Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Sodium chloride may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
for Syrisal contains active substance sodium chloride which is a sodium supplement. Sodium chloride is the chemical name for salt. Sodium is an electrolyte that regulates the amount of water in your body. Sodium also plays a part in transmission of nerve impulses and muscle contractions. Syrisal is used for the treatment and prevention of sodium chloride deficiency.
e Syrisal Do not take Syrisal: ► if you are allergic to sodium chloride or to any of the other ingredients of this medicine (listed in section 6) ► if you have high sodium levels ► if you have fluid retention (oedema) ► if you have heart disease ► think you have a problem drinking enough water ► if you have a disorder which means you produce more aldosterone hormone than normal ► if you have a condition where the heart needs help to maintain blood circulation
PIL/UK/MFG012/06/SMD/v1
if you are being treated to produce salt and water loss, usually if you have fluid retention or heart failure or have high blood pressure.
Warnings and precautions
Talk to your doctor or pharmacist before taking Syrisal.
Syrisal Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
if you have high blood pressure if you have heart failure if you have fluid build-up in the lungs or lower limbs if you have kidney or liver problems if you have pre-eclampsia (high blood pressure during pregnancy) if you are on a low-salt diet if you have diabetes mellitus if you have high levels of fat or protein in the blood stream.
Doses Chronic salt depletion Adults: 40-80ml (2.4-4.8g) daily accompanied by suitable fluid intake at intervals as directed by your healthcare provider.
Other medicines and Syrisal
Kidney Impairment: Dose adjustment may be necessary.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines you buy without a prescription, including herbal medicines and dietary supplements. This is because Syrisal can affect the way some other medicines work and some medicines can have an effect on the way Syrisal works.
Route and method of administration
In particular, tell your doctor if you are taking any of the following:
Instructions for use of syringe:
► ► ► ► ►
Use in Children and adolescents: The healthcare provider will adjust the dose to the individual needs of the child. This medicine can be mixed with breast milk or formula milk for newborn babies.
This medicinal product must be taken orally. Syrisal oral solution may be diluted in a glass of water or baby's bottle. Use the measuring syringe provided in the pack to deliver the required dose.
Open the bottle: press the cap and turn it anticlockwise (figure 1). Separate the adaptor from the syringe (figure 2).
Insert the adaptor into the bottle neck (figure 3). Ensure it is properly fixed. Take the syringe and put it in the adaptor opening (figure 4).
Turn the bottle upside down. Fill the syringe with a small amount of solution by pulling the piston down (figure 5A), then push the piston upwards in order to remove any possible bubble (figure 5B). Pull the piston down to the graduation mark corresponding to the quantity in millilitres (ml) prescribed by your doctor (figure 5C).
► lithium ► diuretics (water tablets) such as furosemide and hydrochlorothiazide ► corticosteroids (e.g. prednisone) or corticotrophin. These may make side effects worse ► drugs used to treat high blood pressure (e.g. furosemide, bumetanide, metolazone). May affect the way these drugs work.
Syrisal with food and drink Syrisal may be taken with or without food.
Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Syrisal does not affect the ability to drive or operate machinery.
Syrisal contains: This product contains 1mmol (23mg) sodium per ml. To be taken into consideration by patients on a controlled sodium diet. This product also contains methyl and propyl parahydroxybenzoate, which may cause allergic reactions (possibly delayed).
TURN OVER
4. Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them. Seek medical attention immediately if any of these severe side effects occur: severe allergic reactions (rash, hives, difficulty in breathing, tightness in chest, swelling of mouth, face, lips, tongue) confusion, weakness seizures muscle twitching. Other side effects include:
Turn the bottle the right way up (figure 6A). Remove the syringe from the adaptor (figure 6B).
Empty the contents of the syringe in a glass of water or baby's bottle by pushing the piston to the bottom of the syringe (figure 7). Drink the whole contents of the glass/baby's bottle immediately. Close the bottle with the plastic screw cap. Wash the syringe with water (figure 8).
If you take more Syrisal than you should If you take more Syrisal than you should, tell your doctor or go to your nearest hospital casualty department straight away. Take the medicine pack with you. Overdose may result in restlessness, weakness, thirst, dry mouth and eyes, swollen tongue, flushing of the skin, dizziness, headache, decreased production of urine, high blood pressure, fast heart beat, delirium. If you forget to take Syrisal If you forget a dose, take it as soon as you remember. However, if it is nearly time for the next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose. If you have any further questions on the use of this medicine, ask your doctor or pharmacist or nurse.
PIL/UK/MFG012/06/SMD/v1
nausea vomiting diarrhoea stomach cramps thirst dry mouth and eyes sweating fever hypotension or hypertension excess salt in your blood system fast heart beat fluid build-up in the lungs or limbs, shortness of breath headache dizziness, restlessness irritability coma and death.
If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any
not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
Syrisal Keep this medicine out of the sight and reach of children. This medicinal product does not require any special storage conditions. Discard 30 days after first opening. Do not use this medicine if you see any visible particles in the solution and contact the manufacturer immediately. Do not use this medicine after the expiry date which is stated on the carton and bottle label after 'Exp'. The expiry date refers to last day of that month. Do not use this medicine if you notice any visible signs of deterioration. Do not throw away any medicines via waste water or household water. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
What Syrisal contains The active substance is sodium chloride. Each ml of oral solution contains 1mmol (58.44mg) sodium chloride. The other ingredients are glycerol (E422), sodium citrate, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216) and purified water. What Syrisal looks like and contents of the pack Syrisal is a clear, colourless solution supplied in an amber glass bottle with a child resistant plastic screw cap with a 20ml oral syringe with 1ml graduation mark for measuring and administering the dose and a syringe adaptor. Syrisal Oral Solution is supplied in bottles containing 100ml and 300ml oral solution. Not all pack size may be marketed. Marketing Authorisation Holder and Manufacturer: SyriMed, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK
POM
This leaflet was last revised in 05/2020. If this leaflet is hard to see or read, please telephone +44 (0) 208 515 3700 for help.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Syrisal 1 mmol/ml oral solution is indicated for the treatment and prophylaxis of sodium chloride deficiency.
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. A typical oral replacement dose of Syrisal in chronic salt-losing conditions is about 40-80 mmol (40-80 ml; 2.4-4.8 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.
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.
Pregnancy
No adverse effects during pregnancy are anticipated.
Breast-feeding
No adverse effects during breast-feeding are anticipated.
Fertility
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 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 at www.mhra.gov.uk/yellowcard.
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.
Ask anything about Syrisal 1 mmol/ml Oral Solution. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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