Description
NAME:
BENACTIVDOLMED 8.75 MG/DOSE ORAL MUCOSA SPRAY, SOLUTION
PHARMACOTHERAPEUTIC CATEGORY:
Pharyngeal cavity preparations, other pharyngeal cavity preparations.
ACTIVE INGREDIENTS:
One spray contains 2.92 mg flurbiprofen, a dose equal to three sprays contains 8.75 mg flurbiprofen, corresponding to 16.2 mg/ml flurbiprofen.
EXCIPIENTS:
Betadex, disodium phosphate dodecahydrate, citric acid monohydrate, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), sodium hydroxide, honey flavour, lemon flavour, N,2,3-Trimethyl-2-isopro pilbutanamide, sodium saccharin (E954), hydroxypropylbetadex, purified water.
Qualitative composition of honey flavouring: flavouring substance(s), flavouring preparation(s), propylene glycol (E1520).
Qualitative composition of lemon flavouring: flavouring substance(s), flavouring preparation(s), propylene glycol (E1520).
DIRECTIONS:
This medicine is indicated for the short-term symptomatic treatment of acute pain in sore throat in adults.
CONTRAINDICATIONS/SIDE EFFECTS:
Hypersensitivity to the active substance or to any of the excipients.
Patients who have previously experienced hypersensitivity reactions (e.g.
asthma, bronchospasm, rhinitis, angioedema or urticaria) in response to acetylsalicylic acid or other NSAIDs.
Current or previous recurrent peptic ulcer/haemorrhage (two or more distinct episodes of demonstrated ulceration) and intestinal ulceration.
History of gastrointestinal bleeding or perforation, severe colitis, haemorrhagic or haematopoietic disorders related to previous NSAID therapy.
Last trimester of pregnancy.
Severe heart failure, severe kidney failure or severe liver failure.
Children and adolescents under the age of 18.
DOSAGE:
Dosage: for short-term treatments only.
Adults aged 18 years and over: one dose (3 sprays) administered into the back of the throat every 3-6 hours as needed, up to a maximum of 5 doses in a 24-hour period.
Paediatric population: The safety and efficacy of this medicine in children or adolescents aged under 18 years have not been established.
Elderly patients: A general dosage recommendation cannot be given as clinical experience to date is limited.
Older people are at increased risk of serious consequences in case of adverse reactions.
The lowest effective dose should be administered for the shortest duration of treatment necessary to control symptoms.
Method of administration: for oromucosal administration.
Do not inhale while dispensing.
This medicine should be used for a maximum of 3 days.
Before first use, activate the pump by pointing the dispenser away from your body and spraying at least four times, until a fine, uniform mist is released.
The pump is then activated and ready for use.
Between uses, point the dispenser away from your body and dispense a minimal amount of product, to ensure that the mist is fine and uniform.
Before using the product, always make sure that the nebulization is fine and uniform.
CONSERVATION:
Do not refrigerate or freeze.
WARNINGS:
Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms.
Infections: Since exacerbation of infectious inflammations (e.g.
development of necrotizing fasciitis) in temporal association with the systemic use of drugs belonging to the class of NSAIDs, the patient is recommended to consult a doctor immediately in case of appearance or worsening of signs of a bacterial infection during therapy with flurbiprofen spray.
It should be taken into consideration whether the initiation of antibiotic therapy is indicated.
In case of purulent bacterial pharyngitis/tonsillitis, the patient is advised to consult the doctor for a re-evaluation of the treatment.
Treatment should be administered for a maximum of 3 days.
If symptoms worsen or new symptoms develop, treatment should be reevaluated.
If mouth irritation occurs, treatment with flurbirprofen should be discontinued.
Elderly population: The elderly have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which may be fatal.
Respiratory effects: Bronchospasm may be precipitated in patients with or with a previous history of bronchial asthma or allergic disease.
Flurbiprofen spray should be used with caution in these patients.
Other NSAIDs: The use of flurbiprofen spray should be avoided in conjunction with other NSAIDs, including selective cyclooxygenase-2 inhibitors.
Systemic lupus erythematosus (SLE) and mixed connective tissue disease: Patients with systemic lupus erythematosus (SLE) 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 spray.
Cardiovascular, renal and 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 on diuretic therapy, and the elderly; however, this effect is not usually seen with products intended for limited, short-term use such as flurbiprofen spray.
Hepatic effects: Mild to moderate liver dysfunction.
Cardiovascular and cerebrovascular effects: Caution is required (consult your doctor or pharmacist) before starting treatment in patients with a history of hypertension and/or heart failure since fluid retention, hypertension and edema have been reported in association with NSAID therapy.
Clinical studies and epidemiological data suggest that use of some NSAIDs (particularly at high doses and in long-term treatment) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke).
There are insufficient data to exclude such a risk with flurbiprofen when administered at a daily dose not exceeding 5 doses (3 actuations for each dose).
Effects on the nervous system.
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: NSAIDs should be administered with caution to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) as these conditions may be exacerbated.
Gastrointestinal bleeding, ulceration or perforation, which can be fatal, have been reported with all NSAIDs at any time during treatment, with or without warning symptoms or a previous history of serious GI events.
The risk of gastrointestinal bleeding, ulceration or perforation is higher with increasing doses of NSAIDs, in patients with a history of ulcer, especially if complicated by haemorrhage or perforation and in the elderly; however, this effect is not usually seen with products intended for limited short-term use such as flurbiprofen spray.
Patients with a history of gastrointestinal toxicity, particularly when elderly, should report any unusual abdominal symptoms (especially gastrointestinal bleeding) to their physician.
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.
If gastrointestinal bleeding or ulceration occurs in patients receiving flurbiprofen, treatment should be discontinued.
Haematological effects: flurbiprofen, like other NSAIDs, may inhibit platelet aggregation and prolong bleeding time.
Flurbiprofen spray should be used with caution in patients with potential for abnormal bleeding.
Dermatological effects: 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 spray should be discontinued at the first appearance of skin rash, mucosal lesions or any other sign of hypersensitivity.
This product contains methyl parahydroxybenzoate and propyl parahydroxybenzoate which may cause allergic reactions (sometimes delayed).
This product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially 'sodium-free'.
Flavors containing allergens: This product contains flavors containing anisyl alcohol, citral, citronellol, d-Limonene, geraniol and linalool.
Anisyl alcohol, citral, citronellol, d-Limonene, geraniol, linalool may cause allergic reactions.
INTERACTIONS:
Flurbiprofen should be avoided in association with: other NSAIDs including cyclooxygenase-2 selective inhibitors: avoid the concomitant use of two or more NSAIDs, as this may increase the risk of adverse effects (especially gastrointestinal adverse events such as ulcers and bleeding).
Acetylsalicylic acid (low doses): unless taking low-dose aspirin (not exceeding 75 mg/day) has been recommended by your doctor, as the risk of adverse events may increase.
Flurbiprofen should be used with caution in association with: anticoagulants: NSAIDs may enhance the effects of anticoagulants such as warfarin.
Antiplatelet agents: There is an increased risk of gastrointestinal ulceration or bleeding.
Antihypertensive drugs (diuretics, ACE inhibitors, angiotensin II antagonists): NSAIDs may reduce the effect of diuretics and other antihypertensive drugs may potentiate the nephrotoxicity caused by the inhibition of cyclooxygenase, especially in patients with impaired renal function.
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. Appropriate monitoring and, if necessary, dose adjustment are recommended.
Ciclosporin: There is an increased risk of nephrotoxicity.
Corticosteroids: There is an increased risk of gastrointestinal ulceration or bleeding.
Lithium: There may be an increase in serum lithium levels; adequate monitoring and, if necessary, dose adjustment is recommended.
Methotrexate: Administration of NSAIDs within 24 hours before or after administration of methotrexate may lead to elevated concentrations of methotrexate and an increase in its toxic effects.
Mifepristone: NSAIDs should not be used for 8 - 12 days after mifepristone administration, as NSAIDs may reduce the effect of mifepristone.
Oral antidiabetics: alterations in blood glucose levels have been reported (an increase in the frequency of checks is recommended).
Phenytoin: Serum levels of phenytoin may increase; adequate monitoring and, if necessary, dose adjustment is recommended.
Potassium-sparing diuretics: concomitant use may cause hyperkalemia.
Probenecid and sulfinpyrazone: Medicines containing probenecid and sulfinpyrazone may delay the excretion of flurbiprofen.
Quinolone antibiotics: Animal data indicate that NSAIDs may increase the risk of convulsions associated with quinolone antibiotics.
Patients taking NSAIDs and quinolones may be at increased risk of developing seizures.
Selective serotonin reuptake inhibitors (SSRIs): There is an increased risk of gastrointestinal ulceration or bleeding.
Tacrolimus: An increased risk of nephrotoxicity is possible when NSAIDs are administered together with tacrolimus.
Zidovudine: There is an increased risk of haematological toxicity when NSAIDs are administered with zidovudine.
Paediatric population: not available in additional formations.
SIDE EFFECTS:
Hypersensitivity reactions to NSAIDs have been reported and may consist of: non-specific allergic reactions and anaphylaxis; respiratory tract reactivity, e.g. asthma, aggravated asthma, bronchospasm, dyspnoea; various skin reactions, e.g. pruritus, urticaria, angioedema and, more rarely, exfoliative and bullous dermatoses (including epidermal necrolysis and erythema multiforme).
Oedema, hypertension and cardiac failure have been reported in association with NSAID treatment.
Data are insufficient to exclude this risk with the use of flurbiprofen oral spray, solution.
The list of adverse effects reported below refers to those recorded with flurbiprofen, used at doses compatible with the OTC classification and for a short period.
(very common (>=1/10), common (>=1/100 to <1/10), uncommon (>=1/1,000 to <1/100), rare (>= 1/10,000 to <1/1,000), very rare (<1/10,000), not known (frequency cannot be estimated from the available data)).
Pathologies of the blood and lymphatic system.
Not known: anemia, thrombocytopenia.
Cardiovascular and cerebrovascular diseases.
Not known: edema, hypertension, cardiac failure.
Pathologies of the nervous system.
Common: dizziness, headache, paraesthesia; uncommon: somnolence.
Respiratory, thoracic and mediastinal pathologies.
Common: throat irritation; uncommon: exacerbation of asthma and bronchospasm, dyspnoea, wheezing, oropharyngeal vesicular eruption, hypoaesthesia of the pharynx.
Gastrointestinal disorders.
Common: diarrhoea, mouth ulceration, nausea, oral pain, oral paraesthesia, oropharyngeal pain, oral discomfort (sensation of heat or burning, tingling of the mouth); uncommon: abdominal distension, abdominal pain, constipation, dry mouth, dyspepsia, flatulence, glossodynia, dysgeusia, oral dysaesthesia, vomiting.
Pathologies of the skin and subcutaneous tissue.
Uncommon: various types of skin rashes, pruritus; not known: severe forms of skin reactions such as bullous reactions, including Stevens-Johnson syndrome and toxic epidermal necrosis.
General pathologies and conditions related to the administration site.
Uncommon: pyrexia, pain.
Immune system disorders.
Rare: anaphylactic reaction.
Psychiatric disorders.
Uncommon: insomnia.
Hepatobiliary pathologies.
Not known: hepatitis.
Reporting of suspected adverse reactions.
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.
Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
PREGNANCY AND BREASTFEEDING:
Pregnancy: Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or embryonic/fetal development.
Data from epidemiological studies suggest an increased risk of miscarriage, cardiac malformation and gastroschisis following the use of a prostaglandin synthesis inhibitor in early pregnancy.
The absolute risk of cardiovascular malformation was increased from less than 1% to approximately 1.5%.
The risk is believed to increase with dose and duration of therapy.
In animals, administration of a prostaglandin synthesis inhibitor has been shown to cause increased pre- and post-implantation loss and embryo-fetal lethality.
In addition, an increased incidence of various malformations, including cardiovascular, has been reported in animals given a prostaglandin synthesis inhibitor during the organogenetic period.
Flurbiprofen should not be administered during the first and second trimester of pregnancy.
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 oligohydramnios; the mother and the neonate, at the end of pregnancy, to: possible prolongation of bleeding time, an antiaggregant effect which may occur even at very low doses.
Inhibition of uterine contractions resulting in a delay or prolongation of labor.
Consequently, flurbiprofen is contraindicated during the third trimester of pregnancy.
Breastfeeding: 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, due to the possible adverse effects of NSAIDs on breast-fed infants, the use of flurbiprofene spray by breast-feeding mothers is not recommended.
Fertility: There is some 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.
