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LEVOCARNITINE 1 G ORAL SOLUTION

Active substance(s): LEVOCARNITINE / LEVOCARNITINE

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Carnitor® 1 g Oral Solution

2970
20.06.17[4]

(levocarnitine)
PATIENT INFORMATION LEAFLET
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
This medicine is available using the above name but will be referred to as
Carnitor solution throughout the following.
In this leaflet:
1. What Carnitor solution is and what it is used for
2. Before you take Carnitor solution
3. How to take Carnitor solution
4. Possible side effects
5. How to store Carnitor solution
6. Further information
1. WHAT CARNITOR SOLUTION IS AND WHAT IT IS USED FOR
Carnitor solution contains levocarnitine which is a type of protein. It is 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 solution makes up for your bodies lack of levocarnitine and helps
give your body more energy.
2. BEFORE YOU TAKE CARNITOR SOLUTION
Do not take Carnitor solution:
- if you are allergic to levocarnitine or any of the other ingredients in
Carnitor solution. These ingredients are listed in section 6 of this leaflet.
If this applies to you, do not take Carnitor solution.
Tell your doctor before you take Carnitor solution 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.
If any of the above applies 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.
Tell your doctor or pharmacist 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 solution. 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 solution.
Important information about some of the ingredients in Carnitor
solution
This product contains methyl hydroxybenzoate (E219) and propyl
hydroxybenzoate (E217) which may cause immediate or delayed allergic
reactions.
Sucrose and sorbitol are types of sugars. If you have been told by your
doctor that you have an intolerance to some sugars, contact your doctor
before taking this medicinal product.
3. HOW TO TAKE CARNITOR SOLUTION
Always take Carnitor solution exactly as your doctor has told you.
How much Carnitor solution should you take
Your doctor will carefully calculate the amount of Carnitor solution that you
should take and may vary it depending on your response to the treatment.
Your doctor may take blood and urine samples to check the amount of the
drug in your body.
Method of administration
Carnitor solution 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 solution 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 much to take and when to take it.
Maintenance therapy for haemodialysis patients
If significant benefit was gained by a first course of Carnitor injection then
ongoing therapy of 1g per day of Carnitor solution may be taken. On the day
of dialysis Carnitor solution must be taken at the end of the session.
If you take more Carnitor solution than you should
If you take too much Carnitor solution, contact your doctor or immediately go
to the nearest hospital casualty department.
If you forget to take Carnitor solution
Do not take a double dose to make up for a forgotten dose. Simply continue
with the next dose as planned.
If you stop taking Carnitor solution
Do not stop taking the medicine without first talking to your doctor.
If you have any further questions about taking this medicine, please ask
your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Carnitor solution 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
- For people also taking anticoagulant medicine, such as warfarin, tests
may show your blood is taking longer than usual to clot.
- Drug-related body odour. Your doctor may reduce your dose to help
lessen or stop the odour.
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 SOLUTION
Keep out of the sight and reach of children.
Do not store above 25oC.
Store in the original package to protect from light.
Do not use Carnitor after the expiry date stated on the bottle. The expiry
date refers to the last day of that month.
Medicines should not be thrown away in waste water or in household waste.
Return any medicine you no longer need to your pharmacist.
If your medicines show any signs of deterioration or discolouration, you
should seek the advice of your pharmacist who will tell you what to do.
6. FURTHER INFORMATION
What Carnitor solution contains
- The active substance is levocarnitine.
- Each 10 ml bottle contains 1 g of levocarnitine
- The other ingredients are sucrose, malic acid, sorbitol, saccharin sodium,
sodium methyl parahydroxybenzoate (E219), sodium propyl
parahydroxybenzoate (E217), mandarin flavour and purified water.
What Carnitor solution looks like and contents of the pack
Carnitor solution is a colourless or slightly yellow solution with an orange
aroma.
It comes in 10 ml amber glass bottles with fully removable plastic caps.
Pack size – 10 bottles x 10 ml.
MANUFACTURER AND PRODUCT LICENCE HOLDER
Carnitor Solution is manufactured by Sigma-Tau Industrie Farmaceutiche
Riunite S.p.A Via Pontina Km. 30, 400-00071 Pomezia, Italy.
Procured from within the EU by Product Licence holder
Star Pharmaceuticals Ltd., 5 Sandridge Close, Harrow, Middlesex, HA1
1XD. Repackaged by Servipharm Ltd.
POM

PL 20636/2970

Leaflet revision and issue date (Ref) 20.06.17[4]
Carnitor is a trademark of Sigma-Tau Industrie Farmaceutiche Riunite
S.p.A.

Blind or partially sighted?
Is this leaflet hard to see or read?
Call 020 8423 2111 to obtain the
leaflet in a format suitable for you.

Levocarnitine 1 g Oral Solution

2970
20.06.17[4]

(levocarnitine)
PATIENT INFORMATION LEAFLET
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
This medicine is available using the above name but will be referred to as
Levocarnitine solution throughout the following.
In this leaflet:
1. What Levocarnitine solution is and what it is used for
2. Before you take Levocarnitine solution
3. How to take Levocarnitine solution
4. Possible side effects
5. How to store Levocarnitine solution
6. Further information
1. WHAT LEVOCARNITINE SOLUTION IS AND WHAT IT IS USED FOR
Levocarnitine solution contains levocarnitine which is a type of protein. It is
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.
Levocarnitine solution makes up for your bodies lack of levocarnitine and
helps give your body more energy.
2. BEFORE YOU TAKE LEVOCARNITINE SOLUTION
Do not take Levocarnitine solution:
- if you are allergic to levocarnitine or any of the other ingredients in
Levocarnitine solution. These ingredients are listed in section 6 of this
leaflet.
If this applies to you, do not take Levocarnitine solution.
Tell your doctor before you take Levocarnitine solution 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.
If any of the above applies 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.
Tell your doctor or pharmacist 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 Levocarnitine solution. 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 Levocarnitine solution.
Important information about some of the ingredients in Levocarnitine
solution
Important information about some of the ingredients in Carnitor
solution
This product contains methyl hydroxybenzoate (E219) and propyl
hydroxybenzoate (E217) which may cause immediate or delayed allergic
reactions.
Sucrose and sorbitol are types of sugars. If you have been told by your
doctor that you have an intolerance to some sugars, contact your doctor
before taking this medicinal product.
3. HOW TO TAKE LEVOCARNITINE SOLUTION
Always take Levocarnitine solution exactly as your doctor has told you.
How much Levocarnitine solution should you take
Your doctor will carefully calculate the amount of Levocarnitine solution that
you should take and may vary it depending on your response to the
treatment. Your doctor may take blood and urine samples to check the
amount of the drug in your body.
Method of administration
Levocarnitine solution 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 Levocarnitine solution 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 much to take and when to take it.
Maintenance therapy for haemodialysis patients
If significant benefit was gained by a first course of Levocarnitine injection
then ongoing therapy of 1g per day of Levocarnitine solution may be taken.
On the day of dialysis Levocarnitine solution must be taken at the end of the
session.
If you take more Levocarnitine solution than you should
If you take too much Levocarnitine solution, contact your doctor or
immediately go to the nearest hospital casualty department.
If you forget to take Levocarnitine solution
Do not take a double dose to make up for a forgotten dose. Simply continue
with the next dose as planned.
If you stop taking Levocarnitine solution
Do not stop taking the medicine without first talking to your doctor.
If you have any further questions about taking this medicine, please ask
your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Levocarnitine solution 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
- For people also taking anticoagulant medicine, such as warfarin, tests
may show your blood is taking longer than usual to clot.
- Drug-related body odour. Your doctor may reduce your dose to help
lessen or stop the odour.
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 LEVOCARNITINE SOLUTION
Keep out of the sight and reach of children.
Do not store above 25oC.
Store in the original package to protect from light.
Do not use Carnitor after the expiry date stated on the bottle. The expiry
date refers to the last day of that month.
Medicines should not be thrown away in waste water or in household waste.
Return any medicine you no longer need to your pharmacist.
If your medicines show any signs of deterioration or discolouration, you
should seek the advice of your pharmacist who will tell you what to do.
6. FURTHER INFORMATION
What Levocarnitine solution contains
- The active substance is levocarnitine.
- Each 10 ml bottle contains 1 g of levocarnitine
- The other ingredients are sucrose, malic acid, sorbitol, saccharin sodium,
sodium methyl parahydroxybenzoate (E219), sodium propyl
parahydroxybenzoate (E217), mandarin flavour and purified water.
What Levocarnitine solution looks like and contents of the pack
Levocarnitine solution is a colourless or slightly yellow solution with an
orange aroma.
It comes in 10 ml amber glass bottles with fully removable plastic caps.
Pack size – 10 bottles x 10 ml.
MANUFACTURER AND PRODUCT LICENCE HOLDER
Levocarnitine Solution is manufactured by Sigma-Tau Industrie
Farmaceutiche Riunite S.p.A Via Pontina Km. 30, 400-00071 Pomezia, Italy.
Procured from within the EU by Product Licence holder
Star Pharmaceuticals Ltd., 5 Sandridge Close, Harrow, Middlesex, HA1
1XD. Repackaged by Servipharm Ltd.
POM

PL 20636/2970

Leaflet revision and issue date (Ref) 20.06.17[4]

Blind or partially sighted?
Is this leaflet hard to see or read?
Call 020 8423 2111 to obtain the
leaflet in a format suitable for you.

Expand Transcript

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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