Benactivdolmed Throat Spray 15ml

Benactivdolmed Throat Spray - Oromucosal Spray, solution

Preparations for the pharyngeal cavity, other preparations for the pharyngeal cavity.
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One puff contains 2.92 mg of flurbiprofen, one dose of three puffs contains 8.75 mg of flurbiprofen, corresponding to 16.2 mg / ml of flurbiprofen.

EXCIPIENTS

Betadex, disodium phosphate dodecahydrate, citric acid monohydrate, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), sodium hydroxide, honey flavoring, lemon flavoring, N, 2,3-Trimethyl-2-isopropylbutanamide, sodium saccharin (E954), hydroxypropylbetadex, purified water. Qualitative composition of honey aroma: flavoring substance (s), flavoring preparation (s), propylene glycol (E1520). Qualitative composition of lemon flavor: flavoring substance (s), flavoring preparation (s), propylene glycol (E1520).

INDICATIONS

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

CONTRAINDICATIONS / SECONDARY 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 past recurrent peptic ulcer / haemorrhage (two or more distinct episodes of proven 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 renal failure or severe liver failure. Children and adolescents under the age of 18.

DOSAGE

Dosage: for short-term treatments only. 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 in a 24 hour period. Pediatric population: the safety and efficacy of this drug in children or adolescents under the age of 18 have not been established. Elderly patients: A general posology 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 necessary to control symptoms. 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 another, point the dispenser away from your body and dispense a minimum quantity of product, in order to ensure that the nebulization is fine and uniform. Before using the product, always make sure that the atomization is fine and uniform.

STORAGE

Do not refrigerate or freeze.

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) has been described in isolated cases in temporal association with the systemic use of drugs belonging to the class of NSAIDs, it is recommended that the patient consult a doctor immediately. if signs of a bacterial infection develop or worsen during therapy with flurbiprofen spray. It must be taken into account if it is
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 manifest
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 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 have an increased risk of aseptic meningitis, however this effect is not usually seen with products intended for single use. limited and short-lived 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 seen with products intended for limited, short-term use such as flurbiprofen spray. Hepatic Effects: Mild to moderate hepatic dysfunction. Cardiovascular and cerebrovascular effects: before starting treatment in patients with a history of hypertension and / or heart failure, caution is required (contact your doctor or pharmacist) as fluid retention, hypertension and edema. 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 of no more than 5 doses (3 puffs for each dose). Effects on the nervous system. Headache induced by analgesics: in case of prolonged or unregulated use of analgesics, headache may occur, which must 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 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 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. If gastrointestinal bleeding or ulceration occurs in patients taking flurbiprofen, treatment should be stopped. Haematological Effects: Flurbiprofen, like other NSAIDs, can inhibit platelet aggregation and prolong bleeding time. Flurbiprofen spray should be used with caution in patients with bleeding potential
abnormal. Dermatological effects: Severe 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 can cause allergic reactions (sometimes even delayed). This product contains less than 1 mmol (23 mg) sodium per dose, ie essentially "sodium free". Flavors containing allergens: this product contains aromas in turn containing anisyl alcohol, citral, citronellol, d-Limonene, geraniol and linalool. Anisyl alcohol, citral, citronellol, d-Limonene, geraniol, linalool can cause allergic reactions.

INTERACTIONS

Flurbiprofen should be avoided in combination 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). Acetylsalicylic acid (low dose): Unless taking aspirin at low doses (not exceeding 75 mg / day) has been recommended by your doctor, as the risk
or adverse events could increase. Flurbiprofen should be used with caution in combination 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, aceinhibitors, angiotensin ii antagonists): NSAIDs can reduce the effect of diuretics and other antihypertensive drugs can potentiate
nephrotoxicity caused by cyclooxygenase inhibition, especially in patients with impaired renal function. Alcohol: may increase the risk of adverse reactions, especially of bleeding in the gastrointestinal tract. Cardiac glycosides: NSAIDs can exacerbate heart failure, reduce vgr (glomerular filtration rate) and increase plasma glycoside levels. Adequate control and, if necessary, dose adjustment is 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: 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 administration of mifepristone, as NSAIDs may reduce the effect of mifepristone. Oral antidiabetics: changes in blood glucose levels have been reported (it is recommended to increase the frequency of controls). Phenytoin: Serum phenytoin levels may increase Adequate monitoring and, if necessary, dose adjustment is recommended. Potassium-sparing diuretics: concomitant use may 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 pos
have an 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 co-administered with tacrolimus. Zidovudine: There is an increased risk of haematological toxicity when NSAIDs are given together with zidovudine. Pediatric population: no additional information is available.

SIDE EFFECTS

Hypersensitivity reactions to NSAIDs have been reported and these may consist of: non-specific allergic reactions and anaphylaxis; respiratory tract reactivity, eg asthma, aggravated asthma, bronchospasm, dyspnoea; various skin reactions, for example itching, 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 <1/10), uncommon (> = 1 / 1,000 to <1/100), rare (> = 1 / 10,000 a <1 / 1,000), very rare (<1 / 10,000), not known (cannot be estimated from the available data). Disorders of the blood and lymphatic system. Not known: anemia, thrombocytopenia. Patolo
cardiovascular and cerebrovascular gies. 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 distention, 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. The reporting of suspected adverse reactions that occur after the authorization of the drug is important, as it allows continuous monitoring of the benefit / risk ratio of the drug. 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 can negatively 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 administered 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 may 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. Lactation: In a limited number of studies, flurbiprofen appears in breast milk at very low concentrations and is unlikely to have adverse effects on the infant when breastfeeding. However, due to the possible adverse effects of NSAIDs on breastfed infants, the use of flurbiprofen spray by nursing mothers is not recommended. Fertility: there is some evidence indicating that cyclooxygenase / prostaglandin synthesis inhibitors may cause an impairment of female fertility through an effect on ovulation. This is reversible upon discontinuation of treatment.

FORMAT

15ml spray.