Description
Substances for local oral treatment.
ACTIVE INGREDIENTS:
Flurbiprofen.
EXCIPIENTS:
Mouthwash and oral mucosa spray, mint flavour: glycerol, ethyl alcohol (ethanol 96%), liquid sorbitol (non-crystallisable), polyoxyethylene 40 hydrogenated castor oil, sodium hydroxide, sodium saccharin, methyl-p-hydroxybenzoate, propyl-p-hydroxybenzoate, trirectified mint essential oil, patent blue V (E 131), citric acid, purified water.
Lemon and honey flavoured oral mucosa spray: glycerol, ethyl alcohol (ethanol 96%), liquid sorbitol (non-crystallisable), polyoxyethylene 40 hydrogenated castor oil, sodium hydroxide, sodium saccharin, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, honey flavouring, lemon flavouring, mint flavouring, sunset yellow (E110), citric acid, purified water.
Orange and honey flavoured oral mucosa spray: glycerol, ethyl alcohol (ethanol 96%), liquid sorbitol (non-crystallisable), polyoxyethylene 40 hydrogenated castor oil, sodium hydroxide, sodium saccharin, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, honey flavouring, orange flavouring, mint flavouring, sunset yellow (E110), citric acid, purified water.
Sugar-free mint-flavored lozenges: glycerol dibehenate, acesulfame potassium, balsamic mint flavor, mannitol, copovidone.
Sugar-free lozenges with lemon and honey flavour: glycerol dibehenate, acesulfame potassium, lemon and honey flavouring, isomalt, c-opovidone.
Sugar-free lozenges, orange and honey flavour: glycerol dihydrobenzoate, acesulfame potassium, orange honey flavour, isomalt, copovid one.
DIRECTIONS:
The mouthwash/spray drug for oral mucosa is used in the 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.
The drug in tablets is used in the symptomatic treatment of irritative-inflammatory conditions also associated with pain in the oropharyngeal cavity (e.g.
gums, stomatitis, pharyngitis).
CONTRAINDICATIONS/SIDE EFFECTS:
Hypersensitivity (asthma, bronchospasm, urticaria or allergic type) to flurbiprofen or to any of the excipients, and to acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (NSAIDs); third trimester of pregnancy; administration of flurbiprofen is not recommended in mothers who are breastfeeding; do not use in patients who suffer from peptic ulcer or who have suffered from it in the past; do not administer the tablets to children under 12 years of age.
DOSAGE:
Mouthwash: the recommended dose is 2-3 rinses or gargles a day with 10 ml of mouthwash (using the appropriate measuring cup), diluted in half a glass of water or pure.
Oral mucosa spray: the recommended dose is 2 sprays 3 times a day directed directly at the affected area; each spray delivers 0.2 ml of solution, equivalent to 0.5 mg of active ingredient.
>>Pads.
Adults and children over 12 years: 1 lozenge to dissolve slowly in the mouth every 3-6 hours, as needed.
Do not exceed the dose of 8 tablets in 24 hours.
Do not administer to children under 12 years of age.
No dosage changes are necessary for elderly people.
CONSERVATION:
Mouthwash and oral mucosa spray: no special storage conditions.
Tablets: store at a temperature not exceeding 25 degrees C.
WARNINGS:
At the recommended doses, when using the medicine in its various pharmaceutical forms, any swallowing does not, in itself, cause any harm to the patient, as these doses are much lower than those commonly used in treatments with flurbiprofen and by systemic administration.
The mouthwash and oral spray (all presentations) contain methyl parahydroxybenzoate and propyl parahydroxybenzoate as preservatives: they may cause allergic reactions (even delayed).
Due to the presence of sorbitol, patients with rare hereditary problems of fructose intolerance should not take the mouthwash and oral mucosa spray (all presentations).
The spray (all presentations) contains a small amount of ethyl alcohol less than 100 mg per dose.
The mouthwash contains 12,15 vol % ethanol (alcohol), i.e.
up to 960 mg per dose, equivalent to approximately 24 ml of beer, 10 ml of wine per dose.
It can be harmful for alcoholics.
To be taken into consideration in pregnant or breastfeeding women, children and high-risk groups such as people with liver disease or epilepsy.
The medicine 0.25% spray for oral mucosa orange and honey flavour and the medicine 0.25% spray for oral mucosa lemon and honey flavour also contain the colouring agent sunset yellow (E110), which may cause allergic reactions.
The medicine 8.75 mg orange and honey flavoured lozenges and the medicine 8.75 mg lemon and honey flavoured lozenges contain isomalt: patients with rare hereditary problems of fructose intolerance should not take this medicine.
In patients with renal, cardiac or hepatic insufficiency the medicine should be used with caution.
It is recommended not to combine the medicine with NSAIDs.
The use, especially if prolonged, of the product may give rise to phenomena of sensitization or local irritation; in such cases it is necessary to interrupt the treatment and consult the doctor to establish, if necessary, an appropriate therapy.
Do not use for prolonged treatments.
After a short period of treatment without appreciable results, consult your doctor.
INTERACTIONS:
However, inform your doctor if you are taking other medicines.
As demonstrated in some clinical studies, flurbiprofen may occasionally reduce the diuretic activity of furosemide.
Furthermore, flur biprofen may occasionally interfere with the action of anticoagulant drugs.
However, no interaction of flur biprofen with digoxin, tolbutamide and antacids has been demonstrated.
SIDE EFFECTS:
The use of the drug, especially if prolonged, may give rise to phenomena of sensitization or local irritation; in such cases it is necessary to interrupt the treatment and institute, if necessary, an appropriate therapy.
The following adverse effects have been reported, particularly after administration of higher systemic doses.
Pathologies of the haemolymphopoietic system: thrombocytopenia, aplastic anaemia and agranulocytosis.
Immune system disorders: anaphylaxis, angioedema, allergic reaction.
Nervous system disorders: dizziness, cerebrovascular accident, visual disturbances, optic neuritis, migraine, paraesthesia, depression, confusion, hallucination, vertigo, discomfort, fatigue and drowsiness.
Ear and labyrinth disorders: tinnitus.
Respiratory, thoracic and mediastinal disorders: respiratory tract reactivity (asthma, bronchospasm and dyspnoea).
Gastrointestinal disorders: The most commonly observed adverse events are gastrointestinal in nature.
Nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, gastrointestinal haemorrhage and exacerbation of colitis and Crohn's disease have been reported following administration of flurbiprofen.
Less frequently, gastritis, peptic ulcer, perforation and ulcer haemorrhage have been observed.
Skin and subcutaneous tissue disorders: Skin disorders including rash, pruritus, urticaria, purpura and very rarely bullous dermatoses (including Stevens-Johnson syndrome, toxic epidermal necrolysis and erythema multiforme).
Renal and urinary disorders: Nephrotoxicity in various forms, including interstitial nephritis and nephrotic syndrome.
Rare cases of renal failure have been reported.
Reporting suspected adverse reactions that occur after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
PREGNANCY AND BREASTFEEDING:
During the first and second trimester of pregnancy, flurbiprofen should not be administered unless clearly necessary.
The medicine administered during pregnancy can delay the onset of labor and increase its duration.
Administration of flurbiprofen is not recommended in breastfeeding mothers.
