For the treatment and prophylaxis of sodium chloride deficiency.

Posology

Adults: For prophylaxis 4-8 tablets per day. For treatment dosage should be adjusted to individual needs up to a maximum of 20 tablets per day in cases of severe salt depletion. For control of muscle cramps during routine maintenance haemodialysis usually 10-16 tablets per dialysis. In some cases of chronic renal salt-wasting up to 20 tablets per day may be required with appropriate fluid intake.

Children: Dosage should be adjusted to individual needs.

Elderly: No special dosage adjustment.

Method of administration

It is important that the tablets should be swallowed whole with water (approx. 70ml per tablet where kidney function is normal to avoid hypernatraemia), and not chewed.

• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1

• 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.

Warnings: None

Precautions Use of Slow Sodium without adequate water supplementation can produce hypernatraemia.

The matrix (ghost) is often eliminated intact and owing to the risk of obstruction Slow Sodium should not be given to patients suffering from Crohn's disease or any other intestinal condition where strictures or diverticula may form.

In hypertensive patients with chronic renal failure Slow Sodium may tend to impair the efficacy of antihypertensive drugs.

Sodium chloride is not expected to have an adverse effect on fertility, pregnancy and lactation at therapeutic doses.

Slow Sodium has no or negligible influence on the ability to drive and use machines.

No side effects have been reported with Slow Sodium at the recommended dosage.

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 or search for 'MHRA Yellow Card' in the Google Play or Apple App Store.

Signs and symptoms. Excessive intake of sodium chloride can result in hypernatraemia. Symptoms of hypernatraemia include restlessness, weakness, thirst, reduced salivation and lachrymation, swollen tongue, flushing of the skin, pyrexia, dizziness, headache, oliguria, hypertension, tachycardia, delirium, hyperpnoea and respiratory arrest.

Treatment. Treatment requires the use of sodium-free liquids and the cessation of excessive sodium intake. In the event of a significant overdose serum sodium levels should be evaluated as soon as possible and appropriate steps taken to correct any abnormalities. The use of a loop diuretic e.g. frusemide (with potassium supplementation as required) may be appropriate in severe cases of hypernatraemia. Levels should be monitored until they return to normal.

Pharmacotherapeutic group: Other mineral supplements, sodium, ATC Code: A12 CA01

Mechanism of action: Sodium chloride is the principle salt involved in maintaining the osmotic tension of blood and tissues. Changes in osmotic tension influence the movement of fluids and diffusion of salts in cellular tissue.

Slow Sodium provides a source of sodium (in the form of sodium chloride) where a deficiency exists.

Absorption

Sodium chloride is readily absorbed from the gastro-intestinal tract.

Distribution

It is present in all body fluids but specially in the extracellular fluid.

Elimination

The amount of sodium lost (as sweat) is normally small. Osmotic balance is maintained by excretion of surplus amounts in the urine.

There is no relevant preclinical data for evaluation of safety beyond those already considered in the Summary of Product Characteristics.

Tablet core

Cetostearyl alcohol

Gelatin

Magnesium stearate

Tablet coating

Hypromellose

Hydroxypropyl cellulose

Talc

Titanium dioxide

Not applicable

Five years.

Store below 30° C. Keep the container tightly closed in order to protect from moisture.

High density polyethylene (HDPE) container with a low density polyethylene (LDPE) cap containing 100 tablets.

No special requirements for disposal.