Patient leaflet - Levocarnitine 1 g solution for injection
What Levocarnitine injection is and what it is used for
Levocarnitine injection contains levocarnitine which is a
type of protein. It is used to treat primary and secondary
carnitine deficiency in adults, children, infants and
newborn children. It can also be used to treat secondary
carnitine deficiency in haemodialysis patients.
Carnitine deficiency occurs when the body has a shortage
of levocarnitine. Levocarnitine injection makes up for
your bodies lack of levocarnitine and helps give your body
more energy.
Before you are given Levocarnitine injection
Do not take Levocarnitine injection
if you are allergic to Levocarnitine or any of the other
ingredients in this medicine (listed in section 6).
If this applies to you, do not take Levocarnitine injection.
Warnings and precautions
Talk to 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.
Other medicines and Levocarnitine
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, pharmacist or nurse if you are taking or
have recently taken any other medicines, including those
obtained without a prescription.
Pregnancy, breast-feeding and fertility
Pregnancy
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor
for advice before taking this medicine.
Breast-feeding
Levocarnitine is a normal component of breast milk.
If you wish to breast-feed, ask your doctor for advice.
Fertility
Levocarnitine has no safety issues on fertility.
Driving and using machines
You can drive or use machines whilst taking
Levocarnitine injection.
How you will be given Levocarnitine injection
Always use this medicine exactly as your doctor has told
you. Check with your doctor if you are not sure.
How much Levocarnitine injection will you be given
Your doctor will carefully calculate the amount of
Levocarnitine injection that you should be given 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
Your doctor will give the injection slowly into your vein
(intravenous injection) over a period of 2-3 minutes.
Primary Carnitine deficiency
The usual dose of Levocarnitine injection is 100mg per
kg of your body weight per day. This will be given over
3-4 doses.
Secondary Carnitine deficiency in haemodialysis
patients (dialysis of the blood)
A dose of 20mg per kg of your body weight should be
given in the same way as above at the end of each
dialysis session (assuming three sessions per week). The
treatment should last at least three months, which is
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The following information is intended for healthcare professionals only:
Name of the medicinal product
Levocarnitine 1g solution for injection
Pharmaceutical form
Solution for injection.
Colourless to yellowish clear solution. Practically free of particles.
Posology and method of administration
Posology
Adults, children, infants and neonates:
It is advisable to monitor therapy by measuring free and acyl carnitine levels in both plasma and urine.
The management of inborn errors of metabolism
The dosage required depends upon the specific inborn error of metabolism concerned and the severity of presentation at the time of treatment. However, the following can be considered as a general guide. In acute decompensation, dosages of up to 100mg/kg/day in 3-4 divided doses are recommended. Higher doses have been used although an increase in adverse events, primarily diarrhoea, may occur.
Secondary carnitine deficiency in haemodialysis patients
It is strongly recommended that, before initiating therapy with Levocarnitine, plasma carnitine is measured. Secondary carnitine deficiency is suggested by a plasma ratio of acyl to free carnitine of greater than 0.4 and/or when free carnitine concentrations are lower than 20μmol/litre.
A dose of 20mg per kg should be administered as an intravenous bolus at the end of each dialysis session (assuming three sessions per week). The duration of intravenous treatment should be at least three months, which is the time usually required to restore normal muscle levels of free carnitine. The overall response should be assessed by monitoring plasma acyl to free carnitine levels and by evaluating the patient’s symptoms.
the time required to restore normal muscle levels of free carnitine. If significant benefit is seen following the first course of treatment ongoing therapy using 1g per day of Levocarnitine oral solution may be used. On the day of dialysis, Levocarnitine oral solution should be taken at the end of the dialysis session.
If you are elderly you do not need special precautions or modifications to Levocarnitine dosage.
If you are given more Levocarnitine injection than you should
If you have been given too much Levocarnitine injection, tell your doctor or nurse.
If you have any further questions on using this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines this medicine can cause side effects, although not everybody gets them.
Common side effects (may affect up to 1 in 10 people):
- Mild stomach upsets such as stomach cramps and vomiting, diarrhoea, or you may feel or be sick for a short time.
Uncommon side effects (may affect up to 1 in 100 people):
- Drug-related body and/or skin odour (your doctor may reduce your dose to help lessen or stop the odour), headache, increased/high blood pressure or low blood pressure, altered taste, sudden and involuntary muscle contraction (muscle spasms), feeling abnormal, injection site reaction, fever.
Very rare side effects (may affect up to 1 in 10,000 people):
- International Normalised Ratio increased; for people also taking an anticoagulant medicine, such as warfarin, tests may show your blood is taking longer than usual to clot.
Not known side effects (frequency cannot be estimated from the available data):
- Convulsions*, itching, rash, muscle rigidity. *In patients with prior convulsive episodes or underling predisposing conditions to convulsions.
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 Website: www.mhra.gov.uk/ yellowcard or search for MHRA Yellow Card in the Google Play or Apple App.
By reporting side affects you can help provide more information on the safety of this medicine.
How to store Levocarnitine injection
Keep out of the sight and reach of children.
Do not use Levocarnitine injection after the expiry date stated on the sealed glass ampoule. The expiry date refers to the last day of that month.
This medicinal product does not require any special temperature storage conditions. Keep the ampoules in the original package in order to protect from light. Do not throw away any medicines via wastewater or in household waste. Ask your pharmacist or nurse how to throw away medicines you no longer use. These measures will help protect the environment.
Contents of the pack and other information
What Levocarnitine injection contains
- The active substance is levocarnitine. Each 5ml ampoule contains 1g of levocarnitine.
Each 1ml contains 200mg of levocarnitine.
- The other ingredients are hydrochloric acid 10% for pH adjustment and water for injections.
What Levocarnitine injection looks like and contents of the pack
Levocarnitine injection is a colourless to yellowish clear liquid, practically free of particles. It comes in 5ml clear glass ampoules. The ampoules are placed in a plastic case, of a capacity to hold 5 ampoules, and packed in carton box along with the patient information leaflet.
Marketing Authorisation Holder
Aspire Pharma Limited
Unit 4, Rotherbrook Court
Bedford Road
Petersfield, GU32 3QG
United Kingdom
Manufacturer
HELP S.A.
Pedini Ioanninon
Ioannina, 45500
Greece.
This leaflet was last revised in May 2026.
1010808 - P1.2
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When carnitine supplementation has been stopped there will be a progressive decline in carnitine levels. The need for a repeat course of therapy can be assessed by plasma carnitine assays at regular intervals and by monitoring the patient’s symptoms.
Haemodialysis - maintenance therapy
If significant clinical benefit has been gained by a first course of intravenous Levocarnitine then maintenance therapy can be considered using 1g per day of Levocarnitine orally. On the day of the dialysis oral Levocarnitine has to be administered at the end of the session.
Elderly
No changes in posology are necessary in elderly patients. The observed safety profile in clinical studies is similar in elderly and younger adults (see section 4.4 of the SmPC).
Method of administration
For slow intravenous administration over 2-3 minutes.
Special precautions for storage
This medicinal product does not require any special temperature storage conditions.
Keep the ampoules in the outer carton in order to protect from light.
Nature and contents of container
Clear type I glass ampoules, of 5ml capacity.
The ampoules are packed in a white plastic case with capacity to hold 5 ampoules in a carton box.
Special precautions for disposal
For single use only. Any unused solution should be discarded.
The medicinal product is to be inspected visually for particulate matter and discolouration prior to administration. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.