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CARNITOR 330MG TABLETS

Active substance: LEVOCARNITINE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Carnitor 330 mg Tablets
(levocarnitine)

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.
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

- 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
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 reduce blood clotting. Your doctor
may need to change how often you are
tested to see how fast your blood clots 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.

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
1. What Carnitor tablets are and what they
take your medicine. If you wish to
are used for
breastfeed, ask your doctor for advice.
Carnitor tablets contain levocarnitine which is
Driving and using machines
a type of protein. They are used to treat
primary and secondary carnitine deficiency in You can drive or use machines whilst taking
Carnitor tablets.
adults and children over 12 years of age.

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

3. How to take Carnitor tablets
Always take Carnitor tablets exactly as your
doctor has told you.
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.
Method of administration
Carnitor tablets are for oral use. They should
be swallowed whole with a glass of water.
20024215

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.

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.

your blood is taking longer than usual to
clot.
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.
If you take more Carnitor tablets than you Store below 25°C.
should
Medicines should not be thrown away in
If you take too many Carnitor tablets, contact waste wastewater or household waste.
your doctor or immediately go to the nearest Return any medicine you no longer need to
hospital casualty department.
your pharmacist.
If you forget to take Carnitor tablets
6. Further information
Do not take a double dose to make up for the
forgotten dose. Simply continue with the next What Carnitor tablets contain
dose as planned.
- The active substance is levocarnitine. Each
330 mg tablet contains 330 mg of levocarIf you stop taking Carnitor tablets
nitine.
Do not stop taking this medicine without first - The other ingredients are magnesium
talking to your doctor.
stearate (E572), polyvinylpyrrolidone and
microcrystalline cellulose.
If you have any further questions about the
use of this medicine, ask your doctor or
What Carnitor tablets look like
pharmacist.
Carnitor tablets are white, round, pillow

Like all medicines Carnitor tablets can cause
side effects, although not everybody gets
them.
Side effects 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

shaped tablets approximately 1.3 cm wide.
They come in blister packs containing 30, 90,
100 and 180 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 2014.

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

20024215

4. Possible side effects

s. p. a.

Carnitor 330 mg - tabl
Uso mano
IXXXXXXX

I

BOZZA n.
proof

II

III

19:02:14 26:02

03:03

TACCA di taglio mm

50

TESA
BOZZA n.
proof

V

17:04

BOZZA n.
proof

PIEGATA
folded

VI

23:04

BOZZA n.
proof

VII

20024215

1 4 7 ,0

TESO
stiff

Helvetica - Times

IV

13:03

DIMENSIONI mm size

CARATTERI UTILIZZATI fonts type

Realizzato

CODICE COMPONENTE material code

20016322

TIPO PIEGA fold type

50 g/m

PANTONE NERO
COLORI
colours
BOZZA n.
BOZZA n.
proof
proof

CODICE A BARRE bar code
BOZZA n.
proof

I

GRAMMATURA weigth
2 ±10%

FOGLIO ILLUSTRATIVO
leaflet

SOSTITUISCE it replaces

PRODUZIONE manifacturing

NOME PRODOTTO product description
CARTA paper

(GB)

SCHEDA MATERIALE DI CONFEZIONAMENTO
Packaging material data sheet

1 4 0 ,0
VIII BOZZA n. IX
proof

BOZZA n.
proof

2 1 0 ,0

N.B.
Il colore PURPLE NON
deve essere
stampato,serve come
indicazione.
Zone retinate libere da
testo e/o vernice.
PURPLE color NOT to
be printed.
It shows text and varnish
no-print area.

3 5,0
X

BOZZA n.
proof

06:09:06 06:09:06 06:09:06 06:09:06

FACCIATA A - TESTO, ALTO
FA C E A - T E X T, U P

PACKAGE LEAFLET: INFORMATION FOR THE USER

Carnitor 330 mg Tablets
(levocarnitine)

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

- 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

60

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 reduce blood clotting. Your doctor
may need to change how often you are
tested to see how fast your blood clots 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.

Codici DE.CA.
DE.CA. codes

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.

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
1. What Carnitor tablets are and what they
take your medicine. If you wish to
are used for
breastfeed, ask your doctor for advice.

210

Carnitor tablets contain levocarnitine which is
Driving and using machines
a type of protein. They are used to treat
primary and secondary carnitine deficiency in You can drive or use machines whilst taking
Carnitor tablets.
adults and children over 12 years of age.

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.

60

Tell your doctor before taking Carnitor
tablets if:
- you have severe kidney problems or kidney
disease and are having dialysis

2,5

10

3. How to take Carnitor tablets
Always take Carnitor tablets exactly as your
doctor has told you.
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.
Method of administration
Carnitor tablets are for oral use. They should
be swallowed whole with a glass of water.
20024215

Codici DE.CA.
DE.CA. codes

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.

2,5

2,5
147

10

2,5

TACCA di taglio mm

50

FACCIATA B - TESTO, ALTO
FA C E B - T E X T, U P

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.

your blood is taking longer than usual to
clot.
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

4. Possible side effects
Like all medicines Carnitor tablets can cause
side effects, although not everybody gets
them.

- 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

shaped tablets approximately 1.3 cm wide.
They come in blister packs containing 30, 90,
100 and 180 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 2014.

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

20024215

Codici DE.CA.
DE.CA. codes

If you forget to take Carnitor tablets
6. Further information
Do not take a double dose to make up for the
forgotten dose. Simply continue with the next What Carnitor tablets contain
dose as planned.
- The active substance is levocarnitine. Each
330 mg tablet contains 330 mg of levocarIf you stop taking Carnitor tablets
nitine.
Do not stop taking this medicine without first - The other ingredients are magnesium
talking to your doctor.
stearate (E572), polyvinylpyrrolidone and
microcrystalline cellulose.
If you have any further questions about the
use of this medicine, ask your doctor or
What Carnitor tablets look like
pharmacist.
Carnitor tablets are white, round, pillow

Side effects are:

60

Codici DE.CA.
DE.CA. codes

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.
If you take more Carnitor tablets than you Store below 25°C.
should
Medicines should not be thrown away in
If you take too many Carnitor tablets, contact waste wastewater or household waste.
your doctor or immediately go to the nearest Return any medicine you no longer need to
hospital casualty department.
your pharmacist.

Expand view ⇕

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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