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Difflam™ 3% Cream is a topical analgesic and non-steroidal anti-inflammatory agent.
Difflam™ 3% Cream is available in two sizes, 35gm and 100gm.
For the relief of symptoms associated with painful inflammation associated with conditions such as myalgia and bursitis and including traumatic conditions such as:
Difflam™ 3% / Difflam™-P 3% Cream is well absorbed through the skin and has been shown to have anti-inflammatory and local anaesthetic actions1, unlike cooling gels and heat patches that work by only cooling or heating the skin. The application of benzydamine to the skin produces slow and prolonged penetration through the tissue.2
The cream should be massaged lightly into the affected area and applied three times a day, (and at the discretion of the doctor up to six times daily in more severe conditions).1 The active ingredient within the cream, benzydamine, works by reducing the locally induced inflammation, oedema, and granuloma formationi, it also demonstrates antipyreticii antiexudativeiii activities.2 It also exhibits analgesic properties if pain is caused by an inflammatory condition and local anaesthetic activity.1
The topical application of Difflam™ 3% cream 3 times daily for 6 days in 50 patients with soft tissue injuries, led to a significant improvement in pain relief, tenderness, erythema, functional impairment and swelling compared to placebo on day 6.1
Benzydamine differs from the aspirin-like NSAIDs* in that it acts on local factors of inflammation, and does not interact with systemic physiological mechanisms. Therefore, it is shown to be gastro-protective and has local anaesthetic effects.2 A well-known feature of aspirin-like NSAIDs is their gastrointestinal toxicity which is largely due to their inhibition of gastro-protective prostaglandins. Under some conditions, the synthesis of PGE2 (Prostaglandin E2) is actually enhanced by benzydamine; PGE2 suppresses T cell receptor signaling and may play a role in resolution of inflammation.3 Therefore, consistent with its lack of significant inhibition on the synthesis of prostaglandins, benzydamine is not toxic to the gastrointestinal tract.2
It is thought that benzydamine inhibits the venoconstriction (narrowing) of blood vessels by a variety of agonists, indicating a non-specific effect on the blood vessels rather than on specific receptors for example the vasodilation and increased vascular permeability induced by histamine are inhibited by benzydamine.4 So benzydamine may exert some of its anti-inflammatory activities by decreasing the vascular changes that may occur during inflammation.2
Topical application of 3% benzydamine cream is effective in the treatment of injuries, such as sprains and fractures.1 It mostly exerts its effects through inhibition of the synthesis of proinflammatory cytokines including tumour necrosis factor-alpha (TNF-α) and Interleukin-1β (IL-1β) without significantly affecting other pro-inflammatory (IL-6 and 8) or anti-inflammatory cytokines (IL-10, IL-1 receptor antagonist).1,2
Further mechanisms of action are hypothesised including the inhibition of the oxidative burst of neutrophils as well as membrane stabilisation as demonstrated by the inhibition of granule release from neutrophils and the stabilization of lysosomes. The local anaesthetic activity of the compound has been related to an interaction with cationic channels.1
Direct effect on the inflammatory cells may contribute to the anti-inflammatory effect of many drugs. Two important responses by phagocytes that play a role in inflammation are the release of lytic enzymes, a consequence of degranulation, and the respiratory burst.2 Benzydamine may inhibit both these responses by phagocytes. Inhibition of the release of granules and lytic enzymes is included in a general phenomenon termed membrane stabilisation. This membrane-stabilising activity may account for some of the anti-inflammatory properties of benzydamine.2
UK/DIF/15/0002e
Date of preparation: September 2016
The topical application of Difflam™ cream 3%, 3 times daily for 6 days in 50 patients with soft tissue injuries, led to a significant improvement in pain relief, tenderness, erythema, functional impairment and swelling compared to placebo on day 6.1
Overall, benzydamine was well tolerated in clinical trials.1
Difflam™ cream has been clinically tested as a short-term treatment for the relief of symptoms associated with painful inflammatory conditions of the musculo-skeletal system including myalgia and bursitis. Further, it showed clinical benefit in traumatic conditions such as sprains, strains, contusions and post fractures (Diebschlag 1985; Haig 1986; Chatterjee 1977). Difflam™ Cream is well absorbed through the skin and has been shown to have anti-inflammatory and local anaesthetic actions.1
Do not use Difflam™ 3% Cream if you are allergic to Benzydamine Hydrochloride or any of the other ingredients listed in the Patient Information Leaflet.
Always read the label. Do not use for more than ten days continuously unless under advice from a healthcare professional. Avoid contact with eyes; mouth; nose, genitals and anus. Keep medicines away from children.
Always use Difflam™ 3% Cream exactly as instructed, and check with a healthcare professional if you are not sure. If your symptoms get worse or do not improve, contact your doctor, pharmacist or dentist.
