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SODIUM CHLORIDE 1 MMOL/ML ORAL SOLUTION

Active substance(s): SODIUM CHLORIDE / SODIUM CHLORIDE / SODIUM CHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Sodium Chloride 1 mmol/ml Oral Solution

D0349900000

Please read all of this leaflet carefully before your infant
is given this medicine.
• Keep this leaflet. You may need to read it again
• If you have further questions, please ask the hospital
doctor who is looking after your infant.
• If you notice any side effects, talk to your doctor.
This includes any possible side effects not listed in
the leaflet. See section 4.

3

Take the syringe and put it in the small
hole in the bottle adaptor.

Warning: This product must be diluted in drinks, breast milk or
formula feed before it is administered.

What is in this leaflet:
1. What Sodium Chloride 1 mmol/ml Oral Solution is and what it
is used for
2. What you need to know before your infant is given Sodium
Chloride 1 mmol/ml Oral Solution
3. How Sodium Chloride1 mmol/ml Oral Solution is given
4. Possible side effects
5. How Sodium Chloride 1 mmol/ml Oral Solution is stored
6. Contents of the pack and other information

4

To fill the syringe turn the bottle with the
syringe attached upside down. Gently
pull the plunger down drawing the
medicine into the syringe.

1. What Sodium Chloride 1 mmol/ml Oral
Solution is and what it is used for
Sodium Chloride 1 mmol/ml Oral Solution is a source of sodium
chloride used to correct hyponatraemia (low blood sodium
levels) in infants. Sodium chloride is found widely in the body,
and is important to normal body functions.

2. What you need to know before your child
is given Sodium Chloride 1 mmol/ml Oral
Solution
Your child, should not be given this medicine if there is known
hypersensitivity (allergy) to any of the ingredients listed in
Section 6.
Warnings and Precautions.
Your child should not be given this medicine if they have:
• Fluid retention.
• Heart failure.
• Intestinal obstruction.
• Aldosteronism (a condition where too much aldosterone
[a hormone] is produced).
• Liver or kidney disease.
If you think you are affected by any of these consult your doctor
or pharmacist before taking this medicine.
Other medicines and Sodium Chloride 1 mmol/ml Oral
Solution
You should tell your child’s doctor if they are having any
medicines, including those obtained without a prescription.
Sodium Chloride 1 mmol/ml Oral Solution Contains Sodium.
Sodium Chloride 1 mmol/ml Oral Solution contains 23 mg
sodium per 1 ml of the solution. Equivalent to 58.44 mg of
sodium chloride (salt) in 1 ml of the solution.

The dose can vary according to need, and your doctor will
normally advise how much to give. In the case of infants this will
normally be calculated based on bodyweight in kg. As a guide:
Infants: 3 to 5 mmol/kg (3 to 5 ml of Sodium Chloride 1 mmol/
ml Oral Solution per kg) daily in divided doses. Dosages can be
adjusted according to patient requirements.

5

If there is an air bubble in the syringe
gently push the plunger back upwards
until the air bubble is expelled back into
the bottle.

6

Then pull the plunger down to the
graduation mark corresponding to the
quantity in milliliters (ml) prescribed by
your doctor.

7

Turn the bottle the right way up and
remove the syringe.

8

Dilute the medicine by emptying the
syringe contents into a drink, breast
milk or formula. Do not administer the
medicine without first diluting.

Shake the bottle before use
If your child is given too much:
If your child is accidentally given too much Sodium Chloride 1
mmol/ml Oral Solution it should not be harmful. However, the
side effects described below may become more noticeable. If
a large excess is given, your child should see a doctor or be
taken to hospital straight away. Take this medicine with you. It
is particularly important to do this for the very young, or if the
child in your care has severe liver or kidney disease. If signs of
side effects are noticed, please tell your doctor.

4. Possible side effects
Like all medicines, Sodium Chloride 1 mmol/ml Oral Solution can
cause side effects, but these are not normally a problem when
this medicine is used as described.
Serious Side Effects
If your child experiences any of the following reactions
stop taking Sodium Chloride 1 mmol/ml Oral Solution and
contact your doctor IMMEDIATELY:
• Thirst (Not always obvious in children, especially very
young infants)
• Lethargy
• Weakness
• Irritability
• Confusion
• Twitching
In more extreme cases this can lead to:
• Seizures
• Coma
Reporting of side effects
If you notice any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in the leaflet.
You can also report side effects directly via the yellow card
scheme, Website: https://yellowcard.mhra.gov.uk. By reporting
side effects you can help provide more information on the safety
of this medicine

5. How Sodium Chloride 1 mmol/ml Oral
Solution is stored
Keep this bottle tightly closed
Keep out of reach and sight of children
Store in the original container and carton
Do not use this medicine after the expiry date which is stated
on the carton and bottle label, or if the solution appears
discoloured or cloudy.
Use within 1 month of first opening.

6. Contents of the pack and other information
What Sodium Chloride 1 mmol/ml Oral Solution contains
The active substance is sodium chloride 1 mmol/ml.
Other ingredients are potassium sorbate (E202), citric acid (E330)
and purified water.
What this product looks like and contents of the pack
Sodium Chloride 1 mmol/ml Oral Solution is a clear, colourless
liquid in a 100 ml amber glass bottle. Each pack contains one
bottle of solution, a 5ml dosing syringe and a syringe adaptor to
fit into the bottle when measuring the dose.
Marketing Authorisation Holder
Viridian Pharma Limited,
Bampton Road
Harold Hill
Romford
Essex
RM3 8UG
United Kingdom
Manufacturer
Macarthys Laboratory Limited T/A Martindale Pharma
Bampton Road
Harold Hill
Romford
Essex
RM3 8UG
United Kingdom
Marketing Authorisation Number
20346/0008
This leaflet was approved:
Oct 2016

3. How Sodium Chloride 1 mmol/ml Oral
Solution is given.
Always give this medicine exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure.
Sodium Chloride 1 mmol/ml Oral Solution is given by mouth.
How the medicine should be given

1

Remove the cap from the bottle by
pressing down firmly and turning
anticlockwise.

2

Hold the button tightly on a firm surface
and push the bottle adaptor into the
neck of the bottle. Push it down until it is
flush with the top of the bottle.

Continued overleaf
D0349900000

100mm Measurement Verification Bar

DEVELOPMENT ARTWORK
D03499
PIL SODIUM CHLORIDE ORAL
SOLUTION
170 x 296 mm

27/10/16

BM

07/11/16

BM

07/03/17

NF

19/04/17

NF

Expand Transcript

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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