BENACTIV GOLA 16PASTL ARAN S/Z

BENACTIV GOLA

active ingredients

BENACTIV GOLA Collumination 100 ml of collutory contain: active ingredient: flurbiprofen 250 mg Excipients with known effects: hydrogenated castor oil-40-polyxyethylene, methyl parahydroxybenzoate, propile parahydroxybenzoate, mint essence (containing d-limonene). BENACTIV GOLA Oral Mucosa Spray 100 ml of solution contain: active ingredient: flurbiprofen 250 mg Excipients with known effects: hydrogenated castor oil-40-polyxyethylene, methyl parahydroxybenzoate, propile parahydroxybenzoate, mint essence (containing d-limonene). BENACTIV GOLA Pastiglie gusto Lemon and Honey A pastel contains: active ingredient: flurbiprofen 8,75 mg Excipients with known effects: liquid glucose (containing sulphites and wheat starch), liquid sucrose, honey, lemon aroma and levomentol (containing hydroxyanisol butilate, citral, citronellol, d-limonene, fosol, geraaniol, linalol). BENACTIV GOLA Pastiglie Without Sugar Taste Orange A pastel contains: active ingredient: flurbiprofen 8,75 mg Excipients with known effects: liquid maltitol (E965), isomalto (E953), orange aroma and levomentol (containing citral, citronellol, d-limonene, geranium, linalol). For the full list of excipients, see paragraph 6.1.

Excellent

BENACTIV GOLA Collumination Glycerol, ethanol (96 per cent), sorbitol 70, hydrogenated castor oil-40-polyxyethylene, sodium hydroxyl, sodium sodium, sodium methyl parahydroxybenzoate, propile parahydroxybenzoate, mint essence (containing d-limonene), blue patent V (E131), purified water. BENACTIV GOLA Oral Mucosa Spray Glycerol, ethanol (96 per cent), sorbitol 70, hydrogenated castor oil-40-polyxyethylene, sodium hydroxyl, sodium sodium, sodium methyl parahydroxybenzoate, propile parahydroxybenzoate, mint essence (containing d-limonene), blue patent V (E131), purified water. BENACTIV GOLA Pastiglie gusto Lemon and Honey Liquid sucrose, liquid glucose (containing sulphites and wheat starch), macrogol 300, hydroxide potassium, lemon aroma and levomentol (containing butilato hydroxysol, citral, citronellol, d-limonene, makesolo, geranium, linalol), honey. BENACTIV GOLA Pastiglie Without Sugar Taste Orange Macrogol 300, hydroxide potassium, orange aroma and levomentol (containing citral, citronellol, dlimonene, geraaniol, linalol), potax acesulphame (E950), liquid maltitol (E965), isomalto (E953).

Therapeutic indications

BENACTIV GOLA Collumination BENACTIV GOLA Oral Mucosa Spray Symptomatic treatment of irritative-inflammatory states also associated with pain of the oropharyngeal cable (e.g. gums, stomatitis, pharyngitis), also as a result of conservative or extractive dentaria therapy. BENACTIV GOLA Pastiglie gusto Lemon and Honey BENACTIV GOLA Pastiglie Without Sugar Taste Orange Symptomatic treatment of irritative-inflammatory states also associated with pain of the oropharyngeal cable (e.g. gums, stomatitis, pharyngitis).

Contraindications

Do not use the medicine in children under 12 years of age. Flurbiprofen is contraindicated in patients with known hypersensitivity towards flurbiprofen or any of the excipients listed in the paragraph 6.1. Patients who have previously shown hypersensitivity reactions (e.g. asthma, hive, allergy, rhinitis, angioedema, bronchospasm) towards ibuprofen, acetylsalicylic acid (aspirin) or other non-steroidal anti-inflammatory drugs (NSAID). Flurbiprofen is also contraindicated in patients with gastrointestinal hemorrhage history or drilling related to previous treatments with NSAIDs. Flurbiprofen should not be taken by patients with active ulcerative or anamnestic colitis, Crohn's disease, recurrent peptic ulcer or gastrointestinal hemorrhage (defined as two or more distinct episodes of proven ulceration or bleeding). Flurbiprofen is contraindicated in patients with severe heart failure, severe liver failure and kidney failure (see paragraph 4.4). Third quarter of pregnancy.

Population

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 paragraph 4.4). BENACTIV GOLA Collumination Population Adults: 2-3 shawls or gargles per day with 10 ml (1 scoop) of collutory. Pediatric population Children over 12 years: as for adults. Children under 12 years old: do not give children under 12 years old (see paragraph 4.3). Special popularity Seniors: clinical data available at the moment are limited, so no recommendation on posology can be made. The elderly have a greater risk of serious consequences in case of adverse reactions (see paragraph 4.4). Patients with liver failure: a reduction in dose in patients with mild to moderate liver failure is not necessary. Flurbiprofen is contraindicated in patients with severe liver failure (see paragraph 4.3). Patients with kidney failure: a reduction in dose is not necessary in patients with mild to moderate kidney failure. Flurbiprofen is contraindicated in patients with severe liver failure (see paragraph 4.3).Method of administration For oropharyngeal use. Rinse or keep in the mouth during gargles up to 1 minute. Don't swallow. The mouthwash can be used pure or diluted in half a glass of water. BENACTIV GOLA Oral Mucosa Spray Population Adults: apply a dose (2 sprays) 3 times a day, directed directly to the affected part. Each spray dispenses 0.2 ml of solution, equivalent to 0.5 mg of active ingredient. Pediatric population Children over 12 years: as for adults. Children under 12 years old: do not give children under 12 years old (see paragraph 4.3). Special popularity Seniors: clinical data available at the moment are limited, so no recommendation on posology can be made. The elderly have a greater risk of serious consequences in case of adverse reactions (see paragraph 4.4). Patients with liver failure: a reduction in dose in patients with mild to moderate liver failure is not necessary. Flurbiprofen is contraindicated in patients with severe liver failure (see paragraph 4.3). Patients with kidney failure: a reduction in dose is not necessary in patients with mild to moderate kidney failure. Flurbiprofen is contraindicated in patients with severe liver failure (see paragraph 4.3).Method of administration For oropharyngeal use. Address the dispenser to the back of the throat and spray on the affected part. BENACTIV GOLA Pastiglie gusto Lemon and Honey BENACTIV GOLA Pastiglie Without Sugar Taste Orange Population Adults: 1 pill every 3-6 hours, depending on the need. Do not exceed the dose of 8 pills in 24 hours. Pediatric population Children over 12 years: as for adults. Children under 12 years old: do not give children under 12 years old (see paragraph 4.3). Special popularity Seniors: clinical data available at the moment are limited, so no recommendation on posology can be made. The elderly have a greater risk of serious consequences in case of adverse reactions (see paragraph 4.4). Patients with liver failure: a reduction in dose in patients with mild to moderate liver failure is not necessary. Flurbiprofen is contraindicated in patients with severe liver failure (see paragraph 4.3). Patients with kidney failure: a reduction in dose is not necessary in patients with mild to moderate kidney failure. Flurbiprofen is contraindicated in patients with severe liver failure (see paragraph 4.3).Method of administration For oropharyngeal use. Dissolve slowly in your mouth. As with all pads, in order to avoid local irritations, also flurbiprofen tablets should be moved inside the mouth during administration. If mouth irritations occur, treatment should be stopped.

Conservation

Benactiv Gola Pastiglie Without Sugar Taste Orange and Benactiv Gola Taste pastries Lemon and Honey: Store at a temperature below 25°C.

Warnings

At recommended doses, in using the medicine in its different pharmaceutical forms, swallowing does not involve any harm to the patient, as the dose of flurbiprofen is widely lower than that commonly used in systemic treatments. Senior patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal hemorrhage and perforation, which can be fatal. Respiratory diseases Cases of bronchospasm with flurbiprofen have been reported in patients with bronchial asthma anamnesi or allergies. Flurbiprofen should be used carefully in these patients. Other It is advisable not to associate the medicine with other NSAIDs (see paragraph 4.5). Systemic erythematous lupus (LES) and mixed connective tissue disease Patients with systemic erythematosum Lupus and mixed connective tissue disease may present an increased risk of aseptic meningitis (see paragraph 4.8), however this effect is not usually observed with products intended for limited and short-term use as flurbiprofen. Heart, liver and kidney failure The medicine should be used with caution in patients with heart, kidney or liver failure. It has been reported that NSAIDs can cause various forms of nephrotoxicity, including interstitial nephritis, nephrosic syndrome and kidney failure. The administration of an NSAID can cause a dose-dependent reduction in prostaglandine formation and cause renal failure. Patients who present the highest risk of developing this reaction are those with impairment of kidney function, heart impairment, liver dysfunction, those in diuretic therapy and the elderly; however, this effect is not usually observed with products intended for limited and short-term use such as flurbiprofen. Cardiovascular and cerebrovascular effects Before starting treatment in patients with positive anamnesi for hypertension and/or heart failure is required caution (disputing with your physician or pharmacist), since in association with treatment with NSAIDs, fluid retention, hypertension and edema were found. Clinical studies and epidemiological data suggest that the use of some NSAIDs especially at high doses and long-term treatments may be associated with a modest increase in the risk of arterial thrombotic events such as myocardial infarction or stroke. There is no sufficient data to exclude a similar risk for flurbiprofen. Patients with uncontrolled hypertension, congestive heart failure, established ischemic cardiopathy, peripheral arterial disease and/or cerebrovascular disease should be treated with flurbiprofen only after careful evaluation. Analogue considerations must be made before starting long-term treatment in patients with risk factors for cardiovascular disease (p.es. hypertension, hyperlipidemia, diabetes mellitus, smoking). Effects on the central nervous system Kefalea induced by analgesics. In case of prolonged or irregular use of analgesics, cephalea can be manifested, which should not be treated by increasing the dose of the medicinal product. Gastrointestinal effects Flurbiprofen should be administered with caution to patients with peptic ulcer anamnesis and other gastrointestinal diseases since such conditions can be reascutized. The risk of gastrointestinal hemorrhage, ulcer or perforation is higher when the dosage of flurbiprofen increases in patients with a history of ulcer, especially if complicated by hemorrhage and perforation and in the elderly. These patients must begin treatment with the lowest dose available. Gastrointestinal bleeding, ulcer or drilling have been reported with all NSAIDs at any time of treatment. These adverse reactions may be fatal and may occur with or without warning symptoms or in case of previous history of serious gastrointestinal reactions. Patients with anamnesi of gastrointestinal diseases, especially if elderly, must report any unusual symptom of abdominal type (especially gastrointestinal hemorrhage) in the early stages of treatment. 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 paragraph 4.2). Caution should be recommended in patients receiving concomitant medicines that can increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or pyastrinic anti-aggregants such as acetylsalicylic acid (see paragraph 4.5). When bleeding or gastrointestinal ulceration occurs in patients who are taking flurbiprofen, treatment must be stopped. Dermatory effects The use of the medicinal product, especially if prolonged, can give rise to phenomena of local sensitization or irritation. In such cases it is necessary to stop treatment and consult a doctor to establish, if necessary, suitable therapy. Severe skin reactions, some of which fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs (see paragraph 4.8). Flurbiprofen should be suspended at the first appearance of skin rash, mucosa lesions or any other sign of hypersensitivity. Infections Since isolated cases of exacerbation of inflammation related to infections (e.g. development of necrotizing fascites) have been described in temporal association with the systemic use of drugs belonging to the class of NSAIDs, it is recommended that patients immediately consult a doctor in case of the appearance or worsening of signs of a bacterial infection during flurbiprofen therapy. An indication should be taken at the beginning of antibiotic therapy. If the mouth irritation develops, the treatment should be stopped. BENACTIV GOLA Collutory and BENACTIV GOLA Spray contains para-hydroxy-benzoates that can cause allergic reactions (also delayed). BENACTIV GOLA Collutory and BENACTIV GOLA Spray contains hydrogenated castor oil40-polyxyethylene which can cause reactions on the localized skin. BENACTIV GOLA Collutory and BENACTIV GOLA Spray contains an aroma in turn containing d-limonene. D-limonene can cause allergic reactions. BENACTIV GOLA Collutory and BENACTIV GOLA Spray contains less than 1 mmol (23mg) of sodium per dose of 10 ml, i.e. essentially “without sodium”. BENACTIV GOLA Pastiglie gusto Limone e Miele contains liquid glucose, liquid sucrose and honey (invert sugar). Patients suffering from rare fructose intolerance problems, glucose-galactosis mal absorption or insufficiency of isomaltase sucrasis should not take this medicine. To consider in people with diabetes mellitus: this medicine contains 1,07 g glucose and 1,41 g sucrose for pastilla. BENACTIV GOLA Pastiglie gusto Limone e Miele contains sulphites. Rarely it can cause serious reactions of hypersensitivity and bronchospasm. BENACTIV GOLA Pastiglie gusto Limone e Miele contains only a very small amount of gluten (from the wheat starch). This medicine is considered “gluten free” and is very unlikely to cause problems to a celiac patient. A pastel contains no more than 21,38 micrograms of gluten. If a patient is allergic to wheat (condition other than celiac disease) he should not take this medicine. BENACTIV GOLA Pastiglie gusto Limone e Miele contains an aroma in turn containing cytral, citronellolo, d-limonene, makesolo, geraniol and linalol. Citral, citronellol, d-limonene, foliage, geranium and linalol can cause allergic reactions. BENACTIV GOLA Pastiglie gusto Limone e Miele contains an aroma in turn containing butylated hydroxyanisol that can cause reactions on the localized skin (e.g. contact dermatitis) or irritation to the eyes and mucosa. BENACTIV GOLA Pastiglie Senza Zucchero gusto Arancia is instead indicated for those patients who have to control the intake of sugars and calories. BENACTIV GOLA Pastiglie Senza Zucchero gusto Arancia contains an aroma in turn containing citral, citronellolo, d-limonene, geraaniol and linalol. Citral, citronellol, d-limonene, geraaniol and linalol may cause allergic reactions. BENACTIV GOLA Pastiglie Senza Zucchero gusto Arancia contains liquid maltitolo and isomalto. Patients suffering from rare hereditary problems of fructose intolerance should not take this medicine. It can have a slight laxative effect. The caloric value of maltitol and isomalto is 2.3 kcal/g. Do not use for extended treatments over 7 days. If you do not notice appreciable results after 3 days of treatment, the cause may be a different pathological condition. It is recommended in these cases to consult the doctor.

Interactions

Attention should be given to patients treated with any of the medicines listed below, since interactions have been reported in some patients. In any case, please inform your doctor if you are taking other medicines. Flurbiprofen should be avoided in association with: - Aspirin: unless intake of aspirin at low doses (not more than 100 mg/day or local prophylactic doses for cardiovascular protection) has been recommended by the doctor; as with other medicines containing NSAIDs, concomitant administration of flurbiprofen and aspirin is not generally recommended due to the potential increase in unwanted effects (see paragraph 4.4). - Cox-2 inhibitors and other NSAIDs: the concomitant use of other NSAIDs, including selective cycloxygenase-2 inhibitors, must be avoided due to potential additive effects and increased risk of adverse reactions (see paragraph 4.4). Flurbiprofen should be used with caution in association with: - Antiagulants: NSAIDs can enhance the effects of anticoagulants such as warfarin (see paragraph 4.4) - Anti-aggregating agents: increased risk of gastrointestinal hemorrhage - Selective serotonin reuptake inhibitors (SSRIs):. Other antihypertensive drugs can enhance nephrotoxicity caused by inhibition of cyclooxygenase, especially in patients with impaired kidney function (these patients must be properly hydrated) - Alcohol: it can increase the risk of adverse reactions, especially bleeding in the gastrointestinal tract - cardiac glycosides: NSAIDs can exacerbate heart failure, reduce blood pressure increased risk of nephrotoxicity - Corticosteroids: increased risk of gastrointestinal ulcer or hemorrhage with NSAID (see paragraph 4.4) - Lithium: there is evidence for a possible increase in plasma levels of lithium - Metotressed: there may be an increase in plasma levels of metotressate - Mifepristone: NSAIDs should not be used for 8-12 days after the administration of mifepristone, since NSAIDs can reduce the effect of mifepristone - Chinolonic antibiotics: animal data indicate that NSAIDs can increase the risk of convulsions associated with chinolonic antibiotics. Patients taking NSAIDs and Chinoloni may have an increased risk of developing seizures - Tacrolimus: possible increase in the risk of nephrotoxicity when NSAIDs are administered along with tacrolimus - Zidovudine: increased risk of hematological toxicity when NSAIDs are administered with zidovudine.

Effects

Reactions of hypersensitivity to NSAIDs have been reported and these can consist of: (a) non-specific allergic reactions and anaphylaxis (b) reactivity of the respiratory tract, for example asthma, aggravated asthma, bronchospasm, dispnea (c) various skin disorders, including for example skin rashes of different types, itching, neticaria, purple, angioedema and more rarely. The most commonly observed adverse reactions are gastrointestinal. The local use of the medicinal product, especially if prolonged, can give rise to phenomena of local sensitization or irritation. Dissolution in the oral cavity of the medicinal product in the form of tablets can be accompanied by sensations of heat or tingling charged with oropharynx. In such cases it is necessary to stop the treatment and to establish, if necessary, suitable therapy. The following undesirable effects were reported, particularly after the administration of formulations for systemic use. They refer to those detected with the use of short-term flurbiprofen and at doses compatible with the classification of automedication medicines. In case of treatment of chronic conditions and for long periods of time additional side effects may occur. The undesirable effects associated with the use of flurbiprofen are below divided according to the classification for systems and organs and frequency. The frequency is defined as: very common (≥ 1/10), common (≥1/100, Classification for systems and organs Frequency Adverse reactions Diseases of emolinfopoietic system Notable Anemia, thrombocytopenia, aplastic anemia and agranulocytosis Diseases of the nervous system Town Chief, headache, paresthesia Not common Sleep Notable Exciting cerebrovascular, optic neuritis, migraine, confusion, vertigo Immune disorders system Rare Anaphylactic reaction Notable Angioedema, hypersensitivity Pathologies of the eye Notable Compromise of vision Ear and labyrinth pathologies Notable Tinnitus Heart disease Notable Heart failure, edema Vascular diseases Notable Hypertension Respiratory, chest and mediastinic pathologies Town Irritation of the throat Not common Asthma, bronchospasm and dispnea, vesicular eruption oropharyngeal, hypoesthesia oropharyngeal Gastrointestinal diseases Town Diarrhea, mouth ulceration, nausea, oral pain, oral paresthesia, oropharyngeal pain, oral discomfort (heat or burning sensation, mouth tingling) Not common Abdomen, abdominal pain, constipation, dry mouth, dyspepsia, flatulence, glossodynia, dysgeusia, oral dysthesia, vomiting Notable Melena, ematemesis, gastrointestinal hemorrhage, colitis, Crohn's disease exacerbation, gastritis, peptic ulcer, gastric drilling, ulcer hemorrhage Pathologies of skin and subcutaneous tissue Not common Skin rash, itching Notable Orticaria, porpora, bollous dermatitis (including Stevens-Johnson syndrome, toxic epidermal necrolysis and multiform erythema) Kidney and urinary pathologies Notable Toxic nephropathy, piline-interstitial nephritis and nephrosic syndrome, kidney failure (as with other NSAIDs) Systemic pathologies and conditions for administration Not common Pyrexia, pain Notable Disagio, fatigue Hepatobiliary diseases Notable Hepatitis Psychiatric disorders Not common Insomnia Notable Depression, hallucination Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

In view of the reduced content of active ingredient and its local use it is unlikely that overdose situations may occur. Synonyms Most patients ingesting clinically important amounts of NSAIDs develop nausea, vomiting, gastrointestinal irritation, epigastric pain, or more rarely diarrhea. Tinnitus, headache and gastrointestinal bleeding are also possible. In more serious cases of intoxication by NSAIDs, toxicity is observed at the expense of the central nervous system, which is manifested with drowsiness, occasionally excitability, blurred vision and disorientation or coma. Occasionally patients develop seizures. In case of severe intoxication from NSAIDs, metabolic acidosis can occur and protrombine/INR time may be prolonged, probably due to interference with the action of the factors of the coagulation present in the circle. Acute kidney failure and liver damage can occur. Asthma exacerbation is possible in asthmatic subjects. Treatment The treatment must be symptomatic and supportive and must include the maintenance of airway pervity and the monitoring of heart function and vital signs until stabilization. The oral administration of activated charcoal should be considered and, if necessary, the correction of the serum electrolytes if the patient occurs within an hour of the ingestion of a potentially toxic quantity. Convulsions must be treated with diazepam or lorazepam intravenously if they are frequent or prolonged. Administer bronchodilators for asthma. There is no specific antidote for flurbiprofen.

Pregnancy

Flurbiprofen should not be administered during the first and second trimester of pregnancy, if not in strictly necessary cases. The use of flurbiprofen during the third trimester of pregnancy is contraindicated.

Food

In a limited number of studies, flurbiprofen appears in breast milk in very low concentrations and is unlikely to have adverse effects on breast-feededed infant. However, the administration of flurbiprofen is not recommended in nursing mothers.

Fertility

Evidence indicates that the inhibitors of the cyclooxygenase/synthesis of prostaglandins can cause a compromise of female fertility through an effect on ovulation. This is reversible as a result of termination of treatment.

Source: Farmadati