CARNITOR 1G CHEWABLE TABLETS

Active substance: LEVOCARNITINE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

20024213

Carnitor 1 g Chewable Tablets
(levocarnitine)
Read all of this leaflet carefully before you
doctor or pharmacist.
start taking this medicine.
- Keep this leaflet. You may need to read it again Taking other medicines
- If you have any further questions, ask your
Tell your doctor if you are taking anticoagulant
doctor or pharmacist
medicine, such as warfarin, or any other drug to
- This medicine has been prescribed for you. Do reduce blood clotting. Your doctor may need to
not pass it on to others. It may harm them,
change how often you are tested to see how fast
even if their symptoms are the same as yours
your blood clots.
- If any of the side effects get serious, or you
Tell your doctor if you are taking or have recently
notice any side effects not listed in this leaflet
taken any other medicines, including those
please tell your doctor or pharmacist.
obtained without a prescription.
- In this leaflet Carnitor 1 g Chewable Tablets are
called Carnitor chewable tablets.
Pregnancy and breast-feeding
Tell your doctor if you are pregnant, think you
In this leaflet:
may be pregnant or if you become pregnant
1. What Carnitor chewable tablets are and what while taking Carnitor chewable tablets. Your
they are used for
doctor will decide whether or not you should
2. Before you take Carnitor chewable tablets
continue to take your medicine. If you wish to
3. How to take Carnitor chewable tablets
breastfeed, ask your doctor for advice.
4. Possible side effects
5. How to store Carnitor chewable tablets
Driving and using machines
6. Further information
You can drive or use machines whilst taking
Carnitor chewable tablets.
1. What Carnitor chewable tablets are and
what they are used for
Important information about some of the
Carnitor chewable tablets contain levocarnitine
ingredients in Carnitor chewable tablets
which is a type of protein. They are used to
This product contains sugar. If you have been
treat primary and secondary carnitine deficiency told by the doctor that you have an intolerance
in adults and children over 12 years of age.
to some sugars, contact your doctor before
Carnitine deficiency occurs when the body has a taking this medicine.
shortage of levocarnitine Carnitor chewable
tablets make up for your bodies lack of
3. How to take Carnitor chewable tablets
levocarnitine and help give your body more
Always take Carnitor chewable tablets exactly
energy.
as your doctor has told you.
2. Before you take Carnitor chewable tablets
Do not take Carnitor chewable tablets:
- if you are allergic to levocarnitine or any of the
other ingredients in Carnitor chewable tablets.
These ingredients are listed in section 6 of this
leaflet.
If this applies to you, do not take Carnitor
chewable tablets.

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.

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

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.

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.
4. Possible side effects
Like all medicines Carnitor chewable 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 your blood is
taking longer than usual to clot.

Do not use Carnitor chewable 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.
6. Further 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 strips containing ten
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 2014.

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 chewable tablets
Keep out of the reach and sight of children.

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

20024213

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.

FACCIATA A - TESTO, ALTO
FA C E A - T E X T, U P
5

PACKAGE LEAFLET: INFORMATION FOR THE USER
(levocarnitine)
Read all of this leaflet carefully before you
doctor or pharmacist.
start taking this medicine.
- Keep this leaflet. You may need to read it again Taking other medicines
- If you have any further questions, ask your
Tell your doctor if you are taking anticoagulant
doctor or pharmacist
medicine, such as warfarin, or any other drug to
- This medicine has been prescribed for you. Do reduce blood clotting. Your doctor may need to
not pass it on to others. It may harm them,
change how often you are tested to see how fast
even if their symptoms are the same as yours
your blood clots.
- If any of the side effects get serious, or you
Tell your doctor if you are taking or have recently
notice any side effects not listed in this leaflet
taken any other medicines, including those
please tell your doctor or pharmacist.
obtained without a prescription.
- In this leaflet Carnitor 1 g Chewable Tablets are
called Carnitor chewable tablets.
Pregnancy and breast-feeding
Tell your doctor if you are pregnant, think you
In this leaflet:
may be pregnant or if you become pregnant
1. What Carnitor chewable tablets are and what while taking Carnitor chewable tablets. Your
they are used for
doctor will decide whether or not you should
2. Before you take Carnitor chewable tablets
continue to take your medicine. If you wish to
3. How to take Carnitor chewable tablets
breastfeed, ask your doctor for advice.
4. Possible side effects
5. How to store Carnitor chewable tablets
Driving and using machines
6. Further information
You can drive or use machines whilst taking
Carnitor chewable tablets.
1. What Carnitor chewable tablets are and
what they are used for
Important information about some of the
Carnitor chewable tablets contain levocarnitine
ingredients in Carnitor chewable tablets
which is a type of protein. They are used to
This product contains sugar. If you have been
treat primary and secondary carnitine deficiency told by the doctor that you have an intolerance
in adults and children over 12 years of age.
to some sugars, contact your doctor before
Carnitine deficiency occurs when the body has a taking this medicine.
shortage of levocarnitine Carnitor chewable
tablets make up for your bodies lack of
3. How to take Carnitor chewable tablets
levocarnitine and help give your body more
Always take Carnitor chewable tablets exactly
energy.
as your doctor has told you.
2. Before you take Carnitor chewable tablets
Do not take Carnitor chewable tablets:
- if you are allergic to levocarnitine or any of the
other ingredients in Carnitor chewable tablets.
These ingredients are listed in section 6 of this
leaflet.
If this applies to you, do not take Carnitor
chewable tablets.

33,5

200

190

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.

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

33,5

Codici DE.CA.
DE.CA. codes

20024213

Carnitor 1 g Chewable Tablets

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.
5

5
5

10
20

125

150

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

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.
4. Possible side effects
Like all medicines Carnitor chewable 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 your blood is
taking longer than usual to clot.

Do not use Carnitor chewable 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.
6. Further 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 strips containing ten
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 2014.

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 chewable tablets
Keep out of the reach and sight of children.

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

20024213

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.

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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