Aspi gola 0.25% - oral mucosa spray 15 ml

Product Description

Spray for the oral mucosa.

Indications

Aspi Gola symptomatic treatment of irritative-inflammatory conditions also associated with pain in the oropharyngeal cavity (e.g. gingivitis, stomatitis, pharyngitis), also as a consequence of conservative or extractive dental therapy.

Active ingredients

Spray for the 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 hydrogenated castor oil-40 polyoxyethylened 2.00 g patent blue V colorant (E131) 0.0006 g For the full list of excipients.

Excipients

Glycerol (98%), ethanol, non-crystallizing liquid sorbitol, polyoxyethylene hydrogenated castor oil-40, sodium saccharin, methyl parahydroxybenzoate, propyl parahydroxybenzoate, mint flavoring, patent blue V (E131), anhydrous citric acid, sodium hydroxide, purified water.

Directions for use

2 sprays 3 times a day directed directly at the affected area.
Each spray delivers 0.2 ml of solution, equivalent to 0.5 mg of active ingredient.

Warnings

Contains parahydroxybenzoates which can cause delayed allergic reactions, such as contact dermatitis; more rarely, they can cause immediate reactions, with urticaria and bronchospasm.
Patent blue V (E131) may cause allergic reactions. Polyoxyethylene hydrogenated castor oil-40 may cause localized skin reactions.
Contains 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.

Contraindications

Flurbiprofen is contraindicated in patients with known hypersensitivity (asthma, bronchospasm, urticaria, or allergic-type) to flurbiprofen or to any of the excipients, and to acetylsalicylic acid or other nonsteroidal 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 a history of ulcerative colitis, Crohn's disease, recurrent peptic ulcer, 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.

Interactions

Caution should be exercised in patients treated with any of the following medications, as interactions have been reported in some patients. However, inform your doctor if you are taking other medications.
Aspirin: As with other NSAID-containing medicines, concomitant administration of flurbiprofen and aspirin is generally not recommended due to the potential for increased adverse 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 cyclooxygenase-2 selective inhibitors, should be avoided due to potential additive effects.

Undesirable effects

The following undesirable effects have been reported, particularly after administration of systemic formulations: Blood and lymphatic system disorders: Thrombocytopenia, aplastic anemia, and agranulocytosis. Immune system disorders: Anaphylaxis, angioedema, allergic reaction. Nervous system disorders: Dizziness, cerebrovascular accident, visual disturbances, optic neuritis, migraine, paraesthesia, depression, confusion, hallucination, vertigo, discomfort, fatigue, and somnolence. Ear and labyrinth disorders Tinnitus Respiratory, thoracic and mediastinal disorders Respiratory tract reactivity (asthma, bronchospasm and dyspnoea) Gastrointestinal disorders The most commonly observed adverse events are gastrointestinal in nature. Nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, gastrointestinal haemorrhage and exacerbation of colitis and Crohn's disease have been reported after administration of flurbiprofen. 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 disorders: 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, may give rise to sensitization or local irritation. Reporting of suspected adverse reactions: Reporting suspected adverse reactions that occur after authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk balance of the medicinal product.

Overdose

Considering the low content of the active ingredient and its local use, overdose situations are unlikely to occur. Symptoms: Symptoms of overdose may include nausea, vomiting, and gastrointestinal irritation. Treatment: Treatment should include gastric lavage and, if necessary, correction of serum electrolyte levels. There is no specific antidote for flurbiprofen.

Pregnancy and breastfeeding

During the first and second trimesters of pregnancy, flurbiprofen should not be administered unless clearly necessary. Administration of flurbiprofen is not recommended for breastfeeding mothers.

Format

15 ml spray.