BENACTIVDOLMED * SPRAY 15ML

  • Reckitt Benckiser Healthcare (Italia)
  • 048231017
Benactivdolmed is a drug based on the active ingredient flurbiprofen (FU) (DC.IT), belonging to the category of dentists and specifically Other preparations for the pharyngeal cavity. Benactivdolmed can be prescribed with OTC Recipe - self-medication. Benactivdolmed is indicated for the short-term symptomatic treatment of acute pain in sore throat in adults.
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BENACTIVDOLMED * SPRAY 15ML

Therapeutic indications

Benactivdolmed is indicated for the short-term symptomatic treatment of acute pain in sore throat in adults.

Dosage and method of use

Dosage: Only for short-term treatments. Adults from 18 years of age: one dose (3 sprays) administered into the back of the throat every 3-6 hours as needed, up to a maximum of 5 doses over a 24 hour period.Pediatric population: The safety and efficacy of Benactivdolmed in children or adolescents aged below 18 years have not been established.Elderly patients: A general dosing recommendation cannot be given as clinical experience to date is limited. The elderly 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 needed to control symptoms (see section 4.4).Method of administration: For oromucosal administration. Do not inhale while dispensing. This medicine should be used for up to 3 days. Before first use, activate the pump, aiming the nozzle away from your body and spraying at least four times, until a fine and uniform mist is released. The pump is then activated and ready for use. Between one use and the next, point the nozzle away from your body and dispense a minimum quantity of product, in order to ensure that the atomization is fine and uniform. Before using the product, always make sure that the atomization is fine and uniform.

Contraindications

• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. • Patients who have previously experienced hypersensitivity reactions (eg asthma, bronchospasm, rhinitis, angioedema or urticaria) in response to acetylsalicylic acid or other NSAIDs. • Current or past recurrent peptic ulcer / haemorrhage (two or more distinct episodes of proven ulceration) and intestinal ulceration. • History of gastrointestinal bleeding or perforation, severe colitis, bleeding or haematopoietic disorders related to previous NSAID therapy. • Last trimester of pregnancy (see section 4.6). • Severe heart failure, severe renal failure or severe hepatic failure (see section 4.4). • Children and adolescents under the age of 18.

Side effects

Hypersensitivity reactions to NSAIDs have been reported and these may consist of: (a) non-specific allergic reactions and anaphylaxis; (b) respiratory tract reactivity, eg asthma, aggravated asthma, bronchospasm, dyspnoea; (c) various skin reactions, eg pruritus, urticaria, angioedema and, more rarely, exfoliative and bullous dermatosis (including epidermal necrolysis and erythema multiforme). Edema, hypertension and heart failure have been reported in association with NSAID treatment. There are insufficient data to exclude this risk with the use of flurbiprofen oral mucosal spray, solution.The list of adverse effects 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 Blood and lymphatic system disorders. Not known: anemia, thrombocytopenia.Cardiovascular and cerebrovascular diseases. Not known: edema, hypertension, heart failure.Nervous system disorders. Common: dizziness, headache, paraesthesia; Uncommon: somnolence.Respiratory, thoracic and mediastinal disorders. Common: throat irritation; Uncommon: exacerbation of asthma and bronchospasm, dyspnoea, wheezing, oropharyngeal vesicular rash, pharyngeal hypoesthesia.Gastrointestinal disorders. Common: diarrhea, mouth ulceration, nausea, oral pain, oral paraesthesia, oropharyngeal pain, oral discomfort (warm or burning sensation, tingling of the mouth); Uncommon: abdominal distension, abdominal pain, constipation, dry mouth, dyspepsia, flatulence, glossodynia, dysgeusia, oral dysesthesia, vomiting.Skin and subcutaneous tissue disorders. Uncommon: various types of skin rashes, itching; Not known: severe forms of skin reactions such as bullous reactions, including Stevens-Johnson syndrome and toxic epidermal necrosis.General disorders and administration site conditions. Uncommon: pyrexia, pain.Disorders of the immune system. Rare: anaphylactic reaction.Psychiatric disorders. Uncommon: insomnia.Hepatobiliary disorders. Not known: hepatitis.Reporting of suspected adverse reactions. Reporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. 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.

Special warnings

Undesirable effects can be minimized by using the lowest effective dose for the shortest duration of treatment needed to control symptoms.Infections: Since an exacerbation of infectious inflammations (e.g. development of necrotizing fasciitis) in temporal association with the systemic use of drugs belonging to the NSAID class has been described in isolated cases, it is recommended that the patient consult a physician immediately in case of appearance or worsening of signs of a bacterial infection during flurbiprofen spray therapy. Consideration should be given to whether the initiation of antibiotic therapy is indicated. In case of purulent bacterial pharyngitis / tonsillitis, the patient is advised to consult the physician for a re-evaluation of the treatment. Treatment should be administered for up to 3 days. If symptoms worsen or new symptoms occur, treatment should be reassessed. If mouth irritation occurs, flurbirprofen treatment should be discontinued.Elderly population: The elderly experience an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which can be fatal.Respiratory effects: Bronchospasm can 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 concomitantly with other NSAIDs, including selective cyclooxygenase-2 inhibitors (see section 4.5).Systemic lupus erythematosus (SLE) and mixed connective tissue disease: Patients with systemic lupus erythematosus (SLE) and mixed connective tissue disease may have an increased risk of aseptic meningitis (see section 4.8), 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 can cause a dose-dependent reduction in prostaglandin formation and precipitate renal failure. Patients at greatest risk of developing this reaction are those with impaired renal function, cardiac impairment, hepatic dysfunction, those on diuretic therapy and the elderly; however, this effect is usually not observed with products intended for limited and short-term use such as flurbiprofen spray.Hepatic effects: Mild to moderate hepatic dysfunction (see sections 4.3 and 4.8).Cardiovascular and cerebrovascular effects: Before starting treatment in patients with a history of hypertension and / or heart failure, caution is required (consult your doctor or pharmacist) as fluid retention, hypertension and edema have been reported in association with NSAID therapy. Clinical studies and epidemiological data suggest that the use of some NSAIDs (particularly at high doses and in long-term treatment) may be associated with a slightly increased risk of arterial thrombotic events (e.g. myocardial infarction or stroke). There are insufficient data to exclude this risk with flurbiprofen when administered at a daily dose not exceeding 5 doses (3 puffs for each dose).Effects on the nervous system: Analgesic-induced headache - Headache may occur with prolonged or unregulated use of analgesics and should not be treated by increasing the dose of the medicinal product.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 (see section 4.8). 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 gastrointestinal events. The risk of gastrointestinal bleeding, ulceration or perforation is higher with increasing NSAID doses, in patients with a history of ulcer, especially if complicated with haemorrhage or perforation (see section 4.3) and in the elderly; however, this effect is usually not seen with products intended for limited, short-term use such as flurbiprofen spray. Patients with a history of gastrointestinal toxicity, particularly if elderly, should report any unusual abdominal symptoms (especially gastrointestinal bleeding) to their treating physician. Caution should be advised in patients receiving concomitant medications that may 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 (see section 4.5). If gastrointestinal bleeding or ulceration occurs in patients taking flurbiprofen, treatment should be discontinued.Hematological effects: Flurbiprofen, like other NSAIDs, can inhibit platelet aggregation and prolong bleeding time. Flurbiprofen spray should be used with caution in patients with abnormal bleeding potential.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 (see section 4.8). Flurbiprofen spray should be discontinued at the first appearance of rash, mucosal lesions or any other signs of hypersensitivity. This product contains methyl parahydroxybenzoate and propyl parahydroxybenzoate which can cause allergic reactions (sometimes even delayed). This product contains less than 1 mmol (23 mg) sodium per dose, ie essentially “sodium-free”. Flavorings containing allergens: This product contains flavors containing anisyl alcohol, citral, citronellol, d-Limonene, geraniol and linalool. Anisyl alcohol, citral, citronellol, d-Limonene, geraniol, linalool can cause allergic reactions.

Pregnancy and breastfeeding

Pregnancy: Inhibition of prostaglandin synthesis may adversely affect pregnancy and / or embryonic / fetal development. Data obtained 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 an increase in pre- and post-implantation losses and embryo-fetal lethality. In addition, an increased incidence of various malformations, including cardiovascular ones, 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 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 oligo-hydramnios; • the mother and the newborn, at the end of pregnancy, to: - possible prolongation of the bleeding time, an antiplatelet effect which 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 (see section 4.3).Feeding time: In a limited number of studies, flurbiprofen appears in breast milk at very low concentrations and is unlikely to have adverse effects on the breastfed infant. However, due to the possible adverse effects of NSAIDs on breastfed infants, the use of flurbiprofen spray by nursing mothers is not recommended.FertilityThere is some evidence indicating that cyclooxygenase / prostaglandin synthesis inhibitors may cause impairment of female fertility by an effect on ovulation. This is reversible upon discontinuation of treatment.

Expiration and retention

Do not refrigerate or freeze.

Interactions with other drugs

The Flurbiprofenmust be avoidedin collaboration with:
Other NSAIDs including selective cyclo oxygenase-2 inhibitors: Avoid 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) (see section 4.4).
Acetylsalicylic acid (in low doses): Unless taking aspirin at low doses (not exceeding 75 mg / day) has been recommended by the physician, as the risk of adverse events may be increased (see section 4.4).

 

Flurbiprofen must be usedwith cautionin collaboration with:
Anticoagulants: NSAIDs may potentiate the effects of anticoagulants such as warfarin (see section 4.4).
Antiplatelet agents: There is an increased risk of gastrointestinal ulceration or bleeding (see section 4.4).
Antihypertensive drugs (Diuretics, ACE inhibitors, angiotensin II antagonists): NSAIDs may reduce the effect of diuretics and other antihypertensive drugs may potentiate nephrotoxicity caused by cyclooxygenase inhibition, especially in patients with impaired renal function.
Alcohol: It may increase the risk of adverse reactions, especially of bleeding in the gastrointestinal tract.
Cardiac glycosides: NSAIDs can exacerbate heart failure, reduce GRV (glomerular filtration rate) and increase plasma glycoside levels - adequate control and, if necessary, dose adjustment is recommended.
Cyclosporine: There is an increased risk of nephrotoxicity.
Corticosteroids: There is an increased risk of gastrointestinal ulceration or bleeding (see section 4.4).
Lithium: There may be an increase in serum lithium levels - adequate monitoring and, if necessary, dose adjustment is recommended.
Methotrexate: The administration of NSAIDs within 24 hours before or after the administration of methotrexate can 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 (it is recommended to increase the frequency of controls).
Phenytoin: Serum phenytoin levels may rise - adequate monitoring and, if necessary, dose adjustment is recommended.
Potassium-sparing diuretics: Concomitant use can cause hyperkalaemia.
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 seizures associated with quinolone antibiotics. Patients taking NSAIDs and quinolones may have an increased risk of developing seizures.
Selective Serotonin Reuptake Inhibitors (SSRIs): There is an increased risk of gastrointestinal ulceration or bleeding (see section 4.4).
Tacrolimus: An increased risk of nephrotoxicity is possible when NSAIDs are co-administered with tacrolimus.
Zidovudine: There is an increased risk of haematological toxicity when NSAIDs are co-administered with zidovudine.
Pediatric population

: No additional information is available.

Overdose

SymptomsThe majority of patients who have ingested clinically significant amounts of NSAIDs will no longer develop nausea, vomiting, epigastric pain, or more rarely diarrhea. Tinnitus, headache, and gastrointestinal bleeding are also possible. In cases of more severe NSAID intoxication, central nervous system toxicity is observed, manifesting as drowsiness, occasionally arousal, blurred vision, and disorientation or coma. Occasionally patients develop seizures. Metabolic acidosis may occur in severe NSAID intoxication and prothrombin time / INR may be prolonged, possibly due to interference with the action of circulating clotting factors. Acute renal failure and liver damage can occur. An exacerbation of asthma is possible in asthmatics.TreatmentTreatment should be symptomatic and supportive and should include maintaining a patent airway and monitoring cardiac function and vital signs until stabilization. Oral administration of activated charcoal or gastric lavage and, if necessary, correction of serum electrolytes should be considered if the patient presents within one hour of ingesting a potentially toxic amount. Seizures, if they are frequent or prolonged, should be treated with intravenous diazepam or lorazepam. Administer bronchodilators for asthma. There is no specific antidote for flurbiprofen.

Active principles

One spray contains 2.92 mg of Flurbiprofen, one dose of three sprays contains 8.75 mg of Flurbiprofen, corresponding to 16.2 mg / ml of Flurbiprofen.Excipients with known effect:Methyl parahydroxy benzoate (E218) 1.181 mg / dose Propyl parahydroxy benzoate (E216) 0.2362 mg / dose Flavors contain allergens (lemon flavoring and honey flavoring) For the full list of excipients, see section 6.1.

Excipients

Betadex, Disodium phosphate dodecahydrate, Citric acid monohydrate, Methyl parahydroxybenzoate (E218), Propyl parahydroxybenzoate (E216), Sodium hydroxide, Honey flavor, Lemon flavor, N, 2,3-Trimethyl-2-isopropylbutanamide, Sodium saccharin (E954), Hydroxypropylbetadex, Purified water. Qualitative aroma composition Honey: Flavoring substance (s), Flavoring preparation (s), Propylene glycol (E1520). Qualitative composition of the Lemon flavor: Flavoring substance (s), Flavoring preparation (s), Propylene glycol (E1520).

048231017

Data sheet

Packaging
8.75 mg / ml spray for oral mucosa lemon and honey flavor 1 fl of 15 ml / 83 dispens. with dosing pump
Product Type
HUMAN DRUG
ATC code
R02AX01
ATC description
Flurbiprofen
Therapeutic Group
Dental
Active principle
flurbiprofen (FU) (DC.IT)
Class
C.
Pharmaceutical form
spray
Type of Administration
buccal / mucoadhesive
Container
spray / can
Quantity
1 bottle
Capacity
15 milliliters
Quantity of the Active Ingredient
8.75MG
Recipe required
OTC - self-medication medicine
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