OSVAREN

Posology Adults 3 to 10 film-coated tablets per day, depending on the serum phosphate level. The daily dose should be subdivided according to the number of meals per the day (usually 3 a day). The recommended starting dose is 3 tablets daily.

If necessary, the dosage may be raised to maximally 12 film-coated tablets per day. Paediatric population The safety and efficacy of OsvaRen in children and adolescence have not been established. 4) Method of administration To achieve the maximum phosphate binding effect, OsvaRen must be taken together with the meal and should not be crushed or chewed.

For easy swallowing, the tablets should be taken together with some liquid. In case the tablets are too large to be swallowed by the patient, the tablets should be broken along the score line immediately before swallowing in order to avoid the development of taste of acetic acid.

5). OsvaRen can be applied long-term.

Very common (≥1/10) Common (≥ 1/100 and <1/10) Uncommon (≥1/1,000 and <1/100) Rare (≥1/10,000 and <1/1,000) Very rare (<1/10,000) Not known (cannot be estimated from the available data) Gastrointestinal disorders: Common: Soft stools, gastrointestinal irritation like nausea, anorexia, sensation of fullness, belching and constipation, diarrhoea.

Metabolism and nutrition disorders:

Common: Hypercalcaemia either asymptomatic or symptomatic, asymptomatic hypermagnesaemia.

Uncommon:

Moderate to severe symptomatic hypercalcaemia, symptomatic hypermagnesaemia.

Very rare:

Hyperkalaemia, magnesium-induced osteal mineralisation disturbances. For symptoms of hypercalcaemia and hypermagnesaemia see section

The use of phosphate binders should be preceded by a dietary consultation with the patient concerning phosphate uptake, and may depend on the kind of dialysis treatment the patient is receiving. 3 mmol2/l2 if • refractory to therapy, • refractory hyperkalaemia, • clinical relevant bradycardia or AV-block II° with bradycardia.

Continuous monitoring of serum phosphate, serum magnesium, serum calcium and the calcium-phosphate-product should be performed, especially in case of simultaneous intake of vitamin D preparations and thiazide diuretics. High doses and long-term administration of OsvaRen may result in hypermagnesaemia.

Hy-permagnesaemia is mostly asymptomatic, but in some cases systemic effects may be seen. 9. Patients should be advised to seek medical advice before taking antacids containing calcium or mag-nesium salts to avoid adding to the calcium or magnesium load.

If patients with a chronic renal insufficiency receive OsvaRen they may develop hypercalcaemic episodes, especially in combination with the administration of metabolites of vitamin D. Patients should be warned of the possible symptoms of hypercalcaemia.

During a long-term therapy with OsvaRen attention must be paid to the progression or the appearance of vascular and soft tissue calcifications. 5 mmol2/l2. In patients receiving digitalis glycosides, OsvaRen should only be administered under ECG control and monitoring of the serum calcium level.

Increased intake of calcium salts may result in the precipitation of fatty acids and bile acid as calcium soap. This may lead to constipation. In case of diarrhoea the dosage of OsvaRen should be reduced. OsvaRen contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

OsvaRen contains sodium. This has to be taken in consideration by patients on a controlled sodium diet. Paediatric population The safety and efficacy of OsvaRen in children and adolescence have not been established. There-fore, the administration of OsvaRen is not recommended in children and adolescents below 18 years of age.

g. 1.