VOCAFEN HONEY AND LEMON FLAVOUR

4). Adults and adolescents over the age of 12 years Slowly suck/dissolve one lozenge in the mouth every 3 to 6 hours as needed. Maximum 5 lozenges in every 24-hour period. This product should be used for a maximum of three days. Paediatric population Not indicated for children under 12 years of age.

Elderly population Due to the limited clinical trials, available, a general dose cannot be recommended. Elderly patients are at higher risk of suffering serious consequences of adverse reactions. Impaired renal function In patients with mild to moderate impairment of renal function no dose reduction is required.

3). Impaired hepatic function In patients with mild to moderate impairment of hepatic function no dose reduction is required. 3). 4). Method of administration For oromucosal administration and short-term use only. 75 mg lozenges should be moved around inside the mouth to avoid local irritation.

Hypersensitivity reactions to NSAIDs have been reported and these may consist of: - Non-specific allergic reactions and anaphylaxis - Respiratory tract reactivity such as asthma, asthma worsening, bronchospasm, and dyspnea. - Several skin reactions, such as itching, urticaria, angioedema and more rarely exfoliative and bullous dermatoses (including epidermal necrolysis and erythema multiform).

Oedema, hypertension, and cardiac failure have been reported in association with NSAID treatment. 4). 75 mg lozenges The following list of adverse effects refers to those reported with flurbiprofen at OTC doses, for short-term use: - (Very common (≥ 1/10, Common (≥ 1/100, < 1/10), Uncommon (≥ 1/1,000, < 1/100), Rare (≥ 1/10,000, < 1/1000), Very rare (< 1/10,000), not known (cannot be estimated from available data)).

System Organ Class Frequency Undesirableeffects Blood and lymphatic system disorders Not known anaemia, thrombocytopenia Rare anaphylactic reaction Immune System disorders Psychiatric disorders Uncommon insomnia Cardiovascular and cerebrovascular disorders Not known oedema, hypertension and cardiac failure Common dizziness, headache, parasthesiaNervous System disorders Uncommon somnolence, Common throat irritation Uncommon exacerbation of asthma and bronchospasm, dyspnoea, wheezing, oropharyngeal blistering, pharyngeal hypoaesthesia.

Respiratory, thoracic and mediastinal disorders:

Not known sinus pain Very common stomatitis 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 Rare icterus Gastrointestinal disorders Very rare gastrointestinal bleeding Hepatobiliary disorders Not known: hepatitis Uncommon: various skin rashes, pruritus.

Undesirable effects may be minimized by using the lowest effective dose for the shortest possible duration necessary to control symptoms (see GI and cardiovascular risks below). Elderly population Elderly patients have an increased frequency of adverse reactions to NSAIDs, particularly gastrointestinal bleeding and perforation, which may be fatal.

Respiratory disorders Bronchospasm can be triggered in patients suffering from, or with history of bronchial asthma or allergic diseases. Flurbiprofen must 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 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 could trigger 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.

8). Cardiovascular and cerebrovascular effects Caution (discussion with doctor or pharmacist) is required to starting treatment in patients with 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 administration of some NSAIDs (particularly at high doses and long-term treatment) may be associated with a small increased risk of arterial thrombotic events (for example, myocardial infarction or stroke).

There is not enough data to exclude this risk for flurbiprofen when administered at a maximum daily dose of 5 lozenges. Patients with uncontrolled hypertension, congestive heart failure, established ischemic heart disease, peripheral artery disease and/or cerebrovascular disease should not be treated with flurbiprofen after careful consideration.

1. g. asthma, bronchospasm, rhinitis, angioedema or urticaria) in response to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs. - Active or history of recurrent peptic ulcer/hemorrhage (two or more distinct episodes of proven ulceration) and intestinal ulceration.

- History of gastrointestinal bleeding or perforation, severe colitis, hemorrhage, or hematopoietic disorders related to previous treatment with NSAIDs. 6). 4)