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

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. Therefore, the administration of OsvaRen is not recommended in children and adolescents below 18 years of age (see section 4.4)

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.

Because the rate and/or extent of absorption of other defined medicinal products may vary when used concomitantly with OsvaRen, none of the oral medicinal products listed in section 4.5 should be taken within the period 2 hours before and 3 hours after administration of OsvaRen (see section 4.5).

OsvaRen can be applied long-term.

An acute hypermagnesaemia (either asymptomatic or with acute systemic toxicity) suppresses both the central and the peripheral neural activity by inhibiting acetylcholine release. Systemic toxicity is to be expected from a serum concentration of 2.5 mmol/l, severe neurotoxic side effects appear from 3 mmol/l and above. With concentrations of 2.5–5.0 mmol/l gastrointestinal disturbances (nausea, anorexia, constipation), cystospasm, muscle weakness, lethargy, missing deep-tendon reflexes and disturbed AV-conduction and ventricular stimulus conduction has been observed.

In case of serum magnesium levels of 5–10 mmol/l, arterial hypotension induced by vasodilatation, paralytic ileus, flaccid paralysis and coma have been observed. At a level of more than 10 mmol/l respiratory arrest and cardiac arrest occur.

Symptoms of hypercalcaemia are initially muscle weakness and gastrointestinal disturbances (abdominal pain, constipation, nausea and vomiting). Severe hypercalcaemia is characterised by disturbances of consciousness (e.g. lethargy,disorientation, stupor, in extreme cases also coma). In patients with a serum calcium level of more than 3.5 mmol/l a hypercalcaemic crisis is possible with the symptoms of:

• Polyuria, polydipsia
• Nausea, anorexia, constipation, pancreatitis (infrequent)
• Arrhythmia, shortening of the QT-interval, adynamia, hypertension
• Muscle weakness up to pseudo paralysis
• Psychosis, somnolence up to coma.

Long-term overdosing may lead to the development of an adynamic osteopathy.

Emergency treatment

In addition to symptomatic treatment, the therapy of hypermagnesaemia consists in lowering the magnesium-concentration of the dialysate and in a reduction of the dose of OsvaRen.

If serum calcium levels increase to more than 2.5 mmol/l, a dose reduction and/or a decrease of the dialysate calcium to 1.25 mmol/l should be considered beside the symptomatic treatment. In the event of a hypercalcaemia (serum calcium >2.75 mmol/l) the therapy with OsvaRen should be temporarily withdrawn. In patients with a serum calcium level of more than 3.5 mmol/l the therapeutic intervention consists of a haemodialysis treatment with calcium-free dialysate. During the treatment with a calcium-free dialysate close monitoring of serum calcium concentration is necessary in order to minimise the risk of hypocalcaemia and adverse cardiovascular reactions.

3 years.

After first opening of the container: 3 months.

Keep the container tightly closed in order to protect from moisture.

For storage conditions after first opening of the medicinal product, see section 6.3.

HDPE container with LDPE cap: Pack size of 180 film-coated tablets.

No special requirements.