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LEVOCARNITINE PAEDIATRIC 30% ORAL SOLUTION

Active substance(s): LEVOCARNITINE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Levocarnitine Paediatric 30% Oral Solution
(levocarnitine)
Your doctor may take blood and urine samples to check the amount of the
drug in your child’s body.

Read all of this leaflet carefully before you start taking this medicine.
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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 Paediatric 30% Oral Solution will be called
Levocarnitine paediatric.

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.

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

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 forgotten dose.
Simply continue with the next dose as planned.

1. WHAT LEVOCARNITINE PAEDIATRIC IS AND WHAT IT IS USED
FOR

If your child stops taking 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.

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.

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.

4. POSSIBLE SIDE EFFECTS
2. BEFORE YOU GIVE YOUR CHILD LEVOCARNITINE PAEDIATRIC
Do not give your child Levocarnitine paediatric:

Like all medicines, Levocarnitine paediatric can cause side effects,
although not everybody gets them.

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Side effects are:

if your child is allergic to levocarnitine or any other ingredients in
Levocarnitine paediatric. These ingredients are listed in section 6 of
this leaflet.

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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 this applies to your child, do not give them Levocarnitine paediatric.

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Tell your doctor before you give your child Levocarnitine paediatric
if:

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Reporting of side effects

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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
you 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 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.

If any of the above apply to your child, talk to your doctor or pharmacist.
5. HOW TO STORE LEVOCARNITINE PAEDIATRIC

Taking other medicines



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.

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.



Medicines should not be thrown away in waste water or in household
waste. Return any medicine you no longer need to the pharmacist.

It also contains methyl hydroxybenzoate (E217) and propyl
hydroxybenzoate (E219) which may cause immediate or delayed allergic
reactions.

6. FURTHER INFORMATION

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.

What Levocarnitine paediatric contains



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.

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Each 1ml contains 300mg of Levocarnitine.
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
Colourless or slightly yellow oral solution with cherry aroma.
It comes in 20 ml amber glass bottles with plastic child proof caps and a
3.3 ml measuring spoon.
Who manufactured your medicine
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 Product Licence Holder
Beachcourse Limited, 20 Alliance Court, Alliance Road, London W3 0RB,
UK.
PL 16378/0577

POM

Revision Date: 13.05.2016
Leaflet reference: LEVOPAED

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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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