Decorenone Coenzyme Q10 50mg 14cps 025230071

DECORENONE 50 * 14CPS 50MG

Therapeutic indications

Treatment of congenital deficiencies of coenzyme Q10.

Dosage and method of use

Hard capsules: the recommended dose is 1 capsule for oral use per day Oral solution: the recommended dose is 1 single-dose vial of solution for oral use per day

Contraindications

Hypersensitivity to ubidecarenone or to any of the excipients listed in section 6.1

Side effects

Undesirable effects are listed below by system organ class and by frequency. Frequencies are defined as: very common (≥1 / 10), common (≥1 / 100,

Special warnings

Important information about some of the ingredients: Decorenone hard capsules contain lactose, therefore patients with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption should not take this medicine. Decorenone hard capsules contain less than 1 mmol (23 mg) sodium per vial, ie essentially “sodium-free”. Decorenone oral solution contains sorbitol The additive effect of co-administration of sorbitol-containing medicinal products and the daily dietary intake of sorbitol should be considered. The content of sorbitol in oral medicinal products may modify the bioavailability of other co-administered oral medicinal products. Patients with hereditary fructose intolerance should not be given this medicine. Decorenone oral solution contains castor oil. It can cause stomach upset and diarrhea. Decorenone oral solution contains 20 mg of sodium benzoate per bottle equivalent to 2mg / ml The increase in bilirubin following its detachment from albumin can increase neonatal jaundice which can lead to kernitterus (deposits of unconjugated bilirubin in brain tissue) . Decorenone oral solution contains less than 1 mmol (23 mg) sodium per vial, ie essentially “sodium-free”.

Pregnancy and breastfeeding

There are no adequate data on the use of Decorenone in pregnant women. Even if the teratological studies conducted with Ubidecarenone on animals have not shown any teratogenic effect, its administration during the first three months of pregnancy should be carried out only in case of real need after an evaluation of the risk / benefit balance.

Expiration and retention

This medicine does not require any special storage conditions.

Interactions with other drugs

Not known.

Overdose

No cases of overdose have been reported.

Active principles

Hard capsules : Each hard capsule contains 50 mg ubidecarenone Excipients with known effect: Lactose Oral solution : 10 ml of oral solution contains 50 mg ubidecarenone Excipients with known effect: Sorbitol, castor oil and sodium For a full list of excipients, see section 6.1

Excipients

Hard capsules Lactose, Colloidal silica, Sodium laurilsulfate, Magnesium stearate Composition of the capsule: Gelatin containing Titanium dioxide (E171), Erythrosine (E127) and Iron oxide (E 172). Oral solution: Sorbitol 70% (not crystallizable), hydrogenated castor oil, polyoxyethylenate 40, sodium benzoate, succinic acid, orange flavor, ammonium glycyrrhizinate, sodium edetate, sodium dehydroacetate, sodium saccharin, purified water