STREFEN HONEY AND LEMON FLAVOUR

Posology For short term use only.

Adults aged 18 years and over:

One dose (3 actuations) administered to the back of the throat every 3-6 hours as required, up to a maximum of 5 doses in a 24 hour period. Paediatric population The safety and efficacy of Strefen Honey and Lemon Flavour in children or adolescents under 18 years has not been established.

Elderly patients 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. 4). Method of Administration For oromucosal administration.

Do not inhale whilst spraying. It is recommended that this product should be used for a maximum of three days. Before first use, activate the pump by pointing the nozzle away from you and spraying a minimum of four times until a fine, consistent mist is produced.

The pump is then primed and ready for use. Between each dose point the nozzle away from you and spray a minimum of once ensuring a fine, consistent mist is produced. Always ensure a fine consistent mist is produced before dosing the product.

g. g. pruritus, urticaria, angioedema and more rarely exfoliative and bullous dermatoses (including epidermal necrolysis and erythema multiforme). Oedema, hypertension and cardiac failure have been reported in association with NSAID treatment.

There is insufficient data to exclude such a risk for flurbiprofen oromucusal spray, solution. The following list of adverse effects relates to those experienced with flurbiprofen at OTC doses for short-term use. (Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1000 to <1/100), Rare (≥1/10000 to <1/1000), Very rare (<1/10000), not known (cannot be estimated from the available data)) Blood and lymphatic system disorders: Not known: anaemia, thrombocytopenia.

Cardiac and vascular disorders:

Not known: Oedema, hypertension, cardiac failure Nervous System disorders: Common: dizziness, headache, parasthesia Uncommon: somnolence Respiratory, thoracic and mediastinal disorders: Common: throat irritation Uncommon: exacerbation of asthma and bronchospasm, dyspnoea, wheezing, oropharyngeal blistering, pharyngeal hypoaesthesia.

Gastrointestinal disorders:

Common: diarrhoea, mouth ulceration, nausea, oral pain, paraesthesia oral, oropharyngeal pain, oral discomfort (warm or burning feeling or tingling of the mouth). Uncommon: abdominal distension, abdominal pain, constipation, dry mouth, dyspepsia, flatulence, glossodynia, dysgeusia, oral dysaesthesia, vomiting Skin and subcutaneous tissue disorders: Uncommon: various skin rashes, pruritus.

Not known: severe forms of skin reaction such as bullous reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis.

General disorders and administration site conditions:

Uncommon: pyrexia, pain Immune System disorders: Rare: anaphylactic reaction Psychiatric disorders: Uncommon: insomnia Hepatobiliary disorders: Not known: hepatitis Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the risk/benefit balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms. 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 spray therapy.

It should be considered whether initiation of an anti-infective antibiotic therapy is indicated. In cases of purulent bacterial pharyngitis/tonsillitis, the patient is advised to consult a physician as the treatment needs to be re-evaluated.

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. 75mg/dose oromucosal spray is administered while the patient suffers from fever or pain in relation to infection, monitoring of infection is advised.

Treatment should be administered for three days maximum. If the symptoms get worse or if new symptoms occur, the treatment should be re- evaluated. If mouth irritation occurs, flurbiprofen treatment should be withdrawn. 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 spray should be used with caution in these patients. 5). 8), however this effect is not usually seen with short term limited use products such as flurbiprofen spray.

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 spray.

8). Cardiovascular and cerebrovascular effects Caution (talk 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 use of some 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 doses (3 sprays per dose). 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.

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. 3), and in the elderly, however this effect is not usually seen with short term limited use products such as flurbiprofen spray.

Patients with a history of GI toxicity, particularly when elderly, should report any unusual abdominal symptoms (especially GI bleeding) to their healthcare professional. 5). If GI bleeding or ulceration occurs in patients receiving flurbiprofen, the treatment should be withdrawn.

Haematological effects Flurbiprofen, like other NSAIDs, may inhibit platelet aggregation and prolong bleeding time. Flurbiprofen spray should be used with caution in patients with a potential for abnormal bleeding. 8). Flurbiprofen spray should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.

This product contains methyl parahydroxybenzoate and propyl parahydroxybenzoate which may cause allergic reactions (possibly delayed). This medicine contains less […]

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. 4). • Children and adolescents below 18 years.