Oki Gola 1.6% mouthwash 150ml

In ottemperanza all'articolo 118 “autorizzazione della pubblicità presso il pubblico” del decreto legislativo 24 aprile 2006, numero 219

INDICATIONS

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 effects: Methyl parahydroxybenzoate, mint flavor (containing d-limonene, linalool) For the complete list of excipients, see paragraph 6.1

EXCIPIENTS

Glycerin, Ethanol, Methyl parahydroxybenzoate, Mint flavor (containing d-limonene, linalool), Menthol, Sodium Saccharin, Certosa Green Colourant, Monobasic Sodium Phosphate, purified water.

CONTRAINDICATIONS AND SIDE EFFECTS

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 non-steroidal anti-inflammatory drugs has caused allergic reactions such as asthma, urticaria or rhinitis. During pregnancy.

DOSAGE

The package includes a measuring cup with a mark corresponding to 10 ml. To open the package you need to firmly press the cap and rotate it counterclockwise at the same time. Two rinses or gargles a day with 10 ml of OKi throat 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 expected systemic dose (160 mg of ketoprofen lysine salt).

CONSERVATION

This medicinal product does not require any special storage conditions.

WARNINGS

The use of topical drugs, especially if prolonged, could give rise to sensitization phenomena, in which case it is necessary to suspend the treatment and adopt suitable therapeutic measures. In prolonged and high-dose therapies, 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 to cause allergic reactions (including delayed reactions). This medicine contains mint flavouring, which in turn contains d-Limonene and linalool which may cause allergic reactions.

INTERACTIONS

At present, no negative interactions with other drugs have emerged.

SIDE EFFECTS

Local irritation phenomena and angioneurotic edema have been reported, especially in subjects with hypersensitivity to NSAIDs, with very rare frequency. There are no known systemic side effects. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit/risk balance of the medicine. 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 non-steroidal anti-inflammatory drugs.

PREGNANCY AND BREASTFEEDING

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 could be harmful to an embryo/fetus. During the third trimester of pregnancy, the systemic use of prostaglandin synthesis inhibitors, including ketoprofen, can induce cardiopulmonary and renal toxicity in the fetus. At the end of pregnancy there may be a prolongation of the bleeding time of the mother and the newborn and labor may be delayed. Consequently, Oki throat is contraindicated during pregnancy (see section 4.3). Breastfeeding OKi throat 1.6% mouthwash should not be used during breastfeeding.

EFFECTS ON DRIVING ABILITY

There are no known effects on the level of attention