Oki Inflammation and Pain Throat Spray 15ml

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 spray for oral mucosa contains as active ingredient: Ketoprofen lysine salt 0.16 grams corresponding to 0.10 grams of Ketoprofen Excipient with known effects: Methyl parahydroxybenzoate, mint flavor (containing d-Limonene, eugenol, linalool), ever cool flavor (containing linalool). For the full list of excipients, see section 6.1

EXCIPIENTS

Glycerol 85%, xylitol, methyl parahydroxybenzoate, monobasic sodium phosphate, poloxamer 407, mint flavor (containing d-Limonene, eugenol, linalool), ever cool aroma (containing linalool), purified water.

CONTRAINDICATIONS AND SIDE EFFECTS

OKi throat 0.16% spray for oral mucosa must not be administered in case of hypersensitivity to the active ingredient, 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) cause asthma attacks, bronchospasm, acute rhinitis, or cause nasal polyps, urticaria or angioneurotic edema, in case of previous bronchial asthma, during pregnancy and breastfeeding.

DOSAGE

1-2 sprays up to 3 times a day, aimed directly at the affected part. Each spray delivers approximately 0.2 ml of solution, equivalent to 0.32 mg of active ingredient.

CONSERVATION

No special instructions

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 suitable therapeutic measures. This medicine contains methyl parahydroxybenzoate, known to cause allergic reactions (including delayed reactions). This medicine contains mint flavouring, which in turn contains d-limonene, eugenol and linalool which may cause allergic reactions. This medicine contains the ever cool flavour, which itself contains linalool which may cause allergic reactions.

INTERACTIONS

At present there are no known interactions with other drugs: interactions which can also be excluded by considering the route of administration and the dosage of drug administered.

SIDE EFFECTS

Local side effects following topical administration on the oral mucosa of ketoprofen lysine salt solution are extremely rare and consist of irritative or allergic phenomena (angioneurotic edema), especially in subjects with hypersensitivity to NSAIDs. However, no systemic side effects emerged considering the route of administration and the dosage of drug administered. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorization 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 accidental overdose possible.

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 0.16% spray for oral mucosa should not be used during breastfeeding.

EFFECTS ON DRIVING ABILITY

There are no known effects on the ability to drive and use machinery: effects which can be excluded considering the route of administration and the dosage of the drug administered.