Descrizione Clinica
ROFIXDOL GOLA AND DOLOR 8,75 MG PASTIGLI GUSTO LIMONE AND MIELE
active ingredients
ROFIXDOL GOLA and DOLORE Taste strawberries Lemon and Honey A pastel contains: active ingredient: flurbiprofen 8,75mg Excipients with known effects: Glucose, sucrose For the full list of excipients, see the paragraph 6.1.Excellent
ROFIXDOL GOLA AND DOLORE Tastes Lemon and Honey Saccarosio, glucose, macrogol, potassium hydroxide, lemon aroma, levomentol, honey.Therapeutic indications
ROFIXDOL GOLA and DOLORE Taste strawberries Lemon and Honey Symptomatic treatment of irritative–inflammatory states also associated with pain of the oropharyngeal cable (e.g. gums, stomatitis, pharyngitis).Contraindications
ROFIXDOL Throat and pain do not use in children under the age of 12. Flurbiprofen is contraindicated in patients with known hypersensitivity (asthma, bronchospasm, hives or allergic type) towards flurbiprofen or any of the excipients listed in paragraph 6.1, and towards acetilsalicylic acid or other non-steroidal anti-inflammatory drugs (FANS). Flurbiprofen is also contraindicated in patients with gastrointestinal hemorrhage history or drilling related to previous treatments with NSAIDs. Flurbiprofen should not be taken by patients with active ulcerative or anamnestic colitis, Crohn's disease, recurrent peptic ulcer or gastrointestinal hemorrhage (defined as two or more distinct episodes of proven ulceration or bleeding). Flurbiprofen is contraindicated in patients with severe heart failure. Third quarter of pregnancy.Population
Undesirable effects can be minimized with the use of the lowest effective dose for the shortest possible duration of treatment needed to control symptoms (see the Special Notes and Precautions for use paragraph). ROFIXDOL GOLA and DOLORE Taste strawberries Lemon and Honey Adults and boys over 12 years: 1 pill to dissolve slowly in the mouth every 3–6 hours, depending on the need. Do not exceed the dose of 8 pills in 24 hours. Do not administer children under the age of 12. Changes in posology are not necessary for older people.Conservation
This medicine does not require any special precaution for conservation.Warnings
At recommended doses, in using the product in its different pharmaceutical forms, swallowing does not involve any harm to the patient, since the dose of flurbiprofen is widely lower than that commonly used in systemic treatments. The use of the product, especially if prolonged, can give rise to phenomena of local sensitization or irritation; in such cases it is necessary to stop the treatment and consult the doctor to establish, if necessary, suitable therapy. In patients with kidney, heart or liver failure, the product must be used with caution. It is recommended not to associate the product with other NSAIDs. Cases of bronchospasm with flurbiprofen have been reported in patients with bronchial asthma anamnesi. Flurbiprofen Gastrointestinal effects should be administered with caution to patients with peptic ulcer anamnesis and other gastrointestinal diseases since such conditions can be reacutized. The risk of gastrointestinal hemorrhage, ulcer or perforation is higher when the dosage of flurbiprofen increases in patients with a history of ulcer, especially if complicated by hemorrhage and perforation and in the elderly. These patients must begin treatment with the lowest dose available. Gastrointestinal bleeding, ulcer or drilling have been reported with all NSAIDs at any time of treatment. These adverse events may be fatal and may occur with or without warning symptoms or in case of previous history of serious gastrointestinal events. Patients with anamnesi of gastrointestinal diseases, especially if elderly, must report any unusual symptom of abdominal type (especially gastrointestinal hemorrhage) in the early stages of treatment. Senior patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal hemorrhage and perforation, which can be fatal. Undesirable effects can be minimized with the use of the lowest effective dose for the shortest possible duration of treatment needed to control symptoms (see paragraph 4.2). Important information about some excipients ROFIXDOL GOLA AND DOLORE Taste strawberries Lemon and Honey contains: • 1,095 g glucose and 1,375 g sucrose for pastilla. Patients with rare hereditary problems of fructose intolerance, glucose–galactose mal absorption, or isomaltase sucrasis failure, should not take this medicine. Do not use for protracted treatments. After short periods of treatment without appreciable results consult your doctor. Keep the medicine out of sight and reach of children.Interactions
It must be paid attention in patients treated with any of the medicines listed below, as interactions have been reported in some patients. In any case, please inform your doctor if you are taking other medicines. Aspirin: As with other medicines containing NSAIDs, concomitant administration of flurbiprofen and aspirin is not generally recommended due to the potential increase in unwanted effects. Anti-aggregating agents: increased risk of gastrointestinal hemorrhage. Selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal hemorrhage. Corticosteroids: increased risk of gastrointestinal ulcer or hemorrhage with NSAIDs. Cox–2 inhibitors and other NSAIDs: the concomitant use of other NSAIDs, including selective cycloxygenase–2 inhibitors, must be avoided due to potential additive effects.Effects
The following undesirable effects were reported, particularly after the administration of systemic formulations:Emolinfopoietic system pathologies Trombocytopenia, aplastic anemia and agranulocytosis Immune system disorders Anaphylaxis, angioedema, allergic reaction Nervous system disorders Capogiri, cerebrovascular accidents, visual disorders, optic neuritis, migraine, paresthesia, depression, confusion, hallucination, dizziness, discomfort, fatigue and drowsiness Ear and labyrinth pathologies Tinnitus Respiratory, chest and mediastinic pathologies Reactivity of the respiratory tract (asthma, bronchospasmo and dispnea) Gastrointestinal diseases The most commonly observed adverse events are gastrointestinal. After administration of flurbiprofen have been reported: nausea, diarrhea vomiting, flatulence, constipation, dyspepsia, abdominal pain, melena, hematemesis, ulcerative stomatitis, gastrointestinal hemorrhage and exacerbation of colitis and Crohn's disease. Less frequently gastritis, peptic ulcer, drilling and ulcer hemorrhage were observed. Pathologies of skin and subcutaneous tissue Skin disorders including rash, itching, hive, porpora and very rarely bollose dermatosis (including Stevens–Johnson Syndrome, Toxic Necrolysis Epidermal and Multiform Erythema). Kidney and urinary pathologies Nephrotoxicity in various forms including interstitial nephritis and nephrotic syndrome. As with other NSAIDs, rare cases of kidney failure were reported. The topical use of the product, especially if prolonged, can give rise to phenomena of local sensitization or irritation. The dissolution in the oral cavity of the product in the form of pads can be accompanied by sensations of heat or tingling charged to the oropharynx. In such cases it is necessary to stop the treatment and to establish, if necessary, suitable therapy. Reporting of suspicious adverse reactions. The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address www.agenziafarmaco.gov.it/it/responsabili.Overdosing
In view of the reduced content of active ingredient and its local use it is unlikely that overdose situations may occur. Symptoms Overdose symptoms may include nausea, vomiting and gastrointestinal irritation. Treatment The treatment must include gastric lavender and, if necessary, correction of the sierial electrolytic framework. There is no specific antidote for flurbiprofen.During the first and second trimester of pregnancy, flurbiprofen should not be administered if not in strictly necessary cases. The drug administered during pregnancy may delay the beginning of labor and aumerate its duration. Flurbiprofene administration is not recommended in nursing mothers.
Source: Farmadati
