Carnitene Oral Solution 1.5 g/5 ml Bottle 20 ml + Measuring Spoon

Oral solution based on l-carnitine.

Therapeutic indications

Carnitene Oral Solution 1,5 g / 5 ml is indicated in case of primary and secondary carnitine deficiencies.

Dosage and posology

Primary and secondary deficiencies in genetic diseases:

The oral daily dose is a function of age and weight; from 0 to 2 years 150 mg per kg of body weight are recommended, from 2 to 6 years 100 mg per kg, from 6 to 12 years 75 mg per kg; over 12 years and in adults 2-4 grams depending on the severity of the disease and the doctor's judgment.

Deficiencies secondary to hemodialysis:

2 - 4 grams per day. Oral solutions must be taken only after dilution, the one in single-dose containers must be diluted in a glass of water.

Special populations:

Patients with renal insufficiency: Patients with severe renal impairment should not be treated with chronic oral administration of high doses of levocarnitine because it can induce an accumulation of the potentially toxic metabolites trimethylamine (TMA) and trimethylamine-N-oxide (TMAO) .

Elderly patients: No special precautions and carnitene dosage modifications are necessary in elderly patients. The safety profile observed in clinical trials is similar in elderly and young adults.

Diabetic patients: the administration of L-carnitine in diabetic patients on insulin treatment or with oral hypoglycemic agents, improving the utilization of glucose, could cause hypoglycemia phenomena. Therefore, in these subjects the glycaemia must be checked regularly in order to promptly provide, if necessary, to the adjustment of the hypoglycemic therapy.

Overdose

Overdose and long-term administration of L-carnitine have been associated with diarrhea. L – carnitine is easily removed from the blood by dialysis.

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in the section. Sodium chloride solution for infusion is contraindicated in patients with hypernatremia and hydrosaline plethora. The solution for infusion with glucose is contraindicated in diabetic patients .

Side effects

Adverse reactions from any source (clinical studies, literature and post-marketing) are listed in the table below by MedDRA system organ class. Within each class, adverse reactions are classified according to frequency. Within each frequency class, adverse reactions are ranked in order of decreasing severity. In addition, the corresponding frequency category for each adverse reaction is based on the following convention (CIOMS III): very common (≥ 1/10),
common (≥ 1/100 to <1/10),
uncommon (≥ 1 / 1,000 to <1/100),
rare (≥ 1 / 10,000 to <1 / 1,000)
very rare (<1 / 10,000),
not known (frequency cannot be estimated from the available data)

* There have been reports of seizures in patients, with or without a history of seizure activity, who received oral or intravenous L-carnitine. Administration of L-carnitine may increase the incidence and / or severity of seizures. In patients with predisposing conditions, treatment with L-carnitine could trigger seizures.
** In subjects with severely impaired renal function or on dialysis, chronic oral administration of L-carnitine can lead to accumulation of TMA and TMAO in the blood resulting in trimethylaminuria, a pathological condition characterized by a strong "fishy odor" present in the urine , in the patient's breath and sweat
*** Mild myasthenic symptoms have been reported in uremic patients
**** Injection site reactions have been reported in iv administration only
***** Very rare cases of increased INR (International Normalized Ratio) have been reported in patients receiving concomitant coumarin therapy. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorization of the medicinal product is important, as it allows continuous monitoring of the benefit / risk ratio of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.

Pregnancy and breastfeeding

• Fertility

In clinical fertility studies, favorable effects were identified and no safety concerns were identified.

• Pregnancy

Reproduction studies were conducted in rats and rabbits. There was no evidence of a teratogenic effect in either species. In rabbits, but not rats, there was a statistically insignificant higher number of post-implantation losses at the maximum dose tested (600 mg / kg per day) than in the control group. The significance of these findings in humans is unknown. No adequate clinical studies have been performed in pregnant women. Carnitene should be given during pregnancy if the benefit to the mother outweighs the potential risks to the fetus.

• Feeding time

L – carnitine is a normal component of human milk. The use of L-carnitine supplementation in nursing mothers has not been studied. Carnitene should be used by the nursing mother if the benefit to the mother outweighs any potential risk to the baby from excessive exposure to carnitine.

Special warnings

In patients with a history of seizure activity, administration of L-carnitine may increase the incidence and / or severity of seizures. In patients with predisposing conditions, treatment with L-carnitine could trigger seizures. The safety and efficacy of oral levocarnitine have not been demonstrated in patients with renal insufficiency. Chronic oral administration of high doses of levocarnitine to patients with severe renal impairment or end stage renal failure (ESRD) and dialysis may induce an accumulation of the potentially toxic metabolites trimethylamine (TMA) and trimethylamine-N-oxide (TMAO) , as these metabolites are normally excreted in the urine. This phenomenon does not occur with intravenous administration. Since L-carnitine is a physiological product, it does not present any risk of addiction or dependence. There have been very rare reports of increased INR (International Normalized Ratio) in patients receiving concomitant coumarin therapy. The INR - or other suitable coagulation tests - should be checked weekly until the values stabilize and then monthly, in patients taking anticoagulants together with Carnitene. Carnitene 1.5 g / 5 ml oral solution and Carnitene 1 g chewable tablets contain sucrose: patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase isomaltase insufficiency, should not take this medicine . It can be bad for your teeth. Furthermore, this should be taken into account in diabetic patients and in those subjected to low-calorie diets. Carnitene 1.5 g / 5 ml oral solution contains, sorbitol. Patients with rare hereditary problems of fructose intolerance should not take this medicine. Carnitene 1.5 g / 5 ml oral solution contains para-hydroxy-benzoates (methyl para-hydroxybenzoate and propyl para-hydroxybenzoate) as preservatives: these can cause allergic reactions (even delayed).

Expiry and Retention

There are no special storage precautions to be observed.

Composition

100 ml of Carnitene oral solution contain:

Active principle

L – carnitine internal salt 30 g.

Excipients

Sucrose, 70 percent sorbitol (not crystallizable), sodium methyl para-hydroxybenzoate, sodium propylpara-hydroxybenzoate, cherry flavor, black cherry flavor, purified water.