Aspi Sore Throat Painkiller Spray 15 ml 0.25%

Aspi is an anti-inflammatory and pain-relieving spray for sore throat, mouth and gum pain based on flurbiprofen

Aspi Gola has a rapid action on sore throat with a triple effect against inflammation, pain and difficulty swallowing. Aspi Gola Spray for oral mucosa can be taken by adults and children from 12 years of age to treat the symptoms of pain and irritation of the gums, mouth and throat (gingivitis, stomatitis, pharyngitis), even after conservative or extractive dental therapy.
Fresh mint aroma.

ACTIVE INGREDIENTS

Active ingredients contained in Aspi Mal di Gola Pain Relief Spray 15 ml 0.25% - What is the active ingredient of Aspi Mal di Gola Pain Relief Spray 15 ml 0.25%?

Aspi Gola 0.25% Mouthwash, 100 ml of solution contain active ingredient: flurbiprofen 250 mg. Aspi Gola 0.25% Spray for oral mucosa, 100 ml of solution contain active ingredient: flurbiprofen 250 mg. Excipients with known effect: methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, hydrogenated castor oil-40 polyoxyethylene. For the full list of excipients, see section 6.1

EXCIPIENTS

Composition of Aspi Mal di Gola Pain Relief Spray 15 ml 0.25% - What does Aspi Mal di Gola Pain Relief Spray 15 ml 0.25% contain?

Aspi Gola Mouthwash and Aspi Gola Spray for oral mucosa: glycerol (98%), ethanol, non-crystallizing liquid sorbitol, hydrogenated castor oil-40 polyoxyethylene, sodium saccharin, methyl parahydroxybenzoate, propyl parahydroxybenzoate, mint flavouring, patent blue V (E131), anhydrous citric acid, sodium hydroxide, purified water.

DIRECTIONS

Therapeutic indications Aspi Mal di Gola Pain Relief Spray 15 ml 0.25% - Why is Aspi Mal di Gola Pain Relief Spray 15 ml 0.25% used? What is it for?

Aspi Gola Mouthwash, Aspi Gola Spray for oral mucosa: 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.

CONTRAINDICATIONS - SIDE EFFECTS

Contraindications Aspi Mal di Gola Pain Relief Spray 15 ml 0.25% - When should Aspi Mal di Gola Pain Relief Spray 15 ml 0.25% not be used?

Do not use the medicinal product 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 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 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 cardiac insufficiency, severe hepatic insufficiency and renal insufficiency (see section 4.4). Third trimester of pregnancy (see section 4.6).

DOSAGE

Quantity and method of taking Aspi Mal di Gola Pain Relief Spray 15 ml 0.25% - How do you take Aspi Mal di Gola Pain Relief Spray 15 ml 0.25%?

The lowest effective dose should be used for the shortest duration necessary to relieve symptoms (see section 4.4). Aspi Gola Mouthwash. Dosage, adults: 2-3 rinses or gargles per day with 10 ml (1 measuring spoon) of mouthwash. Paediatric 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: clinical data currently available are limited, therefore no recommendation on posology can be made. The elderly are at increased risk of serious consequences in case of adverse reactions (see section 4.4). Patients with hepatic impairment: 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 insufficiency: No dosage reduction is necessary in patients with mild to moderate renal insufficiency. Flurbiprofen is contraindicated in patients with severe hepatic insufficiency (see section 4.3). Method of administration For oropharyngeal use. Rinse or keep in the mouth during gargling for up to 1 minute. Do not swallow. The mouthwash can be used pure or diluted in half a glass of water. Aspi Gola Spray for oral mucosa. Dosage, adults: apply one dose (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. Paediatric 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: Currently available clinical data are limited, therefore no recommendation on posology can be made. Elderly are at increased risk of serious consequences in case of adverse reactions (see section 4.4). Patients with hepatic impairment: 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 impairment: No dosage reduction is necessary in patients with mild to moderate renal impairment. Flurbiprofen is contraindicated in patients with severe hepatic impairment (see section 4.3). Method of administration: For oropharyngeal use. Aim the dispenser towards the back of the throat and spray onto the affected area.

CONSERVATION

Storage Aspi Mal di Gola Pain Relief Spray 15 ml 0.25% - How do you store Aspi Mal di Gola Pain Relief Spray 15 ml 0.25%?

This medicinal product does not require any special storage conditions.

WARNINGS

Warnings Aspi Mal di Gola Pain Relief Spray 15 ml 0.25% - About Aspi Mal di Gola Pain Relief Spray 15 ml 0.25% it is important to know that:

At the recommended doses, when using the medicinal 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. 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 medicinal product 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 products intended for limited and short-term use 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 may 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 on 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 advised before initiating treatment in patients with a history of hypertension and/or heart failure (discuss with your doctor or pharmacist), as fluid retention, hypertension and oedema have been reported in association with NSAID treatment. Clinical trial and epidemiological data suggest that use of some NSAIDs, particularly at high doses and in long-term treatment, 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 ischaemic heart disease, peripheral arterial disease and/or cerebrovascular disease should only be treated with flurbiprofen after careful consideration. Similar consideration should be made before initiating long-term treatment in patients with risk factors for cardiovascular disease (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking). Central nervous system effects: Analgesic-induced headache. Headache may occur with prolonged or inappropriate use of analgesics and should not be treated by increasing the dose of the medicinal product. 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 gastrointestinal bleeding, ulceration or perforation is higher with increasing flurbiprofen dosage in patients with a history of ulcer, particularly if complicated with haemorrhage and perforation and in the elderly. These patients should start treatment on the lowest available dose. Gastrointestinal bleeding, ulceration or perforation have been reported with all NSAIDs at any time during treatment. These adverse reactions can be fatal and may occur with or without warning symptoms or in the presence of a previous history of serious gastrointestinal reactions. Patients with a history of gastrointestinal disease, particularly when elderly, should report any unusual abdominal symptoms (especially gastrointestinal bleeding) in the early stages of treatment. Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.2). Caution should be advised in patients receiving concomitant medications which could increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or anti-platelet agents such as acetylsalicylic acid (see section 4.5). When gastrointestinal bleeding or ulceration occurs in patients receiving flurbiprofen, the treatment should be withdrawn. Dermatological effects: Use of the medicinal product, especially if prolonged, may give rise to sensitisation or local irritation phenomena. In such cases, treatment should be discontinued and a doctor should be consulted to institute appropriate therapy if necessary. 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 necrotising fasciitis) have been described in temporal association with systemic use of NSAIDs, patients are advised to seek immediate medical attention if signs of bacterial infection appear or worsen during flurbiprofen therapy. The possibility of initiating antibiotic therapy should be considered. Masking of symptoms of underlying infections: Epidemiological studies suggest that systemic nonsteroidal anti-inflammatory drugs (NSAIDs) may mask the symptoms of infection, which may lead to delays in initiating appropriate treatment and thus worsen the outcome of the infection. This has been observed in community-acquired bacterial pneumonia and in bacterial complications of chickenpox. When ASPI GOLA is administered while the patient is suffering from fever or pain due to infection, monitoring for the infection is advised.

INTERACTIONS

Interactions Aspi Mal di Gola Spray Antidolorifico 15 ml 0.25% - Which medicines or foods can modify the effect of Aspi Mal di Gola Spray Antidolorifico 15 ml 0.25%?'

Caution should be exercised in patients treated with any of the following medicinal products, as interactions have been reported in some patients. In any case, inform your doctor if you are taking other medicinal products. Flurbiprofen should be avoided in combination with acetylsalicylic acid: unless low dose acetylsalicylic acid (not exceeding 100 mg/day or local prophylactic doses for cardiovascular protection) has been recommended by your doctor; as with other NSAID-containing medicinal products, concomitant administration of flurbiprofen and acetylsalicylic acid is generally not recommended due to the potential for increased adverse effects (see section 4.4). Cox-2 inhibitors and other NSAIDs: concomitant use of other NSAIDs, including cyclooxygenase-2 selective 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 combination 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 may reduce the effect of diuretics. Other antihypertensive drugs may enhance 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 cardiac failure, reduce GFR (glomerular filtration rate) and increase plasma glycoside levels. Ciclosporin: Increased risk of nephrotoxicity. Corticosteroids: Increased risk of gastrointestinal ulceration or haemorrhage with NSAIDs (see section 4.4). Lithium: There is evidence of a possible increase in lithium plasma levels. Methotrexate: There may be an increase in methotrexate plasma levels. Mifepristone: NSAIDs should not be used for 8-12 days after mifepristone administration, 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 convulsions. Tacrolimus: Possible increased risk of nephrotoxicity when NSAIDs are administered with tacrolimus. Zidovudine: Increased risk of haematological toxicity when NSAIDs are administered with zidovudine.

SIDE EFFECTS

Like all medicines, Aspi Mal di Gola Spray Antidolorifico 15 ml 0.25% can cause side effects - What are the side effects of Aspi Mal di Gola Spray Antidolorifico 15 ml 0.25%?

Hypersensitivity reactions to NSAIDs have been reported and 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 dermatoses (including epidermal necrolysis and erythema multiforme). The most commonly observed adverse reactions are gastrointestinal in nature. Local use of the medicinal product, especially if prolonged, may give rise to sensitization or local irritation phenomena. In such cases, treatment should be discontinued and appropriate therapy instituted if necessary. The following undesirable effects have been reported, particularly after administration of systemic formulations. They refer to those observed with the use of flurbiprofen used short-term and at doses compatible with the classification of over-the-counter medicinal products. In case of treatment of chronic conditions and over long periods of time, additional undesirable effects may occur. The undesirable effects associated with the use of flurbiprofen are divided below by system organ class and frequency. The 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 (frequency 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. Not known: anaemia, thrombocytopenia, aplastic anaemia and agranulocytosis. Nervous system disorders. Common: dizziness, headache, paraesthesia; uncommon: somnolence; not known: cerebrovascular accident, optic neuritis, migraine, confusional states, vertigo. Immune system disorders. Rare: anaphylactic reactions; not known: angioedema, hypersensitivity. Eye disorders. Not known: visual disturbances. Ear and labyrinth disorders. Not known: tinnitus. Cardiac disorders. Not known: cardiac failure, oedema. Vascular disorders. Not known: hypertension. Respiratory, thoracic and mediastinal disorders. Common: throat irritation; uncommon: asthma, bronchospasm and dyspnoea, oropharyngeal blistering, oropharyngeal hypoaesthesia. Gastrointestinal disorders. Common: diarrhoea, mouth ulcers, nausea, oral pain, oral paraesthesia, oropharyngeal pain, oral discomfort; uncommon: abdominal distension, abdominal pain, constipation, dry mouth, dyspepsia, flatulence, glossodynia, dysgeusia, oral dysaesthesia, vomiting; not known: melaena, haematemesis, gastrointestinal haemorrhage, colitis, exacerbation of Crohn's disease, gastritis, peptic ulcer, gastric perforation, ulcer haemorrhage. Skin and subcutaneous tissue disorders. uncommon: rash, pruritus; not known: urticaria, purpura, bullous dermatitis (including Stevens-Johnson syndrome, toxic epidermal necrolysis and erythema multiforme). Renal and urinary disorders. 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 disorders. Not known: hepatitis. Psychiatric disorders. Uncommon: insomnia; not known: depression, hallucination. Reporting of suspected adverse reactions. Reporting suspected adverse reactions that occur after authorisation of the medicinal product is important. It allows continued 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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

PREGNANCY AND BREASTFEEDING

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking Aspi Mal di Gola Pain Relief Spray 15 ml 0.25%

Pregnancy: There are no clinical data on the use of Aspi Gola during pregnancy. Although systemic exposure is lower than with oral administration, it is not known whether systemic exposure of Aspi Gola achieved after topical administration can be harmful to an embryo/fetus. During the first and second trimester of pregnancy Aspi Gola should not be administered unless strictly necessary. If administered, the dose should be the lowest possible and the duration of treatment as short as possible. During the third trimester of pregnancy, systemic use of prostaglandin synthase inhibitors, including Aspi Gola, may induce cardiopulmonary and renal toxicity in the fetus. At the end of pregnancy, prolonged bleeding time may occur in both mother and child and labor may take longer. Therefore, Aspi Gola is contraindicated during the last trimester of pregnancy (see section 4.3). Breastfeeding: In a limited number of studies, flurbiprofen appears in breast milk at very low concentrations and is unlikely to have any adverse effects on the breast-fed infant. However, administration of flurbiprofen is not recommended in nursing mothers. Fertility: There is evidence to suggest that cyclooxygenase/prostaglandin synthesis inhibitors may cause impairment of female fertility by an effect on ovulation. This is reversible upon discontinuation of treatment. Pregnancy: There are no clinical data on the use of Aspi Gola during pregnancy. Although systemic exposure is lower than with oral administration, it is not known whether the systemic exposure of Aspi Gola achieved after topical administration could be harmful to an embryo/fetus. During the first and second trimester of pregnancy Aspi Gola should not be administered unless strictly necessary. If administered, the dose should be the lowest possible and the duration of treatment as short as possible. During the third trimester of pregnancy, systemic use of prostaglandin synthetase inhibitors, including Aspi Gola, may induce cardiopulmonary and renal toxicity in the fetus. At the end of pregnancy, prolonged bleeding time may occur in both mother and child and labor may take longer. Therefore, Aspi Gola is contraindicated during the last trimester of pregnancy (see section 4.3). Breastfeeding: In a limited number of studies, flurbiprofen appears in breast milk at very low concentrations and is unlikely to have any adverse effects on the breast-fed infant. However, 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.