SEVELAMER HYDROCHLORIDE TABLETS 800MG
CONSUMER INFORMATION
ABOUT THIS MEDICATION
What the medication is used for:
- the control of high phosphorus levels in patients with end-stage renal disease undergoing dialysis (whether hemodialysis or peritoneal dialysis).
What it does:
Sevelamer hydrochloride is a phosphate binder that is not absorbed in your body. When taken with meals Sevelamer hydrochloride inhibits intestinal absorption of ingested phosphate from food.
When it should not be used:
- in patients with low blood 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 hydrochloride or one of the other ingredients in the product (See What the nonmedicinal ingredients are).
What the medicinal ingredient is:
Sevelamer hydrochloride
What the nonmedicinal ingredients are:
colloidal silicon dioxide; diacetylated monoglyceride; hypromellose; iron oxide black; isopropyl alcohol; propylene glycol; and stearic acid.
What dosage forms it comes in:
800 mg tablets
WARNINGS AND PRECAUTIONS
Sevelamer hydrochloride tablets should be swallowed whole and should not be crushed, chewed, dissolved or broken into pieces.
BEFORE you use Sevelamer hydrochloride talk to your doctor or pharmacist if you:
- have difficulty swallowing (swallowing disorders or problems with your oesophagus)
- 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
Sevelamer hydrochloride 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 a prescription and herbal remedies. These medicines may need to be taken one hour before or three hours after Sevelamer hydrochloride. Remember, Sevelamer hydrochloride must always be taken with food.
If you see another doctor or a dentist while you are using Sevelamer hydrochloride, you should tell them that you are using Sevelamer hydrochloride
Drugs that may interact with Sevelamer hydrochloride 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 Sevelamer hydrochloride.
Sevelamer hydrochloride may also interact with drugs that are used to prevent the rejection of a transplanted organ, such as cyclosporin, mycophenolate and tacrolimus.
Sevelamer hydrochloride may interact with drugs that are used to treat stomach ulcer known as proton pump inhibitors (e.g. pantoprazole, omeprazole).
PROPER USE OF THIS MEDICATION
Sevelamer hydrochloride tablets should be swallowed whole and should not be crushed, chewed, dissolved or broken into pieces.
Usual starting dose:
Dosage is individualized. Your doctor will determine your dosage.
Sevelamer hydrochloride 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: Approximately nine 800 mg tablets per day (equivalent to three 800 mg tablets per meal). Always follow your physician?s dosage instructions.
Overdose:
In case of an overdose, contact your doctor or poison control centre 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 Sevelamer hydrochloride is generally well tolerated, some patients may experience side effects, including nausea, vomiting, diarrhoea, indigestion, constipation, rash and itch.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||||
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking the drug and call your doctor or pharmacist | ||
| Only if severe | In all cases | |||
| Common | Abdominal pain | ? | ||
| Dysphagia: | ||||
| Difficulty | ||||
| swallowing problems with | ? | |||
| your oesophagus. | ||||
| Bowel Obstruction | ? | |||
| (ileus), Intestinal | ||||
| Blockage, or | ||||
| hole in the | ||||
| intestine,: | ||||
| sudden | ||||
| abdominal pain, | ||||
| inflammation and | ||||
| Uncommon | ulcers, abdominal discomfort, | |||
| cramping and gas | ||||
| pains, diarrhoea or | ||||
| difficulty passing | ||||
| stools, bleeding | ||||
| (blood in stools), | ||||
| nausea/vomiting | ||||
| especially after | ||||
| meals, excessive | ||||
| burping, loss of | ||||
| appetite; later | ||||
| symptoms | ||||
| include fever and | ||||
| chills |
| 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 | ||
| Unknown | Diverticulitis: left lower quadrant pain, fever, nausea, diarrhoea, or constipation | ? | ||
| 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 Sevelamer hydrochloride, contact your doctor or pharmacist.
HOW TO STORE IT
Store at controlled room temperature 15?C to 30?C. Protect from moisture.
Keep out of reach and sight of children.
Reporting Side Effects
You can report any suspected side effects associated with the use of health.
NOTE: Contact your health professional if you need information about how to manage your side effects.
MANUFACTURED IN INDIA BY:
TAJ LIFE SCIENCES PVT. LTD.
Unit No. 214, Old Bake House,
Bake House Lane, Fort,
Mumbai-400001
at: Ahmedabad- Gujarat, INDIA.
Ho.NO. +91 8448 444 095
Toll Free Phone: (1800-222-434 / 1800-222-825)