Levocarnitine Paediatric 30% Oral Solution
Patient Information Leaflet
Carnitor® Paediatric 30% Oral Solution
(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 your child. Do not pass it on to others. It may harm them, even if their symptoms are the same as your child's
• 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 Paediatric 30% Oral Solution will be called Carnitor paediatric.
In this leaflet:
1) What Carnitor paediatric is and what it is used for
2) Before you give your child Carnitor paediatric
3) How to give your child Carnitor paediatric
4) Possible side effects
5) How to store Carnitor paediatric
6) Further information
1) WHAT CARNITOR PAEDIATRIC IS AND WHAT IT IS USED FOR
Carnitor paediatric contains levocarnitine which is a type of protein. It is used to treat primary and secondary levocarnitine deficiency in children less than 12 years of age, infants and newborns.
Carnitine deficiency occurs when the body has a shortage of levocarnitine.
Carnitor paediatric makes up for the body's lack of levocarnitine and helps give the body more energy.
2) BEFORE YOU GIVE YOUR CHILD CARNITOR PAEDIATRIC
Do not give your child Carnitor paediatric:
• if your child is allergic to levocarnitine or any other ingredients in Carnitor paediatric. These ingredients are listed in section 6 of this leaflet.
If this applies to your child, do not give them Carnitor paediatric.
Tell your doctor before you give your child Carnitor paediatric if:
• your child has severe kidney problems or kidney disease and is having dialysis
• your child is diabetic and taking insulin, or any other drug to treat their diabetes
• your child is a diabetic or is on a diet to reduce calorie intake
• your child is taking anticoagulant medicine, such as warfarin, or any other drug to reduce blood clotting
• your child has an intolerance to some sugars.
If any of the above apply to your child, talk to your doctor or pharmacist. Taking other medicines
Tell your doctor if your child is taking anticoagulant medicine, such as warfarin, or any other drug to reduce blood clotting.
Your doctor may need to change how often your child is tested to see how fast their blood clots.
Tell your doctor or pharmacist if your child is taking or has recently taken any other medicines, including those obtained without a prescription.
Important information about some of the ingredients of Carnitor paediatric
This product contains sorbitol solution which can cause stomach upsets and diarrhoea when taken in large doses.
This product contains sucrose. If you have been told by the doctor that your child has an intolerance to some sugars, contact your doctor before giving your child this medicine.
It also contains methyl hydroxybenzoate (E217) and propyl hydroxybenzoate (E219) which may cause immediate or delayed allergic reactions.
3) HOW TO GIVE YOUR CHILD CARNITOR PAEDIATRIC
Always give your child Carnitor paediatric exactly as your doctor has told you.
How much Carnitor paediatric should you give to your child
Your doctor will carefully calculate the amount of Carnitor paediatric that your child should take and may vary it depending on their response to the treatment. Your doctor may take blood and urine samples to check the amount of the drug in your child's body.
Method of administration
Carnitor paediatric 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 paediatric is up to 200mg per kg of your child's bodyweight per day. This should be taken over 2-4 doses. Higher doses of up to 400mg per kg of bodyweight per day may be necessary. Your doctor will tell you exactly how much medicine to give your child and when to give it.
If you give your child more Carnitor paediatric than you should
If you give your child too much Carnitor paediatric, contact your doctor or immediately go to the nearest hospital casualty department.
If you forget to give your child Carnitor paediatric
Do not give your child a double dose to make up for a forgotten dose. Simply continue with the next dose as planned.
If your child stops taking Carnitor paediatric
Do not stop giving your child this medicine without first talking to your doctor.
If you have any further questions about giving your child this medicine, please ask your doctor or pharmacist.
4) POSSIBLE SIDE EFFECTS
Like all medicines, Carnitor paediatric can cause side effects, although not everybody gets them.
Side effects are:
• Mild stomach upsets such as stomach cramps or diarrhoea, or your child may feel or be sick for a short time
• Drug-related body odour. Your doctor may reduce your child's dose to help lessen or stop the odour.
• For children also taking anticoagulant medicine, such as warfarin, tests may show their blood is taking longer than usual to clot.
Reporting of side effects
If your child gets 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 PAEDIATRIC
• Keep out of the sight and reach of children.
• Do not use Carnitor paediatric after the expiry date which is stated on the bottle label after EXP. The expiry date refers to the last day of that month.
• Do not store above 25oC.
• Keep the bottle in the outer carton in order to protect from light and moisture.
• If your medicine shows any sign of deterioration, return it to your pharmacist.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
What Carnitor paediatric contains
Each 1 ml contains 300mg of levocarnitine.
The other ingredients are sucrose, sorbitol solution 70% (non-crystallising), cherry flavour, black cherry flavour, purified water, sodium methyl parahydroxybenzoate and sodium propyl parahydroxybenzoate as preservatives.
What Carnitor paediatric looks like and contents of the pack
Carnitor paediatric is a colourless or slightly yellow oral solution. It comes in 20ml amber glass bottles with plastic child proof caps and 3.3ml measuring spoon.
Manufactured by
Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.,
Via Pontina km 30,400 - 00040 Pomezia, Italy.
Procured from within the EU by the Product Licence Holder:
MPT Pharma Ltd, Westgate Business Park, Unit 5-7 Tintagel Way, Aldridge, Walsall WS9 8ER.
Repackaged by MPT Pharma Ltd.
POM
PL: 33532/0658
Leaflet dated 6th April 2016 Leaflet coded XXXXXXXXXXX
Carnitor® and sigma-tau® are registered trademarks of Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.
Levocarnitine Paediatric 30% Oral Solution
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 your child. Do not pass it on to others. It may harm them, even if their symptoms are the same as your child's
• 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 Levocarnitine Paediatric 30% Oral Solution will be called Levocarnitine paediatric.
In this leaflet:
1) What Levocarnitine paediatric is and what it is used for
2) Before you give your child Levocarnitine paediatric
3) How to give your child Levocarnitine paediatric
4) Possible side effects
5) How to store Levocarnitine paediatric
6) Further information
1) WHAT LEVOCARNITINE PAEDIATRIC IS AND WHAT IT IS USED FOR
Levocarnitine paediatric contains levocarnitine which is a type of protein.
It is used to treat primary and secondary levocarnitine deficiency in children less than 12 years of age, infants and newborns.
Carnitine deficiency occurs when the body has a shortage of levocarnitine.
Levocarnitine paediatric makes up for the body's lack of levocarnitine and helps give the body more energy.
2) BEFORE YOU GIVE YOUR CHILD LEVOCARNITINE PAEDIATRIC
Do not give your child Levocarnitine paediatric:
• if your child is allergic to levocarnitine or any other ingredients in Levocarnitine paediatric. These ingredients are listed in section 6 of this leaflet.
If this applies to your child, do not give them Levocarnitine paediatric.
Tell your doctor before you give your child Levocarnitine paediatric if:
• your child has severe kidney problems or kidney disease and is having dialysis
• your child is diabetic and taking insulin, or any other drug to treat their diabetes
• your child is a diabetic or is on a diet to reduce calorie intake
• your child is taking anticoagulant medicine, such as warfarin, or any other drug to reduce blood clotting
• your child has an intolerance to some sugars.
If any of the above apply to your child, talk to your doctor or pharmacist. Taking other medicines
Tell your doctor if your child is taking anticoagulant medicine, such as warfarin, or any other drug to reduce blood clotting.
Your doctor may need to change how often your child is tested to see how fast their blood clots.
Tell your doctor or pharmacist if your child is taking or has recently taken any other medicines, including those obtained without a prescription.
Important information about some of the ingredients of Levocarnitine paediatric
This product contains sorbitol solution which can cause stomach upsets and diarrhoea when taken in large doses.
This product contains sucrose. If you have been told by the doctor that your child has an intolerance to some sugars, contact your doctor before giving your child this medicine.
It also contains methyl hydroxybenzoate (E217) and propyl hydroxybenzoate (E219) which may cause immediate or delayed allergic reactions.
3) HOW TO GIVE YOUR CHILD LEVOCARNITINE PAEDIATRIC
Always give your child Levocarnitine paediatric exactly as your doctor has told you.
How much Levocarnitine paediatric should you give to your child
Your doctor will carefully calculate the amount of Levocarnitine paediatric that your child should take and may vary it depending on their response to the treatment. Your doctor may take blood and urine samples to check the amount of the drug in your child's body.
Method of administration
Levocarnitine paediatric 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 paediatric is up to 200mg per kg of your child's bodyweight per day. This should be taken over 2-4 doses. Higher doses of up to 400mg per kg of bodyweight per day may be necessary. Your doctor will tell you exactly how much medicine to give your child and when to give it.
If you give your child more Levocarnitine paediatric than you should
If you give your child too much Levocarnitine paediatric, contact your doctor or immediately go to the nearest hospital casualty department.
If you forget to give your child Levocarnitine paediatric
Do not give your child a double dose to make up for a forgotten dose. Simply continue with the next dose as planned.
If your child stops taking Levocarnitine paediatric
Do not stop giving your child this medicine without first talking to your doctor.
If you have any further questions about giving your child this medicine, please ask your doctor or pharmacist.
4) POSSIBLE SIDE EFFECTS
Like all medicines, Levocarnitine paediatric can cause side effects, although not everybody gets them.
Side effects are:
• Mild stomach upsets such as stomach cramps or diarrhoea, or your child may feel or be sick for a short time
• Drug-related body odour. Your doctor may reduce your child's dose to help lessen or stop the odour.
• For children also taking anticoagulant medicine, such as warfarin, tests may show their blood is taking longer than usual to clot.
Reporting of side effects
If your child gets 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 PAEDIATRIC
• Keep out of the sight and reach of children.
• Do not use Levocarnitine paediatric after the expiry date which is stated on the bottle label after EXP. The expiry date refers to the last day of that month.
• Do not store above 25oC.
• Keep the bottle in the outer carton in order to protect from light and moisture.
• If your medicine shows any sign of deterioration, return it to your pharmacist.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
What Levocarnitine paediatric contains
Each 1 ml contains 300mg of levocarnitine.
The other ingredients are sucrose, sorbitol solution 70% (non-crystallising), cherry flavour, black cherry flavour, purified water, sodium methyl parahydroxybenzoate and sodium propyl parahydroxybenzoate as preservatives.
What Levocarnitine paediatric looks like and contents of the pack
Levocarnitine paediatric is a colourless or slightly yellow oral solution. It comes in 20ml amber glass bottles with plastic child proof caps and 3.3ml measuring spoon.
Manufactured by Sigma-Tau Industrie Farmaceutiche Riunite S.p.A., Via Pontina km 30,400 - 00040 Pomezia, Italy.
Procured from within the EU by the Product Licence Holder:
MPT Pharma Ltd, Westgate Business Park, Unit 5-7 Tintagel Way, Aldridge, Walsall WS9 8ER.
Repackaged by MPT Pharma Ltd.
POM
PL: 33532/0658
Leaflet dated 6th April 2016 Leaflet coded XXXXXXXXXXX
Sigma-tau® is a registered trademark of Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.