Microsoft word - palen-2105495-lctr-sep2012_cv.rtf

L-Carn® solution to drink, liquid for internal use
ENR.:.2105495
Information for use: Information for the user
Information for use: Information for the user
L-Carn® Solution to drink, 1 g levocarnitine / 10 ml, liquid for internal use

Please read the package insert carefully and completely as it contains important information
for you.

This medical product is available without prescription. However, to achieve the best possible
treatment results, L-Carn® solution to drink must be applied in accordance with the
instructions.
• Please preserve the package insert. You may want to refer to it at a later time.
• Consult your pharmacist for further information or advice.
• If your condition deteriorates without any amelioration, you need to consult a physician without
exception.
• If one of the side effects listed here should cause considerable disturbance for you or if you notice
side effects not mentioned in this information for use, please inform your physician or pharmacist.
This package insert includes:
1. What is L-Carn® solution to drink and what is it applied for?
2. What do you need to know before taking L-Carn® solution to drink?
3. How to take L-Carn® solution to drink?
4. What are the possible side effects?
5. How to store L-Carn® solution to drink?
6. Further information
1. WHAT IS L-CARN® SOLUTION TO DRINK AND WHAT IS IT APPLIED FOR?

L-Carn® Trinklösung is used for the treatment of carnitine deficiencies diseases (levocarnitine
substitution treatment).
L-Carn® solution to drink is used:
- to balance levocarnitine losses due to defects of the so-called carnitine transporters in the cell
membrane (substitution in case of a primary systemic carnitine deficiency).
- to balance levocarnitine losses that may have been caused by various diseases and as side effects
of certain types of treatment (substitution in case of a secondary systemic carnitine deficiency).
- to balance treatment-related levocarnitine losses that may result from long-term treatment involving
haemodialysis in patients with kidney failure (substitution of dialysis-related levocarnitine losses in
case of chronic haemodialysis, i.e. as a result of a secondary levocarnitine deficiency)
- as treatment for special forms of muscular dystrophy with concomitant muscular steatosis resulting
from a levocarnitine deficiency of the muscular system (muscular dytrophy with lipid accumulation due
to a primary muscular levocarnitine deficiency).
2. WHAT DO YOU NEED TO KNOW BEFORE TAKING L-CARN® SOLUTION TO DRINK?

L-Carn® solution to drink may not be taken
- if you are hypersensitive (allergic) against the active ingredient levocarnitine, sodium benzoate or any
of the other ingredients of L-Carn® solution to drink.
Particular care with regard to the application of L-Carn® solution to drink is required
- if the function of your kidneys is severely impaired you should not take high doses of L-Carn®
solution to drink over a longer period. The safety and effectiveness of levocarnitine for internal use
(oral application) has not yet been sufficiently examined with patients suffering from impaired kidney
function (kidney insufficiency). If higher doses of levocarnitine are taken over a longer period by
patients with pronounced kidney dysfunction, in particular kidney failure (terminal kidney insufficiency)
under dialysis, this may result in the toxic waste products trimethylamine (TMA) or trimethylamine-N-
oxide (TMAO) that are produced by the intestinal flora collecting in the blood instead of being
discharged with the urine. Therefore, please do not take higher doses of L-Carn® solution to drink
over longer periods if you suffer from a severe impairment of the kidney function or are treated with
regular blood dialyses as a result of a severe kidney dysfunction or kidney failure.
Furthermore, the insufficient discharge of TMA from the blood may lead to the development of a so-
called fish-odour syndrome. This creates a fishy odour emanating from the breath, urine and sweat. In
contrast, such undesired side effects can be largely avoided if levocarnitine is given intravenously. For
blood dialysis patients with severe kidney dysfunction or kidney failure (dialysis patients with therminal
kidney insufficiency), L-Carn® is therefore also available as injectable solution.
As levocarnitine is an endogenic substance which, according to relevant tests, is not decomposed by
metabolic processes but is discharged unmodified with the urine, the dosage-dependent levocarnitine
plasma level may increase in case of kidney dysfunctions, depending on the severity of the
dysfunction. Therefore, please observe the respective dosing instructions if you suffer from a kidney
dysfunction.
- if you undergo blood dialysis (chronic haemodialysis). With patients under long-term treatment
involving blood dialysis (haemodialysis) the triglyceride level may decrease in the short term. As an
increase of the HDL cholesterol concentration has also been observed in some cases, triglycerides as
well as VLDL and HDL cholesterol should be monitored regularly. The dosing of lipid-lowering drugs
(antilipidemic drugs) must therefore be adapted accordingly.
- if you have diabetes. In persons with diabetes the administration of levocarnitine enhances the
utilisation of glucose. If you take insulin or other blood-sugar-decreasing medical drugs, a so-called
hypoglycaemia may occur if levocarnitine is taken at the same time. For this reason the blood sugar
level must be checked at regular intervals in such cases so as to adjust the dosing of blood-sugar-
decreasing medical drugs accordingly.
Use of other medical products concomitantly with L-Carn® solution to drink:
If you use insulin or other blood-sugar-decreasing medical products, a so-called hypoglycaemia may
occur if levocarnitine is taken at the same time (also see section ‘Particular care with regard to the
application of L-Carn® solution to drink is required’).
There have been very rare reports of increased International Normalised Ratio (INR) in patients
treated concomitantly with L-Carnitine and coumarinic drugs. INR – or other appropriate tests of
coagulation – should be checked weekly until they become stable, and monthly thereafter, in patients
taking such anticoagulants together with L-Carnitine.
Please inform your physician or pharmacist if you are taking/using, or have been taking or using until
recently, other medical drugs, even if these are not prescription drugs.
When taking L-Carn® solution to drink concomitantly with food and beverages
So far, we are not of any impact of food and beverages on the effect of L-Carn® solution to drink.
Pregnancy and lactation period
Please consult your physician or pharmacist before taking or using and medical products.
Fitness to drive and operate machinery:
L-Carn® solution to drink does not affect the fitness to drive or operate machinery.
Important information on specific other components of L-Carn® solution to drink
L-Carn® solution to drink contains sodium benzoate. Sodium benzoate may cause hypersensitivity
reactions. Therefor particular care with regard to the application of L-Carn® solution to drink is
required.
3. HOW TO TAKE L-CARN® SOLUTION TO DRINK?

Always take L-Carn® solution to drink faithfully according to the instructions of this package insert.
Please consult your physician or pharmacist in case of doubt.
Unless prescribed otherwise by the physician the usual dose is:
mg levocarnitine, but not more than 5 flasks (corresponding to 5,000 mg levocarnitine) (corresponding to 1,000 mg levocarnitine) (corresponding to 1,500 mg levocarnitine) flask (corresponding to 2,000 mg levocarnitine) (corresponding to 3,000 mg levocarnitine) 3,000 mg levocarnitine) but not more than 5 flasks (corresponding to 5,000 mg levocarnitine) Please take L-Carn® solution to drink undiluted.
There are no restrictions concerning the period over which L-Carn® solution to drink can be taken. If
you take L-Carn® without a physician’s prescription and are unsure as to the period over which to take
the product, please consult your physician or pharmacist.
Dosing in case of a kidney dysfunction
In cases with severe impairments of the primary urine volume (glomerular filtrate below 10 ml/min), the
product should be used under monitoring of the serum level.
Dosing in case of blood dialysis (haemodialysis)
After every haemodialysis take 10 to 20 ml solution corresponding to 1-2 g levocarnitine, i.e. 1 to 2
flasks, after the haemodialysis.
As this is a treatment to balance levocarnitine losses (substitution treatment), your physician will
decide, depending on the clinical picture and in consideration of the lab tests cited above, for how long
you should L-Carn® solution to drink.
Please talk to your physician or pharmacist if you think that the effect of L-Carn® solution to drink is
too weak or too strong.
If you have taken a larger amount of L-Carn® solution to drink than you should
Because of the very low toxicity of levocarnitine, no toxic effect must be expected even if the dose has
temporarily exceeded the recommended dose. No special measures are required in this case. When
resuming treatment, please adhere to the recommended dose.
If you have forgotten to take L-Carn® solution to drink
Do not take a double dose if you have forgotten to take the previous dose.
If you stop taking L-Carn® solution to drink

In the event of severe side effects or a hypersensitivity (allergy), you must stop taking L-Carn®
solution to drink immediately. If you stop taking L-Carn® solution to drink for this or other reasons, you
do not have to expect any detrimental effects resulting from this, with the possible exception of an
unsatisfactory treatment success.
If you have any further question concerning the use of the medical product, please consult your
physician or pharmacist.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following frequency information is used as the basis for the assessment of side effects:
Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Rare: may affect up to 1 in 1,000 people
Very rare: may affect up to 1 in 10,000 people
Not known: frequency cannot be estimated from the available data
Possible side effects:
L-Carn® solution to drink is generally very well-digestible. Therefore side effects of levocarnitine are
rarely observed. Following the administration of Levocarnitine, in particular in high doses, a rare
consequence may be nausea, vomiting or diarrhea. Also rare are signs of muscle weakness in
patients with uraemia.
Very rare side effects are abdominal cramps or an odour of the body. In patients that were treated
concomitantly with L-carnitine and coumarinic drugs (acenocumarol and warfarin) an increase in the
so-called International Normalised Ratio (INR) was observed.
In some isolated cases, cerebral convulsions were observed following the administration of
Levocarnitine. In this regard, no relation with any previously known predisposition to such attacks was
established.
In such cases you should stop taking L-Carn® solution to drink immediately and discuss the further
treatment with your physician.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side
effects not listed in this leaflet.
5. HOW TO STORE L-CARN® SOLUTION TO DRINK?

Keep the medical product out of the reach of children.
You may not use the medical product after the use-by date printed on the outer box and the flask seal
after “Use by”. The use-by date refers to the last day of the month.
Storage conditions:
Do not store above 25 °C.
Note on the shelf life following opening or preparation
You may not use L-Carn® solution to drink if turbidity or coagulation can be seen in the liquid. The
liquid needs to be clear and may not contain any particles.
The medical product may not be disposed of in the sewer or with household waste. If you no longer
need the medical product, consult your pharmacist on how to dispose of it. This helps to protect the
environment.
6. FURTHER INFORMATION

What L-Carn® solution to drink contains:
The active ingredient is: Levocarnitine
1 flask with 10 ml liquid contains: Levocarnitine 1 g
The other ingredients are:
sodium benzoate, sodium saccharin ·2H2O, malic acid, hydrochloric acid 23%, cleaned water.
How L-Carn® solution to drink looks, content of the package:
Folding carton with 10 [N1], 30 [N2] and 50 [N3] flasks with 10 ml liquid for internal use each.
Marketing authorisation holder
sigma-tau Arzneimittel GmbH, Schadowstraße 44, 40212 Düsseldorf, Germany, telephone: 0211-
687717-0, fax: 0211-161527, info@sigma-tau.de, www.sigma-tau.de
Manufacturer
sigma-tau industrie farmaceutiche riunite s.p.a., Via Pontina km 30.400, I – 00040 Pomezia (Rome),
Italy
This medical product is authorised in the member states of the European Economic Area (EEA)
under the following names:
Germany L-Carn®
L-Carnitin "Fresenius"- orale Lösung
This information for use was last revised in October 2012.

Source: http://www.sigma-tau.de/fileadmin/product_docs/l_carn/tr_loesung/open/L-Carn_oral_drops_en.pdf