FENECOX GOLA SPRAY 15ML 0.25%

FENECOX

active ingredients

FENECOX 0.25% Collutory 100 ml of solution contain: Active ingredient: Flurbiprofene 0.25 g FENECOX 0.25% Oral Mucosa Spray 100 ml of solution contain: Active ingredient: Flurbiprofen 0.25 g Excipients with known effects : ethanol 8,64 g methyl p-hydroxybenzoate 0.10 g p-hydroxybenzoate 0.02 g hydrogenated castor oil-40 polyxyethylene 2,00 g coloring blue patent V (E131) 0,0006 g For the complete list of excipients, see paragraph 6.1

Excellent

FENECOX 0.25% Collutory and FENECOX 0.25% Oral Mucosa Spray Glycerol (98%), ethanol, non crystallized liquid sorbitol, hydrogenated castor oil-40 polyxyethylene, sodium saccharin, methyl parahydroxybenzoate, propile parahydroxybenzoate, mint aroma, blue patent V (E131), citric acid anidro, sodium.

Therapeutic indications

Symptomatic treatment of irritative-inflammatory states also associated with pain of the oropharyngeal cable (e.g. gums, stomatitis, pharyngitis), also as a result of conservative or extractive dentaria therapy.

Contraindications

• Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1. • Flurbiprofen is contraindicated in patients with known hypersensitivity (asthma, hives or allergic type) towards flurbiprofen or any of the excipients, and aspirin or other NSAIDs. Flurbiprofen is also contraindicated in patients with gastrointestinal hemorrhage history or drilling related to previous treatments with NSAIDs. • Flurbiprofen should not be taken by patients with active ulcerative or anamnestic colitis, Crohn's disease, recurrent peptic ulcer or gastrointestinal hemorrhage (defined as two or more distinct episodes of proven ulceration or bleeding). • Flurbiprofen is contraindicated in patients with severe heart failure. • Third quarter of pregnancy (see paragraph 4.6).

Population

Undesirable effects can be minimized with the use of the lowest effective dose for the shortest possible duration of treatment needed to control symptoms (see paragraph 4.4). Collumination: The recommended dose is two or three rinses or gargles per day with 10 ml of collutory. It can be diluted in water. Oral Mucosa Spray: The recommended dose is 2 sprays 3 times a day directly addressed to the affected part.

Conservation

This medicine does not require any special condition of conservation.

Warnings

At recommended doses, the possible swallowing of FENECOX 0.25% Collutory and FENECOX 0.25% Oral mucosa Spray does not entail any harm to the patient as such doses are largely lower than those of the single posology of the product by systemic means. During the first and second quarter of pregnancy, flurbiprofen should not be administered unless strictly necessary (see paragraph 4.6). The administration of flurbiprofen is not recommended in nursing mothers with breast milk (see paragraph 4.6). The use of FENECOX 0.25% Collutory and FENECOX 0.25% Oral Mucosa Spray, especially if prolonged, can give rise to awareness or local irritation phenomena; in such cases it is necessary to stop the treatment and consult the doctor to establish, if necessary, suitable therapy. Do not use for protracted treatments. After short periods of treatment without appreciable results it is necessary to check the patient. In patients with kidney, heart or liver failure, the product must be used with caution. It is recommended not to associate the product with others FANS.Sono cases of bronchospasm with flurbiprofen in patients with bronchial asthma anamnesi. Gastrointestinal effects Flurbiprofen should be administered with caution to patients with peptic ulcer anamnesis and other gastrointestinal diseases since such conditions can be reascutized. The risk of gastrointestinal hemorrhage, ulcer or perforation is higher when the dosage of flurbiprofen increases in patients with a history of ulcer, especially if complicated by hemorrhage and perforation and in the elderly. These patients must begin treatment with the lowest dose available. Gastrointestinal bleeding, ulcer or drilling have been reported with all NSAIDs at any time of treatment. These adverse events may be fatal and may occur with or without warning symptoms or in case of previous history of serious gastrointestinal events. Patients with anamnesi of gastrointestinal diseases, especially if elderly, must report any unusual symptom of abdominal type (especially gastrointestinal hemorrhage) in the early stages of treatment. Senior patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal hemorrhage and perforation, which can be fatal. Undesirable effects can be minimized with the use of the lowest effective dose for the shortest possible duration of treatment needed to control symptoms (see paragraph 4.2). Important information about some excipients The mouthwashing and oral mucosa spray contain para-hydroxybenzoates that can cause allergic reactions (also delayed). The blue coloring license V (E131) can cause allergic reactions. Hydrogenated castor oil-40 polyxyethylene can cause localized skin reactions. Both collutory and spray contain a small amount of ethyl alcohol, less than 100 mg per dose.

Interactions

Attention should be given to patients treated with any of the medicines listed below, since interactions have been reported in some patients. In any case, please inform your doctor if you are taking other medicines. Aspirin: As with other medicines containing NSAIDs, concomitant administration of flurbiprofen and aspirin is not generally recommended due to the potential increase in unwanted effects. Anti-aggregation agents: increased risk of gastrointestinal hemorrhage. Selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal hemorrhage. Courtesy: increased risk of gastrointestinal ulcer or hemorrhage with NSAIDs. Cox-2 inhibitors and other NSAIDs: Concurrent use of other NSAIDs, including selective cycloxygenase-2 inhibitors, must be avoided due to potential additive effects.

Effects

The following undesirable effects were reported, particularly after the administration of systemic formulations:Emolinfopoietic system pathologiesTrombocytopenia, aplastic anemia and agranulocytosis Disorders of the Immunitarian system Anaphylaxis, angioedema, allergic reaction. Psychiatric disorders Depression Diseases of the nervous system Capogiri, cerebrovascular accidents, visual disorders, optic neuritis, migraine, paresthesia, depression, confusion, hallucination, dizziness, malaise, fatigue and drowsiness. Pathologies of the ear and labyrinth Tinnitus Heart disease Edema, hypertension and heart failure Clinical studies and epidemiological data suggest that taking some NSAIDs (especially if at high doses and in case of long-term treatment) may be associated with an increase in the risk of arterial thrombotic events (e.g. myocardial infarction or stroke). Respiratory, chest and mediastinic pathologies Reactivity of the respiratory tract (asthma, bronchospasmo and dispnea) Gastrointestinal diseases The most commonly observed adverse events are gastrointestinal. After administration of flurbiprofen have been reported: nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melena, hematitis, ulcerative stomatitis, gastrointestinal hemorrhage and Crohn's exacerbation (see section 4.3 "Controindications"). Less frequently gastritis, peptic ulcer, drilling and ulcer hemorrhage were observed. With the suppositories, irritation can occur at the local level. Very rarely have been reported cases of Pancreatis. Pathologies of skin and subcutaneous tissue Skin disorders including rash, itching, hives, porpora, angioedema and very rarely bollose dermatosis (including Stevens-Johnson syndrome, Toxic Necrolysis Epidermal and Multiform Erythema). During clinical studies carried out with flurbiprofene-based patches, the most commonly reported adverse reactions were local skin reactions (including redness, rash, itching, eruptions, insensitivity and tingling); however, the incidence was low (4.6%). Kidney and urinary pathologies Nephrotoxicity in various forms, including interstitial nephritis and nephrotic syndrome. As with other NSAIDs, rare cases of kidney failure were reported. Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address www.agenziafarmaco.gov.it/it/responsabili.

Overdosing

Synonyms Overdose symptoms may include nausea, vomiting and gastrointestinal irritation. Treatment The treatment must include gastric lavender and, if necessary, correction of the sierial electrolytic framework. There is no specific antidote for flurbiprofen.

Pregnancy The inhibition of prostaglandin synthesis can adversely affect pregnancy and/or embryo/fetal development. Results of epidemiological studies suggest an increased risk of abortion and cardiac malformation and gastroschisis after the use of an inhibitor of prostaglandin synthesis in the early stages of pregnancy. The absolute risk of heart failure increased from less than 1% to about 1.5%. It has been considered that the risk increases with dose and duration of therapy. In animals, the administration of prostaglandin synthesis inhibitors showed an increase in pre- and post-system loss and embryo-fetal mortality. In addition, an increase in the incidence of various malformations, including cardiovascular disorders, was reported in animals that had been given prostaglandin synthesis inhibitors during the organogenetic period. During the first and second trimester of pregnancy, the use of flurbiprofen is not recommended therefore it should be administered in cases strictly necessary. If flurbiprofen is used by a woman waiting for conception or during the first and second trimester of pregnancy, the dose and duration of treatment must be kept as low as possible. During the third trimester of pregnancy, all prostaglandin synthesis inhibitors can expose the fetus to: • cardiopulmonary toxicity (with premature closure of arterial duct and pulmonary hypertension); • kidney dysfunction, which can progress in kidney failure with oligo-idroamnios; • the mother and the newborn, at the end of pregnancy, to: • Possible prolongation of bleeding time, an anti-aggregating effect that can occur even at very low doses; • Inhibition of uterine contractions resulting in delay or extension of labor. Therefore flurbiprofen is contraindicated during the third trimester of pregnancy. Food Flurbiprofen is excreted in breast milk; however the excreta quantity is only a small fraction of the maternal dose. Flurbiprofene administration is not recommended in nursing mothers with breast milk.

Source: Farmadati