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SLOW SODIUM

Active substance(s): SODIUM CHLORIDE / SODIUM CHLORIDE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
®Slow Sodium

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
The active ingredient is Sodium Chloride Ph.Eur. Sodium Chloride contains
not less than 99.0 per cent and not more than 100.5 per cent of NaCl.
One coated tablet contains 600 mg sodium chloride.

3

PHARMACEUTICAL FORM
Coated tablets.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
For the treatment and prophylaxis of sodium chloride deficiency.

4.2.

Posology and 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.
Adults: For prophylaxis 4-8 tablets per day. For treatment dosage to 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.

4.3.

Contra-indications
Slow Sodium 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.

4.4.

Special Warnings and Precautions for Use
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.

4.5.

Interactions with other Medicaments and other forms of Interaction
In hypertensive patients with chronic renal failure Slow Sodium may tend to
impair the efficacy of antihypertensive drugs.

4.6.

Pregnancy and Lactation
As with most medicines, consult your doctor first if you are pregnant or
breastfeeding.

4.7.

Effects on Ability to Drive and Use Machines
Nil

4.8

Undesirable effects
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 national reporting system in the United Kingdom: Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard

4.9.

Overdose
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 eg
frusemide (with potassium supplementation as required) may be appropriate in
severe cases of hypernatraemia. Levels should be monitored until they return
to normal.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Mode 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.

5.2.

Pharmacokinetic Properties

Sodium chloride is readily absorbed from the gastro-intestinal tract. It is
present in all body fluids but specially in the extracellular fluid. The amount
of sodium lost (as sweat) is normally small. Osmotic balance is maintained by
excretion of surplus amounts in the urine.

5.3.

Preclinical Safety Data
No information available.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Cetostearyl alcohol
Gelatin
Magnesium stearate
Tablet coating
Acacia
Gelatin
Talc
Titanium dioxide (E171)
Polyethylene glycol
Printing ink
Shellac
Red Iron Oxide (E172)
Lecithin (E322)
Antifoam DC 1510-US

6.2.

Incompatibilities
None known.

6.3.

Shelf Life
Five years.

6.4.

Special Precautions for Storage
Protect from moisture and store below 30°C.
The tablets should be dispensed in moisture proof containers.
Medicines should be kept out of reach of children.

6.5.

Nature and Contents of Container
The tablets are available in containers of 100 tablets.

6.6.

Instruction for Use/Handling
None.

7

MARKETING AUTHORISATION HOLDER

HK Pharma Ltd
PO BOX 845
BEDFORD,
MK45 9EB

8

MARKETING AUTHORISATION NUMBER(S)
PL 16784/0003

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
28 April 1998

10

DATE OF REVISION OF THE TEXT
22/07/2015

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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