Carnitor 30% Paediatric Oral Solution
PACKAGE LEAFLET: INFORMATION FOR THE USER
Carnitor 30% Paediatric 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
The name of your medicine is Carnitor 30% Paediatric Oral Solution but will be referred to as Carnitor throughout this leaflet.
In this leaflet:
1. What Carnitor is and what it is used for
2. Before you give your child Carnitor
3. How to give your child Carnitor
4. Possible side effects
5. How to store Carnitor
6. Further information
1. What Carnitor is and what it is used for
Carnitor 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 makes up for the body's lack of levocarnitine and helps give the body more energy.
2. Before you give your child Carnitor
Do not give your child Carnitor:
- if your child is allergic to levocarnitine or any other ingredients in Carnitor. These ingredients are listed in section 6 of this leaflet.
If this applies to your child, do not give them Carnitor.
Tell your doctor before you give your child Carnitor 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
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
Always give your child Carnitor exactly as your doctor has told you.
How much Carnitor should you give to your child
Your doctor will carefully calculate the amount of Carnitor 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 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 is up to 200mg per kg of your child's bodyweight per day. This should be taken over 24 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 than you should
If you give your child too much Carnitor, contact your doctor or immediately go to the nearest hospital casualty department.
If you forget to give your child Carnitor
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
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 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 you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.
Alternatively you can call Free phone 0808 100 3352 (available between 10am - 2pm Monday - Friday) or fill in a paper form available from your local pharmacy.
5. How to store Carnitor
• Keep out of the sight and reach of children.
• Do not store above 25°C.
• Store in the original package in order to protect from light and moisture.
• Do not take Carnitor after the expiry date which is stated on the carton and bottle label after 'Exp'. The expiry date refers to the last day of that month.
• If the solution become discoloured or show any signs of deterioration, seek the advice of 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.
6. Further information
What Carnitor contains
The active ingredient in Carnitor is levocarnitine.
Each ml contains 300mg of levocarnitine.
The other ingredients are sucrose, sorbitol 70% (noncrystallizing), sodium propylhydroxybenzoate (E217), sodium methylhydroxybenzoate (E219), tartaric acid (E334), cherry flavour, black cherry flavour and purified water.
What Carnitor looks like and the contents of the pack
Carnitor is a colourless or slightly yellow solution.
It comes in 20ml amber glass bottles with plastic child proof caps and one measuring spoon.
Manufactured by: SIGMA-TAU Industrie Farmaceutiche Riunite S.p.A., Via Pontina km 30, 400-00040 Pomezia (Rome, Italy).
Procured from within the EU and repackaged by the Product Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.
Carnitor 30% Paediatric Oral Solution
PL 18799/2927
POM
Leaflet date: 27.06.2016
PACKAGE LEAFLET: INFORMATION FOR THE USER
Levocarnitine 30% Paediatric 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
The name of your medicine is Levocarnitine 30% Paediatric Oral Solution but will be referred to as Levocarnitine throughout this leaflet.
In this leaflet:
1. What Levocarnitine is and what it is used for
2. Before you give your child Levocarnitine
3. How to give your child Levocarnitine
4. Possible side effects
5. How to store Levocarnitine
6. Further information
1. What Levocarnitine is and what it is used for
Levocarnitine 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 makes up for the body's lack of levocarnitine and helps give the body more energy.
2. Before you give your child Levocarnitine
Do not give your child Levocarnitine:
- if your child is allergic to levocarnitine or any other ingredients in Levocarnitine. These ingredients are listed in section 6 of this leaflet.
If this applies to your child, do not give them Levocarnitine.
Tell your doctor before you give your child Levocarnitine 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
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
Always give your child Levocarnitine exactly as your doctor has told you.
How much Levocarnitine should you give to your child
Your doctor will carefully calculate the amount of Levocarnitine 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 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 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 than you should
If you give your child too much Levocarnitine, contact your doctor or immediately go to the nearest hospital casualty department.
If you forget to give your child Levocarnitine
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
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 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 you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.
Alternatively you can call Free phone 0808 100 3352 (available between 10am - 2pm Monday - Friday) or fill in a paper form available from your local pharmacy.
5. How to store Levocarnitine
• Keep out of the sight and reach of children.
• Do not store above 25°C.
• Store in the original package in order to protect from light and moisture.
• Do not take Levocarnitine after the expiry date which is stated on the carton and bottle label after 'Exp'. The expiry date refers to the last day of that month.
• If the solution become discoloured or show any signs of deterioration, seek the advice of 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.
6. Further information
What Levocarnitine contains
The active ingredient in Levocarnitine is levocarnitine. Each ml contains 300mg of levocarnitine.
The other ingredients are sucrose, sorbitol 70% (non-crystallizing), sodium propylhydroxybenzoate (E217), sodium methylhydroxybenzoate (E219), tartaric acid (E334), cherry flavour, black cherry flavour and purified water.
What Levocarnitine looks like and the contents of the pack
Levocarnitine is a colourless or slightly yellow solution.
It comes in 20ml amber glass bottles with plastic child proof caps and one measuring spoon.
Manufactured by: SIGMA-TAU Industrie Farmaceutiche Riunite S.p.A., Via Pontina km 30, 400-00040 Pomezia (Rome, Italy).
Procured from within the EU and repackaged by the Product Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.
Levocarnitine 30% Paediatric Oral Solution
PL 18799/2927
POM
Leaflet date: 27.06.2016