Epifarma Ketodol throat mouthwash 2,5ml/mg 160ml

Product Description

Mouthwash indicated in case of oropharyngeal pain caused by irritation and inflammation.

Indications

Ketodol Gola Mouthwash Ketodol Gola Spray for oral mucosa Symptomatic treatment of irritative-inflammatory conditions also associated with oropharyngeal pain (e.g. gingivitis, stomatitis, pharyngitis), also as a result of conservative or extractive dental therapy.

Composition

Active ingredients

Ketodol Gola 2.5 mg/ml Mouthwash 100 ml of solution contain: Active ingredient: Flurbiprofen 250 mg Ketodol Gola 2.5 mg/ml Spray for oral mucosa 100 ml of solution contain: Active ingredient: Flurbiprofen 250 mg Excipients with known effects: methyl para-hydroxybenzoate 0.10 g, propyl para-hydroxybenzoate 0.02 g, hydrogenated castor oil-40 polyoxyethylene 2.00 g. For the full list of excipients, see section 6.1.

Excipients

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

Directions for use and Dosage

2-3 rinses or gargles a day with 10 ml (1 measuring spoon) of mouthwash. Paediatric population Children over 12 years of age: as for adults. Children under 12 years: Do not administer to children under 12 years of age (see section 4.3). Special populations: Elderly: Clinical data are currently limited, therefore no dosage recommendation can be made. Elderly are at increased risk of serious 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 renal impairment (see section 4.3). Method of administration: For oropharyngeal use. Rinse or hold in mouth while gargling for up to 1 minute. Do not swallow. The mouthwash may cause irritation. It can be used pure or diluted in half a glass of water.

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 Elderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which can 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 medicine 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 highest 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 observed with products intended for limited and short-term use such as flurbiprofen. Cardiovascular and cerebrovascular effects Caution is required 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 edema have been reported in association with NSAID treatment. Clinical studies and epidemiological data suggest that the use of some NSAIDs, particularly at high doses and for long-term treatment, may be associated with a modest 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 be treated with flurbiprofen only after careful consideration. Similar considerations should be made before initiating long-term treatment in patients with risk factors for cardiovascular disease (e.g., hypertension, hyperlipidemia, diabetes mellitus, smoking). Central nervous system effects: Analgesic-induced headache. Headache may occur with prolonged or inappropriate use of analgesics, which should not be treated by increasing the dose of the drug. 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 by haemorrhage 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 may occur with or without warning symptoms or with 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) early in the course of treatment. Undesirable effects may be minimized 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 antiplatelet agents such as aspirin (see section 4.5). When gastrointestinal bleeding or ulceration occurs in patients taking flurbiprofen, treatment should be discontinued. Dermatological effects Use of the medicinal product, especially if prolonged, may give rise to sensitization or local irritation. In such cases, treatment should be discontinued and a physician 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 flurbiprofen is a potentially life-threatening complication of NSAIDs, it is recommended that patients with severe skin reactions (including those with severe skin reactions) receive adequate medical attention. 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 advised to consult a doctor immediately if signs of a bacterial infection appear or worsen during flurbiprofen therapy. The possible indication for initiation of antibiotic therapy should be considered. If mouth irritation develops, treatment should be discontinued. Important information about some of the excipients KETODOL GOLA Mouthwash and KETODOL GOLA Spray contain: - parahydroxybenzoates which can cause allergic reactions (possibly delayed) - hydrogenated castor oil-40 polyoxyethylene which can cause localized skin reactions. Do not use for prolonged treatments exceeding 7 days. If no appreciable results are seen after 3 days of treatment, the cause may be another pathological condition. In these cases, it is advisable to consult your doctor.

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 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, severe hepatic failure, and renal failure (see section 4.4). Third trimester of pregnancy.

Undesirable 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, for example, rashes of various types, pruritus, urticaria, purpura, angioedema, and, more specifically, rashes of various types, e.g. ... 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, may give rise to sensitization or local irritation. In such cases, treatment should be discontinued and appropriate therapy instituted, if necessary. The following adverse reactions have been reported, particularly after administration of systemic formulations. They refer to those observed with short-term use of flurbiprofen at doses compatible with the classification of over-the-counter medicines. Additional adverse reactions may occur when treating chronic conditions and over long periods of time. The adverse reactions associated with the use of flurbiprofen are divided below according to system organ class and frequency. 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.

Overdose

Considering the low 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 diarrhoea. Tinnitus, headache and gastrointestinal bleeding are also possible. In more severe cases, the risk of serious side effects is higher. In severe NSAID intoxication, central nervous system toxicity is observed, manifested by drowsiness, occasionally excitability, blurred vision, and disorientation or coma. Patients occasionally 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. Exacerbation of asthma is possible in asthmatics.
Treatment: Treatment should be symptomatic and supportive and should include maintaining a patent airway and monitoring cardiac function and vital signs until stable. Oral administration of activated charcoal 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 frequent or prolonged. Bronchodilators for asthma should be administered. There is no specific antidote for flurbiprofen.

Pregnancy and breastfeeding

Pregnancy: Flurbiprofen should not be administered during the first and second trimesters of pregnancy unless clearly necessary. The use of flurbiprofen during the third trimester of pregnancy is contraindicated. 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 breast-feeding 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.

Format

160 ml