DECORENCE 50 OS 10FL 50MG

DECORENCE

active ingredients

Hard capsules: Each rigid capsule contains ubidecarenone 50 mg Excipients with known effects: Lactose Solution oral oral oral: 10 ml oral solution contain ubidecarenone 50 mg Eccipients with known effects: Sorbitol, castor oil and sodium For the full list of excipients, see paragraph 6.1

Excellent

Hard capsules Lactose, colloidal Silica, Laurilsulfate Sodium, Magnesium stearate Composition of the capsule: Gelatin containing Titanium dioxide (E171), Erythrosine (E127) and Iron Oxide-Ico (E 172). Oral Solution: Sorbitol 70% (not crystallized), hydrogenated castor oil, polyxyethylene 40, benzoate sodium, succinic acid, orange aroma, glycirrizinate ammonium, sodium edetato, sodium deidroacetate, sodium saccharin, purified water

Therapeutic indications

Treatment of congenital deficiency of coenzyme Q10.

Contraindications

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

Population

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

Conservation

This medicine does not require any special condition of conservation.

Warnings

Important information about some excipients: Decoration capsules rigid contains lactose, for which patients suffering from rare hereditary problems of galactose intolerance, from total lactase deficiency, or from glucose-galactose mal absorption, should not take this medicine. Decorenone rigid capsules contains less than 1 mmol (23 mg) of sodium for bottle, i.e. essentially “without sodium”. Decoration solution solution oral oral oral contains sorbitol The additive effect of co-administration of medicinal products containing sorbitol and the daily intake of sorbitol with the diet should be considered. The content of sorbitol in oral medicines may change the bioavailability of other oral medications co- administered. Patients with hereditary fructose intolerance should not be given this medicine. Decoration solution solution oral oral oral contains castor oil. It can cause gastric disorders and diarrhea. Decorenone oral solution contains 20 mg benzoate sodium for bottle equivalent to 2mg/ml The increase in bilirubin as a result of its detachment from albumin can increase the neonatal hetero that can evolve in kernittero (deposits of bilirubin not conjugated in the brain tissue). Decorenone oral solution contains less than 1 mmol (23 mg) sodium per bottle, i.e. essentially “without sodium”.

Interactions

Not known.

Effects

Undesirable effects are listed below by organic and frequency systemic classification. The frequencies are defined as: very common (≥1/10), common (≥1/100,

Overdosing

No overdose cases have been reported.

There are no adequate data on the use of Decorenone in pregnant women. Although the theological studies conducted with Ubidecarenone on animals have not evidenced any teratogenic effect its administration during the first three months of pregnancy should only be carried out in case of actual need after a risk/benefit assessment.

Source: Farmadati