Levocarnitine Paediatric 30% Oral Solution alcohol free & sugar free

• 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 signs of illness are the same as your child’s.
• If your child gets any side effects, talk to your doctor or pharmacist. This includes any possible side effect not listed in this leaflet. See section 4.
• In this leaflet Levocarnitine Paediatric 30% Oral Solution will be called Levocarnitine paediatric.

1. What Levocarnitine paediatric is and what it is used for
2. What you need to know 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. Contents of the pack and other information

• if your child is allergic to levocarnitine or any of the other ingredients in this medicine (listed in section 6).

Talk to 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 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.

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.

This medicine contains 200mg of 70% sorbitol solution in each 2ml dose which is equivalent to 100mg/ml.

Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you (or your child) take or receive this medicine.

It also contains methyl hydroxybenzoate (E217) and propyl hydroxybenzoate (E219) which may cause immediate or delayed allergic reactions.

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.

Levocarnitine paediatric is for oral use. It can be drunk directly or diluted further with water or fruit juices.

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 too much Levocarnitine paediatric, contact your doctor or immediately go to the nearest hospital casualty department.

Do not give your child a double dose to make up for a forgotten dose. Simply continue with the next dose as planned.

Do not stop giving your child this medicine without first talking to your doctor.

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 - Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

The active substance is levocarnitine. Levocarnitine paediatric contains 30% w/v (300mg/ml) levocarnitine in each 20ml, 40ml and 50ml amber glass bottle.

The other ingredients are sorbitol solution (E420), sodium methyl hydroxybenzoate (E219) and sodium propyl hydroxybenzoate (E217), purified water and hydrochloric acid, concentrated (E507).

Levocarnitine paediatric is a colourless to yellowish, clear solution. It comes in 20ml, 40ml and 50ml amber glass bottles with plastic polyethylene-polypropylene child-proof caps and a graduated dosage pipette, along with the patient information leaflet.