OSVAREN Film-coated tablet Ref.[10708] Active ingredients: Calcium acetate Magnesium carbonate

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.

OsvaRen should only be administered with caution (only with continuous monitoring of serum calcium, magnesium and phosphate) in case of severe hyperphosphataemia with a calcium-phosphate-product of more than 5.3 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. Hypermagnesaemia is mostly asymptomatic, but in some cases systemic effects may be seen.

For symptoms and management of hypermagnesaemia and hypercalcaemia please see section 4.9.

Patients should be advised to seek medical advice before taking antacids containing calcium or magnesium 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. The risk decreases by lowering the calcium-phosphate-product to <4.5 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. Therefore, the administration of OsvaRen is not recommended in children and adolescents below 18 years of age.

To prevent an interaction between OsvaRen and other defined medicinal products when taken concomitantly, none of the oral medicinal products listed in this section should be taken within the period 2 hours before and 3 hours after administration of OsvaRen (see section 4.2).

OsvaRen affects the absorption of antibiotics (such as tetracyclines, doxycycline, norfloxacin, some cephalosporins like cefpodoxime, cefuroxime, and some quinolones (gyrase inhibitors) like ciprofloxacin), biphosphonates, fluorides, ketokonazole, estramustin-preparation, anticholinergics, zinc, urso- and chenodesoxychol acid, halofantrine.

In case of an additional treatment with oral iron preparations, attention has to be paid to the fact that simultaneous intake of magnesium may influence iron absorption.

Magnesium salts may adsorb digoxin in the gastrointestinal tract, decreasing its bioavailability.

Adsorption of nitrofurantoin may occur, decreasing the bioavailability and possibly the anti-infective effect of this medicinal product.

Further, the gastrointestinal absorption of penicillamine may be decreased, possibly decreasing its pharmacological effects.

A combination of magnesium carbonate, hydroxide and aluminium hydroxide with levothyroxine may cause an increased absorption of levothyroxine.

Vitamin D and derivatives increase the absorption of calcium. Thiazide diuretics reduce the renal elimination of calcium. In case of a simultaneous administration of OsvaRen and thiazides or vitamin D derivatives it is therefore necessary to control the serum calcium level (see section 4.4).

Concurrent use of oestrogens with OsvaRen may increase calcium absorption.

The sensitivity for glycosides and therefore the risk for arrhythmia is increased by elevated serum calcium levels (see section 4.4).

The administration of adrenalin in patients with increased serum calcium levels may lead to severe arrhythmia.

The effect of calcium antagonists may be reduced.

Pregnancy

There are no or limited amount of data from the use of OsvaRen in pregnant women. Animal studies are insufficient with respect to reproductive toxicity (see section 5.3). OsvaRen should not be used during pregnancy unless the clinical condition of the woman requires treatment with calcium acetate and magnesium carbonate.

Breastfeeding

Calcium acetate and magnesium carbonate are excreted in human milk to such an extent that effects on the breastfed newborns/infants are likely (see section 5.2).

Breast-feeding is not recommended during treatment with OsvaRen.

Fertility

No data available.

Not relevant.

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 4.9.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard.

Not applicable.