Description
BENACTIV THROAT
PHARMACOTHERAPEUTIC CATEGORY:
Dental.
ACTIVE INGREDIENTS:
Flurbiprofen.
EXCIPIENTS:
Mouthwash: glycerol, ethyl alcohol, sorbitol 70, hydrogenated castor oil-40-polyoxyethylene, sodium hydroxide, sodium saccharinate, methyl parahydroxybenzoate, propyl parahydroxybenzoate, mint essence, patent blue V (E131), purified water.
Oral mucosa spray: glycerol, ethyl alcohol, sorbitol 70, hydrogenated castor oil-40-polyoxyethylene, sodium hydroxide, sodium saccharinate, methyl parahydroxybenzoate, propyl parahydroxybenzoate, mint essence, patent blue V (E131), purified water.
Lemon and Honey flavoured lozenges: sucrose, glucose, macrogol 300, potassium hydroxide, lemon flavouring, menthol, honey.
Orange flavoured sugar-free lozenges: macrogol 300, potassium hydroxide, orange extract, levomenthol, acesulfame K, E110, maltitol syrup, isomaltose.
DIRECTIONS:
Mouthwash and oral mucosa spray: 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.
Lemon and Honey flavoured lozenges and Orange flavoured sugar-free lozenges: symptomatic treatment of irritative-inflammatory conditions also associated with pain in the oropharyngeal cavity (e.g.
gingivitis, stomatitis, pharyngitis).
CONTRAINDICATIONS/SIDE EFFECTS:
Do not use the medicine in children under 12 years of age; contraindicated in patients with known hypersensitivity to flurbiprofen or to any of the excipients listed; patients who have previously shown hypersensitivity reactions (e.g.
asthma, urticaria, allergy, rhinitis, angioedema, bronchospasm) to ibuprofen, acetylsalicylic acid (aspirin) or other non-steroidal anti-inflammatory drugs (NSAIDs); 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 history of ulcerative colitis, Crohn's disease, recurrent peptic ulcer or gastrointestinal bleeding (defined as two or more distinct episodes of proven ulceration or bleeding); contraindicated in patients with severe heart failure, severe hepatic failure and renal failure; third trimester of pregnancy.
DOSAGE:
Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms.
>>Mouthwash.
Adults: 2-3 rinses or gargles per day with 10 ml (1 measuring spoon) of mouthwash.
Children over 12 years of age: as for adults.
Children under 12 years of age: Do not administer to children under 12 years of age.
Elderly: Clinical data currently available are limited, therefore no recommendation on dosage can be made.
Older adults are at increased risk of serious consequences if adverse reactions occur.
Patients with hepatic impairment: No dosage reduction is necessary in patients with mild to moderate hepatic impairment.
Flurbiprofen is contraindicated in patients with severe hepatic impairment.
Patients with renal impairment: No dosage reduction is necessary in patients with mild to moderate renal impairment.
Flurbiprofen is contraindicated in patients with severe hepatic impairment.
Method of administration: for oropharyngeal use.
Rinse or hold in mouth while gargling for up to 1 minute.
Do not ingest.
The mouthwash can be used pure or diluted in half a glass of water.
>>Oral mucosa spray.
Adults: apply one dose (2 sprays) 3 times a day, directed directly onto the affected area.
Each spray delivers 0.2 ml of solution, equivalent to 0.5 mg of active ingredient.
Children over 12 years: as for adults.
Children under 12 years of age: Do not administer to children under 12 years of age.
Elderly: Clinical data currently available are limited, therefore no recommendation on dosage can be made.
Older people are at increased risk of serious consequences if adverse reactions occur.
Patients with hepatic impairment: No dosage reduction is necessary in patients with mild to moderate hepatic impairment.
Flurbiprofen is contraindicated in patients with severe hepatic impairment.
Patients with renal impairment: No dosage reduction is necessary in patients with mild to moderate renal impairment.
Flurbiprofen is contraindicated in patients with severe hepatic impairment.
Method of administration: for oropharyngeal use.
Point the dispenser towards the back of the throat and spray the affected area.
>>Lemon and Honey Flavored Lozenges - Orange Flavored Sugar Free Lozenges.
Adults: 1 tablet every 3-6 hours, as needed.
Do not exceed the dose of 8 tablets in 24 hours.
Children over 12 years: as for adults.
Children under 12 years of age: Do not administer to children under 12 years of age.
Elderly: Clinical data currently available are limited, therefore no recommendation on dosage can be made.
Older people are at increased risk of serious consequences if adverse reactions occur.
Patients with hepatic impairment: No dosage reduction is necessary in patients with mild to moderate hepatic impairment.
Flurbiprofen is contraindicated in patients with severe hepatic impairment.
Patients with renal impairment: No dosage reduction is necessary in patients with mild to moderate renal impairment.
Flurbiprofen is contraindicated in patients with severe hepatic impairment.
Method of administration: for oropharyngeal use.
Dissolve slowly in your mouth.
As with all lozenges, flurbiprofen lozenges should be moved around the mouth during administration to avoid local irritation.
If mouth irritation occurs, treatment should be discontinued.
CONSERVATION:
Sugar Free Orange Flavor Lozenges and Lemon and Honey Flavor Lozenges: Store below 25 degrees C.
WARNINGS:
At the recommended doses, when using the medicine in its various pharmaceutical forms, any swallowing does not cause any harm to the patient, as the dose of flurbiprofen is much lower than that commonly used in systemic treatments.
Elderly: have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which may be fatal.
Respiratory disorders: Cases of bronchial spasm have been reported with flurbiprofen in patients with a history of bronchial asthma or allergies.
Flurbiprofen should be used with caution in these patients.
Other NSAIDs It is advisable not to combine the medicine with other NSAIDs.
Patients with systemic lupus erythematosus and mixed connective tissue disease may be at increased risk of aseptic meningitis, however this effect is not usually seen with products intended for limited and short-term use such as flurbiprofen.
Cardiac, hepatic and renal impairment: The medicinal product should be used with caution in patients with cardiac, renal or hepatic impairment.
NSAIDs have been reported to cause various forms of nephrotoxicity, including interstitial nephritis, nephrotic syndrome, and renal failure.
Administration of an NSAID may cause a dose-dependent reduction in prostaglandin formation and precipitate renal failure.
Patients at greatest risk of developing this reaction include those with impaired renal function, cardiac impairment, hepatic dysfunction, those receiving diuretic therapy, and the elderly; however, this effect is not usually seen with products intended for limited, short-term use such as flurbiprofen.
Cardiovascular and cerebrovascular effects: Caution is required before starting treatment in patients with a history of hypertension and/or heart failure (discuss with your doctor or pharmacist), since fluid retention, hypertension and edema have been reported in association with treatment with NSAIDs.
Central nervous system effects: analgesic-induced headache.
In case of prolonged or irregular use of analgesics, headache may occur, which should not be treated by increasing the dose of the medicine.
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, ulceration or perforation is higher with increasing flurbiprofen dosage in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation, and in the elderly.
These patients should start treatment on the lowest available dose.
Gastrointestinal bleeding, ulceration or perforation have been reported with all NSAIDs at any time during treatment.
These adverse reactions can be fatal and may occur with or without warning symptoms or in case of a previous history of serious gastrointestinal reactions.
Patients with a history of gastrointestinal disease, particularly when elderly, should report any unusual abdominal symptoms (especially gastrointestinal bleeding) in the initial stages of treatment.
Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms.
Caution should be advised in patients receiving concomitant medications which could increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or antiplatelet agents such as acetylsalicylic acid.
When gastrointestinal bleeding or ulceration occurs in patients receiving flurbiprofen, treatment should be discontinued.
Dermatological effects: the use of the medicine, especially if prolonged, can give rise to phenomena of sensitization or local irritation.
In such cases, treatment should be discontinued and, if necessary, appropriate therapy should be instituted.
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.
Flurbiprofen should be discontinued at the first appearance of skin rash, mucosal lesions or any other sign of hypersensitivity.
Infections: Since isolated cases of exacerbation of inflammation related to infections (e.g.
development of necrotizing fasciitis) in temporal association with the systemic use of drugs belonging to the NSAID class, patients are advised to consult a doctor immediately in case of appearance or worsening of signs of a bacterial infection during flurbiprofen therapy.
A possible indication for the initiation of antibiotic therapy must be taken into consideration.
If mouth irritation develops, treatment should be discontinued.
The Mouthwash and Spray contain para-hydroxybenzoates.
Lemon and Honey flavoured lozenges contain 1.069 g of glucose and 1.407 g of sucrose per lozenge.
The Orange Flavor Sugar Free Lozenges are instead indicated for those patients who need to control their sugar and calorie intake.
Sugar-free Orange flavoured lozenges contain the colouring E110 which may cause allergic reactions.
Do not use for prolonged treatments exceeding 7 days.
If you do not notice any noticeable results after 3 days of treatment, the cause may be a different medical condition.
In these cases, it is advisable to consult your doctor.
INTERACTIONS:
Caution should be exercised in patients treated with any of the following medicinal products, as interactions have been reported in some patients.
However, inform your doctor if you are taking other medicines.
Avoid Flurbiprofen with the following combinations.
Aspirin: Unless low-dose aspirin (not exceeding 100 mg/day or local prophylactic doses for cardiovascular protection) has been recommended by your doctor; as with other NSAID-containing medicinal products, concomitant administration of flurbiprofen and aspirin is generally not recommended due to the potential for increased adverse effects.
Cox-2 inhibitors and other NSAIDs: Concomitant use of other NSAIDs, including cyclooxygenase-2 selective inhibitors, should be avoided due to potential additive effects and increased risk of adverse reactions.
Flurbiprofen should be used with caution in association with: anticoagulants: NSAIDs may enhance the effects of anticoagulants such as warfarin.
Antiplatelet agents: increased risk of gastrointestinal bleeding.
Selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding.
Antihypertensives (diuretics, ACE inhibitors and angiotensin II antagonists): NSAIDs may reduce the effect of diuretics.
Other antihypertensive drugs may potentiate the nephrotoxicity caused by cyclooxygenase inhibition, especially in patients with impaired renal function (these patients must be adequately hydrated).
Alcohol: may increase the risk of adverse reactions, especially bleeding in the gastrointestinal tract.
Cardiac glycosides: NSAIDs may exacerbate heart failure, reduce GFR (glomerular filtration rate) and increase plasma glycoside levels.
Ciclosporin: increased risk of nephrotoxicity.
Corticosteroids: increased risk of gastrointestinal ulceration or bleeding with NSAIDs.
Lithium: There is evidence of a possible increase in plasma lithium levels.
Methotrexate: There may be an increase in plasma levels of methotrexate.
Mifepristone: NSAIDs should not be used for 8-12 days after administration of mifepristone, as NSAIDs may reduce the effect of mifepristone.
Quinolone antibiotics: Animal data indicate that NSAIDs may increase the risk of convulsions associated with quinolone antibiotics.
Patients taking NSAIDs and quinolones may have an increased risk of developing convulsions.
Tacrolimus: possible increased risk of nephrotoxicity when NSAIDs are administered with tacrolimus.
Zidovudine: Increased risk of haematological toxicity when NSAIDs are administered with zidovudine.
SIDE EFFECTS:
Hypersensitivity reactions to NSAIDs have been reported and may include: non-specific allergic reactions and anaphylaxis; respiratory tract reactivity, e.g. asthma, aggravated asthma, bronchospasm, dyspnoea; various skin disorders, including e.g. rashes of various types, pruritus, urticaria, purpura, angioedema and, more rarely, exfoliative and bullous dermatoses (including epidermal necrolysis and erythema multiforme).
The most commonly observed adverse reactions are gastrointestinal in nature.
Local use of the medicine, especially if prolonged, may give rise to phenomena of sensitization or local irritation.
Dissolution of the medicinal product in tablet form in the oral cavity may be accompanied by sensations of heat or tingling in the oropharynx.
In such cases, treatment should be interrupted and, if necessary, appropriate therapy should be instituted.
The following adverse effects have been reported, particularly after administration of systemic formulations.
These refer to those detected with the use of flurbiprofen used short-term and at doses compatible with the classification of self-medication medicines.
When treating chronic conditions and over long periods of time, additional side effects may occur.
The undesirable effects associated with the use of flurbiprofen are divided below according to system organ class and frequency.
Frequency is defined as: very common (>= 1/10), common (>=1/100, <1/10), uncommon (>=1/1,000, <1/100), rare (>=1/10,000, <1/1,000), very rare (<1/10,000) and not known.
Pathologists and the haemolymphopoietic system.
Not known: anaemia, thrombocytopenia, aplastic anaemia and agranulocytosis.
Pathologies of the nervous system.
Common: dizziness, headache, paraesthesia; uncommon: somnolence; not known: cerebrovascular accident, optic neuritis, migraine, confusional states, vertigo.
Immune system disorders.
Rare: anaphylactic reactions; not known: angioedema, hypersensitivity.
Eye pathologies.
N ote: visual disturbances.
Pathologies of the ear and labyrinth.
Not known: tinnitus.
Heart disease.
Not known: cardiac failure, edema.
Vascular pathologies.
Not known: hypertension.
Respiratory, thoracic and mediastinal pathologies.
Common: throat irritation; uncommon: asthma, bronchospasm and dyspnoea, oropharyngeal blistering, oropharyngeal hypoesthesia.
Gastrointestinal disorders.
Common: diarrhoea, mouth ulcers, nausea, oral pain, oral paraesthesia, oropharyngeal pain, oral discomfort (warm or burning sensation, tingling in the mouth); uncommon: abdominal distension, abdominal pain, constipation, dry mouth, dyspepsia, flatulence, glossodynia, dysgeusia, oral dysaesthesia, vomiting; not known: melaena, haematemesis, gastrointestinal haemorrhage, colitis, exacerbation of Crohn's disease, gastritis, peptic ulcer, gastric perforation, ulcer haemorrhage.
Pathologists of the skin and subcutaneous tissue.
Uncommon: rash, pruritus; not known: urticaria, purpura, bullous dermatitis (including Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis and Erythema multiforme).
Renal and urinary disorders.
Not known: nephrotoxicity, tubulointerstitial nephritis and nephrotic syndrome, renal failure (as with other NSAIDs).
Systemic pathologies and conditions related to the administration site.
Uncommon: pyrexia, pain; not known: discomfort, fatigue.
Hepatobiliary pathologies.
Not known: hepatitis.
Psychiatric disorders.
Uncommon: insomnia; not known: depression, hallucination.
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:
Flurbiprofen should not be administered during the first and second trimester of pregnancy unless clearly necessary.
The use of flurbiprofen during the third trimester of pregnancy is contraindicated.
In a limited number of studies, flurbiprofen appears in breast milk at very low concentrations and is unlikely to have any adverse effects on the breast-fed infant.
However, the administration of flurbiprofen is not recommended in breastfeeding mothers.
There is evidence to suggest that cyclooxygenase/prostaglandin synthesis inhibitors may cause impairment of female fertility by an effect on ovulation.
This is reversible upon discontinuation of treatment.
