proton pump inhibitors”, may reduce the effect of Sevelamer Mylan. Your doctor may want to check the phosphate levels in your blood.
Your doctor will regularly check the risk of Sevelamer Mylan being affected or affected by other medicines.
In some cases, Sevalemer Mylan should be taken at the same time as another medicine. Your doctor may ask you to take this medicine 1 hour before or 3 hours after taking Sevalemer Mylan. Your doctor may also want to check the levels of the other medicine in your blood.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine. It is unknown whether Sevelamer Mylan affects unborn babies.
The potential risk of Sevelamer Mylan during human pregnancy is unknown. Talk to your doctor who will decide if you can continue Sevelamer Mylan treatment or not.
It is unknown if Sevelamer Mylan can pass into breast milk and affect your baby. Talk to your doctor who will decide if you can breastfeed or not and if it is necessary to stop treatment with Sevelamer Mylan.
Driving and using machines
Sevelamer Mylan is unlikely to 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.
Sevelamer Mylan contains lactose
Sevelamer Mylan contains lactose (milk sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
How to take Sevelamer Mylan
Always use Sevelamer Mylan exactly as your doctor has told you. Your doctor will base your dose on the levels of phosphorus in your blood.
The recommended starting dose of Sevelamer Mylan tablets for adults and the elderly (over 65 years) is one to two tablets of 800 mg at each meal, ie 3 times a day. If you are not sure, talk to your doctor, pharmacist, or nurse.
The tablets must be swallowed whole. They must not be crushed, chewed, or split.
Initially, your doctor will check the phosphorus levels in your blood at 2-4 week intervals and may adjust Sevelamer Mylandos as needed to achieve a suitable phosphate level.
Patients taking Sevelamer Mylan should follow their prescribed diet.
If you take more Sevelamer Mylan than you should
If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor or hospital immediately for an assessment of the risk and advice.
If you forget to take Sevelamer Mylan
If you have missed a dose, skip this dose and take the next dose at the usual time with meals. Do not take a double dose to make up for a forgotten dose.
If you stop taking Sevelamer Mylan
Taking Sevelamer Mylan treatment is important to maintain a suitable level of phosphate in your blood. Quitting Sevelamer Mylan would lead to significant consequences such as calcification of the blood vessels. If you are considering stopping treatment with Sevelamer Mylan, contact your doctor or pharmacist first.
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.
Tell your doctor or pharmacist as soon as possible if you experience any of the following:
Very common (may affect more than 1 user in 10):
– constipation, which may be an early sign of a blockage in the intestine
Very rare (may affect up to 1 in 10,000 people)
– Severe allergic reactions, including swelling of the face, lips, tongue, or throat and causing difficulty in breathing or swallowing
No frequency is known (can not be calculated from the available data
) itching, rash, slow bowel motility (mobility), bowel obstruction (symptoms include severe bloating, abdominal pain, swelling or cramping; severe constipation), intestinal wall hole (symptoms include: severe abdominal pain, chills, fever, nausea, vomiting, or sore abdomen), intestinal bleeding, inflammation of the colon and deposition of sevelamer crystals in the intestinal mucosa have been reported.
Other side effects reported in patients taking sevelamer carbonate:
Very common (may affect more than 1 user in 10)
vomiting _
-pain in the upper abdomen
-nausea
Common (may affect up to 1 in 10 people)
-diarré
abdominal pain
-indigestion
gas formation in the stomach
How to store Sevelamer 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 can and carton after “EXP”. The expiration date is the last day of the specified month.
No special storage instructions.
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 packaging and other information
Content declaration
- The active substance is sevelamer carbonate. Each film-coated tablet contains 800 mg of sevelamer carbonate.
- The other ingredients are lactose monohydrate, silica ( colloidal, anhydrous), and zinc stearate. The tablet coating contains hypromellose (E464) and diacetylated monoglycerides.
What the medicine looks like and the contents of the pack
Sevelamer Mylan 800 mg film-coated tablets, white to off-white, oval-shaped, and marked with “SVL” on one side. The tablets are approximately 20 mm long and 7 mm wide.
The tablets are packed in cans of high-density polyethylene with polypropylene lids.
Each jar contains 180, 200, or 210 tablets.
Packages containing 1, 2, or 3 cans are available.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Mylan AB
Box 23033
104 35 Stockholm
Manufacturer
Synthon Hispania SL
Castelló 1, Polígono Las Salinas,
08830 Sant Boi de Llobregat
Spain
Mylan Hungary Kft
H-2900 Komárom
Mylan UTC 1
Hungary