Rofixdol Throat Flurbiprofen Lemon Honey product 16 Tablets

Therapeutic indications

ROFIXDOL THROAT AND PAIN Lemon and Honey flavored tablets Symptomatic treatment of irritative-inflammatory states also associated with oropharyngeal pain (eg gingivitis, stomatitis, pharyngitis).

Dosage

Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms (see section Special warnings and precautions for use). ROFIXDOL THROAT AND PAIN Lemon and Honey flavored tablets Adults and children over 12 years: 1 tablet to be dissolved slowly in the mouth every 3–6 hours, as needed. Do not exceed the dose of 8 tablets in 24 hours. Do not give to children under the age of 12. Dosage changes are not necessary for the elderly.

Overdose

Considering the reduced content of active ingredient and its local use, it is unlikely that overdose situations will occur. Symptoms Symptoms of overdose may include nausea, vomiting and gastrointestinal irritation. Treatment Treatment should include gastric lavage and, if necessary, correction of the serum electrolyte picture. There is no specific antidote for flurbiprofen.

Contraindications

ROFIXDOL THROAT AND PAIN Tablets: do not use in children under 12 years of age. Flurbiprofen is contraindicated in patients with known hypersensitivity (asthma, bronchospasm, urticaria or allergic type) to flurbiprofen or to any of the excipients listed in section 6.1, and to acetylsalicylic acid or other non-steroidal 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 anamnestic ulcerative colitis, Crohn's disease, recurrent peptic ulcer or gastrointestinal haemorrhage (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.

Side effects

The following undesirable effects have been reported, particularly after administration of formulations for systemic use: Blood and lymphatic system disorders Thrombocytopenia, aplastic anemia and agranulocytosis Immune system disorders Anaphylaxis, angioedema, allergic reaction Nervous system disorders Dizziness, cerebrovascular accidents, disorders vision, 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 most commonly observed adverse events are gastrointestinal in nature. Nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, gastrointestinal haemorrhage and exacerbation of colitis and Crohn's disease have been reported following administration of flurbiprofen. Gastritis, peptic ulcer, perforation and ulcer haemorrhage were observed less frequently. Skin and subcutaneous tissue disorders Skin disorders including rash, pruritus, urticaria, purpura and very rarely bullous dermatosis (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. The topical use of the product, especially if prolonged, can give rise to sensitization phenomena or local irritation. The dissolution in the oral cavity of the product in the form of tablets may be accompanied by sensations of heat or tingling in the oropharynx. In such cases, treatment must be interrupted and appropriate therapy instituted if necessary. Reporting of suspected adverse reactions. Reporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.

Pregnancy and breastfeeding

During the first and second trimester of pregnancy, flurbiprofen should not be administered except in strictly necessary cases. The drug administered during pregnancy can delay the onset of labor and increase its duration. Administration of flurbiprofen is not recommended in nursing mothers.

Special warnings

At the recommended doses, when using the 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. The use of the product, especially if prolonged, can give rise to sensitization phenomena or local irritation; in such cases it is necessary to interrupt the treatment and consult the doctor to establish, if necessary, a suitable therapy. In patients with renal, cardiac or hepatic insufficiency the product should be used with caution. It is advisable not to associate the product with other NSAIDs. Cases of bronchospasm have been reported with flurbiprofen in patients with a history of bronchial asthma. 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, ulcer 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 with the lowest available dose. Gastrointestinal bleeding, ulcer or perforation have been reported with all NSAIDs at any time during treatment. These adverse events can be fatal and can occur with or without warning symptoms or with a previous history of serious gastrointestinal events. Patients with a history of gastrointestinal disease, particularly if elderly, should report any unusual abdominal symptoms (especially gastrointestinal bleeding) in the initial stages of treatment. Elderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal haemorrhage and perforation, which can be fatal. Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms (see section 4.2). Important information about some of the ingredients ROFIXDOL THROAT AND PAIN Lemon and Honey flavored tablets contain: • 1,095 g of glucose and 1,375 g of sucrose per tablet. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase insufficiency should not take this medicine. Do not use for prolonged treatments. After short periods of treatment without appreciable results, consult your doctor. Keep this medicine out of the sight and reach of children.

Expiry and Retention

This medicinal product does not require any special storage conditions.

Active principles

ROFIXDOL THROAT AND PAIN Lemon and Honey flavored tablets One tablet contains: active ingredient: flurbiprofen 8.75mg Excipients with known effects: Glucose, sucrose For the full list of excipients, see section 6.1.

Excipients

ROFIXDOL THROAT AND PAIN Tablets Lemon and Honey flavor Sucrose, glucose, macrogol, potassium hydroxide, lemon flavor, levomenthol, honey.