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CARNITOR 330MG TABLETS

Active substance(s): LEVOCARNITINE

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10.33

DIGITAL template
NOME PRODOTT O product description

CORREZIONE /
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SOSTITUISCE it replaces

(UK) CARNITOR 1 g - tbs
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FOGLIO ILLUSTRATIVO
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PACKAGE LEAFLET: INFORMATION FOR THE USER

Carnitor 1 g Chewable Tablets
(levocarnitine)

Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.
- 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 you only. Do not pass it on to others. It may harm
them, even if their signs of illness are the same as yours
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible
side effects not listed in this leaflet. See section 4.
- In this leaflet Carnitor 1 g Chewable Tablets are called Carnitor chewable tablets.

1. What Carnitor chewable tablets are and what they are used for
Carnitor chewable tablets contain levocarnitine which is a type of protein. They are used to
treat primary and secondary carnitine deficiency in adults and children over 12 years of age.
Carnitine deficiency occurs when the body has a shortage of levocarnitine. Carnitor chewable
tablets make up for your body’s lack of levocarnitine and help give your body more energy.

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Codici DE.CA.
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What is in this leaflet:
1. What Carnitor chewable tablets are and what they are used for
2. What you need to know before you take Carnitor chewable tablets
3. How to take Carnitor chewable tablets
4. Possible side effects
5. How to store Carnitor chewable tablets
6. Contents of the pack and other information

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2. What you need to know before you take Carnitor chewable tablets
Do not take Carnitor chewable tablets:
- if you are allergic to levocarnitine or any of the other ingredients of this medicine (listed in
section 6).

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Warnings and Precautions
Tell your doctor before taking Carnitor chewable tablets if:
- you have severe kidney problems or kidney disease and are having dialysis
- you are diabetic and taking insulin, or any other drug to treat your diabetes
- you are on a diet to reduce calorie intake
- you have an intolerance to some sugars
- you are taking anticoagulant medicine, such as warfarin, or any other drug to reduce blood
clotting
If any of the above apply to you, talk to your doctor or pharmacist.

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Other medicines and Carnitor chewable tablets
Tell your doctor if you are taking, have recently taken or might take any other medicine.
Tell your doctor if you are taking anticoagulant medicine, such as warfarin, or any other drug
to reduce blood clotting. Your doctor may need to change how often you are tested to see
how fast your blood clots.
Pregnancy and breast-feeding
Tell your doctor if you are pregnant, think you may be pregnant or if you become pregnant
while taking Carnitor chewable tablets. Your doctor will decide whether or not you should
continue to take your medicine. If you wish to breastfeed, ask your doctor for advice.
Driving and using machines
You can drive or use machines whilst taking Carnitor chewable tablets.
Carnitor chewable tablets contain sugar
This product contains sugar. If you have been told by the doctor that you have an intolerance
to some sugars, contact your doctor before taking this medicine.
3. How to take Carnitor chewable tablets
Always take this medicine exactly as your doctor has told you. Check with your doctor if you
are not sure.
How many Carnitor chewable tablets should you take
Your doctor will carefully calculate the number of chewable tablets you should take and may
change it depending on your response to treatment. Your doctor may take blood and urine
samples to check the amount of the drug in your body.
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Method of administration
Carnitor chewable tablets are for oral use. They should be chewed, not swallowed whole.
Primary and secondary Carnitine deficiency
The usual dose of Carnitor chewable tablets is 200 mg per kg of your body weight per day.
This should be taken over 2-4 doses. Higher doses of up to 400 mg per kg of your body
weight per day may be necessary. Your doctor will tell you exactly how many chewable tablets
to take and when to take them.
• UK • 20028070

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Maintenance therapy for haemodialysis patients
If significant clinical benefit was gained by a first course of Carnitor injection, then ongoing
therapy of one Carnitor chewable tablet per day may be taken. On the day of dialysis, the
chewable tablet should be taken at the end of the session.
If you take more Carnitor chewable tablets than you should
If you take too many Carnitor chewable tablets, contact your doctor or immediately go to the
nearest hospital casualty department.
If you forget to take Carnitor chewable tablets
Do not take a double dose to make up for the forgotten dose. Simply continue with the next
dose as planned.
If you stop taking Carnitor chewable tablets
Do not stop taking this medicine without first talking to your doctor.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

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4. Possible side effects
Like all medicines this medicine can cause side effects, although not everybody gets them.
Very rare side effects (may affect up to 1 in 10,000 people) are:
- Mild stomach upsets such as stomach cramps and diarrhoea, or you may feel or be sick for
a short time.
- Drug-related body odour. Your doctor may reduce your dose to help lessen or stop the
odour.
- For people also taking anticoagulant medicine, such as warfarin, tests may show your
blood is taking longer than usual to clot.

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Reporting of side effects
If you get 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 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.

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5. How to store Carnitor chewable tablets
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after Exp. The
expiry date refers to the last day of that month.
Store below 25°C.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist
how to throw away medicines you no longer use. These measures will help protect the
environment.
6. Contents of the pack and other information
What Carnitor chewable tablets contain
-The active substance is levocarnitine. Each 1 g chewable tablet contains 1 g of levocarnitine.
-The other ingredients are compressible sugar (DIPAC), magnesium stearate (E572), mint
flavour and liquorice flavour.
What Carnitor chewable tablets look like
Carnitor chewable tablets are white, round, pillow shaped chewable tablets, approximately
2.2 cm wide. They come in blisters containing two chewable tablets. The medicine comes in
packs of 10, 30, 50 and 100 chewable tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Sigma-tau Industrie Farmaceutiche Riunite S. p.A, Viale Shakespeare 47 – 00144, Rome, Italy.
Manufacturer
Sigma-tau Industrie Farmaceutiche Riunite S.p.A., Pomezia, Italy.
This leaflet was last updated January 2016.

industrie farmaceutiche riunite s.p.a.
viale shakespeare, 47 - 00144 rome, italy
• UK • 20028070

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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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