Rofixdol Inflammation and Pain Spray Oral Solution 0.16% Ketoprofen 15 ml

Therapeutic indications

Symptomatic treatment of irritative-inflammatory states also associated with oropharyngeal pain (eg gingivitis, stomatitis, pharyngitis), also as a consequence of conservative or extractive dental therapy.

Dosage

1–2 sprays up to 3 times a day, addressed directly to the affected area. Each spray delivers approximately 0.2 ml of solution, equivalent to 0.32 mg of active ingredient.

Overdose

To date there are no known cases of overdose even considering the amount of active ingredient that would not make an accidental overdose possible.

Contraindications

ROFIXDOL INFLAMMATION AND PAIN 0.16% oral mucosal spray should 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) cause asthma attacks, bronchospasm, acute rhinitis, or cause nasal polyps, urticaria or angioneurotic edema, in case of previous bronchial asthma, during pregnancy and lactation.

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.

Pregnancy and breastfeeding

As with other non-steroidal anti-inflammatory drugs, the product should not be used in case of known or suspected pregnancy and during breastfeeding.

Special 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. Important information about some of the ingredients : The medicinal product contains para-hydroxybenzoates, which can cause allergic reactions (possibly delayed).

Expiry and Retention

No special instructions.

Active principles

100 ml of oral mucosal spray contain as active ingredient: Ketoprofen lysine salt 0.16 g corresponding to 0.10 g of Ketoprofen. Excipients : Methyl p – hydroxybenzoate 0.10 g Propyl p – hydroxybenzoate 0.02 g For a full list of excipients, see section 6.1.

Excipients

Glycerol 85%, xylitol, methyl para-hydroxybenzoate, propyl para-hydroxybenzoate, monobasic sodium phosphate, poloxamer, mint flavor, purified water.