Symptomatic treatment of irritative-inflammatory conditions also associated with pain in the oropharyngeal cavity (e.g. gingivitis, stomatitis, pharyngitis), also as a consequence of conservative or extractive dental therapy.
Active Ingredients
100 ml of oral mucosa spray contains as active ingredient: Ketoprofen lysine salt 0.16 grams corresponding to 0.10 grams of Ketoprofen Excipient with known effects: Methyl parahydroxybenzoate, mint flavour (containing d-Limonene, eugenol, linalool), ever cool flavour (containing linalool). For the full list of excipients, see section 6.1
Excipients
Glycerol 85%, xylitol, methyl parahydroxybenzoate , sodium phosphate monobasic, poloxamer 407, mint flavouring (containing d-Limonene, eugenol, linalool) , ever cool flavouring (containing linalool) , purified water.
Dosage
1-2 sprays up to 3 times a day, directed directly onto the affected area. Each spray delivers approximately 0.2 ml of solution, equivalent to 0.32 mg of active ingredient.
Warnings
The use, especially if prolonged, of topical medications could give rise to sensitization phenomena, in which case it is necessary to suspend the treatment and adopt appropriate therapeutic measures. This medicine contains methyl parahydroxybenzoate, known for the possibility of causing allergic reactions (even delayed). This medicine contains the mint flavor, in turn containing d-limonene, eugenol and linalool which can cause allergic reactions. This medicine contains the ever cool flavor, in turn containing linalool which can cause allergic reactions.
Conservation
No special instructions required
Contraindications
OKi gola 0.16% spray for oral mucosa must not be administered in case of hypersensitivity to the active substance, to other non-steroidal anti-inflammatory drugs (NSAIDs) or to any of the excipients, to patients in whom substances with a similar mechanism of action (for example acetylsalicylic acid or other NSAIDs) provoke asthma attacks, bronchospasm, acute rhinitis, or cause nasal polyps, urticaria or angioneurotic edema, in case of previous bronchial asthma, during pregnancy and breastfeeding.
Side effects
Local side effects following topical administration of ketoprofen lysine salt solution to the oral mucosa are extremely rare and consist of irritative or allergic phenomena (angioneurotic edema) especially in subjects with hypersensitivity to NSAIDs. However, no systemic side effects have emerged considering the route of administration and the dosage of the drug administered. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorisation of the medicinal product is important, as it allows continuous 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
Overdose
To date, there are no known cases of overdose, even considering the quantity of active ingredient which would not make an accidental overdose possible.
Pregnancy
Pregnancy There are no clinical data associated with the use of topical formulations of ketoprofen during pregnancy. Despite the lower systemic exposure compared to oral administration, it is not known whether the systemic exposure of ketoprofen achieved following topical administration can be harmful to an embryo/fetus. During the third trimester of pregnancy, systemic use of prostaglandin synthesis inhibitors, including ketoprofen, can induce cardiopulmonary and renal toxicity in the fetus. At the end of pregnancy, a prolongation of bleeding time in the mother and the newborn and labor may be delayed. Consequently, Oki gola is contraindicated during pregnancy (see section 4.3). Breastfeeding Oki gola 0.16% spray for oral mucosa must not be used during breastfeeding.
