Aspi Gola 8.75mg 16 Honey Lemon Flavored Lozenges

INDICATIONS

Symptomatic treatment of irritative-inflammatory conditions also associated with oropharyngeal pain (e.g. gingivitis, stomatitis, pharyngitis).

ACTIVE INGREDIENTS

One tablet contains: Active ingredient: flurbiprofen 8.75 mg Excipients with known effects: glucose, sucrose For the full list of excipients, see section 6.1.

EXCIPIENTS

Sucrose, glucose, macrogol, potassium hydroxide, lemon flavouring, levomenthol, honey.

CONTRAINDICATIONS AND SIDE EFFECTS

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 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.

DOSAGE

Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms (see section 4.4). Dosage Adults: 1 tablet every 3-6 hours, as needed. Do not exceed the dose of 8 tablets in 24 hours. Pediatric population Children over 12 years old: same as adults. Children under 12 years of age: Do not administer to children under 12 years of age (see section 4.3). Special populations Elderly: The clinical data currently available are limited, therefore no recommendation regarding posology can be made. Elderly people are at greater risk of serious consequences in case of adverse reactions (see section 4.4). Patients with liver failure: A dosage reduction is not necessary in patients with mild to moderate hepatic impairment. Flurbiprofen is contraindicated in patients with severe hepatic impairment (see section 4.3). Patients with renal failure: A dosage reduction is not necessary in patients with mild to moderate renal impairment. Flurbiprofen is contraindicated in patients with severe renal impairment (see section 4.3). Method of administration For oropharyngeal use. Dissolve slowly in your mouth. As with all lozenges, in order to avoid local irritation, flurbiprofen lozenges should also be moved inside the mouth during administration. If mouth irritation occurs, treatment should be discontinued.

CONSERVATION

This medicinal product does not require any special precautions for storage.

WARNINGS

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 bleeding 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 bleeding, ulcer or perforation is higher with increasing dosage of flurbiprofen in patients with a history of ulcer, particularly if complicated by bleeding 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 the 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. Important information about some excipients ASPI GOLA Lemon and Honey flavored lozenges contain glucose. Patients suffering from rare problems of glucose-galactose malabsorption should not take this medicine. ASPI GOLA Lemon and Honey flavored lozenges contain sucrose. Patients suffering from rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase isomaltase insufficiency should not take this medicine. 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: - Acetylsalicylic acid: unless the intake of acetylsalicylic acid in low doses (not exceeding 100 mg/day or local prophylactic doses for cardiovascular protection) has been recommended by the doctor; As with other medicinal products containing NSAIDs, concomitant administration of flurbiprofen and acetylsalicylic acid 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 may potentiate the effects of anticoagulants such as warfarin (see section 4.4). - Antiplatelet agents: increased risk of gastrointestinal bleeding. - Selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding. - Antihypertensives (diuretics, ACE inhibitors and angiotensin II antagonists): NSAIDs can reduce the effect of diuretics. Other antihypertensive drugs may potentiate nephrotoxicity caused by cyclooxygenase inhibition, 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 can exacerbate heart failure, reduce VGR (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: Animal data 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.

Blood and lymphatic system disorders - Frequency: Not known. Adverse reactions: Anemia, thrombocytopenia, aplastic anemia and agranulocytosis.

Nervous system disorders - Frequency: Common. Adverse reactions: Dizziness, headache, paraesthesia.

Nervous system disorders - Frequency: Uncommon. Adverse reactions: Drowsiness.

Nervous system disorders - Frequency: Not known. Adverse reactions: Cerebrovascular accidents, optic neuritis, migraine, confusional states, dizziness.

Immune system disorders - Frequency: Rare. Adverse reactions: Anaphylactic reactions.

Immune system disorders - Frequency: Not known. Adverse reactions: Angioedema, hypersensitivity

Eye disorders - Frequency: Not known. Adverse reactions: Visual disturbances.

Ear and labyrinth disorders - Frequency: Not known. Adverse reactions: Tinnitus.

Cardiac disorders - Frequency: Not known. Adverse reactions: Heart failure, edema.

Vascular disorders - Frequency: Not known. Adverse reactions: Hypertension.

Respiratory, thoracic and mediastinal disorders - Frequency: Common. Adverse reactions: Throat irritation.

Respiratory, thoracic and mediastinal disorders - Frequency: Uncommon. Adverse reactions: Asthma, bronchospasm and dyspnea, blisters in the oropharynx, oropharyngeal hypoesthesia.

Gastrointestinal disorders - Frequency: Common. Adverse reactions: Diarrhoea, mouth ulcers, nausea, oral pain, oral paraesthesia, oropharyngeal pain, oral discomfort (hot or burning sensation, tingling in the mouth).

Gastrointestinal disorders - Frequency: Uncommon. Adverse reactions: Abdominal distension, abdominal pain, constipation, dry mouth, dyspepsia, flatulence, glossodynia, dysgeusia, oral dysesthesia, vomiting.

Gastrointestinal disorders - Frequency: Not known. Adverse reactions: Melena, haematemesis, gastrointestinal haemorrhage, colitis, exacerbation of Crohn's disease, gastritis, peptic ulcer, gastric perforation, ulcer haemorrhage.

Skin and subcutaneous tissue disorders - Frequency: Uncommon. Adverse reactions: Rash, itching.

Skin and subcutaneous tissue disorders - Frequency: Not known. Adverse reactions: Urticaria, purpura, bullous dermatitis (including Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis and Erythema multiforme).

Renal and urinary disorders - Frequency: Not known. Adverse reactions: Nephrotoxicity, tubulointerstitial nephritis and nephrotic syndrome, renal failure (as with other NSAIDs).

General disorders and administration site conditions - Frequency: Uncommon. Adverse reactions: Pyrexia, pain.

General disorders and conditions relating to the administration site - Frequency: Not known. Adverse reactions: Discomfort, fatigue.

Hepatobiliary disorders - Frequency: Not known. Adverse reactions: Hepatitis.

Psychiatric disorders - Frequency: Uncommon. Adverse reactions: Insomnia.

Psychiatric disorders - Frequency: Not known. Adverse reactions: 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 www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetti-reazione-avversa.

OVERDOSE

Given the reduced content of the active ingredient and its local use, it is unlikely that overdose situations may occur. Symptoms The majority of patients who ingest clinically large quantities of NSAIDs develop nausea, vomiting, gastrointestinal irritation, epigastric pain, or more rarely diarrhea. Tinnitus, headache and gastrointestinal bleeding are also possible. In more severe cases of NSAID intoxication, central nervous system toxicity is observed, manifested by drowsiness, occasionally excitability, blurred vision and disorientation or coma. Occasionally patients develop seizures. In case of severe NSAID intoxication, metabolic acidosis may occur and the prothrombin time/INR may be prolonged, probably due to interference with the action of coagulation factors present in circulation. Acute renal failure and liver damage may occur. An exacerbation of asthma is possible in asthmatic subjects. Treatment Treatment 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 and, if necessary, correction of serum electrolytes should be considered if the patient presents within one hour of ingesting a potentially toxic amount. Seizures should be treated with intravenous diazepam or lorazepam if they are frequent or prolonged. Administer bronchodilators for asthma. There is no specific antidote for flurbiprofen.

PREGNANCY AND BREASTFEEDING

Pregnancy Flurbiprofen should not be administered during the first and second trimester of pregnancy unless strictly necessary. The use of flurbiprofen during the third trimester of pregnancy is contraindicated. Breastfeeding In a limited number of studies, flurbiprofen appears in breast milk in very low concentrations and is unlikely to have negative effects on the breastfed infant. However, administration of flurbiprofen is not recommended in breastfeeding mothers. Fertility There is evidence to suggest that cyclooxygenase/prostaglandin synthesis inhibitors may cause impairment of female fertility through an effect on ovulation. This is reversible upon discontinuation of treatment.

EFFECTS ON DRIVING ABILITY

It does not interfere with the ability to drive and use machinery.