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LEVOCARNITINE PAEDIATRIC 30% ORAL SOLUTION

Active substance(s): LEVOCARNITINE / LEVOCARNITINE / LEVOCARNITINE

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Ref: 1680/300916/1/F

Levocarnitine 30% Paediatric Oral Solution
Patient Information Leaflet
Read all of this leaflet carefully before you start taking this medicine.
* Keep this leaflet. You may need to read it again
* If you have any further questions, ask your doctor or pharmacist
* This medicine has been prescribed for your child. Do not pass it on to
others. It may harm them, even if their symptoms are the same as your
child’s
* If any of the side effects get serious, or you notice any side effects not
listed in this leaflet please tell your doctor or pharmacist
Your medicine is called Levocarnitine Paediatric 30% Oral Solution
throughout this leaflet it will be referred to as Levocarnitine paediatric.
In this leaflet:
1

What Levocarnitine paediatric is and what it is used for

2

Before you give your child Levocarnitine paediatric

3

How to give your child Levocarnitine paediatric

4

Possible side effects

5

How to store Levocarnitine paediatric

6

Further information

1

What Levocarnitine paediatric is and what it is used
for

Levocarnitine paediatric contains levocarnitine which is a type of protein. It is
used to treat primary and secondary levocarnitine deficiency in children less
than 12 years of age, infants and newborns.
Carnitine deficiency occurs when the body has a shortage of levocarnitine.
Levocarnitine paediatric makes up for the body’s lack of levocarnitine and
helps give the body more energy.

2

Before you give your child Levocarnitine paediatric

Taking other medicines
Tell your doctor if your child is taking anticoagulant medicine, such as
warfarin, or any other drug to reduce blood clotting.
Your doctor may need to change how often your child is tested to see how
fast their blood clots.
Tell your doctor or pharmacist if your child is taking or has recently taken any
other medicines, including those obtained without a prescription.
Important information about some of the ingredients of Levocarnitine
paediatric.
This product contains sorbitol solution which can cause stomach upsets and
diarrhoea when taken in large doses. This product contains sucrose. If you
have been told by the doctor that your child has an intolerance to some
sugars, contact your doctor before giving your child this medicine. It also
contains methyl hydroxybenzoate (E217) and propyl hydroxybenzoate
(E219) which may cause immediate or delayed allergic reactions.

3

How to give your child Levocarnitine paediatric

Always give your child Levocarnitine paediatric exactly as your doctor has
told you.
How much Levocarnitine paediatric should you give to your child
Your doctor will carefully calculate the amount of Levocarnitine paediatric
that your child should take and may vary it depending on their response to
the treatment. Your doctor may take blood and urine samples to check the
amount of the drug in your child’s body.
Method of administration
Levocarnitine paediatric is for oral use. It can be drunk directly or diluted
further with water or fruit juices.
Primary and secondary carnitine deficiency
The usual dose of Levocarnitine paediatric is up to 200 mg per kg of your
child’s bodyweight per day. This should be taken over 2-4 doses. Higher
doses of up to 400 mg per kg of bodyweight per day may be necessary.
Your doctor will tell you exactly how much medicine to give your child and
when to give it.

Do not give your child Levocarnitine paediatric:
* if your child is allergic to levocarnitine or any other ingredients in
Levocarnitine paediatric. These ingredients are listed in section 6 of this
leaflet.
If this applies to your child, do not give them Levocarnitine paediatric.

If you give your child more Levocarnitine paediatric than you should
If you give your child too much Levocarnitine paediatric, contact your doctor
or immediately go to the nearest hospital casualty department.

Tell your doctor before you give your child Levocarnitine paediatric if:
* your child has severe kidney problems or kidney disease and is having
dialysis
* your child is diabetic and taking insulin, or any other drug to treat their
diabetes
* your child is a diabetic or is on a diet to reduce calorie intake
* your child is taking anticoagulant medicine, such as warfarin, or any
other drug to reduce blood clotting
* your child has an intolerance to some sugars.
If any of the above apply to your child, talk to your doctor or pharmacist.

If your child stops taking Levocarnitine paediatric
Do not stop giving your child this medicine without first talking to your doctor.
If you have any further questions about giving your child this medicine,
please ask your doctor or pharmacist.

If you forget to give your child Levocarnitine paediatric
Do not give your child a double dose to make up for a forgotten dose.
Simply continue with the next dose as planned.

Ref: 1680/061016/1/B

Levocarnitine Paediatric 30% Oral Solution
Patient Information Leaflet (continued)
4

Possible side effects

Like all medicines, Levocarnitine paediatric can cause side effects, although
not everybody gets them.
Side effects are:
* Mild stomach upsets such as stomach cramps or diarrhoea, or your child
may feel or be sick for a short time
* Drug-related body odour. Your doctor may reduce your child’s dose to help
lessen or stop the odour.
* For children also taking anticoagulant medicine, such as warfarin, tests
may show their blood is taking longer than usual to clot.
If any of the side effects gets serious or if you notice any side effects not
listed in this leaflet, tell your doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet. You can also report side
effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the
safety of this medicine.

5

How to store Levocarnitine paediatric

KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Do not store above 25°C.
Store in the original package in order to protect from light and moisture.
Do not use Levocarnitine paediatric after the expiry date shown on the
bottle label or carton. The expiry date refers to the last day of that month.
If your doctor tells you to stop using this medicine, take any remaining
medicine back to the pharmacist for safe disposal. Only keep this medicine if
your doctor tells you to.
If your medicine becomes discoloured or shows any other signs of
deterioration consult your pharmacist who will tell you what to do.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
These measures will help to protect the environment.

6

Further information

What Levocarnitine paediatric contains:
Each ml contains 300mg levocarnitine.
The other ingredients are sucrose, sorbitol solution (70%),
sodium propylhydroxybenzoate, sodium methylhydroxybenzoate,
cherry flavour, black cherry flavour, and purified water.

What this Levocarnitine paediatric looks like and contents of the pack
Levocarnitine paediatric is a colourless or slightly yellow solution with a
cherry aroma.
Each bottle contains 20ml oral solution in an amber glass bottle with a
measuring spoon.
Manufacturer and Licence Holder
Manufactured by SIGMA-TAU Industrie Farmaceutiche Riunite S.p.A. Via
Pontina km 30,400 - 00040 Roma, Italy and is procured from within the EU
and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18,
Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and
will be able to advise you.

POM

PL 15184/1680

Levocarnitine 30% Paediatric Oral Solution

Revision date: 06/10/16

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

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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