Zenvela Tablet 800 mg (Sevelamer Carbonate)

Adult dose

This medicine should be taken with meals 3 times daily. 1) Administration to patients not taking a phosphate binder The recommended initial dose of this medicine is 0.8g to 1.6g. Take 1~2 tablets of this medicine with each meal according to the serum phosphorus level, as follows. Serum phosphorus 5.5 - 7.5 ㎎/dL: Take 1 tablet 3 times daily with meals Serum phosphorus 7.5 ㎎/dL or higher: Take 2 tablets 3 times daily with meals 2) Substitution of this medicine for patients taking sevelamer hydrochloride tablets When substituting this medicine for sevelamer hydrochloride tablets, administer the same dose. Appropriate dose adjustment may be necessary to achieve the target serum phosphorus level. The maximum daily dose of sevelamer carbonate studied in patients with chronic kidney disease receiving dialysis was 14g. 3) Substitution of this medicine for patients taking calcium acetate preparations Initial dose in dialysis patients when substituting this medicine for calcium acetate preparations (containing 667mg calcium acetate per tablet): 1 tablet 3 times daily; 1 tablet 3 times daily; 2 tablets 3 times daily; 2 tablets 3 times daily; 3 tablets 3 times daily; 3 tablets 3 times daily 4) Substitution between sevelamer carbonate tablets and powder, or between powder and tablets When substituting between sevelamer carbonate tablets and powder, administer the same dose. Appropriate dose adjustment may be necessary to achieve the target serum phosphorus level 5) Dose adjustment in all patients taking this medicine If necessary, increase or decrease the dose of this medicine by 0.8g, taken 3 times daily with meals, at 2-week intervals until the target serum phosphorus level is achieved.

This medication should not be used in patients with allergies to the active ingredients or excipients. It should also not be used in patients with abnormally low phosphorus levels (hypophosphatemia) or intestinal obstruction due to the risk of swelling in the gastrointestinal tract, which may cause perforation or obstruction. Care should be taken when administering this medication to patients with intestinal strictures or constipation, and immediate consultation with healthcare professionals is needed should side effects occur. Gastrointestinal symptoms such as vomiting, nausea, diarrhea, dyspepsia, abdominal pain, bloating, and constipation may occur while taking this medication; if symptoms worsen, consult a doctor. Patients undergoing peritoneal dialysis are at risk for serious infections such as peritonitis and should seek immediate treatment upon symptom occurrence; regular monitoring is necessary. This medication may be difficult to swallow for patients with dysphagia; powdered forms of the medication may be considered. Regular monitoring of serum calcium, bicarbonate, and chloride levels is necessary to detect issues such as hypocalcemia or acidosis early and receive appropriate treatment. Long-term use may lead to deficiencies in fat-soluble vitamins A, D, E, K, and folic acid; regular evaluation of vitamin status and supplementation if necessary is recommended. When taken with other oral medications, it may interfere with their absorption, so it is safest to take this medication 1 to 3 hours before or after other medications. Importantly, do not take it simultaneously with ciprofloxacin, and when combined with warfarin, digoxin, enalapril, metoprolol, or iron, monitor blood concentrations according to medical advice. Women who are pregnant or may become pregnant should only use this medication if the benefits outweigh the risks after consulting a doctor, as it may affect the fetus. Nursing mothers should consider the very low possibility of this medication being excreted in breast milk when making decisions about breastfeeding and medication therapy. It is advisable not to use this medication in children under 18 years of age, as safety and efficacy have not been established. Older adults should generally start with a lower dose and be monitored closely for adverse reactions. This medication must be taken with meals, and the tablets should not be chewed or crushed but taken whole. There are no specific reports of overdose; however, care should be taken not to exceed the recommended dose. If symptoms such as severe constipation, persistent abdominal pain, or vomiting occur while taking this medication, discontinue use immediately and inform healthcare professionals. The effects of this medication on driving or machinery operation are not known, so caution is advised.

• Vomiting
• nausea
• diarrhea
• indigestion
• abdominal pain
• bloating
• constipation
• allergic reactions
• itching
• rash

This medication must be stored in a tightly sealed container to prevent exposure to air or moisture. It is important to maintain a storage temperature between 1 to 30 degrees Celsius.

Appearance

Oval film-coated tablets, white or pale yellow

Package unit

30 tablets/bottle, 180 tablets/bottle