L-Carn drinking solution, 30X10 ml

Areas of application

This preparation is used to treat carnitine deficiency diseases.It is used for levocarnitine replacement therapy and is used in various situations.This includes compensating for levocarnitine losses due to defects in the carnitine transporter in the cell membrane, i.e. in primary systemic carnitine deficiency.It is also used to compensate for levocarnitine losses that occur due to various diseases or as side effects of certain treatments, i.e. in secondary systemic carnitine deficiency.It also serves to compensate for treatment-related levocarnitine losses that can occur as a result of long-term treatment through blood washing in patients with kidney failure, i.e. to replace dialysis-related levocarnitine losses in chronic hemodialysis.Finally, it can also be used as a treatment trial for special forms of muscle wasting diseases with accompanying fatty degeneration of the muscles, which are caused by a levocarnitine deficiency in the muscles, i.e. in muscular dystrophy with lipid accumulation, which is based on a primary muscular levocarnitine deficiency.

Active ingredients and ingredients

This medicine contains 1 g of levocarnitine per 10 ml of solution.Other ingredients include malic acid, saccharin sodium 2 water, concentrated hydrochloric acid, purified water and sodium benzoate as excipients.

Contraindications

The medicine must not be taken if you are hypersensitive (allergic) to the active ingredient levocarnitine or any of the other ingredients of the preparation.

Dosage

Always take the medicine exactly as directed.Please ask your doctor or pharmacist if you are not sure.No prescription is required for this product.

Unless otherwise prescribed by the doctor, the usual dose for children is a total daily dose divided into one or more individual doses;25 to 100 mg levocarnitine per kilogram of body weight.The exact dosage depends on body weight and can be as follows:

For a body weight of up to 5 kg: single dose maximum of half a bottle, total daily dose maximum of half a bottle (corresponding to 500 mg levocarnitine).

For a body weight of up to 10 kg: single dose half a bottle, daily total dose maximum twice half a bottle (corresponding to 1000 mg levocarnitine).

For a body weight of up to 15 kg: single dose half a bottle, daily total dose a maximum of three times half a bottle (corresponding to 1500 mg levocarnitine).

For a body weight of up to 20 kg: single dose half or a whole bottle, daily total dose maximum four times half a bottle or two times a whole bottle (corresponding to 2000 mg levocarnitine).

For a body weight of up to 30 kg: single dose of a whole bottle, daily total dose of a maximum of three times a whole bottle (corresponding to 3000 mg levocarnitine).

If you weigh more than 30 kg: a single dose of one whole bottle, a total daily dose of three times a whole bottle (corresponding to 3000 mg levocarnitine), but a maximum of five bottles (corresponding to 5000 mg levocarnitine).

There are no restrictions on how long you can take the drug.If you take the preparation without a doctor's prescription and you are not sure how long it will take, please ask your doctor or pharmacy.

In the case of kidney dysfunction, administration should be carried out under monitoring of serum levels, especially if the primary urine volume is severely limited (glomerular filtrate below 10 ml/min).When washing blood (hemodialysis), you should take 10 to 20 ml of solution corresponding to 1 to 2 g of levocarnitine, which is 1 to 2 bottles, after each blood wash.

Please talk to your doctor or pharmacist if you have the impression that the effect of the medicine is too strong or too weak.

Even if the recommended dosage is temporarily exceeded, no poisoning is to be expected due to the low toxicity of levocarnitine.No special measures are then required.If you continue therapy, please stick to the recommended dosage.

Do not take a double dose if you forget to take the previous dose.

You must stop taking the medicine immediately if any serious side effects or hypersensitivity (allergy) occur.If you stop taking the preparation for these or other reasons, no further undesirable consequences are to be expected, apart from the possible insufficient success of the therapy.

If you have any further questions about using the medicine, ask your doctor or pharmacy.

Intake

Please take the solution undiluted.

Patient information

Take special care when taking the medicine if you suffer from severely impaired kidney function.In this case, you should not take high doses of the preparation for long periods of time.The safety and effectiveness of oral levocarnitine have not been adequately studied in patients with impaired renal function.If taken for a longer period of time in high doses, in patients with severe kidney dysfunction, especially in kidney failure under dialysis, the toxic excretion products trimethylamine (TMA) or trimethylamine N-oxide (TMAO), which are formed by the intestinal flora and are formed in large quantities, become enriched in the blood instead of being excreted in the urine.Therefore, please do not use high doses of the drug for long periods of time if you have severely impaired kidney function or are regularly treated with blood washes as a result of severe kidney dysfunction or kidney failure.

Insufficient removal of TMA from the blood can also lead to the development of the so-called fish odor syndrome.This creates a fishy smell in your breath, urine and sweat.However, with intravenous administration of levocarnitine, these undesirable side effects can be largely avoided.The product is therefore also available as an injection solution for hemorrhage patients with severe kidney dysfunction or kidney failure (dialysis patients with end-stage renal disease).

Since levocarnitine is an endogenous substance that, according to the available studies, is not broken down by metabolic processes but is excreted unchanged in the urine, increases in the dose-dependent levocarnitine plasma level can occur in cases of kidney dysfunction, depending on the degree of dysfunction.If you have severe kidney dysfunction, please note the relevant dosage information.

If you are undergoing blood washing (chronic hemodialysis), the administration of levocarnitine can briefly reduce triglyceride levels in patients on long-term treatment with blood washing.Since an increase in HDL-cholesterol concentration has also been observed in some cases, triglycerides as well as VLDL and HDL-cholesterol should be monitored regularly.The dosage of lipid-lowering drugs must be adjusted accordingly.

If you are diabetic, giving levocarnitine improves the utilization of glucose.If you use insulin or other blood sugar-lowering medicines, so-called low blood sugar (hypoglycemia) can occur if you take levocarnitine at the same time.For this reason, the blood sugar level must be checked regularly in such cases so that the dosage of blood sugar-lowering drugs can be corrected accordingly.

The medicine has no influence on the ability to drive or use machines.

Pregnancy

Before taking or using any medicines, ask your doctor or pharmacy for advice.

Notes

For information about risks and side effects, read the package leaflet and ask your doctor or pharmacy.

Other

The urine may have a slightly fishy smell, which is harmless.When blood is washed, certain blood lipid levels can decrease (triglyceride levels) or increase (HDL-cholesterol concentration).Therefore, blood lipid levels should be checked regularly.The amount of lipid-lowering medication taken must be adjusted accordingly.