Aspi Gola Dolact 8.75mg/dose oral mucosa spray 15ml

INDICATIONS

Aspigoladolact is indicated for the short-term symptomatic treatment of acute pain in sore throat in adults.

ACTIVE INGREDIENTS

One spray contains 2.91 mg of flurbiprofen. 3 sprays are equivalent to one dose, which contains 8.75 mg of flurbiprofen, corresponding to 17.16 mg/ml of flurbiprofen. Excipients with known effect: ethanol: 0.22 mg/dose. For the full list of excipients, see section 6.1.

EXCIPIENTS

Betadex (E459), Hydroxypropylbetadex, Dibasic sodium phosphate dodecahydrate, Citric acid monohydrate, Sodium hydroxide, Cherry flavouring, Sodium saccharin (E954), Purified water. Qualitative composition of the Cherry aroma: Flavoring substances, Flavoring preparation, Ethyl alcohol, Glyceryl triacetate (E1518), Propylene glycol (E1520), Ascorbic acid (E300), Di-alpha tocopherol (E307), Water.

CONTRAINDICATIONS AND SIDE EFFECTS

- Hypersensitivity to the active substance or to any of the excipients listed in paragraph 6.1. - Patients who have previously shown hypersensitivity reactions (e.g., asthma, bronchospasm, rhinitis, angioedema or urticaria) in response to acetylsalicylic acid or other NSAIDs. - Patients with current or previous recurrent peptic ulcers/haemorrhages (two or more distinct episodes of demonstrated ulceration) and intestinal ulcer. - Patients with a history of gastrointestinal bleeding or perforation, severe colitis, bleeding or haematopoietic disorders related to previous therapy with NSAIDs. - Severe heart failure, renal failure or hepatic failure (see section 4.4). - Last trimester of pregnancy (see section 4.6). - Children and adolescents under 18 years of age.

DOSAGE

Dosage Adults aged 18 years and over: One dose (3 sprays) directed to the affected part of the throat every 3-6 hours as needed, up to a maximum of 5 doses in a 24-hour period. Do not reduce the number of sprays per dose. This medicine should not be used for more than 3 days. Pediatric population The safety and effectiveness of Aspigoladolact have not been established in children or adolescents under 18 years of age. Elderly patients A general dosing recommendation cannot be given, as clinical experience to date is limited. Elderly people are at increased risk of serious consequences in case of adverse reactions. The lowest effective dose should be administered for the shortest possible duration of treatment needed to control symptoms (see section 4.4). Method of administration Do not inhale while dispensing. For administration on the oral mucosa and only for short-term treatments. Before first use, it is necessary to activate the pump 4 times, pointing the nozzle away from your body, until the release of a uniform and constant mist is obtained. The pump is then ready for use. Between one use and another, dispense a minimum quantity of product, away from your body, in order to ensure that the nebulization is uniform and constant. Before using the product, always make sure that the nebulization is uniform and constant.

CONSERVATION

Do not refrigerate or freeze.

WARNINGS

Side effects can be minimized by using the lowest effective dose for the shortest duration of treatment needed to control symptoms. 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 therapy based on flurbiprofen spray. A possible indication for starting antibiotic therapy must be taken into consideration. In case of purulent bacterial pharyngitis/tonsillitis, the patient should consult the doctor for a re-evaluation of the treatment. Treatment should not be administered for more than 3 days. Respiratory disorders Bronchospasm may be precipitated in patients with or with a history of bronchial asthma or allergic disease. Flurbiprofen spray should be used with caution in these patients. Other NSAIDs The use of flurbiprofen spray should be avoided concomitantly with other NSAIDs, including selective cyclooxygenase-2 inhibitors (see section 4.5). Systemic lupus erythematosus (SLE) and mixed connective tissue disease Patients with systemic lupus erythematosus (SLE) 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 short-term use such as flurbiprofen spray. Cardiovascular, renal and hepatic impairment 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 prostaglandin formation 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; this effect is not usually observed with products intended for short-term use such as flurbiprofen spray. Hepatic effects Mild to moderate hepatic dysfunction (see sections 4.3 and 4.8). 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. Data from clinical and epidemiological studies suggest that the use of some NSAIDs (particularly at high doses and in long-term treatments) may be associated with a slight increase in the risk of arterial thrombotic events (for example myocardial infarction or stroke). There are insufficient data to exclude this risk with flurbiprofen when administered at a daily dosage of less than 5 doses (3 actuations for each dose). Effects on the central nervous system Headache induced by analgesics - 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 disorders NSAIDs should be administered with caution in patients with a history of gastrointestinal diseases (ulcerative colitis, Crohn's disease) as these conditions may be exacerbated (see section 4.8). Gastrointestinal bleeding, ulceration or perforation, which may be fatal, have been reported with all NSAIDs at any time during treatment, in the presence or absence of warning symptoms or a history of serious gastrointestinal events. The risk of gastrointestinal bleeding, ulceration or perforation is higher with increasing doses of NSAIDs, in patients with a history of ulcer, especially if complicated with the presence of haemorrhage or perforation (see section 4.3) and in the elderly; this effect is not usually observed with products intended for short-term use such as flurbiprofen spray. Patients with a history of gastrointestinal toxicity, particularly the elderly, should report any unusual abdominal symptoms (especially gastrointestinal bleeding) to their healthcare provider. 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. Hematological effects Flurbiprofen, like other NSAIDs, can inhibit platelet aggregation and prolong bleeding time. Flurbiprofen spray should be used with caution in patients with potential bleeding abnormalities. Dermatological effects 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 spray should be discontinued at the first appearance of skin rash, mucosal lesions or any other sign of hypersensitivity. This medicinal product contains less than 1 mmol (23 mg) sodium per dose (3 sprays), i.e. essentially 'sodium-free'. This medicine contains 0.22mg ethanol per dose (3 sprays), which is equivalent to 0.044% (w/v). The amount in the dose of this medicine is equivalent to less than 0.9 ml of beer or 0.4 ml of wine. Treatment should be reevaluated if symptoms worsen or new symptoms occur. If mouth irritation develops, treatment with flurbiprofen should be discontinued. Elderly population Elderly people experience an increased frequency of adverse reactions to NSAIDs, especially bleeding and gastrointestinal perforation, which can be fatal.

INTERACTIONS

Flurbiprofen should be avoided in association with:

Other NSAIDs including selective cyclooxygenase-2 inhibitors: Avoid concomitant use of two or more NSAIDs, as this may increase the risk of adverse effects (especially gastrointestinal adverse events such as ulcers and bleeding) (see section 4.4).

Acetylsalicylic acid (low doses): Unless taking low doses of aspirin (not exceeding 75 mg/day) has been recommended by your doctor, as the potential risk of adverse events may increase (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: There is an increased risk of gastrointestinal ulceration or bleeding (see section 4.4).

Antihypertensive drugs (Diuretics, ACE inhibitors, 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.

Cardiac glycosides: NSAIDs can exacerbate heart failure, reduce VGR (glomerular filtration rate) and increase plasma levels of glycosides, therefore adequate control and, if necessary, dose adjustment is recommended.

Cyclosporine: There is an increased risk of nephrotoxicity.

Corticosteroids: There is an increased risk of gastrointestinal ulceration or bleeding (see section 4.4).

Lithium: There may be an increase in serum lithium levels - adequate monitoring and, if necessary, dose adjustment is recommended.

Methotrexate: The administration of NSAIDs within 24 hours before or after the administration of methotrexate can lead to high concentrations of methotrexate and an increase in its toxic effects.

Mifepristone: NSAIDs should not be used for 8 - 12 days following administration of mifepristone, as they may reduce the effect of mifepristone.

Oral antidiabetics: Alterations in blood glucose levels have been reported (increasing the frequency of checks is recommended).

Phenytoin: Serum levels of phenytoin may increase, therefore adequate monitoring and, if necessary, dose adjustment is recommended.

Potassium-sparing diuretics: Concomitant use may cause hyperkalemia.

Probenecid and Sulfinpyrazone: Medicines containing probenecid and sulfinpyrazone may delay the excretion of flurbiprofen.

Quinolone antibiotics: Animal data indicate that NSAIDs may increase the risk of convulsions associated with quinolone antibiotics. Patients taking NSAIDs and quinolones may be at increased risk of developing seizures.

Selective serotonin reuptake inhibitors (SSRIs): There is an increased risk of gastrointestinal ulceration or bleeding (see section 4.4).

Tacrolimus: An increased risk of nephrotoxicity is possible when NSAIDs are administered concomitantly with tacrolimus.

Zidovudine: There is an increased risk of hematological toxicity when NSAIDs are administered with zidovudine.

Alcohol: May increase the risk of adverse reactions, especially bleeding in the gastrointestinal tract.

No studies have yet found any interaction between flurbiprofen and tolbutamide or antacids. Pediatric population No additional information is available.

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 reactions, e.g. pruritus, urticaria, angioedema and, more rarely, exfoliative and bullous dermatosis (including epidermal necrolysis and erythema multiforme). Edema, hypertension and heart failure have been reported in association with treatment with NSAIDs. Data are insufficient to exclude this risk following the use of flurbiprofen oral mucosal spray, solution. The list of adverse effects reported below refers to what was experienced with flurbiprofen, used short term and at doses compatible with those reported in point 4.2. Very common (≥ 1/10); Common (≥ 1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥ 1/10,000 to <1/1,000); Very rare (<1/10,000); Not known (frequency cannot be estimated from the available data). Pathologies of the blood and lymphatic system. Not known: anemia, thrombocytopenia. Cardiovascular and cerebrovascular diseases. Not known: edema, hypertension, heart failure. Nervous system disorders. Common: dizziness, headache, paraesthesia. Uncommon: drowsiness. Respiratory, thoracic and mediastinal disorders. Common: throat irritation; Uncommon: exacerbation of asthma and bronchospasm, dyspnoea, wheezing, oropharyngeal blistering, pharyngeal hypoesthesia. Gastrointestinal disorders. Common: diarrhoea, mouth ulceration, nausea, oral pain, oral paraesthesia, oropharyngeal pain, oral discomfort (hot or burning sensation, tingling in the mouth); Uncommon: abdominal distension, abdominal pain, constipation, dry mouth, dyspepsia, flatulence, glossodynia, dysgeusia, oral dysesthesia, vomiting. Pathologies of the skin and subcutaneous tissue. Uncommon: various types of skin rashes, itching; Not known: severe skin reactions such as bullous reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis. Systemic pathologies and conditions relating to the administration site. Uncommon: pyrexia, pain. Immune system disorders. Rare: anaphylactic reaction. Psychiatric disorders. Uncommon: insomnia. Hepatobiliary disorders. Not known: hepatitis 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: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

OVERDOSE

Symptoms The majority of patients who have ingested clinically large quantities of NSAIDs will develop nausea, vomiting, 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 or gastric lavage 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 Inhibition of prostaglandin synthesis can negatively influence pregnancy and/or embryonic/fetal development. Data obtained from epidemiological studies suggest an increased risk of miscarriage, cardiac malformations and gastroschisis following the use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk of cardiovascular malformations was increased from less than 1% to approximately 1.5%. The risk is thought to increase with the dose and duration of therapy. In animals, the administration of a prostaglandin synthesis inhibitor has been shown to cause an increase in pre- and post-implantation losses and embryo-foetal lethality. In addition, an increased incidence of several malformations, including cardiovascular ones, has been reported in animals administered a prostaglandin synthesis inhibitor during the organogenetic period. Flurbiprofen should not be administered during the first and second trimester of pregnancy. During the third trimester of pregnancy, all inhibitors of prostaglandin synthesis can expose: • the fetus to: - cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension); - renal dysfunction which may progress to renal failure with oligohydramnios. • the mother and newborn, at the end of pregnancy, to: - possible prolongation of bleeding time, an anti-aggregating effect which can occur even at very low doses. - inhibition of uterine contractions resulting in a delay or prolongation of labor. Consequently, flurbiprofen is contraindicated during the third 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 negative effects on the breastfed infant. However, due to the possible adverse effects of NSAIDs on breast-fed infants, the use of flurbiprofen spray by breastfeeding mothers is not recommended. 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

No studies on the effects on the ability to drive and use machines have been performed. Dizziness, drowsiness and visual disturbances are side effects that can arise following the intake of NSAIDs. If these effects occur, patients should not drive or use machinery.