1. Name Of The Medicinal Product
Strefen Honey and Lemon.
2. Qualitative And Quantitative Composition
Active ingredient flurbiprofen 8.75 mg
For excipients, see 6.1
3. Pharmaceutical Form
Lozenge
A round, pale yellow to brown lozenge with an icon intagliated on both sides of the lozenge.
4. Clinical Particulars
4.1 Therapeutic Indications
Strefen Honey and Lemon are indicated for the symptomatic relief of sore throat.
4.2 Posology And Method Of Administration
Adults 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:
No dose modification is required.
As with all lozenges, to avoid local irritation, Strefen Honey and Lemon should be moved around the mouth whilst sucking.
4.3 Contraindications
Hypersensitivity to flurbiprofen, aspirin, other NSAIDs or other lozenge ingredients. Existing or history of peptic ulceration.
History of bronchospasm, rhinitis, or urticaria associated with aspirin or other NSAIDs.
Severe heart failure
4.4 Special Warnings And Precautions For Use
Bronchospasm may be precipitated in patients suffering from, or with a previous history of bronchial asthma. Strefen Honey and Lemon should be used with caution in these patients.
NSAIDs have been reported to cause nephrotoxicity in various forms including interstitial nephritis, nephrotic syndrome and renal failure. In patients with renal, cardiac or hepatic impairment, caution is required since the use of NSAIDs may result in deterioration of renal function. Caution is required in patients with hypertension.
Flurbiprofen can prolong bleeding time and caution is required in patients with a potential for abnormal bleeding.
Undesirable effects may be minimised by using the minimum effective dose for the shortest possible duration necessary to control symptoms (see GI and cardiovascular risks below).
Strefen Honey and Lemon should not be taken with other NSAIDs.
The lozenge should be moved round the mouth whilst sucking.
The label will include the following wording or similar: “Do not use if you ever had a stomach ulcer or are allergic to flurbiprofen, aspirin or any other NSAID. If you are allergic to or taking any other pain killer, are pregnant, or suffer from asthma, speak to your doctor before taking flurbiprofen. If symptoms persist consult your doctor. Keep out of the reach and sight of children.”
Cardiovascular and cerebrovascular effects
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 one to five lozenges.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
Studies have shown that Flurbiprofen can occasionally reduce the diuretic response to furosemide. Similarly, interference with the action of anticoagulants has occasionally been reported. Other studies have failed to show any interaction between Flurbiprofen and digoxin, oral hypoglycaemics or antacids. NSAIDs may diminish the effect of antihypertensive drugs. Flurbiprofen may decrease the elimination rate of lithium. NSAIDs should not be used for 8 – 12 days after mifepristone administration as NSAIDs can reduce the effect of mifepristone. Animal data indicate that NSAIDs can increase the risk of convulsions associated with quinolone antibiotics. Patients taking NSAIDs and quinolone may have an increased risk of developing convulsions.
4.6 Pregnancy And Lactation
The use of Strefen Honey and Lemon in the last three months of pregnancy should be avoided. Regular use of NSAIDs during the third trimester of pregnancy may result in premature closure of the foetal ductus arteriosus in utero and persistent pulmonary hypertension of the newborn. Flurbiprofen appears in the breast milk in very low concentrations and is unlikely to affect the breast-fed infant adversely.
4.7 Effects On Ability To Drive And Use Machines
Dizziness and visual disturbances are possible undesirable effects after taking NSAIDs. If affected, patients should not drive or operate machinery.
4.8 Undesirable Effects
Dyspepsia, nausea, vomiting, gastrointestinal haemorrhage, diarrhoea, mouth ulcers, fluid retention and oedema have been reported. Exacerbation of peptic ulceration and perforation have also been reported.
Urticaria, angioedema and rashes of varying description, dizziness and visual disturbances have been reported.
Very rarely, jaundice and thrombocytopenia have been reported. These are usually reversible on withdrawal of the drug.
Very rarely, aplastic anaemia and agranulocytosis have been reported in association with the use of flurbiprofen but causality has not been established.
Strefen Honey and Lemon have the potential for inducing transient local irritation of the buccal mucosa. The most frequently reported adverse event in clinical trials was taste perversion.
Oedema, hypertension, and cardiac failure, have been reported in association with NSAID treatment.
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) (see section 4.4).
4.9 Overdose
Symptoms of overdose may include nausea, vomiting, headache, drowsiness, blurred vision and dizziness. Treatment should consist of gastric lavage and if necessary correction of serum electrolytes. There is no specific antidote to flurbiprofen.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Flurbiprofen is a non-steroidal anti-inflammatory drug which has potent analgesic, antipyretic and anti-inflammatory properties which are thought to result from the drug's ability to inhibit prostaglandins synthesis.
The onset of pain relief, reduction in throat soreness and reduction in throat swelling was observed 30 minutes after taking a lozenge and duration of action extended to 2-3 hours.
5.2 Pharmacokinetic Properties
Flurbiprofen is rapidly absorbed following the use of Strefen Honey and Lemon with plasma concentrations peaking at 30 - 40 minutes. Peak concentrations are achieved more rapidly than, but are of similar magnitude to, those achieved after an equivalent swallowed dose.
Flurbiprofen is rapidly distributed throughout the body. It is mainly metabolised by hydroxylation and excreted via the kidneys.
It is extensively bound to plasma proteins and has an elimination half-life of 3 to 6 hours.
Flurbiprofen is excreted in very small amounts in human milk (less than 0.05 ug/ml).
5.3 Preclinical Safety Data
In rats exposed to 0.4 mg/kg/day and above during pregnancy an increased incidence of stillborn pregnancy has been observed. However, the relevance of this fact to humans is doubtful and not reflected in human experience with flurbiprofen so far.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Macrogol 300
Potassium hydroxide
Lemon flavour
Levomenthol
Liquid sucrose
Liquid glucose
Honey
6.2 Incompatibilities
Not applicable.
6.3 Shelf Life
36 months.
6.4 Special Precautions For Storage
Store in the original package.
6.5 Nature And Contents Of Container
A push through strip consisting of 250 microns opaque PVC/PVdC (polyvinyl chloride/polyvinyl di-chloride) blister, heat sealed to hard tempered 20 micron aluminium foil. Blisters are enclosed in a cardboard carton in pack sizes of 2, 4, 6, 8, 10, 12, or 16 lozenges.
6.6 Special Precautions For Disposal And Other Handling
None.
7. Marketing Authorisation Holder
Crookes Healthcare Limited
1 Thane Road West
Nottingham
NG2 3AA
United Kingdom
8. Marketing Authorisation Number(S)
PL 00327/0135
9. Date Of First Authorisation/Renewal Of The Authorisation
19/09/2006
10. Date Of Revision Of The Text
04/04/2007
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