Descrizione Clinica
ACTION MANAGEMENT
active ingredients
Each tablet without sugar contains: Active principles: Benzidamina hydrochloride: 3,0 mg. Chloride cetilpiridinium: 1.0 mg. 1 ml oral mucosa spray solution contains: Active principles: Benzidamina hydrochloride: 1.5 mg. Chloride cetilpiridinium: 5.0 mg. 1 ml of collutory contains: Active principles: Benzidamina hydrochloride: 1.5 mg. Chloride cetilpiridinium: 0.5 mg. Excipients with known effects: GOLA ACTION's orosoluble tablets contain: sorbitol, aspartame. GOLA ACTION oral mucosa spray contains: polyxyethylene hydrogenated castor oil, mint aroma containing citral, citronellol, eugenol, D-limonene, linalol. GOLA ACTION collutory contains: polyxyethylene hydrogenated castor oil. For the full list of excipients see paragraph 6.1.Excellent
GOLA ACTION's orosoluble tablets contain: sorbitol, mannitol, magnesium stearate, mint aroma, aspartame. GOLA ACTION's oral mucosa spray contains: glycerol, mint aroma (containing citral, citronellol, eugenol, D-limonene, linalol), polyxyethylene hydrogenate, sodium saccharin, purified water. GOLA ACTION collutorio contains: sodium saccharin, mint aroma, polyxyethylene hydrogenated castor oil, glycerol, alcohol, chinoline yellow (E104), blue V license (E131), purified water.Therapeutic indications
GOLA ACTION (orosoluble compression, oral mucosa spray and mouthwashing) is indicated for anti-inflammatory, analgesic and antiseptic treatment in throat, mouth and gum irritations, gums, pharyngitis and laryngitis. Indicated even before and after tooth extractions.Contraindications
Hypersensitivity to active ingredients or any of the excipients listed in paragraph 6.1. For the type of pharmaceutical form, GOLA ACTION tablets, collutory and spray are contraindicated in children under the age of 6. Not to be used in children aged 6 to 12, except for a different prescription. For the presence of aspartame, source of phenylalanine, orosoluble tablets are contraindicated in patients suffering from phenylchetonuria.Population
Population Adults (including seniors) and children from 12 years old: Orosoluble tablets: 1 tablet to dissolve slowly in mouth 3-4 times a day. Oral Mucosa Spray: 1-2 nebulizations. Repeat the application 3-5 times in the day. Collutory: 15 ml slides, 2-3 times a day, using the special dispenser cup. Pediatric population GOLA ACTION is contraindicated in children under the age of 6. GOLA ACTION should not be used in children aged 6 to 12 years, unless otherwise prescribed. Method of administration Oral Mucosa Spray: turn the spout and press 1-2 times the dosing button. At the first use of the product, in order to obtain a regular dispensing, press the dispensing button sometimes empty. The delivery is exactly predominated by a particular dosing valve: 100 mcl contain benzidamine hydrochloride 0.15 mg and cetilpiridinium chloride 0.5 mg. Collutory: Cap with locking system of difficult opening. To open: press and simultaneously turn. To close: screw thoroughly by pressing. Minimum interval between two administrations: 2 hours. For an optimal effect, it is recommended not to use the product immediately before or after washing the teeth. Do not use other antiseptics at the same time. Do not exceed the recommended doses.Conservation
Collutory: This medicine does not require any special condition for conservation. Orosoluble tablets and oral mucosa Spray: do not store at a temperature greater than 25°C.Warnings
Do not use for more than 10 days. If you do not notice appreciable results, consult your doctor. The long-term use of topical preparations could give rise to awareness-raising phenomena, in which case it is necessary to suspend treatment and establish suitable therapy. GOLA ACTION tablets, mouthwashing and spray should not be used along with anionic compounds, such as those present for example in toothpastes, therefore it is recommended not to use the product immediately before or after washing the teeth. Notices related to excipients GOLA ACTION tablets contains sorbitol and aspartame. This medicine contains 1138 mg of sorbitol per tablet. Sorbitol is a source of fructose. Patients with rare hereditary problems of fructose intolerance should not take this medicine. Sorbitol can cause gastrointestinal problems and have a slight laxative effect. GOLA ACTION tablets do not contain sugars and therefore can be administered in diabetic subjects or in hypocaloric diet. This medicine contains 8 mg of aspartame per tablet. Aspartame is a source of phenylalanine that can be harmful in patients suffering from phenylchetonuria. GOLA ACTION collutory contains polyxyethylene hydrogenated castor oil that can cause skin reactions. GOLA ACTION spray for oral mucosa: avoid contact with eyes. GOLA ACTION spray contains polyxyethylene hydrogenated castor oil that can cause skin reactions. GOLA ACTION spray contains an aroma in turn containing citral, citronellol, eugenol, D-limonene, linalol. These allergens can cause allergic reactions. GOLA ACTION spray contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially ‘without sodium’. Pediatric population TENERE THE MEDICINAL FUORI FROM THE PORTED AND THE VIEW OF CHILDREN.Interactions
Avoid the contemporary use of other antiseptics.Effects
Following the topical application of benzidamin to the oral cavity and throat, burning and anesthesia of the oral mucosa were reported; often hypersensitivity reactions, including hives, photosensitivity and bronchospasm may occur. With cetilpiridinium it is possible to observe, very rarely, local irritation or a slight burning sensation at the level of the oral cable. With tablets, such effects can be prevented by avoiding leaving the tablet in contact with the same oral mucosa area for a long time. Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur 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: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.Overdosing
Toxic manifestations of benzidamine overdose consist of excitement, seizures, sweating, ataxia, tremors and vomiting; hallucinations and psychosis can also occur. Since there is no specific antidote, the treatment of acute poisoning by benzidamine is purely symptomatic. Signs and symptoms of intoxication resulting from ingestion of significant amounts of cetilpiridinium chloride include nausea, vomiting, dispnea, cyanosis, asphyxiation, resulting in paralysis of respiratory muscles, SNC depression, hypotension and coma. In man the lethal dose is about 1-3 grams. The treatment of overdose from cetilpiridinium is also symptomatic. In case of overdose it is necessary to consult the doctor.In pregnancy and during lactation GOLA ACTION tablets, mouthwashing and spray should be used under medical control.
Source: Farmadati
