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CARNITOR PAEDIATRIC 30% ORAL SOLUTION

Active substance(s): LEVOCARNITINE

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Patient Information Leaflet

Carnitor® Paediatric 30% Oral Solution
(levocarnitine)
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 Carnitor Paediatric 30% Oral Solution will be called
Carnitor paediatric.
In this leaflet:
1) What Carnitor paediatric is and what it is used for
2) Before you give your child Carnitor paediatric
3) How to give your child Carnitor paediatric
4) Possible side effects
5) How to store Carnitor paediatric
6) Further information

3) HOW TO GIVE YOUR CHILD CARNITOR PAEDIATRIC
Always give your child Carnitor paediatric exactly as your doctor has told
you.
How much Carnitor paediatric should you give to your child
Your doctor will carefully calculate the amount of Carnitor 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
Carnitor paediatric is for oral use. It can be drunk directly or diluted
further with water or fruit juices.

1) WHAT CARNITOR PAEDIATRIC IS AND WHAT IT IS USED FOR

Primary and secondary carnitine deficiency
The usual dose of Carnitor paediatric is up to 200mg per kg of your
child’s bodyweight per day. This should be taken over 2-4 doses. Higher
doses of up to 400mg 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.

Carnitor 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.

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

Carnitine deficiency occurs when the body has a shortage of
levocarnitine.

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

Carnitor paediatric makes up for the body’s lack of levocarnitine and
helps give the body more energy.
2) BEFORE YOU GIVE YOUR CHILD CARNITOR PAEDIATRIC
Do not give your child Carnitor paediatric:
• if your child is allergic to levocarnitine or any other ingredients in
Carnitor paediatric. These ingredients are listed in section 6 of this
leaflet.

If your child stops taking Carnitor 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

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

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

Tell your doctor before you give your child Carnitor 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.

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 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.
Important information about some of the ingredients of Carnitor
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.

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 CARNITOR PAEDIATRIC
• Keep out of the sight and reach of children.
• Do not use Carnitor paediatric after the expiry date which is stated on
the bottle label after EXP. The expiry date refers to the last day of that
month.
• Do not store above 25oC.
• Keep the bottle in the outer carton in order to protect from light and
moisture.
• If your medicine shows any sign of deterioration, return it to your
pharmacist.
• 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 Carnitor paediatric contains
Each 1ml contains 300mg of levocarnitine.
The other ingredients are sucrose, sorbitol solution 70%
(non-crystallising), cherry flavour, black cherry flavour, purified water,
sodium methyl parahydroxybenzoate and sodium propyl
parahydroxybenzoate as preservatives.
What Carnitor paediatric looks like and contents of the pack
Carnitor paediatric is a colourless or slightly yellow oral solution. It comes
in 20ml amber glass bottles with plastic child proof caps and 3.3ml
measuring spoon.
Manufactured by
Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.,
Via Pontina km 30,400 - 00040 Pomezia, Italy.
Procured from within the EU by the Product Licence Holder:
MPT Pharma Ltd, Westgate Business Park, Unit 5-7 Tintagel Way,
Aldridge, Walsall WS9 8ER.
Repackaged by MPT Pharma Ltd.
PL: 33532/0658

POM

Leaflet dated 6th April 2016
Leaflet coded XXXXXXXXXXX
Carnitor® and sigma-tau® are registered trademarks of
Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.

Patient Information Leaflet

Levocarnitine Paediatric 30% Oral Solution
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 Paediatric 30% Oral Solution will be called
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
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
• 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.
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 200mg per kg of your
child’s bodyweight per day. This should be taken over 2-4 doses. Higher
doses of up to 400mg 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 forgotten 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.
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 use Levocarnitine paediatric after the expiry date which is
stated on the bottle label after EXP. The expiry date refers to the last
day of that month.
• Do not store above 25oC.
• Keep the bottle in the outer carton in order to protect from light and
moisture.
• If your medicine shows any sign of deterioration, return it to your
pharmacist.
• 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 1ml contains 300mg of levocarnitine.
The other ingredients are sucrose, sorbitol solution 70%
(non-crystallising), 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 oral solution. It
comes in 20ml amber glass bottles with plastic child proof caps and
3.3ml measuring spoon.
Manufactured by Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.,
Via Pontina km 30,400 - 00040 Pomezia, Italy.
Procured from within the EU by the Product Licence Holder:
MPT Pharma Ltd, Westgate Business Park, Unit 5-7 Tintagel Way,
Aldridge, Walsall WS9 8ER.
Repackaged by MPT Pharma Ltd.
PL: 33532/0658

POM

Leaflet dated 6th April 2016
Leaflet coded XXXXXXXXXXX
Sigma-tau® is a registered trademark of
Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.

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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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