Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2021 Publisher: Syri Limited, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK Trading as: Thame Laboratories, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK OR Trading as: SyriMed, Unit 4, Bradfield Road, ...
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.
Hypersensitivity to any of the excipients listed in section 6.1.
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.
No interaction studies have been performed. In hypertensive patients with chronic renal failure sodium chloride may tend to impair the efficacy of antihypertensive drugs. Increasing sodium serum levels may result in a decrease in serum lithium levels in patients receiving lithium therapy.
No adverse effects during pregnancy are anticipated.
No adverse effects during breast-feeding are anticipated.
Sodium chloride is not expected to have an adverse effect on fertility.
None.
Injudicious saline therapy (e.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. The following adverse reactions are classified by system organ class and ranked under heading of frequency using the following convention: very common (≥10%), common (≥1% and <10%); uncommon (≥0.1% and <1%); rare (≥0.01% and <0.1%), very rare (<0.01%), 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 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 at www.mhra.gov.uk/yellowcard.
None known.
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