Name
FENICOX

Active ingredients
FENECOX 0.25% Mouthwash 100 ml of solution contain: Active ingredient: Flurbiprofen 0.25 g FENECOX 0.25% Spray for oral mucosa 100 ml of solution contain: Active ingredient: Flurbiprofen 0.25 g Excipients with known effect : ethanol 8.64 g methyl p-hydroxybenzoate 0.10 g propyl p-hydroxybenzoate 0.02 g hydrogenated castor oil-40 polyoxyethylene 2.00 g patent blue V colouring (E131) 0.0006 g For the full list of excipients, see section 6.1

Therapeutic 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.

Dosage
Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4). Mouthwash : The recommended dose is two or three rinses or gargles per day with 10 ml of mouthwash. It can be diluted in water. Mucosal spray : The recommended dose is 2 sprays 3 times per day directed directly at the affected area.

Conservation
This medicinal product does not require any special storage conditions.

Pregnancy and breastfeeding
Pregnancy Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/foetal development. Results of epidemiological studies suggest an increased risk of miscarriage and of cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk of cardiac malformations increased from less than 1%, up to approximately 1.5%. The risk was believed to increase with dose and duration of therapy. In animals, administration of prostaglandin synthesis inhibitors has been shown to result in increased pre- and post-implantation loss and embryo-foetal mortality. In addition, an increased incidence of various malformations, including cardiovascular, has been reported in animals given prostaglandin synthesis inhibitors during the organogenetic period. During the first and second trimester of pregnancy, the use of flurbiprofen is not recommended and should therefore be administered on a strictly necessary basis. If flurbiprofen is used by a woman attempting to conceive or during the first and second trimester of pregnancy, the dose and duration of treatment should be kept as low as possible. During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the fetus to: • Cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension); • Renal dysfunction, which may progress to renal failure with oligo-hydroamniosis; • the mother and neonate, at the end of pregnancy, to: • Possible prolongation of bleeding time, an anti-aggregating effect which may occur even at very low doses; • Inhibition of uterine contractions resulting in delayed or prolonged labor. Consequently, flurbiprofen is contraindicated during the third trimester of pregnancy. Breastfeeding Flurbiprofen is excreted in breast milk; however, the amount excreted is only a small fraction of the maternal dose. Administration of flurbiprofen is not recommended in mothers who are breastfeeding.