Active ingredients: Flurbiprofen
FROBEN THROAT 0.25% Mouthwash
FROBEN THROAT 0.25% Oral mucosal spray
Why is Froben throat used? What is it for?
WHAT IS IT
Froben Gola is a non-steroidal anti-inflammatory drug for oropharyngeal use
WHY IT IS USED
Froben Gola is used for the symptomatic treatment of irritative-inflammatory states also associated with pain in the oropharyngeal cavity (eg gingivitis, stomatitis, pharyngitis), also as a consequence of conservative or extractive dental therapy.
Contraindications When Froben throat should not be used
Hypersensitivity to the active substance or to any of the excipients
Hypersensitivity to aspirin or other NSAIDs.
Do not use in patients who have a peptic ulcer or have had it in the past.
Do not use during the third trimester of pregnancy.
Precautions for use What you need to know before taking Froben throat
At the recommended doses, the possible swallowing of FROBEN THROAT does not involve any harm to the patient as these doses are far lower than those of the single systemic dosage of the product.
Given the lack of propellant gas in the formulation of FROBEN THROAT 0.25% Spray for oral mucosa, when using the product for the first time, press the dispenser several times until you have a regular nebulization.
The use, especially if prolonged, of the product can give rise to sensitization phenomena or local irritation; in such cases it is necessary to interrupt the treatment and consult the doctor to establish, if necessary, a suitable therapy.
Interactions Which drugs or foods can modify the effect of Froben throat
Tell your doctor or pharmacist if you have recently taken any other medicines, even those without a prescription.
At the recommended doses, no interactions with other medicinal products or other types have been reported
Warnings It is important to know that:
FROBEN THROAT should not be used for prolonged treatments. After short periods of treatment with no appreciable results, consult your doctor.
When it can be used only after consulting your doctor
Patients who have a peptic ulcer or have had one in the past should consult their doctor before taking Froben Gola
What to do during pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine During the first and second trimester of pregnancy, flurbiprofen should not be administered unless strictly necessary. Administration of flurbiprofen is not recommended in nursing mothers.
Effects on ability to drive and use machines
FROBEN THROAT does not affect the ability to drive or use machines.
Doping warning
Both mouthwash and oral mucosal spray contain ethyl alcohol.
For those who carry out sporting activities, the use of medicines containing ethyl alcohol can determine positivity to doping tests in relation to the alcohol concentration limits indicated by some sports federations
Health education notes
In favorable environmental conditions (lowering or sudden changes in temperature, raising the level of humidity, etc.) the upper respiratory tract can be the site of engraftment of pathogenic germs that cause inflammation.
The characteristic symptoms of inflammation of the upper respiratory tract (mouth, nose, throat) include sore throat, burning sensation, difficulty in swallowing and can be partially controlled by avoiding exposure to additional irritating factors such as smoke, smog, dry air, crowded places, etc.
Inflammation can also be present in the gums. It could be a sign of dental problems in the initial phase: in this case, a check-up at a dentist could be useful to avoid an unpleasant development of the disorder.
Furthermore, as a result of conservative dental therapies, dental extractions, small dental surgeries, the gums and the oral cavity can be the site of redness, inflammation and pain.
Dosage and method of use How to use Froben throat: Dosage
HOW MUCH
Warning: do not exceed the indicated doses.
- Mouthwash: The recommended dose is two or three rinses or gargles a day with 10ml of mouthwash.
- Oromucosal spray: the recommended dose is 2 sprays 3 times a day.
WHEN AND FOR HOW LONG
The medicine can be used at any time of the day
Warning: use only for short periods of treatment. Consult your doctor if the disorder occurs repeatedly or if you notice any recent change in its characteristics
LIKE
Mouthwash:
the product can be used in pure form (10 ml), or alternatively it can be diluted in water.
Oral mucosal spray
Direct the sprays directly on the affected part.
ISTRUTIONS FOR USING FROBEN THROAT 0.25% Oral mucosal spray
Turn the spout to the right or left, without tampering with the dispenser.
Press the dispenser.
Overdose What to do if you have taken too much Froben throat
Symptoms
Symptoms of overdose may include nausea, vomiting and gastrointestinal irritation.
Treatment
Treatment should include gastric lavage and, if necessary, correction of the serum electrolyte picture.
There is no specific antidote for flurbiprofen.
In case of accidental ingestion / intake of an excessive dose of FROBEN THROAT, notify your doctor immediately or go to the nearest hospital.
IF YOU HAVE ANY DOUBT ABOUT USING FROBEN THROAT, CONTACT YOUR DOCTOR OR PHARMACIST
Side Effects What are the side effects of Froben throat
Like all medicines, FROBEN THROAT can cause side effects, although not everybody gets them.
At the recommended doses no undesirable effects are reported.
The following undesirable effects have been reported, particularly after administration of formulations for systemic use
Disorders of the blood and lymphatic system
Thrombocytopenia, aplastic anemia and agranulocytosis
Disorders of the immune system
Anaphylaxis, angioedema, allergic reaction.
Disorders of the nervous system
Dizziness, cerebrovascular accidents, visual disturbances, optic neuritis, migraine, paraesthesia, depression, confusion, hallucination, vertigo, malaise, fatigue and somnolence.
Acoustic and labyrinth disturbances
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, diarrhea, 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. Gastritis, peptic ulcer, perforation and ulcer haemorrhage were observed less frequently. Cases of pancreatitis have been reported very rarely.
Skin and subcutaneous tissue disorders
Skin disorders including rash, pruritus, urticaria, purpura, angioedema and very rarely bullous dermatosis (including Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis and Erythema multiforme).
Kidney and urinary system disorders
Nephrotoxicity in various forms, including interstitial nephritis and nephrotic syndrome. As with other NSAIDs, rare cases of renal failure have been reported.
Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. Undesirable effects can also be reported directly through the national reporting system at "https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse". By reporting side effects you can help provide more information on the safety of this medicine. "
Expiry and Retention
Expiry: see the expiry date indicated on the package. The expiry date indicated refers to the product in intact packaging, correctly stored.Warning: do not use the medicine after the expiry date indicated on the package.
Shelf life after first opening: 1 year.
Mouthwash: This medicine does not require any special storage conditions.
Oromucosal spray: this medicine does not require any particular storage temperature; keep the bottle in the outer carton to protect from light.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
KEEP THE MEDICINAL PRODUCT OUT OF THE SIGHT AND REACH OF CHILDREN
It is important to always have the information on the medicine available, so keep both the box and the package leaflet.
COMPOSITION
FROBEN THROAT 0.25% mouthwash
100 ml of solution contain:
Active ingredient: Flurbiprofen 0.25 g.
Excipients: purified water, alcohol, patent blue VE 131, glycerol, mint essence, 40-polyoxyethylene hydrogenated castor oil, potassium bicarbonate, sodium saccharinate, sorbitol.
FROBEN THROAT 0.25% spray for oral mucosa
100 ml of solution contain
The active ingredient is Flurbiprofen 0.25 g.
Excipients: purified water, alcohol, patent blue VE 131, glycerol, mint essence, 40-polyoxyethylene hydrogenated castor oil, potassium bicarbonate, sodium saccharinate, sorbitol.
HOW IT LOOKS
0.25% Mouthwash - 1 bottle of 160 ml 0.25% Oromucosal spray - 1 bottle of 15 ml
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
FROBEN THROAT 0.25%
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
• FROBEN THROAT 0.25% Mouthwash
100 ml of solution contain:
Active principle:
Flurbiprofen 0.25 g
• FROBEN THROAT 0.25% Spray for oral mucosa
100 ml of solution contain:
Active principle:
Flurbiprofen 0.25 g
For the full list of excipients, see section 6.1
03.0 PHARMACEUTICAL FORM
Mouthwash
Oral mucosal spray
04.0 CLINICAL INFORMATION
04.1 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.
04.2 Posology and method of administration
Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms (see section 4.4).
MOUTHWASH
The recommended dose is two or three rinses or gargles a day with 10ml of mouthwash. It can be diluted in water.
SPRAY FOR ORAL MUCOSA
The recommended dose is 2 sprays 3 times a day addressed directly to the affected area.
04.3 Contraindications
Flurbiprofen is contraindicated in patients with known hypersensitivity (asthma, urticaria or allergic type) to flurbiprofen or to any of the excipients, and to aspirin or other NSAIDs.
Flurbiprofen is also contraindicated in patients with a history of gastrointestinal bleeding or perforation related to previous NSAID treatment.
Flurbiprofen should not be taken by patients with active or anamnestic ulcerative colitis, Crohn's disease, recurrent peptic ulcer or gastrointestinal bleeding (defined as two or more distinct episodes of proven ulceration or bleeding).
Flurbiprofen is contraindicated in patients with severe heart failure.
Third trimester of pregnancy
04.4 Special warnings and appropriate precautions for use
Gastrointestinal Effects
Flurbiprofen should be administered with caution to patients with a history of peptic ulcer and other gastrointestinal diseases as these conditions may be exacerbated.
The risk of gastrointestinal bleeding, ulcer or perforation is higher with increasing flurbiprofen dosage in patients with a history of ulcer, particularly if complicated with haemorrhage and perforation and in the elderly. These patients should start treatment at the lowest dose. available.
Gastrointestinal bleeding, ulcer or perforation have been reported with all NSAIDs at any time during treatment. These adverse events can be fatal and can occur with or without warning symptoms or with a previous history of serious gastrointestinal events.
Patients with a history of gastrointestinal disease, particularly if elderly, should report any unusual abdominal symptoms (especially gastrointestinal bleeding) in the initial stages of treatment.
Elderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal haemorrhage 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 section 4.2 and the paragraphs below on gastrointestinal and cardiovascular risks).
Concomitant use of protective agents (misoprostol or proton pump inhibitors) should be considered for these patients and also for patients taking low dose aspirin or other drugs that may increase the risk of gastrointestinal events (see below and section 4.5).
When gastrointestinal bleeding or ulceration occurs in patients taking Froben the treatment should be discontinued.
Cardiovascular and cerebrovascular effects
Adequate monitoring and instruction are required in patients with a history of mild to moderate hypertension and / or congestive heart failure as fluid retention and edema have been reported in association with NSAID treatment.
Clinical studies and epidemiological data suggest that the use of some NSAIDs, especially at high doses and for long-term treatments, may be associated with a modest increased risk of arterial thrombotic events such as myocardial infarction or stroke. There are no data. sufficient to rule out a similar risk for flurbiprofen.
Patients with uncontrolled hypertension, congestive heart failure, established ischemic heart disease, peripheral arterial disease and / or cerebrovascular disease should only be treated with flurbiprofen after careful consideration. Similar considerations should be made before initiating long-term treatment in patients with risk factors for cardiovascular disease (eg, hypertension, hyperlipidaemia, diabetes mellitus, smoking).
Flurbiprofen, like other NSAIDs, can inhibit platelet aggregation and prolong bleeding time.
Skin reactions
Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs. Patients appear to be at higher risk in the early stages of therapy. : The onset of the reaction occurs in most cases within the first month of treatment. Flurbiprofen should be discontinued at the first appearance of skin rash, mucosal lesions or any other signs of hypersensitivity.
Other Reactions
Caution should be used when initiating treatment with NSAIDs such as flurbiprofen in patients with considerable dehydration. Particular caution should be taken in the treatment of patients with severely reduced renal, cardiac or hepatic function, as the use of NSAIDs may lead to deterioration of renal function. In such patients the dosage should be kept as low as possible and renal function must be monitored.
Cases of bronchospasm have been reported with flurbiprofen in patients with a history of bronchial asthma.
The effects reported above have been reported in particular after the administration of formulations based on Flurbiprofen for systemic use.
At the recommended doses, the possible swallowing of FROBEN THROAT does not involve any harm to the patient as these doses are far lower than those of the single systemic dosage of the product.
The use of FROBEN THROAT, especially if prolonged, can give rise to sensitization phenomena or local irritation; in such cases it is necessary to interrupt the treatment and consult the doctor to establish, if necessary, a suitable therapy.
Do not use for prolonged treatments. After short periods of treatment without appreciable results, consult your doctor.
Both the mouthwash and the spray contain ethyl alcohol. For those who carry out sports activities, the use of medicines containing ethyl alcohol can determine a positive anti-doping test in relation to the alcohol concentration limits indicated by some sports federations.
04.5 Interactions with other medicinal products and other forms of interaction
Attention should be paid in patients treated with any of the medicines listed below, as interactions have been reported in some patients.
Diuretics, ACE inhibitors and angiotensin II antagonists: NSAIDs may reduce the effect of diuretics and other antihypertensive drugs. In some patients with impaired renal function (e.g. dehydrated patients or elderly patients with impaired renal function) the co-administration of an ACE inhibitor or angiotensin II antagonist and agents that inhibit the cyclo-oxygenase system may lead to further deterioration of renal function, including possible acute renal failure, usually reversible. These interactions should be considered in patients taking Flurbiprofen concomitantly with ACE inhibitors or angiotensin II antagonists. Therefore, the combination should be administered with caution, especially in elderly patients.
Patients should be adequately hydrated and monitoring of renal function should be considered after initiation of concomitant therapy and on a periodic basis thereafter.
Cardiac glycosides: NSAIDs can exacerbate heart failure, reduce the degree of glomerular filtration and increase plasma levels of cardiac glycosides.
Anticoagulants, such as warfarin: increased anticoagulant effect.
Aspirin: As with other NSAID-containing medicinal products, concomitant administration of flurbiprofen and aspirin is generally not recommended due to the potential for increased side effects.
Anti-aggregating agents: increased risk of gastrointestinal bleeding.
Selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding.
Lithium salts: lithium removal decrease.
Methotrexate: Caution is advised in case of concomitant administration of flurbiprofen and methotrexate as NSAIDs may increase methotrexate levels.
Ciclosporins: increased risk of nephrotoxicity with NSAIDs.
Corticosteroids: increased risk of gastrointestinal ulcer or haemorrhage with NSAIDs.
Cox-2 inhibitors and other NSAIDs: Concomitant use of other NSAIDs, including selective cyclooxygenase-2 inhibitors, should be avoided due to potential additive effects.
Quinolone Antibiotics: Results from animal studies suggest that NSAIDs may increase the risk of seizures associated with the use of quinolone antibiotics. Patients taking NSAIDs and quinolones may have an increased risk of developing seizures.
Mifepristone: NSAIDs should not be taken for 8-12 days after administration of mifepristone as NSAIDs may reduce the effects of mifepristone.
Tacrolimus: Possible increased risk of nephrotoxicity when co-administered with NSAIDs.
Zidovudine: increased risk of haematic toxicity when co-administered with NSAIDs. There is evidence of an increased risk of haemarthrosis and hematoma in HIV-infected haemophiliac patients concomitantly treated with Zidovudine and other NSAIDs.
The interactions reported above have been reported in particular after the administration of formulations based on Flurbiprofen for systemic use.
At the recommended doses of FROBEN THROAT no interactions with other medicinal products or other types have been reported. However, inform your doctor if you are taking other medications.
04.6 Pregnancy and lactation
Injury and pregnancy
Inhibition of prostaglandin synthesis can adversely affect pregnancy and / or embryo / fetal development.
Results of epidemiological studies suggest an increased risk of miscarriage and 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% to approximately 1.5%. The risk has been considered to increase with dose and duration of therapy. In animals, administration of prostaglandin synthesis inhibitors has been shown to cause increased pre- and post-implantation loss and mortality. embryo-fetal.
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, flurbiprofen should not be administered except in strictly necessary cases.
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 can expose the fetus to:
• Cardiopulmonary toxicity (with premature closure of the arterial duct and pulmonary hypertension);
• Renal dysfunction, which can progress to renal failure with oligohydroamnios;
the mother and the newborn, at the end of pregnancy, to:
• Possible prolongation of bleeding time, an antiplatelet effect that can 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.
Feeding time
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 nursing mothers.
04.7 Effects on ability to drive and use machines
It does not affect the ability to drive and use machines.
04.8 Undesirable effects
The following undesirable effects have been reported, particularly after administration of formulations for systemic use:
Disorders of the blood and lymphatic system
Thrombocytopenia, aplastic anemia and agranulocytosis
Disorders of the immune system
Anaphylaxis, angioedema, allergic reaction.
Psychiatric disorders
Depression
Disorders of the nervous system
Dizziness, cerebrovascular accidents, visual disturbances, optic neuritis, migraine, paraesthesia, depression, confusion, hallucination, vertigo, malaise, fatigue and somnolence.
Acoustic and labyrinth disturbances
Tinnitus
Cardiovascular Disorders
Edema, hypertension and heart failure
Clinical studies and epidemiological data suggest that the intake of some NSAIDs (especially at high doses and in the case of long-term treatment) may be associated with an increased risk of arterial thrombotic events (eg myocardial infarction or stroke).
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, diarrhea, 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 (see Contraindications section). Gastritis, peptic ulcer, perforation and ulcer haemorrhage were observed less frequently. Local irritation can occur with suppositories.
Cases of pancreatitis have been reported very rarely.
Skin and subcutaneous tissue disorders
Skin disorders including rash, pruritus, urticaria, purpura, angioedema and very rarely bullous dermatosis (including Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis and Erythema multiforme).
During clinical trials with flurbiprofen patches, the most commonly reported adverse reactions were local skin reactions (including redness, rash, itching, rash, numbness and tingling); however the incidence was low (4.6%).
Kidney and urinary system disorders
Nephrotoxicity in various forms, including interstitial nephritis and nephrotic syndrome.
As with other NSAIDs, rare cases of renal failure have been reported.
"Reporting of suspected adverse reactions.
Reporting of suspected adverse reactions occurring after authorization of the medicinal product is important as it allows continuous monitoring of the benefit / risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system. "address https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse".
04.9 Overdose
Symptoms
Symptoms of overdose may include nausea, vomiting and gastrointestinal irritation.
Treatment
Treatment should include gastric lavage and, if necessary, correction of the serum electrolyte picture.
There is no specific antidote for flurbiprofen.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: Anti-inflammatory and antirheumatic drugs,
stomatological
ATC CODE: A01AD11
Flurbiprofen possesses analgesic, anti-inflammatory and antipyretic properties. This is thought to be related to the drug's ability to inhibit prostaglandin synthesis.
05.2 Pharmacokinetic properties
Following oral administration, flurbiprofen is readily absorbed from the gastrointestinal tract, with peak plasma concentrations occurring approximately 90 minutes after ingestion. Compared to tablets, absorption from suppositories may be more rapid but peak concentration serum is lower.
Flurbiprofen is about 99% protein bound and has an elimination half-life of about 3-4 hours. The urinary excretion rate of flurbiprofen and its two major metabolites, both in the free and conjugated state, is similar in both free and conjugated states. the oral and rectal routes of administration The metabolic patterns are also similar from a quantitative point of view for both routes of administration.
05.3 Preclinical safety data
Toxicological tests on animals have shown that flurbiprofen is well tolerated. Acute toxicity tests on various animal species, for oral administration, have shown that the LD50 of flurbiprofen is between 228-344 mg / kg. The administration of NSAIDs to pregnant rats can result in restriction of the fetal arterial duct.
Long-term clinical studies have shown no significant effects on hepatic or renal function or on the haematopoietic system.
There is no further information on preclinical data other than that already reported elsewhere in this Summary of Product Characteristics (see section 4.6).
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Purified water, alcohol, patent blue VE 131, glycerol, mint essence, 40-polyoxyethylene hydrogenated castor oil, potassium bicarbonate, sodium saccharinate, sorbitol.
06.2 Incompatibility
There are no known chemical-physical incompatibilities of flurbiprofen with other compounds.
06.3 Period of validity
• 2 years
• Validity after first opening: 1 year
06.4 Special precautions for storage
Mouthwash: This medicine does not require any special storage conditions. Oromucosal spray: this medicine does not require any particular storage temperature; keep the bottle in the outer carton to protect from light.
06.5 Nature of the immediate packaging and contents of the package
Mouthwash
• Carton containing a dark PET bottle with polypropylene cap of 160 ml of solution
Oral mucosal spray
Carton containing a white glass bottle with microdosing pump and dispenser of 15 ml of solution
06.6 Instructions for use and handling
FROBEN THROAT 0.25% Oromucosal spray:
Turn the nozzle to the right or left as shown, without tampering with the dispenser.
Press the dispenser.
07.0 MARKETING AUTHORIZATION HOLDER
BGP Products S.r.l., viale Giorgio Ribotta 11, 00144 - Rome
08.0 MARKETING AUTHORIZATION NUMBER
• 0.25% mouthwash - 160 ml bottle - A.I.C .: n. 042822015
• 0.25% oral mucosal spray - 15 ml bottle - A.I.C .: n. 042822027
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
• 0.25% mouthwash - 160 ml bottle: 27.04.1991
• 0.25% oral mucosal spray - 15 ml bottle: 11.11.1996
Renewal of the authorization: 01.06.2010