Cocarnitin B12 500 mg + 2 mg 10 vials powder + solvent for oral suspension

Cocarnitin B12 500 mg + 2 mg 10 vials powder + solvent for oral suspension is a medicine specifically formulated to support energy metabolism and general well-being in situations of vitamin deficiency , nutritional deficiencies and states of debilitation . Each pack contains 10 vials with powder and solvent, to be mixed to obtain an oral suspension that is easily administered to both children and adults . The product combines two fundamental active ingredients: L-carnitine (500 mg per vial), known for its role in the transport of fatty acids into the mitochondria and in energy production, and cobamamide (2 mg per cap), an active form of vitamin B12 essential for the synthesis of red blood cells and the correct functioning of the nervous system.

Thanks to its composition, Cocarnitin B12 is an ideal tonic and energizer in cases of loss of appetite , pathological weight loss , growth retardation in children, convalescence and asthenia . It is particularly indicated for the treatment of malnutrition in infants, premature babies and children, but it is also used in internal medicine for adults who are thin without apparent cause , hyperproteinemia from liver disease or nephrosis, or who require an anticatabolic during prolonged cortisone therapy or thyrotoxicosis.

The formulation in vials with powder and solvent guarantees maximum stability of the active ingredients and a simple and safe preparation of the oral suspension . The selected excipients, including sorbitol, sucrose and natural flavours, make the product pleasant to the taste and suitable even for the little ones. Cocarnitin B12 is the optimal solution for those looking for an effective supplement to stimulate the metabolism, promote growth and energy recovery, and combat symptoms related to vitamin deficiencies and physical debilitation .

ACTIVE INGREDIENTS

Active ingredients contained in Cocarnitin B12 500 mg + 2 mg 10 vials powder + solvent for oral suspension - What is the active ingredient of Cocarnitin B12 500 mg + 2 mg 10 vials powder + solvent for oral suspension?

One cap contains: Active ingredient : Cobamamide 2 mg. One vial contains: Active ingredient : L-Carnitine internal salt 500 mg. Excipients with known effect: sorbitol solution 70% (E420). 4.075 g, sucrose 1.5 g, sodium benzoate 0.048 (E211) g. For the full list of excipients, see section 6.1.

EXCIPIENTS

Composition of Cocarnitin B12 500 mg + 2 mg 10 vials powder + solvent for oral suspension - What does Cocarnitin B12 500 mg + 2 mg 10 vials powder + solvent for oral suspension contain?

The cap contains: polyethylene glycol 4000, mannitol powder. The vial contains : sorbitol solution 70%, sodium benzoate, black cherry juice, orgeat juice, sucrose, demineralized water q.b.

DIRECTIONS

Therapeutic indications Cocarnitin B12 500 mg + 2 mg 10 vials powder + solvent for oral suspension - Why is Cocarnitin B12 500 mg + 2 mg 10 vials powder + solvent for oral suspension used? What is it used for?

Pediatrics: All malnutrition states in children, infants and premature babies, growth retardation, underweight, dystrophies, anorexia, weight loss from any cause, states of post-infectious debilitation. Internal Medicine: Pathological weight loss of any etiology, thinness without apparent cause, loss of appetite, asthenia, convalescence, as an anti-catabolic in prolonged cortisone therapy and in thyrotoxicosis, in hypoproteinemia of liver disease and nephrosis.

CONTRAINDICATIONS AND SIDE EFFECTS

Contraindications Cocarnitin B12 500 mg + 2 mg 10 vials powder + solvent for oral suspension - When should Cocarnitin B12 500 mg + 2 mg 10 vials powder + solvent for oral suspension not be used?

Hypersensitivity to the active substance or to any of the excipients listed in paragraph 6.1.

DOSAGE

Quantity and method of taking Cocarnitin B12 500 mg + 2 mg 10 vials powder + solvent for oral suspension - How is Cocarnitin B12 500 mg + 2 mg 10 vials powder + solvent for oral suspension taken?

Infants and premature babies: one vial per day diluted in water. Children and adolescents: 1-2 vials per day diluted in water. Adults: 2-3 vials per day. Special populations. Elderly patients: No dosage adjustments of CoCarnitin B12 are necessary in elderly patients. Patients with renal insufficiency: Patients with severe renal impairment should not be treated with high doses of L-Carnitine for prolonged periods by mouth because it may induce an accumulation of potentially toxic metabolites, see section 4.4. No data are available for the use of Vitamin B12 in patients with renal insufficiency . Patients with hepatic insufficiency: No data are available in patients with hepatic insufficiency. The characteristics of CoCarnitin B12 may be altered by exposure to light and if it is not used immediately after mixing with liquids or food.

CONSERVATION

Storage Cocarnitin B12 500 mg + 2 mg 10 vials powder + solvent for oral suspension - How is Cocarnitin B12 500 mg + 2 mg 10 vials powder + solvent for oral suspension stored?

Do not store above 25°C.

WARNINGS

Warnings Cocarnitin B12 500 mg + 2 mg 10 vials powder + solvent for oral suspension - About Cocarnitin B12 500 mg + 2 mg 10 vials powder + solvent for oral suspension it is important to know that:

Chronic oral administration of high doses of L-Carnitine in patients with severe renal insufficiency may lead to accumulation of the potentially toxic metabolites: trimethylamine (TMA) and trimethylamine-N oxide (TMAO). Very rare cases of increased INR (International Normalized Ratio) have been reported in patients receiving concomitant therapy with L-Carnitine and coumarin drugs. INR or other appropriate coagulation tests should be monitored weekly until values ​​stabilize and monthly thereafter in patients taking anticoagulants together with L-Carnitine. Cases of convulsions have been reported in patients, with or without a history of convulsive activity, who received oral or intravenous L-Carnitine. In patients with underlying predisposing conditions, treatment with L-Carnitine may trigger convulsive seizures. CoCarnitin B12 contains 4.075 g sorbitol per vial. Sorbitol may cause gastrointestinal disturbances and have a mild laxative effect. The additive effect of co-administration of medicinal products containing sorbitol (or fructose) and daily dietary intake of sorbitol (or fructose) should be taken into account. The sorbitol content of oral medicinal products may alter the bioavailability of other concomitantly administered oral medicinal products. Patients with hereditary fructose intolerance should not be given this medicine. CoCarnitin B12 contains 1.5 g sucrose per vial. Sucrose may be harmful to teeth. Patients with rare problems of fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase insufficiency should not take this medicine. CoCarnitin B12 contains 0.048 g sodium benzoate per vial. The increase in bilirubinemia following its separation from albumin may increase neonatal jaundice which may evolve into kernicterus (deposits of unconjugated bilirubin in brain tissue). This medicinal product contains less than 1 mmol (23 mg) sodium per dose, i.e. essentially 'sodium-free'. Given the particular lability and photosensitivity of Cobamamide, any solution of the product in liquids or its mixing in other foods must take place immediately before the time of administration. The drug does not cause habituation or dependence. Products containing Cobamamide must not be administered to anaemic subjects unless on the basis of investigations aimed at establishing the exact nature of the anemia.

INTERACTIONS

Interactions Cocarnitin B12 500 mg + 2 mg 10 vials powder + solvent for oral suspension - Which medicines or foods can modify the effect of Cocarnitin B12 500 mg + 2 mg 10 vials powder + solvent for oral suspension?

Oral anticoagulants: Very rare cases of increased INR (International Normalized Ratio) have been reported in patients receiving concomitant therapy with L-Carnitine and coumarin drugs (see section 4.4). INR or other appropriate coagulation tests should be monitored weekly until values ​​stabilize and then monthly in patients taking L-Carnitine together with coumarin drugs (see section 4.4). Other interactions: Concomitant administration of L-Carnitine with drugs that induce hypocarnitinemia due to increased renal carnitine loss (valproic acid, prodrugs containing pivalic acid, cephalosporins, cisplatin, carboplatin and ifosfamide) may reduce the availability of L-Carnitine. No interactions of Vitamin B12 with other drugs are known.

SIDE EFFECTS

Like all medicines, Cocarnitin B12 500 mg + 2 mg 10 vials powder + solvent for oral suspension can cause side effects - What are the side effects of Cocarnitin B12 500 mg + 2 mg 10 vials powder + solvent for oral suspension?

Adverse reactions from any source (clinical studies, published clinical data for the individual active substances and post-marketing data for CoCarnitin B12) are listed below by MedDRA system organ class. Within each class, adverse reactions are classified by frequency. Within each frequency grouping, adverse reactions are ranked in order of decreasing seriousness. 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, <1/10), uncommon (≥1/1,000, <1/100), rare (≥1/10,000, <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data). Nervous system disorders: Uncommon: Headache. Gastrointestinal disorders: Uncommon: Abdominal distension, Gastrointestinal pain, Vomiting; Common: Abdominal pain, Diarrhoea, Nausea. Cases of convulsions have been reported in patients, with or without a history of seizure activity, who received oral or intravenous L-Carnitine (see section 4.4). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

OVERDOSE

Overdose Cocarnitin B12 500 mg + 2 mg 10 vials powder + solvent for oral suspension - What are the risks of Cocarnitin B12 500 mg + 2 mg 10 vials powder + solvent for oral suspension in case of overdose?

No cases of overdose have been reported.

PREGNANCY AND BREASTFEEDING

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 Cocarnitin B12 500 mg + 2 mg 10 vials powder + solvent for oral suspension.

Pregnancy: L-Carnitine crosses the placenta. Carnitine levels in newborns reflect those of the mother. There are no clinical studies with the administration of vitamin B12 or CoCarnitine B12 in pregnant women. Breastfeeding: L-Carnitine is a normal component of breast milk. There are no clinical studies in breastfeeding women with supplements containing L-Carnitine or CoCarnitine B12. Fertility: Fertility clinical studies with L-Carnitine have not reported safety concerns. There are no clinical fertility studies with vitamin B12.

DRIVING AND USE OF MACHINERY

Taking Cocarnitin B12 500 mg + 2 mg 10 vials powder + solvent for oral suspension before driving or using machines - Does Cocarnitin B12 500 mg + 2 mg 10 vials powder + solvent for oral suspension affect driving or using machines?

CoCarnitin B12 does not alter the ability to drive vehicles or use machines.