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CARNITOR 30% PAEDIATRIC ORAL SOLUTION

Active substance(s): LEVOCARNITINE

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SCHEDA MATERIALE DI CONFEZIONAMENTO
Packaging material data sheet

NOME PRODOTTO product description

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PACKAGE LEAFLET: INFORMATION FOR THE USER

CARNITOR 30% Paediatric Oral Solution

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(levocarnitine 30% w/v)
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 30% Paediatric 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
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.

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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.
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.
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

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CODICE COMPONENTE material code

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TIPO PIEGA fold type

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SOSTITUISCE it replaces

PRODUZIONE manifacturing

CARNITOR

FOGLIO ILLUSTRATIVO
leaflet

(UK)

140

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.
If you have any unwanted side-effects you should talk to
your doctor, pharmacist or other healthcare professional.
Also, you can help make sure medicines remain as safe as
possible by reporting any unwanted side-effects via the
internet at www.mhra.gov.uk/yellowcard alternatively you
can call Freephone 0808 100 3352 (available between 10am
- 2pm Monday - Friday) or fill in a paper form available from
your local pharmacy.
5. How to store CARNITOR paediatric
Keep out of the reach and the sight of children.
Do not use CARNITOR paediatric after the expiry date stated
on the amber glass bottle. The expiry date
refers to the last day of that month.
Store below 25ºC. Protect from light and moisture.
Medicines should not be thrown away in waste water or in
household waste. Return any medicine you no longer need
to the pharmacist.
6. Further information
What CARNITOR paediatric contains
- The active substance is levocarnitine. CARNITOR paediatric
contains 30% w/v levocarnitine in each 20 ml amber glass
bottle.
- The other ingredients are sorbitol solution (70%) (E420),
tartaric acid (E334), sodium propyl hydroxybenzoate (E217),
sodium methyl hydroxybenzoate (E219), colourless cherry
flavour, colourless sour black cherry flavour, sucrose and
purified water.
What CARNITOR paediatric looks like and contents of
the pack
CARNITOR paediatric is a colourless or slightly yellow
solution. It comes in 20 ml amber glass bottles with plastic
child proof caps.
Marketing Authorisation Holder:
sigma-tau Industrie Farmaceutiche Riunite SpA
Viale Shakespeare, 47 - 00144 Rome, Italy
Manufacturer:
sigma-tau Industrie Farmaceutiche Riunite SpA
Pomezia, Italy
This leaflet was last revised in March 2013.

industrie farmaceutiche riunite s.p.a.
viale shakespeare, 47 - roma

20022328

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.

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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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