STREFEN EUCALYPTUS AND MANUKA HONEY FLAVOUR

4).

Adults and adolescents 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.

Impaired hepatic:

In patients with mild to moderate impairment of hepatic function no dose reduction is required. 3).

Impaired renal:

In patients with mild to moderate impairment of renal function no dose reduction is required. 3). Method of administration For oromucosal administration and short-term use only. 75mg Lozenges should be moved around the mouth whilst sucking.

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.

4). 75 mg lozenges. The following list of adverse effects relates to those experienced with flurbiprofen at OTC doses for short-term use. Adverse events which have been associated with flurbiprofen are given below, tabulated by system organ class and frequency.

Frequencies are defined as: (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)) System Organ Class Frequency Adverse Events Blood and Lymphatic System Disorders Not known Anaemia, thrombocytopenia Rare Anaphylactic reactionImmune System Disorders Not known Hypersensitivity Psychiatric Disorders Uncommon Insomnia Common Dizziness, headache, paraesthesiaNervous System Disorders Uncommon Somnolence Cardiac disorders Not known Cardiac failure, oedema Vascular disorders Not known Hypertension Common Throat irritationRespiratory, Thoracic and Mediastinal Disorders Uncommon Exacerbation of asthma and bronchospasm, dyspnoea, oropharyngeal blistering, pharyngeal hypoaesthesia Gastrointestina l Disorders Common Diarrhoea, mouth ulceration, nausea, oral pain, paraesthesia oral, oropharyngeal pain, oral discomfort (warm and burning feeling or tingling in the mouth) Uncommon Abdominal distension, abdominal pain, constipation, dry mouth, dyspepsia, flatulence, glossodynia, dysgeusia, oral dysaesthesia, vomiting Hepatobiliary Disorders Not known Hepatitis Uncommon PruritusSkin and Subcutaneous Tissue Disorders Not known Severe forms of skin reaction such as bullous reactions, including Stevens- Johnson Syndrome, erythema multiform and toxic epidermal necrolysis General Disorders and Administration Site Conditions Uncommon Pyrexia, pain Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

Undesirable effects may be minimized 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. 5). 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 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 lozenges. 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.

1. 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).