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, email@example.com, 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.
Folder Preferences New Features! QUEENS UNIV LIBRARY Advanced Databases New Search Keyword Publications Subject Terms Cited References Indexes Result List | Refine Search Add to folder Citation HTML Full Text Times Cited in this Database(1) Title: WHY ARE WE SO fat? By: Newman, Cathy, National Geographic, 00279358, Aug2004, Vol. 206,