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Strefen

Travellers familiar with Strefen from pharmacies in southern Europe or the eastern Mediterranean are unlikely to encounter the same brand much further afield โ€” it is registered in only five countries. Its active ingredient is flurbiprofen, a non-steroidal anti-inflammatory molecule that, in the context of this product, is formulated as a throat preparation rather than as a systemic tablet.

Strefen is used for the symptomatic relief of sore throat. Flurbiprofen belongs to the broader non-steroidal anti-inflammatory class and carries analgesic, anti-inflammatory, and antipyretic properties; in lozenge-style throat preparations the ingredient is delivered locally to the inflamed tissue rather than absorbed primarily for systemic effect. The structured indication block further down this page lists the registered uses recognised by the regulators in the markets where Strefen is sold.

The brand's footprint is concentrated across France, Spain, Turkey, Denmark, and Israel โ€” a small cluster spanning Western Europe, Scandinavia, and the eastern Mediterranean. Outside these markets, a traveller searching for Strefen specifically will usually come up empty, even though flurbiprofen-based throat lozenges and other sore-throat preparations using related non-steroidal anti-inflammatory ingredients circulate widely under a range of regional brand names.

Anyone who has been using Strefen at home and is now abroad will generally be able to find a comparable product in the destination country, but it will most likely be a different brand and possibly a different active ingredient within the same therapeutic category. A local pharmacist is well placed to identify the appropriate equivalent on the regional shelf. Decisions about whether a given sore-throat preparation is suitable โ€” particularly alongside other medication, or for a child โ€” belong with a healthcare provider rather than at the point of self-selection.

How does this drug class actually work?
Read the plain-language explainer in Pharmacology Academy (Non-steroidal anti-inflammatory drugs) โ†’

Shelf life

36 months.

Incompatibilities

Not applicable.

List of excipients

Macrogol 300

Potassium hydroxide

Lemon flavour

Levomenthol

Liquid sucrose

Liquid glucose

Honey

Preclinical safety data

There are no preclinical data of relevance additional to information already included in other relevant sections.

Pharmacotherapeutic group

Throat preparations, other throat preparations.

Pharmacodynamic properties

Pharmacotherapeutic Group: 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 blood 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 act on the central nervous system; the suggested mechanism is by inhibition of induced COX-2 at the level of the spinal cord.

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.

Paediatric Population

No specific studies in children have been undertaken. Efficacy and safety studies on flurbiprofen 8.75mg lozenges have included children aged 12 - 17 years, although small sample size means that no statistical conclusions can be drawn.

Pharmacokinetic properties

Absorption

Flurbiprofen 8.75mg lozenges dissolve over 5 - 12 minutes and the flurbiprofen is readily absorbed, with detection in the blood at 5 minutes and plasma concentrations peaking at 40 - 45 minutes after administration but remaining at a mean low level of 1.4ร‚ยตg/mL which is approximately 4.4 times lower than a 50mg tablet dose. Absorption of flurbiprofen can occur from the buccal cavity by passive diffusion. Rate of absorption is dependent on pharmaceutical form with peak concentrations achieved more rapidly than, but of similar magnitude to, those achieved after an equivalent swallowed dose.

Distribution

Flurbiprofen is rapidly distributed throughout the body and is extensively bound to plasma proteins.

Metabolism / Excretion

Flurbiprofen is mainly metabolised by hydroxylation and excreted via the kidneys. It has an elimination half-life of 3 to 6 hours. Flurbiprofen is excreted in very small amounts in human milk (less than 0.05 ร‚ยตg/ml). Approximately 20-25% of a flurbiprofen oral dose is excreted unchanged.

Special Groups

No difference in pharmacokinetic parameters between elderly and young adult volunteers has been reported following oral administration of flurbiprofen tablets. No pharmacokinetic data have been generated in children below 12 years of age following administration of Flurbiprofen 8.75 mg however administration of both flurbiprofen syrup and suppository formulations indicate no significant differences in pharmacokinetic parameters compared with adults.

Date of revision of the text

22/07/2016

Marketing authorisation holder

Reckitt Benckiser Healthcare (UK) Ltd

103-105 Bath Road

Slough

Berkshire

SL1 3UH

United Kingdom

Special precautions for storage

Store in the original package

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

Marketing authorisation number(s)

PL 00063/0714

Special precautions for disposal and other handling

None

Date of first authorisation/renewal of the authorisation

19/09/2006

Frequently asked questions

What conditions does Strefen treat?

Strefen is used for the symptomatic relief of sore throat. Its active ingredient belongs to the non-steroidal anti-inflammatory category and carries analgesic, anti-inflammatory, and antipyretic properties, applied locally to the throat in this formulation rather than taken for systemic effect. The structured indication section below this introduction sets out the registered uses recognised by national regulators in the markets where Strefen is sold.

Which active substance is in Strefen?

Strefen contains flurbiprofen, a non-steroidal anti-inflammatory molecule. Flurbiprofen is used internationally in several different formulations โ€” including throat preparations, ophthalmic products, and topical preparations for joint and muscular pain โ€” and circulates under a number of brand names depending on the country and the route of administration. The same active ingredient appears across multiple product types worldwide.

In how many countries is Strefen available?

Strefen is registered in five countries: France, Spain, Turkey, Denmark, and Israel. The brand's footprint is concentrated across Western Europe, Scandinavia, and the eastern Mediterranean, and it is not broadly available beyond that cluster. If your country is not on this list, a local pharmacist can confirm whether a comparable flurbiprofen-based throat preparation, or another sore-throat product, is available locally.

Are there alternatives to Strefen?

Flurbiprofen-based throat lozenges are sold under several brand names internationally, and the wider category of sore-throat preparations includes other non-steroidal anti-inflammatory ingredients as well as different therapeutic approaches altogether. These products are not freely interchangeable, since formulations and intended uses differ. To identify a regional option, search the active ingredient flurbiprofen on Pill2Trip or ask a pharmacist in your destination country.

Is Strefen a prescription medication?

Prescription status for sore-throat preparations varies between countries โ€” in some markets flurbiprofen lozenges are sold over the counter, in others they are restricted. Regardless of how it is dispensed locally, anyone with a persistent or severe sore throat, an underlying medical condition, or other concurrent medication should check with a healthcare provider before using Strefen, particularly when travelling between countries with different regulatory regimes.

Strefen

Available in 5 countries