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  • Strefen Honey and Lemon & Strefen Orange flavour Sugar Free
    / rb


    Active Ingredient
    Flurbiprofen 8.75 mg

    Status in Israel
    OTC

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Lozenges

    16 X 8.75 mg

    not in the basket chart 11455

    Dosage

    Adults, the elderly and children over the age of 12 years: One lozenge sucked/dissolved slowly in the mouth every 3 – 6 hours as required. Maximum 5 lozenges in a 24 hour period.
    It is recommended that this product should be used for a maximum of three days.
    Children: Not indicated for children under 12 years.
    Elderly: A general dose recommendation cannot be given, since to date clinical experience is limited. The elderly are at increased risk of the serious consequences of adverse reactions.


    Indications

    For the short term relief of symptoms of sore throat such as throat pain and soreness in adults and children over the age of 12 years.


    Contra-Indications

    Hypersensitivity to flurbiprofen or any of the excipients in the product.
    Patients who have previously shown hypersensitivity reactions (e.g. asthma, bronchospasm, rhinitis, angioedema, or urticaria) in response to acetylsalicylic acid or other NSAIDs.
    Active or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration) and intestinal ulceration.
    History of gastrointestinal bleeding or perforation, severe colitis, haemorrhagic or haematopoietic disorders related to previous NSAID therapy.
    Last trimester of pregnancy.
    Severe cardiac failure, severe renal failure or severe hepatic failure.


    Special Precautions

    Elderly population: The elderly have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which may be fatal.
    Respiratory:: Bronchospasm may be precipitated in patients suffering from, or with a previous history of bronchial asthma or allergic disease. Flurbiprofen
    lozenges should be used with caution in these patients.
    Other NSAIDs: The use of this product with concomitant NSAIDS including cyclooxygenase-2 selective inhibitors should be avoided.
    Systemic lupus erythematosus and mixed connective tissue disease: Patients with systemic lupus erythematosus and mixed connective tissue disease may have an increased risk of aseptic meningitis, however this effect is not usually seen with short term limited use products such as flurbiprofen lozenges.
    Cardiovascular, Renal and Hepatic Impairment: NSAIDs have been reported to cause nephrotoxicity in various forms including interstitial nephritis, nephrotic syndrome and renal failure. The administration of an NSAID may cause a dose dependent reduction in prostaglandin formation and precipitate renal failure. Patients at greatest risk of this reaction are those with impaired renal function, cardiac impairment, liver dysfunction, those taking diuretics and the elderly, however, this effect is not usually seen with short term, limited use
    products such as flurbiprofen lozenges.
    Cardiovascular and cerebrovascular effects: Caution (discussion with doctor or pharmacist) is required prior to starting treatment in patients with a history of hypertension and/or heart failure as fluid retention, hypertension and oedema have been reported in association with NSAID therapy.
    Hepatic: Mild to moderate hepatic dysfunction.
    Nervous System effects: Analgesic induced headache- In the event of prolonged use of analgesics or use beyond the regulations headache may occur, which must not be treated with increased doses of the medicinal product.
    Gastrointestinal: NSAIDs should be given with care to patients with a history of
    gastrointestinal disease (ulcerative colitis, Crohn’s disease) as these conditions may be exacerbated.
    Gastrointestinal bleeding, ulceration or perforation, which can be fatal has been reported with all NSAIDs at anytime during treatment, with or without warning symptoms or a previous history of serious GI events.
    The risk of GI bleeding, ulceration or perforation is higher with increasing NSAID doses, in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation, and in the elderly, however this effect is not usually seen with short term limited use products such as flurbiprofen lozenges.
    Patients with a history of GI toxicity, particularly the elderly, should report any unusual abdominal symptoms (especially GI bleeding) to their healthcare professional. 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.
    If GI bleeding or ulceration occurs in patients receiving flurbiprofen, the treatment should be withdrawn.
    Dermatological: 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 NSAIDSs. Flurbiprofen lozenges should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.
    Infections: Since in isolated cases an exacerbation of infective inflammations (e.g. development of necrotising fasciitis) has been described in temporal association with the use of systemic NSAIDs as a class, the patient is advised to consult a physician immediately if signs of a bacterial infection occur or worsen during the flurbiprofen lozenges therapy. It should be considered whether initiation of an anti-infective antibiotic therapy is indicated.
    Sugar intolerance: Patients with rare hereditary problems of fructose intolerance, glucosegalactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
    If the symptoms get worse or if new symptoms occur, the treatment
    should be re-evaluated.
    If mouth irritation occurs, treatment should be withdrawn.
    See prescribing information for full details.


    Side Effects

    Common: dizziness, headache, parasthesia, throat irritation, diarrhoea, mouth ulceration, nausea, oral pain, paraesthesia oral, oropharyngeal pain, oral discomfort (warm or burning feeling or tingling of the mouth).
    See prescribing information for full details.


    Drug interactions

    Flurbiprofen should be avoided in combination with: Other NSAIDS including
    cyclooxygenase-2 selective inhibitors, Acetylsalicylic acid (low dose).
    Flurbiprofen should be used with caution in combination with: 
    Anticoagulants, Anti-platelet Agents , Antihypertensive drugs (Diuretics, ACE
    inhibitors, angiotensinII-antagonists), Alcohol, Cardiac glycosides,
    Ciclosporin, Corticosteroids, Lithium, Methotrexate, Mifepristone, Oral antidiabetics, Phenytoin, Potassium sparing diuretics, Probenecid Sulfinpyrazone, Quinolone antibiotics, Selective serotonin reuptake inhibitors
    (SSRI’s), Tacrolimus, Zidovudine.
    See prescribing information for full details.


    Pregnancy and Lactation

    Pregnancy: Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/foetal development.
    During the first and second trimester of pregnancy, flurbiprofen should not be given unless clearly necessary. If flurbiprofen is used by a woman attempting to conceive, or during the first and second trimester of pregnancy, the dose should be kept as low and duration of treatment as short as possible.
    During the third trimester flurbiprofen is contraindicated.
    Lactation: Flurbiprofen is not recommended for use in nursing mothers.
    See prescribing information for full details.


    Overdose

    Symptoms: Most patients who have ingested clinically important amounts of NSAIDs will develop no more than nausea, vomiting, epigastric pain, or more rarely diarrhoea. Tinnitus, headache and gastrointestinal bleeding are also possible. In more serious poisoning with NSAIDs, toxicity is seen in the central nervous system, manifesting as drowsiness, occasionally excitation, blurred vision and disorientation or coma. Occasionally patients develop convulsions. In serious poisoning with NSAIDs metabolic acidosis may occur and the prothrombin time/ INR may be prolonged, probably due to interference with the actions of circulating clotting factors. Acute renal failure and liver damage may occur. Exacerbation of asthma is possible in asthmatics.
    Management: Management should be symptomatic and supportive and include the maintenance of a clear airway and monitoring of cardiac and vital signs until stable. Consider oral administration of activated charcoal or gastric lavage and if necessary correction of serum electrolytes and if the patient presents within 1 hour of ingestion or a potentially toxic amount. If frequent or prolonged, convulsions should be treated with intravenous diazepam or lorazepam. Give bronchodilators for asthma. There is no specific antidote to flurbiprofen.


    Important notes

    Shelf life: Strefen Honey and Lemon: 36 months; Strefen Orange Sugar Free: 24 months.


    Manufacturer
    Reckitt Benckiser
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