ASPI GOLA 24PASTL LIM MIELE

ASPI GOLA 8,75 MG LEMON AND HONEY FLAVOR PADS

active principles

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

Exceptions

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

Therapeutic indications

Symptomatic treatment of irritative-inflammatory states also associated with pain in the oropharynx (eg 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) to 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 treatments. Flurbiprofen should not be taken by patients with active or history of ulcerative colitis, Crohn's disease, recurrent peptic ulcer disease, or gastrointestinal bleeding (defined as two or more distinct episodes of proven ulceration or bleeding). Flurbiprofen is contraindicated in patients with severe heart failure, severe hepatic insufficiency and renal insufficiency (see section 4.4). Third trimester of pregnancy.

Posology

Undesirable effects may be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms (see section 4.4). Posology Adults: 1 lozenge every 3-6 hours, as needed. Do not exceed the dose of 8 lozenges in 24 hours. Pediatric population Children over 12 years of age: as for adults. Children under 12 years of age: Do not administer to children under 12 years of age (see section 4.3). Special populations Elderly people: Currently available clinical data are limited, therefore no recommendation on a posology can be made. The elderly have an increased risk of serious consequences in case of adverse reactions (see section 4.4). Patients with hepatic insufficiency: No dosage reduction is 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 insufficiency: No dosage reduction is necessary in patients with mild to moderate renal insufficiency. Flurbiprofen is contraindicated in patients with severe renal impairment (see section 4.3). Method of administration For oropharyngeal use. Slowly dissolve in the mouth. As with all lozenges, flurbiprofen lozenges should also be moved within the mouth during administration to avoid local irritation. If mouth irritation occurs, treatment should be discontinued.

Storage

This medicinal product does not require any special storage precautions.

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 much lower than that commonly used in systemic treatments. Elderly peopleElderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which can be fatal. Respiratory pathologies 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 drug 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 be at increased risk of aseptic meningitis (see section 4.8), however this effect is not usually seen with short term, limited use products such as flurbiprofen. Cardiac, hepatic and renal impairment The medicinal product 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. 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 receiving diuretic therapy and the elderly; however, this effect is not usually seen with products intended for limited and short-term use such as flurbiprofen. Cardiovascular and cerebrovascular effects Caution is required before starting treatment in patients with a history of hypertension and/or heart failure (discuss with your doctor or pharmacist), since fluid retention, hypertension and edema have been reported in association with NSAID treatment. Clinical studies and epidemiological data suggest that the use of some NSAIDs, especially at high doses and in long-term treatments, may be associated with a small increased 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 only be treated with flurbiprofen after careful consideration. Similar considerations should be made before starting long-term treatment in patients with risk factors for cardiovascular disease (p.es. hypertension, hyperlipidaemia, diabetes mellitus, smoking). Effects on the central nervous system Analgesic-induced headache. In case of prolonged or irregular use of analgesics, headaches may occur, which should 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 ulcer and other gastrointestinal diseases as these conditions may be exacerbated. The risk of GI bleeding, ulceration or perforation is higher with increasing flurbiprofen dosage in patients with a history of ulcer, particularly if complicated with bleeding and perforation, and in the elderly. These patients should start treatment on the lowest available dose. Gastrointestinal bleeding, ulceration or perforation has 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 with a previous history of severe 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 may 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 which 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, the 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, a 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 infection-related inflammation (e.g. development of necrotizing fasciitis) have been described in temporal association with the systemic use of drugs belonging to the class of NSAIDs, patients are recommended to immediately consult a doctor in case of new or worsening signs of a bacterial infection during flurbiprofen therapy. A possible indication for the initiation of antibiotic therapy should be considered. If mouth irritation develops, treatment should be discontinued. Important information about some excipients ASPI GOLA Lemon and Honey flavored lozenges contain glucose. Patients with rare glucose-galactose malabsorption problems should not take this medicine. ASPI GOLA Lemon and Honey flavored pastilles contain sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicinal product. Do not use for prolonged treatments beyond 7 days. If no appreciable results are noticed 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 receiving any of the medicinal products 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 combination with:- Acetylsalicylic acid: unless the intake of acetylsalicylic acid at low doses (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, the concomitant administration of flurbiprofen and acetylsalicylic acid is generally not recommended due to the potential for increased undesirable effects (see section 4.4). - Cox-2 inhibitors and other NSAIDsConcomitant 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 conjunction with:- Anticoagulants: nSAIDs may enhance 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 the 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 the GFR (glomerular filtration rate) and increase plasma levels of glycosides. - Cyclosporine: Increased risk of nephrotoxicity. - Corticosteroids: Increased risk of gastrointestinal ulceration or bleeding 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 can reduce the effect of mifepristone. - Quinolone antibioticsAnimal 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.

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 e.g. rashes of various types, pruritus, urticaria, purpura, angioedema and, more rarely, exfoliative and bullous dermatosis (including epidermal necrolysis 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 sensitization or local irritation phenomena. The dissolution in the oral cavity of the medicinal product in tablet form may be accompanied by sensations of warmth or tingling in the oropharynx. In such cases it is necessary to interrupt the treatment and institute, if necessary, a suitable therapy. The following undesirable effects have been reported, especially after the administration of formulations for systemic use. They refer to those found with the use of flurbiprofen used in the short term and at doses compatible with the classification of self-medication medicines. Additional side effects may occur when treating conditions chronically and over long periods of time. Undesirable effects associated with the use of flurbiprofen are listed below by system organ class and frequency. Frequency is defined as: very common (≥1/10), common (≥1/100, System Organ Classification Frequency Adverse reactions Pathologies of the hemolymphopoietic system Not known Anaemia, thrombocytopenia, aplastic anemia and agranulocytosis Pathologies of the nervous system Common Dizziness, headache, paraesthesia Uncommon Drowsiness Not known Cerebrovascular accident, optic neuritis, migraine, confusional states, vertigo Immune system disorders Rare Anaphylactic reactions Not known Angioedema, hypersensitivity Eye pathologies Not known Visual disturbances Pathologies of the ear and labyrinth Not known Tinnitus Heart pathologies Not known Heart failure, edema Vascular pathologies Not known Hypertension Respiratory, thoracic and mediastinal disorders Common Throat irritation Uncommon Asthma, bronchospasm and dyspnoea, oropharyngeal blistering, oropharyngeal hypoaesthesia Gastrointestinal pathologies Common Diarrhoea, mouth sores, nausea, oral pain, oral paraesthesia, oropharyngeal pain, oral discomfort (warming or burning sensation, tingling in the mouth) Uncommon Abdominal distension, abdominal pain, constipation, dry mouth, dyspepsia, flatulence, glossodynia, dysgeusia, oral dysaesthesia, 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 Rash, itching Not known Urticaria, purpura, bullous dermatitis (including Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis, and Erythema multiforme) Kidney and urinary pathologies Not known Nephrotoxicity, tubulointerstitial nephritis and nephrotic syndrome, renal failure (as with other NSAIDs) General disorders and administration site conditions Uncommon Pyrexia, pain Not known Discomfort, fatigue Hepatobiliary pathologies Not known Hepatitis Psychiatric disorders Uncommon Insomnia Not known Depression, hallucination Reporting of suspected adverse reactions. Reporting suspected adverse reactions after authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.

Overdose

In view of the reduced content of the active ingredient and its local use, overdose situations are unlikely to occur. Symptoms The majority of patients who ingest clinically important 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, manifesting as drowsiness, occasionally excitability, blurred vision, and disorientation or coma. Occasionally patients develop seizures. In severe NSAID intoxication, metabolic acidosis may occur and the prothrombin time/INR may be prolonged, probably due to interference with the action of circulating coagulation factors. Acute renal failure and liver damage may occur. An exacerbation of asthma is possible in people with asthma. Treatment Treatment should be symptomatic and supportive and should include maintenance of a patent airway and monitoring of cardiac function and vital signs until stabilised. Oral administration of activated charcoal and, if necessary, correction of serum electrolytes should be considered if the patient presents within one hour of ingestion of a potentially toxic amount. Seizures should be treated with intravenous diazepam or lorazepam if they are frequent or prolonged. Give bronchodilators for asthma. There is no specific antidote for flurbiprofen.

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.

Feeding time

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

Fertility

There is evidence that cyclooxygenase/prostaglandin synthesis inhibitors may cause impairment of female fertility by an effect on ovulation. This is reversible upon discontinuation of treatment.

Source: Farmadati