Special Warning : אזהרת שימוש

4.4   Special warnings and precautions for use
Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms
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 Strefen Honey and Lemon & Strefen Orange flavour Sugar Free lozenges with concomitant NSAIDS including cyclooxygenase-2 selective inhibitors should be avoided (see section 4.5).
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 (see section 4.8), 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.
Clinical trial and epidemiological data suggest that the use of NSAIDs (particularly at high doses and in long term treatment) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke). There are insufficient data to exclude such a risk for flurbiprofen when given at a daily dose of no more than 5 lozenges.

Hepatic:
Mild to moderate hepatic dysfunction (see sections 4.3 and 4.8)
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 (see section 4.8)
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 (see Section 4.3), 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 (see section 4.5).
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 (see section 4.8).
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.

Masking of symptoms of underlying infections:
Epidemiological studies suggest that systemic non-steroidal anti-inflammatory drugs (NSAIDs) can mask symptoms of infection, which may lead to delayed initiation of appropriate treatment and thereby worsening the outcome of the infection. This has been observed in bacterial community acquired pneumonia and bacterial complications to varicella. When Strefen is administered while the patient suffers from fever or pain in relation to infection, monitoring of infection is advised.

Important Information about some of the ingredients of Strefen Honey and Lemon

• This medicine contains only very low levels of gluten (from wheat starch). It is regarded as ‘gluten-free’ and is very unlikely to cause problems if you have coeliac disease. One lozenge contains no more than 21.38 micrograms of gluten.
If you have wheat allergy (different from coeliac disease) you should not take this medicine.
• This medicine contains 1.407 g Sucrose per lozenge and 1.069 g Glucose per lozenge. Patients with rare hereditary problems of fructose intolerance, glucose galactose malabsorption or sucrase isomaltase insufficiency should not take this medicine.
• This medicine contains sulphites, which may rarely cause severe hypersensitivity reactions and bronchospasm.
• This medicine contains fragrance with Citral, Citronellol, d-Limonene, Farnesol, Geraniol and Linalool. Citral, Citronellol, d-Limonene, Farnesol, Geraniol and Linalool may cause allergic reactions.
• This medicine contains Butylated hydroxyanisole (E320) (present in Lemon flavour) which may cause local skin reactions (e.g. contact dermatitis), or irritation to the eyes and mucous membranes.

Important Information about some of the ingredients of Strefen Orange flavour Sugar Free

This product contains liquid maltitol (510 mg/lozenge) and Isomalt (2039 mg/lozenge), patients with rare hereditary problems of fructose intolerance should not take this medicine. May have a mild laxative effect. Calorific value 2.3 kcal/g for liquid maltitol and isomalt .

It also contains fragrances in the orange flavour containing Citral, Citronellol, d- Limonene, Geraniol and Linalool which may cause allergic reactions.

This product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially 'sodium-free'.

Effects on Driving

4.7 Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use of machines have been performed.