Patient Medication Information: uses, side effects, how to take - Intelli-Sevelamer
ABOUT THIS MEDICATION
What the medication is used for:
- the control of high phosphorus levels in patients with end stage kidney disease undergoing dialysis (whether hemodialysis or peritoneal dialysis)
What it does:
INTELLI-SEVELAMER is a phosphate binder that is not absorbed in your body. When taken with meals INTELLI-SEVELAMER inhibits intestinal absorption of ingested phosphate from food.
When it should not be used:
- in patients with low phosphorus levels.
- in patients with bowel obstruction/blockage, or with known active damage to the lining of the digestive tract such as necrosis (death of tissue), perforation (hole), ulcers (sores) or bleeding.
- in patients allergic to sevelamer carbonate or one of the other ingredients in the product (See What the nonmedicinal ingredients are).
What the medicinal ingredient is:
Sevelamer carbonate
What the nonmedicinal ingredients are:
Lactose monohydrate, colloidal anhydrous silica, zinc stearate, Diacetylated monoglycerides, hypromellose.
What dosage forms it comes in:
800 mg tablets
WARNINGS AND PRECAUTIONS
SERIOUS WARNING AND PRECAUTION INTELLI-SEVELAMER may cause serious side effects that may require hospitalization and surgery. Tell your doctor or go to the hospital right away if you have difficulty swallowing, bowel obstruction, or bowel perforation. |
INTELLI-SEVELAMER tablets should be swallowed whole and should not be crushed, chewed, or broken into pieces.
BEFORE you use INTELLI-SEVELAMER talk to your doctor or pharmacist if you:
- have difficulty swallowing (swallowing disorders or problems with your esophagus)
- have an intestinal disorder such as, conditions that slow down the passage of food through the intestine and lead to blockage.
- have had surgery on your intestines.
- have severe or worsening constipation
- have low phosphorus levels in your blood.
- have low calcium levels in your blood.
are pregnant, plan to become pregnant or are nursing
- have any allergies to this drug or its ingredients or components of the container
INTERACTIONS WITH THIS MEDICATION
INTELLI-SEVELAMER may affect the way other medicines work. Please tell your doctor or pharmacist what medicine you have recently taken, are taking or intend to take including those available without prescription and herbal remedies. These medicines may need to be taken one hour before or three hours after INTELLI-SEVELAMER. Remember, INTELLI-SEVELAMER must always be taken with food.
If you see another doctor or a dentist while you are using INTELLI-SEVELAMER, you should tell them that you are using INTELLI-SEVELAMER.
Drugs that may interact with INTELLI-SEVELAMER include: ciprofloxacin and levothyroxine. Your doctor may order blood tests to more closely monitor the thyroid hormones in your blood if you are taking levothyroxine and INTELLI-SEVELAMER.
INTELLI-SEVELAMER may also interact with drugs that are used to prevent the rejection of a transplanted organ, such as cyclosporin, mycophenolate and tacrolimus.
INTELLI-SEVELAMER may interact with drugs that are used to treat stomach ulcer known as proton pump inhibitors (e.g. pantoprazole, omeprazole).
| PROPER USE OF THE MEDICATION |
Tablets should be swallowed intact and should not be crushed, chewed, or broken into pieces prior to administration.
Usual starting dose:
Dosage is individualized. Your doctor will determine your dosage.
INTELLI-SEVELAMER should be taken immediately prior to or with meals.
The total daily dose should be divided according to meal portions during the day.
Average maintenance dose is approximately 7-8 tablets of 800 mg each day. Always follow your physician’s dosage instructions.
Overdose:
In case of an overdose, contact your doctor or regional poison control center immediately.
Missed Dose:
If a dose is forgotten, it should be skipped. Double dosing is not advisable.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Although INTELLI-SEVELAMER is generally well tolerated, some patients may experience side effects, including: nausea, vomiting, diarrhea, indigestion, constipation, abdominal pain, rash, itch, and flatulence (gas). Tell your doctor if you have new onset or worsening of constipation.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||||
|---|---|---|---|---|
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharmacist | ||
| Only if severe | In all cases | |||
| Common | Abdominal pain | √ | ||
| Uncommon | Dysphagia: Difficulty swallowing problems with your esophagus | √ | ||
| Bowel Obstruction (ileus), Intestinal Blockage, or hole in the intestine: sudden abdominal pain, inflammation and ulcers, abdominal discomfort, cramping and gas pains, diarrhea or difficulty passing stools, bleeding (blood in stools), nausea/vomiting especially after meals, excessive burping, loss of appetite; later symptoms include fever and chills | √ | |||
| Unknown | Diverticulitis: left lower quadrant pain, fever, nausea, diarrhea, or constipation | √ | ||
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM |
|---|
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharmacist |
|---|
| Only if severe | In all cases | ||
|---|---|---|---|
| Allergic reactions: rash, swelling of the face or mouth, difficulty breathing. | √ | ||
This is not a complete list of side effects. For any unexpected effects while taking INTELLI-SEVELAMER, contact your doctor or pharmacist.
HOW TO STORE IT
Store at controlled room temperature 15°C to 30°C in original container. Protect from moisture and heat.
Keep out of reach and sight of children.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
MORE INFORMATION
Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (http://hc-sc.gc.ca/index-eng.php); the manufacturer’s website http://www.intellipharm.org, or by calling 1-888-620-5236.