Rofixdol Inflammation And Pain Mouthwash 1.6% Ketoprofen 150ml

Therapeutic indications

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

Dosage

The package includes a measuring cup with a mark corresponding to 10 ml. To open the package it is necessary to press the cap firmly and turn counterclockwise at the same time. Two rinses or gargles a day with 10 ml of Kelosan 1.6% mouthwash diluted in about 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 systemic dose (160 mg of ketoprofen lysine salt).

Overdose

No cases of overdose have ever been reported with the use of the ketoprofen lysine salt solution. In case of misuse or accidental overdose, general therapeutic measures of the type normally adopted in case of poisoning with non-steroidal anti-inflammatory drugs should be used.

Contraindications

Hypersensitivity to the active substance or to any of the excipients. Individual hypersensitivity in subjects in whom the use of other non-steroidal anti-inflammatory drugs has led to allergic reactions such as asthma, urticaria or rhinitis. Pregnancy and breastfeeding.

Side effects

No local or systemic side effects have been reported due to the use of the solution containing ketoprofen lysine salt. If unwanted effects occur, consult your doctor.

Pregnancy and breastfeeding

As with other non-steroidal anti-inflammatory drugs, Kelosan 1.6% mouthwash should not be used if you are pregnant or suspected and are 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. In prolonged and high-dose therapies, the possibility of competition between absorbed ketoprofen and other drugs with high plasma protein binding should be borne in mind. Important information about some of the ingredients : The medicinal product contains para-hydroxybenzoates, which can cause allergic reactions (possibly delayed). Quinoline Yellow Dye (E104) and Patented Blue Dye V (E131) can cause allergic reactions. The mouthwash also contains a small amount of ethyl alcohol, less than 100 mg per dose.

Expiry and Retention

None.

Active principles

100 ml of mouthwash contain as active ingredient: Ketoprofen lysine salt 1.6 g corresponding to 1g of Ketoprofen. Excipients : Ethyl alcohol 96% 4g Methyl p - hydroxybenzoate 0.10g Propyl p - hydroxybenzoate 0.02g Green dye [quinoline yellow (E104) and the patented blue dye V (E131)] 0.048g For the complete list of excipients, see section 6.1.

Excipients

Glycerol 85%, ethyl alcohol 96%, sodium saccharin, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, mint flavor, levomentol, green dye, monobasic sodium phosphate, purified water.