ACTIVE INGREDIENTS

Each sugar-free tablet contains: Active ingredients: Benzidamine hydrochloride 3.0 mg, Cetylpyridinium chloride 1.0 mg. 1 ml of oromucosal spray solution contains: Active ingredients: Benzidamine hydrochloride 1.5 mg, Cetylpyridinium chloride 5.0 mg. 1 ml of mouthwash contains: Active ingredients: Benzidamine hydrochloride 1.5 mg, Cetylpyridinium chloride 0.5 mg. Excipients with known effects: GOLA ACTION orodispersible tablets contain: sorbitol, aspartame. GOLA ACTION oromucosal spray contains: polyoxyethylened hydrogenated castor oil, mint flavor containing citral, citronellol, eugenol, D-limonene, linalool. GOLA ACTION mouthwash contains: polyoxyethylened hydrogenated castor oil. For a full list of excipients, see section 6.1.
EXCIPIENTS

GOLA ACTION orodispersible tablets contain: sorbitol, mannitol, magnesium stearate, mint flavoring, aspartame. GOLA ACTION orodispersible spray contains: glycerol, mint flavoring (containing citral, citronellol, eugenol, D-limonene, linalool), polyoxyethylened hydrogenated castor oil, sodium saccharin, purified water. GOLA ACTION mouthwash contains: sodium saccharin, mint flavoring, polyoxyethylened hydrogenated castor oil, glycerol, alcohol, quinoline yellow (E104), patent blue V (E131), purified water.
THERAPEUTIC INDICATIONS

GOLA ACTION (oral-dissolvable tablets, oral spray, and mouthwash) is indicated for the anti-inflammatory, analgesic, and antiseptic treatment of throat, mouth, and gum irritation, gingivitis, pharyngitis, and laryngitis. It is also recommended before and after tooth extractions.
DOSAGE

Dosage Adults (including the elderly) and children aged 12 years and over: Orodispersible tablets: 1 tablet to dissolve slowly in the mouth 3-4 times a day. Oral mucosa spray: 1-2 sprays. Repeat the application 3-5 times a day. Mouthwash: 15 ml rinse, 2-3 times a day, using the appropriate measuring cup. Paediatric population GOLA ACTION is contraindicated in children under 6 years of age. GOLA ACTION should not be used in children aged 6 to 12 years, unless otherwise prescribed by a doctor. Method of administration Oral mucosa spray: Turn the nozzle and press the dosing button 1-2 times. When using the product for the first time, to obtain a regular dispensing, press the dispenser button a few times until empty. The dosage is precisely pre-dosed by a special dosing valve: 100 mcl contain 0.15 mg of benzydamine hydrochloride and 0.5 mg of cetylpyridinium chloride. Mouthwash: Capsule with a difficult-to-open closure. To open: press and twist simultaneously. To close: screw tightly while pressing. Minimum interval between two administrations: 2 hours. For optimal effect, it is recommended not to use the product immediately before or after brushing your teeth. Do not use simultaneously with other antiseptics. Do not exceed the recommended dose.
CONSERVATION

Mouthwash: This medicine does not require any special storage conditions. Orodispersible tablets and oral spray: Do not store above 25°C.
WARNINGS

Do not use for more than 10 days. If you do not see significant results, consult your doctor. Use of topical preparations, especially if prolonged, may cause sensitization. In this case, discontinue treatment and initiate appropriate therapy. GOLA ACTION tablets, mouthwash, and spray should not be used with anionic compounds, such as those found in toothpastes. Therefore, it is recommended not to use the product immediately before or after brushing your teeth. Warnings regarding excipients: GOLA ACTION tablets contain 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 mild laxative effect. GOLA ACTION tablets do not contain sugars and can therefore be administered to diabetics or those on a low-calorie diet. This medicine contains 8 mg aspartame per tablet. Aspartame is a source of phenylalanine, which may be harmful to patients with phenylketonuria. GOLA ACTION mouthwash contains polyoxyethylened hydrogenated castor oil, which may cause skin reactions. GOLA ACTION oromucosal spray: avoid contact with eyes. GOLA ACTION spray contains polyoxyethylened hydrogenated castor oil, which may cause skin reactions. GOLA ACTION spray contains a flavoring containing citral, citronellol, eugenol, D-limonene, and linalool. These allergens may cause allergic reactions. GOLA ACTION spray contains less than 1 mmol (23 mg) sodium per dose, i.e., essentially 'sodium-free'. Paediatric population: KEEP THIS MEDICINAL PRODUCT OUT OF THE REACH AND SIGHT OF CHILDREN.
INTERACTIONS

Avoid the simultaneous use of other antiseptics.
OVERDOSE

Toxic manifestations of benzydamine overdose include excitation, convulsions, sweating, ataxia, tremors, and vomiting; hallucinations and psychosis may also occur. Since there is no specific antidote, treatment of acute benzydamine poisoning is purely symptomatic. Signs and symptoms of poisoning following ingestion of significant amounts of cetylpyridinium chloride include nausea, vomiting, dyspnea, cyanosis, and asphyxia resulting from respiratory muscle paralysis, CNS depression, hypotension, and coma. The lethal dose in humans is approximately 1–3 grams. Treatment of cetylpyridinium overdose is also symptomatic. In case of overdose, medical attention is required.
PREGNANCY AND BREASTFEEDING

Pregnancy: There are no clinical data on the use of GOLA ACTION during pregnancy. During the third trimester of pregnancy, systemic use of prostaglandin synthesis inhibitors may induce cardiopulmonary and renal toxicity in the fetus. At the end of pregnancy, prolonged bleeding time may occur in both mother and child, and labor may be delayed. It is not known whether systemic exposure to GOLA ACTION achieved after topical administration could be harmful to an embryo/fetus. Therefore, GOLA ACTION should not be used during pregnancy unless clearly necessary. If used, the dose should be as low as possible and the duration of treatment as short as possible. Breastfeeding: During breastfeeding, GOLA ACTION should be used under medical supervision.

icon-Download.svg
See the package leaflet

Important information
icon-ChevronDown.svg
SIDE EFFECTS

Following topical application of benzydamine to the mouth and throat, burning and a sensation of anesthesia of the oral mucosa have been reported; hypersensitivity reactions, including urticaria, photosensitivity, and bronchospasm, may rarely occur. With cetylpyridinium, local irritation or a mild burning sensation in the oral cavity may be observed very rarely. With tablets, these effects can be prevented by avoiding prolonged contact of the tablet with the same area of ​​the oral mucosa. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorization of the medicinal product is important as 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.