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CARNITOR 330MG TABLETS

Active substance(s): LEVOCARNITINE / LEVOCARNITINE

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TIPO PIEGA fold type

50 g/m

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PLEASE RETURN THE SIGNED FILE WITH THE CORRECTIONS AND/OR APPROVALS INCLUDED IN DIGITAL FORM

COMPILAZIONE
operator

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La responsabilità per la compilazione del file deve intendersi conclusa con la spedizione. Ogni l’utilizzo successivo per la stampa DEVE essere preventivamente confrontato con una bozza od un file FIRMATI.
The responsibility for compilation of the file to be considered concluded with the shipping. Any subsequent use for printing MUST first be compared with a draft or SIGNED file.

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N.B.
Per evitare equivoci, si rammenta che prima
della spedizione bisogna controllare l’esattezza
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I file .pdf (Acrobat) sono affidabili per il
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20028330

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ALTRA CODIFICA other CODE

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CODICE COMPONENTE material code

Il colore PURPLE NON deve essere
stampato,serve come indicazione.
Zone retinate libere da testo e/o vernice.
PURPLE color NOT to be printed.
Shaded area indicate text and varnish free
area.

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SOSTITUISCE it replaces

(UK) CARNITEN 330 mg - tbs
CODICE A BARRE bar code
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I = SOTTILE thin
CARTA paper

FOGLIO ILLUSTRATIVO
leaflet

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NOME PRODOTT O product description

CORREZIONE /
APPROVAZIONE /
SPEDIZIONE

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DIGITAL template

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(GB) CARN tbl ii 28330.ai

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Carnitor 330 mg Tablets
(levocarnitine)

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reduce blood clotting. Your doctor may need to
change how often you are tested to see how fast
your blood clots. Tell your doctor if you are taking
or have recently taken any other medicines,
including those obtained without a prescription.

In this leaflet:
1. What Carnitor tablets are and what they are
used for
2. Before you take Carnitor tablets
3. How to take Carnitor tablets
4. Possible side effects
5. How to store Carnitor tablets
6. Further information

Driving and using machines
You can drive or use machines whilst taking
Carnitor tablets.

1. What Carnitor tablets are and what they are
used for

How many Carnitor tablets should you take
Your doctor will carefully calculate the number of
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.

Pregnancy and breast-feeding
Tell your doctor if you are pregnant, think you may
be pregnant or if you become pregnant while
taking Carnitor 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.

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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 you. Do
not pass it on to others. It may harm them, even
if their symptoms are the same as yours
- 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 330 mg Tablets are called
Carnitor tablets.

3. How to take Carnitor tablets
Always take Carnitor tablets exactly as your
doctor has told you.

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Carnitor 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 tablets make
up for your bodies lack of levocarnitine and help
give your body more energy.
2. Before you take Carnitor tablets
Do not take Carnitor tablets:
- if you are allergic to levocarnitine or any of the
other ingredients in Carnitor tablets. These
ingredients are listed in section 6 of this leaflet.
If this applies to you, do not take Carnitor tablets.
Tell your doctor before taking Carnitor 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 taking anticoagulant medicine, such as
warfarin, or any other drug to reduce blood
clotting
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If any of the above apply to you, talk to your
doctor or pharmacist.
Taking other medicines
Tell your doctor if you are taking anticoagulant
medicine, such as warfarin, or any other drug to

Method of administration
Carnitor tablets are for oral use. They should be
swallowed whole with a glass of water.
Primary and secondary Carnitine deficiency
The usual dose of Carnitor 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 tablets to take and when to take them.
Maintenance therapy for haemodialysis
patients
If significant clinical benefit was gained by a first
course of Carnitor injection, then ongoing therapy
of 1 g Carnitor tablets per day may be taken. On
the day of dialysis, the tablets should be taken at
the end of the session.
If you take more Carnitor tablets than you
should
If you take too many Carnitor tablets, contact your
doctor or immediately go to the nearest hospital
casualty department.
If you forget to take Carnitor tablets
Do not take a double dose to make up for the
forgotten dose. Simply continue with the next
dose as planned.
• UK • 20028330

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If you stop taking Carnitor tablets
Do not stop taking this medicine without first
talking to your doctor.

6. Further information

What Carnitor tablets contain
- The active substance is levocarnitine. Each 330
If you have any further questions about the use of
mg tablet contains 330 mg of levocarnitine.
this medicine, ask your doctor or pharmacist.
- The other ingredients are magnesium stearate
(E572), polyvinylpyrrolidone and microcrystalline
4. Possible side effects
cellulose.

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Like all medicines Carnitor tablets can cause side What Carnitor tablets look like
effects, although not everybody gets them.
Carnitor tablets are white, round, pillow shaped
tablets approximately 1.3 cm wide. They come in
Side effects are:
blister packs containing 30, 90, 100 and 180
tablets. Not all pack sizes may be marketed.
- Mild stomach upsets such as stomach cramps
and diarrhoea, or you may feel or be sick for a
Marketing Authorisation Holder
short time.
Sigma-tau Industrie Farmaceutiche Riunite S.p.A,
- Drug-related body odour. Your doctor may
Viale Shakespeare 47 – 00144, Rome, Italy.
reduce your dose to help lessen or stop the
odour.
Manufacturer
- For people also taking anticoagulant medicine,
Sigma-tau Industrie Farmaceutiche Riunite S.p.A.,
such as warfarin, tests may show your blood is Pomezia, Italy.
taking longer than usual to clot.
This leaflet was last updated February 2016.
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 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 tablets
Keep out of the reach and sight of children.
Do not use Carnitor tablets after the expiry date
on the carton. The expiry date refers to the last
day of that month.
Store below 25°C.
Medicines should not be thrown away in waste
wastewater or household waste. Return any
medicine you no longer need to your pharmacist.

industrie farmaceutiche riunite s.p.a.
viale shakespeare, 47 - roma (italy)
• UK • 20028330

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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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