Benactiv Throat Orange 16 Lozenges

In compliance with article 118 "authorization of advertising to the public" of the legislative decree of 24 April 2006, number 219

INDICATIONS

BENACTIV THROAT Mouthwash BENACTIV THROAT Spray for oral mucosa Symptomatic treatment of irritative-inflammatory states also associated with pain in the oropharyngeal cavity (e.g. gingivitis, stomatitis, pharyngitis), also as a consequence of conservative or extractive dental therapy. BENACTIV THROAT Lemon and Honey flavored lozenges BENACTIV GOLA Orange flavored sugar-free lozenges Symptomatic treatment of irritative-inflammatory conditions also associated with oropharyngeal pain (e.g. gingivitis, stomatitis, pharyngitis).

CONTRAINDICATIONS

Do not use the medicine in children under 12 years of age. Flurbiprofen is contraindicated in patients with known hypersensitivity to flurbiprofen or to any of the excipients listed in section 6.1. Patients who have previously shown hypersensitivity reactions (e.g. asthma, urticaria, allergy, rhinitis, angioedema, bronchospasm) towards ibuprofen, acetylsalicylic acid (aspirin) or other non-steroidal anti-inflammatory drugs (NSAIDs). Flurbiprofen is also 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 anamnestic ulcerative colitis, Crohn's disease, recurrent peptic ulcer or gastrointestinal haemorrhage (defined as two or more distinct episodes of demonstrated ulceration or bleeding). Flurbiprofen is contraindicated in patients with severe heart failure, severe hepatic failure and renal failure (see section 4.4). Third trimester of pregnancy.

WARNINGS AND PRECAUTIONS FOR USE

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 significantly lower than that commonly used in systemic treatments. Elderly: Elderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal haemorrhage and perforation, which may be fatal. Respiratory disorders Cases of bronchospasm 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 (see section 4.5). Systemic lupus erythematosus (SLE) and mixed connective tissue disease Patients with systemic lupus erythematosus 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. Cardiac, hepatic and renal impairment The medicine should be used with caution in patients with cardiac, renal or hepatic insufficiency. NSAIDs have been reported to cause various forms of nephrotoxicity, including interstitial nephritis, nephrotic syndrome, and renal failure. The administration of an NSAID can cause a dose-dependent reduction in the formation of prostaglandins and precipitate renal failure. Patients at highest risk of developing this reaction are those with impaired renal function, cardiac impairment, liver dysfunction, those on 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 a positive history of hypertension and/or heart failure, caution is required (discuss with your doctor or pharmacist), since fluid retention, hypertension and edema have been reported in association with treatment with NSAIDs. Clinical studies and epidemiological data suggest that the use of some NSAIDs, especially at high doses and for long-term treatments, may be associated with a modest increase in the risk of arterial thrombotic events such as myocardial infarction or stroke. There are insufficient data to exclude a similar risk for flurbiprofen. Patients with uncontrolled hypertension, congestive heart failure, established ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease should be treated with flurbiprofen only after careful consideration. Similar considerations must be made before starting long-term treatment in patients with risk factors for cardiovascular disease (e.g. hypertension, hyperlipidemia, diabetes mellitus, smoking). Effects on the central nervous system Analgesic-induced headache. In case of prolonged or irregular use of analgesics, headache may occur, which must 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 ulcers and other gastrointestinal diseases as these conditions may be exacerbated. The risk of gastrointestinal haemorrhage, ulcer or perforation is higher with increasing dosage of flurbiprofen in patients with a history of ulcer, particularly if complicated by haemorrhage and perforation, and in the elderly. These patients should start treatment with the lowest available dose. Gastrointestinal bleeding, ulcer or perforation have been reported with all NSAIDs at any time during treatment. These adverse reactions can be fatal and can occur with or without warning symptoms or in case of a previous history of serious gastrointestinal reactions. Patients with a history of gastrointestinal disease, especially if elderly, should report any unusual abdominal symptoms (especially gastrointestinal bleeding) in the initial stages of treatment. Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms (see section 4.2). Caution should be advised in patients receiving concomitant medicinal products 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). When gastrointestinal bleeding or ulceration occurs in patients taking flurbiprofen, treatment should be discontinued. Dermatological effects The use of the medicine, especially if prolonged, can give rise to sensitization or local irritation phenomena. In such cases it is necessary to interrupt treatment and consult a doctor to institute, if necessary, suitable therapy. 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 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) have been described in temporal association with the systemic use of drugs belonging to the NSAID class, patients are recommended to immediately consult a doctor in case of appearance or worsening of signs of a bacterial infection during flurbiprofen-based therapy. A possible indication for starting antibiotic therapy must be taken into consideration. If mouth irritation develops, treatment should be discontinued. BENACTIV GOLA Mouthwash and BENACTIV GOLA Spray contain para-hydroxybenzoates which can cause allergic reactions (even delayed). BENACTIV GOLA Mouthwash and BENACTIV GOLA Spray contain hydrogenated 40-polyoxyethylene castor oil which may cause localized skin reactions. BENACTIV GOLA Mouthwash and BENACTIV GOLA Spray contain an aroma which in turn contains d-limonene. D-limonene can cause allergic reactions. BENACTIV GOLA Mouthwash and BENACTIV GOLA Spray contain less than 1 mmol (23mg) sodium per 10 ml dose, i.e. essentially "sodium-free". BENACTIV GOLA Lemon and Honey flavored lozenges contain liquid glucose, liquid sucrose and honey (invert sugar). Patients suffering from rare problems of fructose intolerance, glucose-galactose malabsorption or sucrase isomaltase insufficiency should not take this medicine. To be taken into consideration in people with diabetes mellitus: this medicine contains 1.07 g of glucose and 1.41 g of sucrose per tablet. BENACTIV GOLA Lemon and Honey flavored lozenges contain sulphites. Rarely it can cause serious hypersensitivity reactions and bronchospasm. BENACTIV GOLA Lemon and Honey flavored lozenges contain only a very small amount of gluten (from wheat starch). This medicine is considered “gluten-free” and is very unlikely to cause problems for a celiac patient. One tablet contains no more than 21.38 micrograms of gluten. If a patient is allergic to wheat (condition other than celiac disease) he or she should not take this medicine. BENACTIV THROAT Lemon and Honey flavored lozenges contain an aroma which in turn contains citral, citronellol, d-limonene, farfalle, geraniol and linalool. Citral, citronellol, d-limonene, farfalle, geraniol and linalool can cause allergic reactions. BENACTIV THROAT Lemon and Honey flavored lozenges contain an aroma which in turn contains butylated hydroxyanisole which can cause localized skin reactions (e.g. contact dermatitis) or irritation to the eyes and mucous membranes. BENACTIV GOLA Sugar-Free Lozenges Orange flavor is instead indicated for those patients who need to control their intake of sugars and calories. BENACTIV GOLA Orange flavored sugar-free lozenges contain an aroma which in turn contains citral, citronellol, d-limonene, geraniol and linalool. Citral, citronellol, d-limonene, geraniol and linalool can cause allergic reactions. BENACTIV GOLA Orange flavored sugar-free lozenges contain liquid maltitol and isomalt. Patients with rare hereditary problems of fructose intolerance should not take this medicine. May have a mild laxative effect. The caloric value of maltitol and isomalt is 2.3 kcal/g. Do not use for prolonged treatments beyond 7 days. If you do not notice appreciable results after 3 days of treatment, the cause could be a different pathological condition. In these cases it is advisable to consult your doctor.

INTERACTIONS

Caution should be exercised in patients treated with any of the medicines listed below, as interactions have been reported in some patients. However, inform your doctor if you are taking other medicines. Flurbiprofen should be avoided in association with: - Aspirin: unless the intake of low-dose aspirin (not exceeding 100 mg/day or local prophylactic doses for cardiovascular protection) has been recommended by the doctor; As with other NSAID-containing medicinal products, concomitant administration of flurbiprofen and aspirin is generally not recommended due to the potential for increased side effects (see section 4.4). - Cox-2 inhibitors and other NSAIDs: concomitant use of other NSAIDs, including selective cyclooxygenase-2 inhibitors, should be avoided due to potential additive effects and an increased risk of adverse reactions (see section 4.4). Flurbiprofen should be used with caution in association with: - Anticoagulants: NSAIDs can potentiate the effects of anticoagulants such as warfarin (see section 4.4) - Antiaggregating agents: increased risk of gastrointestinal bleeding - Selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding - Antihypertensives (diuretics, ACE inhibitors and angiotensin II antagonists): i NSAIDs can reduce the effect of diuretics. Other antihypertensive drugs may potentiate nephrotoxicity caused by inhibition of cyclooxygenase, 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 levels of glycosides - Cyclosporine: increased risk of nephrotoxicity - Corticosteroids: increased risk of gastrointestinal ulcer or haemorrhage with NSAIDs (see section 4.4) - Lithium: there is evidence for 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: data obtained in animals 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 seizures - Tacrolimus: possible increased risk of nephrotoxicity when NSAIDs are administered together with tacrolimus - Zidovudine: increased risk of haematological toxicity when NSAIDs are administered with zidovudine.

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, e.g. asthma, aggravated asthma, bronchospasm, dyspnoea (c) various skin disorders, including for example skin rashes of different types, pruritus, urticaria, purpura, angioedema and, more rarely, exfoliative and bullous dermatosis (including necrolysis epidermal and erythema multiforme). The most commonly observed adverse reactions are gastrointestinal in nature. Local use of the medicine, especially if prolonged, can give rise to local sensitization or irritation phenomena. The dissolution of the medicine in tablet form in the oral cavity may be accompanied by sensations of heat or tingling in the oropharynx. In such cases it is necessary to interrupt treatment and institute, if necessary, suitable therapy. The following side effects have been reported, particularly after the administration of formulations for systemic use. They 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 for long periods of time, additional side effects may occur. The side effects associated with the use of flurbiprofen are divided below based on system organ classification 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 (cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

Classification by systems and organs | Frequency | Adverse reactions

Pathologies of the blood and lymphatic system | Not known | Anemia, thrombocytopenia, aplastic anemia and agranulocytosis

Pathologies of the nervous system | Municipality | Dizziness, headache, paraesthesia

Uncommon | Drowsiness

Not known | Cerebrovascular accident, optic neuritis, migraine, confusional states, dizziness

Disorders of the immune system | Rare | Anaphylactic reaction

Not known | Angioedema, hypersensitivity

Eye diseases | Not known | Vision impairment

Ear and labyrinth disorders | Not known | Tinnitus

Cardiac disorders | Not known | Heart failure, edema

Vascular pathologies | Not known | Hypertension

Respiratory, thoracic and mediastinal disorders | Municipality | Throat irritation

Uncommon | Asthma, bronchospasm and dyspnea, oropharyngeal vesicular rash, oropharyngeal hypoesthesia

Gastrointestinal disorders | Municipality | Diarrhoea, mouth ulceration, nausea, oral pain, oral paraesthesia, oropharyngeal pain, oral discomfort (hot or burning sensation, tingling in the mouth)

Uncommon | Abdominal distension, abdominal pain, constipation, dry mouth, dyspepsia, flatulence, glossodynia, dysgeusia, oral dysesthesia, vomiting

Not known | Melena, haematemesis, gastrointestinal haemorrhage, colitis, exacerbation of Crohn's disease, gastritis, peptic ulcer, gastric perforation, ulcer haemorrhage

Skin and subcutaneous tissue disorders | Uncommon | Skin rash, itching

Not known | Urticaria, purpura, bullous dermatitis (including Stevens-Johnson syndrome, toxic epidermal necrolysis and erythema multiforme)

Renal and urinary disorders | Not known | Toxic nephropathy, tubulointerstitial nephritis and nephrotic syndrome, renal failure (as with other NSAIDs)

Systemic disorders and conditions relating to the administration site | Uncommon | Pyrexia, pain

Not known | Discomfort, tiredness

Hepatobiliary disorders | Not known | Hepatitis

Psychiatric disorders | Uncommon | Insomnia

Not known | Depression, hallucination

Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit/risk balance 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.