800 mg film-coated tablets
sevelamer carbonate
What Sevelamer carbonate Winthrop is and what it is used for
Sevelamer carbonate Winthrop contains the active substance sevelamer carbonate. It binds phosphate from the food in the digestive tract and thus lowers the serum levels of phosphorus in the blood.
This medicine 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.
This medicine should be used together 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.
What you need to know before you take Sevelamer carbonate Winthrop
Do not take Sevelamer carbonate Winthrop
- if you are allergic to densevelamer carbonate 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 intestinal obstruction
Warnings and cautions
Talk to your doctor before taking Sevelamer carbonate Winthrop:
- if you have swallowing problems. Your doctor may instead prescribe sevelamer carbonate powder for oral suspension.
- if you have problems with motility (mobility) in the stomach and intestines
- 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 carbonate Winthrop:
- 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. 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
Do not give this medicine to children under 6 years of age as the safety and efficacy in children (under 6 years of age) have not been studied.
Other medicines and Sevelamer carbonate Winthrop
Tell your doctor or pharmacist if you have recently taken, or might take any other medicines.
- You should not take Sevelamer carbonate Winthrop 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 carbonate Winthrop.
- Sevelamer carbonate Winthrop may reduce the effects of such medicines as cyclosporine, 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 can be less common in some people taking levothyroxine (used to treat low levels of thyroid hormone) and Sevelamer carbonate Winthrop. Therefore, your doctor may check the levels of thyroid-stimulating hormone in your blood more closely.
- Medicines 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 carbonate Winthrop. Your doctor may want to check the phosphate levels in your blood.
Your doctor will regularly check the risk of Sevelamer carbonate Winthrop being affected or affected by other medicines.
In some cases when Sevelamer carbonate Winthrop is 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 carbonate Winthrop. 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 carbonate Winthrop 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 carbonate Winthrop 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 carbonate Winthrop.
Driving and using machines
Sevelamer carbonate Winthrop is unlikely to affect your ability to drive or use machines.
Excipients
This medicine contains less than 1 mmol sodium (23 mg) per tablet, ie it is essentially ‘sodium-free’.
How to take Sevelamer carbonate Winthrop
Always take this medicine exactly as your doctor has told you. Your doctor will base dose one on your serum phosphorus level.
The recommended starting dose of this medicine for adults and the elderly 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 carbonate Winthrop after a meal or with food.
The tablets must be swallowed whole. They must not be crushed, chewed, or broken into pieces.
Initially, your doctor will check the phosphorus levels in your blood at 2-4 week intervals and may adjust the Sevelamer carbonate Winthrop dose as needed to achieve an appropriate phosphate level.
Follow the diet prescribed by your doctor.
If you take more Sevelamer carbonate Winthrop than you should
In the event of an overdose, contact your doctor immediately.
If you forget to take Sevelamer carbonate Winthrop
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 carbonate Winthrop
Taking Sevelamer carbonate Winthrop is important for maintaining a proper level of phosphate in your blood. Quitting Sevelamer carbonate Winthrop would lead to significant consequences such as calcification of the blood vessels. If you are considering stopping treatment with Sevelamer carbonate Winthrop, talk to 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.
Constipation is a very common side effect. 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 cramps), and severe constipation) have been reported. No known frequency (frequency can not be calculated from available data).
- Holes in the intestinal wall (symptoms include severe abdominal pain, chills, fever, nausea, vomiting, or sore abdomen). No known frequency.
- Severe inflammation of the colon (symptoms include: severe abdominal pain, gastrointestinal upset, or blood in the stool [gastrointestinal bleeding]) and precipitation of sevelamer crystals in the intestinal mucosa have been reported. No known frequency.
Other side effects have been reported in patients taking Sevelamer carbonate Winthrop:
Very common (may affect more than 1 in 10 people):
- vomiting
- pain in the upper abdomen
- nausea
Common (may affect up to 1 in 10 people):
- diarrhea
- abdominal pain
- indigestion
- weather voltage
No known frequency (frequency can not be calculated from available data):
- cases of itching
- rash
- slow bowel motility (mobility)
How to store Sevelamer carbonate Winthrop
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.
Close the jar tightly. Moisture sensitive.
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 microcrystalline cellulose, sodium chloride, zinc stearate, hypromellose (E464), diacetylated monoglycerides, black iron oxide (E172), isopropyl alcohol, and propylene glycol.
What the medicine looks like and the contents of the pack
Sevelamer carbonate Winthrop film-coated tablets are white to off-white tablets with “SC800” debossed on one side. The tablets are packaged in high-density polyethylene cans fitted with a child-resistant polypropylene cap and an induction seal.
Pack sizes:
Each jar contains 30 or 180 tablets.
Packs of 1 can with 30 or 180 tablets without outer carton.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Genzyme Europe BV
Paasheuvelweg 25
1105 BP Amsterdam
Netherlands
Manufacturer
Genzyme Ireland Ltd.
IDA Industrial Park
Old Kilmeaden Road
Waterford
Ireland
Contact the representative of the marketing authorization holder to find out more about this medicine.
Sanofi AB
Tel: +46 (0) 8 634 50 00