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LEVOCARNITINE 30% PAEDIATRIC ORAL SOLUTION

Active substance(s): LEVOCARNITINE

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Levocarnitine 30% Paediatric Oral Solution
(levocarnitine)
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.
• In this leaflet Levocarnitine 30% Paediatric Oral Solution will be
called Levocarnitine paediatric.

• 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.
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.

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

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.

1) What Levocarnitine paediatric is and what it is used for

3) How to give your child Levocarnitine paediatric

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.

Always give your child Levocarnitine paediatric exactly as your doctor has
told you.

2) Before you give your child Levocarnitine paediatric
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.
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

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.

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

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.

6) Further information
What Levocarnitine paediatric contains
• The active substance is levocarnitine. Each 1ml contains 300mg of
Levocarnitine in each 20 ml amber glass bottle.
• The other ingredients are sucrose, sorbitol solution 70% (noncrystallising), cherry flavour, black cherry flavour, purified water, sodium
methyl parahydroxybenzoate and sodium propyl parahydroxybenzoate
as preservatives.
What Levocarnitine paediatric looks like and contents of the pack
Levocarnitine paediatric is a colourless or slightly yellow solution with
cherry aroma.
It comes in 20 ml amber glass bottles with plastic child proof caps and a
3.3ml measuring spoon.
PL 10383/2114

Levocarnitine 30% Paediatric Oral Solution POM

This product is manufactured by Sigma-Tau Industrie Farmaceutiche
Riunite S.p.A. Via Pontina km 30,400-00040 Pomezia, Italy. Procured from
within the EU and repackaged by the Product License holder: Primecrown
Ltd., 4/5 Northolt Trading Estate, Belvue Road, Northolt, Middlesex UB5
5QS.
Leaflet date: 15.07.2015

Reporting of side effects
If your child gets any side effects, talk to your doctor, pharmacist or nurse.
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.
• Keep the bottle in the outer carton in order to protect from light and
moisture.
• Do not use Levocarnitine paediatric after the expiry date stated on the
amber glass bottle. The expiry date refers to the last day of that month.
• If your medicine becomes discoloured or shows any other signs of
deterioration, you should seek the advice of your pharmacist who will tell
you what to do.
• Medicines should not be thrown away in waste water or in household
waste. Return any medicine you no longer need to the pharmacist.

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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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