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CARNITOR PAEDIATRIC 30% ORAL SOLUTION

Active substance(s): LEVOCARNITINE / LEVOCARNITINE

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Carnitor® Paediatric 30%
Oral Solution

2969
18.11.16[2]

(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
This medicine is available using the above name but will be referred to as
Carnitor paediatric throughout the following.
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
1. WHAT CARNITOR PAEDIATRIC IS AND WHAT IT IS USED FOR
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.
Carnitine deficiency occurs when the body has a shortage of levocarnitine.
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 this applies to your child, do not give them Carnitor paediatric.
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
- 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 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 sodium methyl hydroxybenzoate (E219) and sodium propyl
hydroxybenzoate (E217) which may cause immediate or delayed allergic
reactions.
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.
Primary and secondary carnitine deficiency
The usual dose of Carnitor 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 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.
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.
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
Like all medicines, Carnitor 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 CARNITOR PAEDIATRIC
Keep out of the sight and reach of children.
Do not store above 25°C. Keep 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.
Medicines should not be thrown away in waste water or in household waste.
Return any medicine you no longer need to the pharmacist.
If your medicines show any signs of deterioration or discolouration, you
should seek the advice of your pharmacist who will tell you what to do.
6. FURTHER INFORMATION
What Carnitor paediatric contains
The active substance is levocarnitine.
Each 1ml contains 300mg levocarnitine.
Also includes sucrose, sorbitol, sodium propyl hydroxybenzoate (E217),
sodium methyl hydroxybenzoate (E219), tartaric acid, cherry flavour, black
cherry flavour and purified water.
What Carnitor paediatric looks like and contents of the pack
Carnitor paediatric is a colourless or slightly yellow solution with a cherry
aroma.
Available in a 40 ml amber glass bottle with plastic child proof caps and a
3.3 ml measuring spoon.
MANUFACTURER AND PRODUCT LICENCE HOLDER
Carnitor paediatric is manufactured by Sigma-Tau Industrie Farmaceutiche
Riunite S.p.A Via Pontina Km. 30, 400-00071 Pomezia, Italy.
Procured from within the EU by Product Licence holder
Star Pharmaceuticals Ltd., 5 Sandridge Close, Harrow, Middlesex, HA1
1XD. Repackaged by Servipharm Ltd.
POM

PL 20636/2969

Leaflet revision and issue date (Ref) 18.11.16[2]
Carnitor is a trademark of Sigma-Tau Industrie Farmaceutiche Riunite
S.p.A.

Levocarnitine Paediatric 30%
Oral Solution

2969
18.11.16[2]

(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
This medicine is available using the above name but will be referred to as
Levocarnitine paediatric throughout the following.
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
- 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 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 sodium methyl hydroxybenzoate (E219) and sodium propyl
hydroxybenzoate (E217) 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.
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 store above 25°C. Keep 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.
Medicines should not be thrown away in waste water or in household waste.
Return any medicine you no longer need to the pharmacist.
If your medicines show any signs of deterioration or discolouration, you
should seek the advice of your pharmacist who will tell you what to do.
6. FURTHER INFORMATION
What Levocarnitine paediatric contains
The active substance is levocarnitine.
Each 1ml contains 300mg levocarnitine.
Also includes sucrose, sorbitol, sodium propyl hydroxybenzoate (E217),
sodium methyl hydroxybenzoate (E219), tartaric acid, cherry flavour, black
cherry flavour and purified water.
What Levocarnitine paediatric looks like and contents of the pack
Levocarnitine paediatric is a colourless or slightly yellow solution with a
cherry aroma.
Available in a 40 ml amber glass bottle with plastic child proof caps and a
3.3 ml measuring spoon.
MANUFACTURER AND PRODUCT LICENCE HOLDER
Levocarnitine paediatric is manufactured by Sigma-Tau Industrie
Farmaceutiche Riunite S.p.A Via Pontina Km. 30, 400-00071 Pomezia, Italy.
Procured from within the EU by Product Licence holder Star
Pharmaceuticals Ltd., 5 Sandridge Close, Harrow, Middlesex, HA1 1XD.
Repackaged by Servipharm Ltd.
POM

PL 20636/2969

Leaflet revision and issue date (Ref) 18.11.16[2]

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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