SYRISAL

Posology Adults (including the elderly):

The recommended dosing regimen has been impirically derived. It is therefore important that the dosage selection should be adjusted according to the age, weight, the extent of sodium deficit and clinical condition of the patient. 8 g) of sodium daily, given as divided doses.

A maximum rate of administration of 10-12 mmol per litre of body water per 24 hour period, or 18 mmol/L/48 hours should observed. Paediatric population As for adults dosage should be adjusted to individual needs. Typically, children should receive 1- 2 mmol per kg (1-2ml/kg; 60-120 mg/kg) over a 24 hour period.

In neonates, the dose should be administered in breast milk (3-4 mmol/100ml; 3-4ml/100ml) or formula milk (2 mmol/100ml; 2ml/100ml). Renal impairment Dose adjustment may be necessary depending on the clinical condition of the patient and close monitoring of serum sodium levels.

Method of administration For oral administration. The oral solution may be diluted in a glass of water or baby’s bottle. Syrisal solution should not be used to induce emesis as there is a danger of induction of hypernatraemia.

g. post-operatively and in patients with impaired cardiac or renal function) may cause hypernatraemia. The most serious effects of hypernatraemia is caused by osmotically induced water shifts that decrease intracellular volume, resulting in dehydration of internal organs, especially the brain.

Dehydration of the brain may cause somnolence and confusion, progressing to convulsions, coma, respiratory failure, and death. General adverse effects of sodium chloride excess in the body are as follows. 01%), not known (cannot be estimated from the available data).

MedDRA System Organ Class Adverse Reaction Gastrointestinal disorders:

Frequency: Not known Nausea, Vomiting, Diarrhoea, Abdominal cramps, thirst, reduced salivation and lachrymation Cardiac disorders Frequency: Not known tachycardia Vascular disorders Frequency: Not known Hypertension, hypotension Nervous system disorders Frequency: Not known Headache, dizziness General disorders and administration site conditions Frequency: Not known Fever, sweating, restlessness, irritability, weakness, muscular twitching and rigidity Administration of large doses may give rise to sodium accumulation, oedema, and hyperchloraemic acidosis.

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. uk/yellowcard.

Syrisal 1 mmol/ml Oral Solution should be administered with caution to patients with hypertension, heart failure, peripheral and pulmonary oedema, renal impairment, pre-eclampsia, or other conditions associated with sodium retention.

Patients with the above mentioned conditions should be monitored frequently during the period of medication with Syrisal oral solution. In addition, care is also required when administering this solution to very young or to elderly patients.

Pseudohyponatraemia is a condition in which spuriously low concentrations of sodium are found when plasma sodium is measured by conventional methods. It may occur when there is an abnormally high concentration of large molecules and hence an abnormally low percentage of plasma water.

This may occur in hyperlipaemia and hyperproteinaemia and has also been reported in patients with diabetes mellitus. Correct values may be obtained by referring the concentration to plasma water.

Excipient(s) warning:

This product contains propyl parahydroxybenzoate (E216) and methyl parahydroxybenzoate (E218), which may cause allergic reactions (possibly delayed). This product also contains 1mmol (23mg) sodium per ml. To be taken into consideration by patients on a controlled sodium diet.

Syrisal 1mmol/ml oral solution is contra-indicated in any situation where salt retention is undesirable, such as oedema, heart disease, cardiac decompensation and primary or secondary aldosteronism; or where therapy is being given to produce salt and water loss.

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