800 mg film-coated tablets
sevelamer carbonate
What Sevelamer Sandoz is and what it is used for
Sevelamer Sandoz contains sevelamer carbonate as the active ingredient. It binds phosphate from the food in the digestive tract and thus lowers the serum levels of phosphorus in the blood.
Sevelamer Sandoz is used to controlling 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 Sandoz 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 Sandoz 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 Sandoz
Do not take Sevelamer Sandoz
- if you have low levels of phosphate in your blood (your doctor will check this for you)
- if you have intestinal obstruction
- if you are allergic to sevelamer carbonate or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Talk to your doctor before taking Sevelamer Sandoz if any of the following apply to you:
- if you have swallowing problems. Your doctor may instead prescribe sevelamer powder for oral suspension.
- 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.
Talk to your doctor during treatment with Sevelamer Sandoz:
- if you experience severe abdominal pain, gastrointestinal upset, or blood in the stool ( gastrointestinal bleeding). These symptoms may be due to severe inflammatory bowel disease caused by 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. Because Sevelamer Sandoz 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 Sandoz is not recommended for use in children below 6 years of age.
Other drugs and Sevelamer Sandoz
Tell your doctor if you have recently taken, or might take any other medicines.
- You should not take Sevelamer Sandoz 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 Sandoz.
- Sevelamer Sandoz may reduce the effects of such medicines as ciclosporin, mycophenolate mofetil, and tacrolimus ( medicines used to suppress the immune system ). Your doctor will advise you if you are taking these medicines.
- Thyroid hormone deficiency may be less common in some people taking levothyroxine (used to treat low levels of thyroid hormone) and Sevelamer Sandoz. 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 Sandoz. Your doctor may want to check the phosphate levels in your blood.
Your doctor will regularly check the risk of Sevelamer Sandoz being affected or affected by other medicines.
In some cases, Sevelamer Sandoz should be taken while you are taking another medicine. Your doctor may ask you to take this medicine 1 hour before or 3 hours after taking Sevelamer Sandoz. 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. The potential risk of Sevelamer Sandoz during human pregnancy is unknown. Talk to your doctor who will decide if you can continue treatment or not.
It is not known if Sevelamer Sandoz 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 Sandoz.
Driving and using machines
Sevelamer Sandoz 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 Sandoz contains lactose
Sevelamer Sandoz 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.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
How to take Sevelamer Sandoz
Always take this medicine exactly as your doctor has told you. Consult a doctor if you are unsure. Your doctor will base dose one on your serum phosphorus level.
The recommended starting dose of Sevelamer Sandoz 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.
Take Sevelamer Sandoz after a meal or with food.
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 the dose of Sevelamer Sandoz as needed to reach an appropriate phosphate level.
Follow the diet prescribed by your doctor.
If you take more Sevelamer Sandoz than you should
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.
If you forget to take Sevelamer Sandoz
If you have missed a dose, skip this dose and take the next dose at regular meal times. Do not take a double dose to make up for a forgotten dose.
If you stop taking Sevelamer Sandoz
Taking Sevelamer Sandoz is important for maintaining a proper level of phosphate in your blood. Quitting Sevelamer Sandoz would lead to significant consequences such as calcification of the blood vessels. If you are considering stopping treatment with Sevelamer Sandoz, talk to your doctor or pharmacist first.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Constipation is a very common side effect (may affect more than 1 in 10 people). It can be an early symptom of intestinal blockage. In case of constipation, you should contact a doctor or pharmacist. Some side effects can be serious. If you get any of the following side effects, seek medical advice immediately:
- Allergic reaction (symptoms include rash, hives, swelling, and difficulty breathing). This is a very rare side effect (may affect up to 1 in 10,000 people).
- Intestinal blockage (symptoms include severe bloating (abdominal pain, swelling, or cramping), and severe constipation) have been reported (occurring in an unknown number of users).
- Holes in the intestinal wall (symptoms include severe abdominal pain, chills, fever, nausea, vomiting, or sore abdomen) have been reported (occurring in an unknown number of users).
- Severe inflammation of the colon (symptoms include severe abdominal pain, gastrointestinal upset or blood in the stool ( gastrointestinal bleeding)), and deposition of sevelamer crystals in the intestinal mucosa have been reported (occurring in an unknown number of users).
Other side effects have been reported in patients taking Sevelamer Sandoz:
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):
diarrhea, abdominal pain, indigestion, flatulence
Has been reported (occurs in an unknown number of users):
cases of itching, rash, and slow bowel motility (mobility).
How to store Sevelamer Sandoz
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 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), zinc stearate, hypromellose (E464), and diacetylated monoglycerides.
What the medicine looks like and the contents of the pack
Sevelamer Sandoz is oval, white to off-white film-coated tablets with “SVL” embossed on one side.
HDPE cans with polypropylene lids.
Each jar contains 180, 200, or 210 tablets.
Packages containing 1, 2, or 3 cans are available.
HDPE cans contain a desiccant. Do not remove the desiccant from the jar.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Sandoz A / S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark
Manufacturer
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany