Description
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 mouthwash contains as active ingredient: Ketoprofen lysine salt 1.6 grams Excipient with known effect: Methyl parahydroxybenzoate, mint flavour (containing d-limonene, linalool) For the full list of excipients, see section 6.1
Excipients
Glycerin, Ethanol, Methyl parahydroxybenzoate, Mint flavouring (containing d-limonene, linalool) , Menthol, Sodium saccharin, Certosa green colouring, Monobasic sodium phosphate, purified water.
Dosage
The package contains a measuring cup with a mark corresponding to 10 ml. To open the package, press the cap firmly and simultaneously turn it counterclockwise. Two rinses or gargles a day with 10 ml of OKi gola 1.6% mouthwash diluted in approximately 100 ml of water. Any involuntary swallowing of the solution used for rinsing and gargling does not cause any particular harm to the patient as it is equivalent to the dose expected for systemic use (160 mg of ketoprofen lysine salt).
Warnings
The use, especially if prolonged, of topical drugs could give rise to sensitization phenomena, in which case it is necessary to suspend the treatment and adopt appropriate therapeutic measures. In prolonged therapies and with high doses, keep in mind the possibility of competition between absorbed ketoprofen and other drugs with high binding to plasma proteins. This medicine contains methyl parahydroxybenzoate, known for the possibility of causing allergic reactions (even delayed). This medicine contains the mint flavoring, which in turn contains d-Limonene and linalool which can cause allergic reactions.
Conservation
This medicinal product does not require any special storage conditions.
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in paragraph 6.1. Individual hypersensitivity in subjects in whom the use of other nonsteroidal anti-inflammatory drugs has caused allergic reactions such as asthma, urticaria or rhinitis. During pregnancy.
Side effects
Local irritation and angioneurotic edema have been reported, especially in subjects with hypersensitivity to NSAIDs, with a very rare frequency. No systemic side effects are known. 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
No cases of overdose have ever been reported with the use of ketoprofen lysine salt solution. In case of improper use or accidental overdose, it is advisable to resort to general therapeutic measures of the type normally adopted in case of poisoning with nonsteroidal anti-inflammatory drugs.
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 1.6% mouthwash should not be used during breastfeeding.
