Strepsils Intensive 8.75mg Lozenges

Addition of the following text:

 

Pharmacotherapeutic group: Respiratory System; Throat preparations; Other throat preparations.

ATC Code: R02AX01

 

Flurbiprofen is a propionic acid derivative NSAID which acts through inhibition of prostaglandin synthesis.  In humans flurbiprofen has potent analgesic, antipyretic and anti-inflammatory properties and the 8.75mg dose dissolved in artificial saliva has been shown to reduce prostaglandin synthesis in cultured human respiratory cells.

 

According to studies using the whole body assay, flurbiprofen is a mixed COX-1/COX-2 inhibitor with some selectivity towards COX-1.  Pre-clinical studies suggest that the R (-) enantiomer of flurbiprofen and related NSAIDs may relieve pain by acting on the central nervous system.

Reduction in throat soreness was observed after 15 minutes while onset of pain relief and reduction of throat swelling was observed 30 minutes after taking a lozenge.  Duration of action extended up to 3 hours.

 

A single dose of flurbiprofen 8.75mg delivered locally to the throat in a lozenge has been demonstrated to relieve sore throat, including swollen and inflamed sore throats through a significant reduction (LS Mean Difference) in sore throat pain intensity from 22 minutes (-5.5mm), reaching a maximum at 70 minutes (-13.7mm) and remaining significant for up to 240 minutes (-3.5mm) including patients with streptococcal and non-streptococcal infections, reduction in difficulty swallowing from 20 minutes (-6.7mm), reaching a maximum at 110 minutes (-13.9mm) and for up to 240 minutes (-3.5mm) and reduction in the feeling of a swollen throat at 60 minutes (-9.9mm), reaching a maximum at 120 minutes (-11.4mm) and for up to 210 minutes (-5.1mm).

 

Multiple dose efficacy measured using Sum of Pain Intensity Differences (SPID) over 24 hours has demonstrated significant reduction in sore throat pain intensity (-473.7mm*h to -529.1mm*h), difficulty swallowing (-458.4mm*h to -575.0mm*h) and swollen throat (-482.4mm*h to -549.9mm*h) with statistically significant greater summed reduction in pain at each hourly interval over 23 hours for all three measures and statistically significantly greater sore throat relief each hour over the 6 hour assessment time. Efficacy of multiple doses after 24 hours and over 3 days has also been demonstrated.

 

For those patients taking antibiotics for streptococcal infection, there was statistically significant greater relief of sore throat pain intensity for flurbiprofen 8.75mg from 7 hours and onwards after antibiotics were taken. The analgesic effect of flurbiprofen 8.75 mg was not reduced by the administration of antibiotics to treat patients with streptococcal sore throat.

 

At 2 hours post first dose, flurbiprofen 8.75mg lozenges provided significant resolution of some of the associated symptoms of sore throat present at baseline including coughing (50% vs 4%), loss of appetite (84% vs 57%) and feverishness (68% vs 29%). The lozenge format dissolves in the mouth over 5 - 12 minutes and provides a measurable soothing and coating effect at 2 minutes.

Storage conditions have been updated to "Store below 25C" 

addition of diabetic warnings to SmPC 

Section 6.5 - updated to include 90gsm blister pack type

correction to name from Strespils Intensive Honey & Lemon 8.75mg Lozenges to Strepsils Intensive 8.75mg Lozenges

In section 1, the name of the product has been changed from Strepsils Intensive 8.75mg to Strepsils Intensive Honey & Lemon 8.75mg

Revison of text has been updated from January 2009 to June 2011

Section 1: Strengh added to name
Section 6.1: Flavour change from Cherry to Honey & Lemon
Section 9: License renewal

Update section 4.3, 4.4, 4.5 and 4.8 of the SPC as directed by the IMB letter regarding Class Wording for OTC products for systemic administration containing flurbiprofen.

Transfer of MA to Reckitt Benckiser Ireland Ltd and change of PA number