ASPI GOLA OS SPRAY 15ML 0.25%

ASPI GOLA 0.25% Mouthwash ASPI GOLA 0.25% Spray for oral mucosa

active principles

ASPI GOLA 0.25% Mouthwash 100 ml of solution contain: Active ingredient: Flurbiprofen 0.25 g ASPI GOLA 0.25% Spray for oral mucosa 100 ml of solution contain: Active ingredient: Flurbiprofen 0.25 g Excipients with known effects : ethanol 8.64 g methyl p-hydroxybenzoate 0.10 g propyl p-hydroxybenzoate 0.02 g polyoxyethylene hydrogenated castor oil-40 2.00 g blue patent V dye (E131) 0.0006 g For the complete list of excipients, see section 6.1

Exceptions

ASPI GOLA Mouthwash and ASPI GOLA Spray for oral mucosa Glycerol (98%), ethanol, non-crystallisable liquid sorbitol, polyoxyethylene hydrogenated castor oil-40, sodium saccharin, methyl parahydroxybenzoate, propyl parahydroxybenzoate, mint flavour, patent blue V (E131), anhydrous citric acid, sodium hydroxide , purified water.

Therapeutic indications

ASPI GOLA Mouthwash ASPI GOLA Oral mucosa spray Symptomatic treatment of irritative-inflammatory states also associated with oropharyngeal cavity pain (e.g. gingivitis, stomatitis, pharyngitis), also as a result of conservative or extraction dental therapy.

Contraindications

Flurbiprofen is contraindicated in patients with known hypersensitivity (asthma, bronchospasm, urticaria or allergic type) to flurbiprofen or to any of the excipients listed in section 6.1, and to 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. 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). ASPI GOLA Mouthwash 2-3 rinses or gargles a day with 10 ml (1 measuring cup) of mouthwash diluted in half a glass of water or pure. ASPI GOLA Oral mucosa spray 2 sprays 3 times a day directed directly to the affected part. Each spray delivers 0.2 ml of solution, equivalent to 0.5 mg of active ingredient.

Storage

This medicinal product does not require any special storage precautions.

Warnings

At the recommended doses, when using the product 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. The use of the product, especially if prolonged, can give rise to sensitization or local irritation phenomena; in such cases it is necessary to interrupt the treatment and consult the doctor to institute, if necessary, a suitable therapy. In patients with renal, cardiac or hepatic insufficiency, the product should be used with caution. It is advisable not to associate the product with other NSAIDs. Cases of bronchospasm have been reported with flurbiprofen in patients with a history of bronchial asthma. 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 events can be fatal and can occur with or without warning symptoms or with a previous history of serious gastrointestinal events. 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. Elderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal haemorrhage and perforation, which can be fatal. 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). Important information about some excipients ASPI GOLA mouthwash and ASPI GOLA Sprays contain para-hydroxybenzoates which can cause delayed-type allergic reactions, such as contact dermatitis; more rarely they can cause immediate-type reactions, with urticaria and bronchospasm. The dye patent blue V (E131) can cause allergic reactions. Polyoxyethylene-40 hydrogenated castor oil can cause localized skin reactions. Both the mouthwash and the spray contain a small amount of ethyl alcohol, less than 100 mg per dose. Do not use for prolonged treatments. After short periods of treatment without appreciable results, 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. Aspirin: As with other NSAID-containing medicines, co-administration of flurbiprofen and aspirin is generally not recommended due to the potential for increased side effects. Antiplatelet agents: Increased risk of gastrointestinal bleeding. Selective serotonin reuptake inhibitors (SSRIs): Increased risk of gastrointestinal bleeding. Corticosteroids: Increased risk of gastrointestinal ulceration or bleeding with NSAIDs. Cox-2 inhibitors and other NSAIDs: Concomitant use of other NSAIDs, including selective cyclooxygenase-2 inhibitors, should be avoided due to potential additive effects.

Effects

The following undesirable effects have been reported, especially after the administration of formulations for systemic use:Pathologies of the hemolymphopoietic system Thrombocytopenia, aplastic anemia and agranulocytosis Immune system disorders Anaphylaxis, angioedema, allergic reaction. Pathologies of the nervous system Dizziness, cerebrovascular accident, visual disturbances, optic neuritis, migraine, paraesthesia, depression, confusion, hallucination, vertigo, discomfort, fatigue and drowsiness. Pathologies of the ear and labyrinth Tinnitus Respiratory, thoracic and mediastinal disorders Respiratory tract reactivity (asthma, bronchospasm and dyspnoea) Gastrointestinal pathologies The most commonly observed adverse events are gastrointestinal in nature. The following have been reported after flurbiprofen administration: nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, gastrointestinal haemorrhage and exacerbation of colitis and Crohn's disease. Less frequently, gastritis, peptic ulcer, perforation and ulcer haemorrhage have been observed. Skin and subcutaneous tissue disorders Skin disorders including rash, pruritus, urticaria, purpura and very rarely bullous dermatoses (including Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis and Erythema multiforme). Renal and urinary pathologies Nephrotoxicity in various forms, including interstitial nephritis and nephrotic syndrome. As with other NSAIDs, rare cases of renal failure have been reported. Topical use of the product, especially if prolonged, can give rise to sensitization or local irritation phenomena. 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/it/responsabili.

Overdose

In view of the reduced content of the active ingredient and its local use, overdose situations are unlikely to occur. Symptoms Overdose symptoms may include nausea, vomiting, and gastrointestinal irritation. Treatment Treatment should include gastric lavage and, if necessary, correction of serum electrolytes. There is no specific antidote for flurbiprofen.

During the first and second trimester of pregnancy, flurbiprofen should not be administered unless strictly necessary. The administration of flurbiprofen is not recommended in nursing mothers.

Source: Farmadati