OS GTT 25ML

ARICODILTOSSE 15 MG/ML ORAL GOCCE, DEVELOPMENT

active ingredients

100 ml contain: Active ingredient: right-handed bromitted 1,50 g. Excipients with known effects: ethanol fructose For the full list of excipients, see paragraph 6.1

Excellent

Ethyl alcohol 95%, sodium salt saccharin, fructose, monohydrate citric acid, dihydrate citrate sodium, sweet orange extract, purified water q.b. 100 ml.

Therapeutic indications

Syntomatic treatment of non-productive toxes.

Contraindications

Individual hypersensitivity ascertained towards the product. Do not administer during or in the two weeks following antidepressant therapy. The product is not recommended in asthmatic patients.

Population

Adults: from 15 to 30 drops two or three times a day Children: (2–4 years) from 5 to 10 drops, two or three times a day.

Conservation

This medicine does not require any special condition of conservation.

Warnings

In process with ARICODILTOSSE it is not recommended to take alcoholic beverages. In children under two years, the product must be administered only in case of actual need and under the direct control of the doctor. After 5–7 days of treatment without appreciable results, consult your doctor. Cases of detachment were reported. It is recommended to pay special attention to teenagers and young adults as well as patients with a history of drug abuse or psychoactive substances. The rightmetorphan is metabolized by the liver cytochrome P450 2D6. The activity of this enzyme is genetically determined. About 10% of the population slowly metabolizes CYP2D6. In slow metabolizers and patients with concomitant use of CYP2D6 inhibitors, exaggerated and/or prolonged effects of dextromethtorphan may occur. It is therefore necessary to pay attention to CYP2D6 slow metabolizer patients or to use CYP2D6 inhibitors (see also paragraph 4.5). ARICODILTOSSE contains fructose. Patients suffering from rare hereditary problems of fructose intolerance should not take this medicine. ARICODILTOSSE contains 30 vol% ethanol (alcohol), e.g. up to 206 mg per dose, equivalent to 5.1 ml of beer, 2.1 ml of wine per dose. It can be harmful to alcoholics. To be taken into account in pregnant or nursing women, children and high-risk groups such as people with liver or epilepsy disorders.

Interactions

Do not administer during or in the two weeks following antidepressant therapy. • CYP2D6 inhibitors The dextromethtorphan is metabolized by the CYP2D6 and has a wide metabolism of the first step. Concurrent use of powerful CYP2D6 enzyme inhibitors can increase the concentrations of dextromethtorphan in the body at many times higher than normal value. This increases the risk for the patient of toxic effects of dextromethtorphan (acting, confusion, tremor, insomnia, diarrhea and respiratory depression) and of development of serotonin syndrome. Powerful inhibitors of CYP2D6 are fluoxetine, paroxetine, chinidine and terbinaphine. In use in conjunction with chinidine, plasma concentrations of dextromethtorphan have increased up to 20 times, resulting in increased adverse effects on the central nervous system of the agent. Also amiodarone, flecainide and propafenone, sertralin, bupropion, methadone, cinacalcet, aloperidol, perfenazine and thiodazine have similar effects on the metabolism of the dextromethtorphan. If the concomitant use of CYP2D6 inhibitors and dextromethtorphans is necessary, the patient must be monitored and it may be necessary to reduce the dose of dextromethtorphan.

Effects

The administration of ARICODILTOSSE may occasionally give rise to nausea, vomiting, dizziness and drowsiness, especially in case of overdose or in patients at a very advanced age or sufferers of affections that already in themselves tend to cause drowsiness: in these cases it is usually sufficient to decrease the doses using the administration of the drops, with the use of which a greater posological adaptability is possible. Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions occurring after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at: http://www.agenziafarmaco.gov.it/it/responsabili

Overdosing

The naloxone was successfully used as antagonist of the dextromethtorphan.

There is no adequate data regarding the use of dextromethtorphan in pregnant women. Animal studies are insufficient to highlight the effects on pregnancy, embryo/fetal development, birth or post-natal development. The potential risk for human beings is not known. ARICODILTOSSE should not be used during pregnancy and nursing.

Source: Farmadati