Carnitor 30% Paediatric Oral Solution

Document: leaflet MAH BRAND_PL 08381-0005 change

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CARNITOR 30% Paediatric Oral Solution

(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 oflevocarnitine. CARNITOR paediatric makes up for the body’s lack of levocarnitine and helps give the body moie 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

-    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,

It also contains methyl hydroxybenzoate (E217) and propyl hydroxybenzoate (E2l9) 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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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.

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 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 25°C. Protect from light and moisture.

Medicines should not be thrown away in waste water or in g 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

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