NIFLUMA GEL & CREAM

Description

PROPERTIES:
NlFLUMA, in the form of cream or gel, contains niflumic acid which possesses analgesic and anti-inflammatory properties with beneficial effects in painful and inflammatory conditions of joints and muscles. Following topical application of NIFLUMA cream or gel, niflumic acid readily penetrates the stratum corneum of the skin and reaches the inflamed tissues. The inhibition of cyclooxygenase at the site of inflammation by niflumic acid results in local reduction of the synthesis of prostaglandins involved in the pathogenesis of pain and inflammation with remarkable analgesic and efficacious anti-inflammatory effects. Therefore, in joint and muscle inflammation of traumatic or rheumatic origin, NIFLUMA cream or gel causes rapid relief of pain, redness and edema; and shortens the time to restore normal function. In addition, NIFLUMA cream or gel has a soothing effect and is non-irritant, non-greasy and non-staining. NIFLUMA in the form of cream or gel is, therefore, a well-tolerated effective formulation for the topical treatment of joint and musculoskeletal pain and inflammation.

PHARMACOKINETICS:
NIFLUMA cream or gel acts topically on affected joints or muscles with minimal systemic absorption from intact skin.

INDICATIONS:
– Post-traumatic pain and inflammation of tendons, ligaments, muscles and joints, e.g.due to sprains, strains and heavy exercises .
– Localized forms of soft-tissue rheumatism, e.g. Tendinitis, tenosynovitis, brusitis and periarthropathy.
– Other painful and inflammatory joint and musculoskeletal disorders, e.g. painful shoulder, neck stiffness, lumbago and sciatica.

DOSAGE & ADMINISTRATION:
A sufficient amount of NIFLUMA cream or gel is massaged gently into the affected areas 3 or 4 times daily or as directed by the physician.

SIDE EFFECTS:
NIFLUMA cream or gel is safe and well tolerated. Rare cases of allergic skin reactions as local irritation, pruritus and local erythema may occur.

CONTRAINDICATIONS:
Hypersensitivity to niflumic acid.

DRUG INTERACTIONS:
Because of poor systemic absorption of niflumic acid from intact skin following topical application, the possibilities of drug interactions are minimal.

PREGNANCY & LACTATION:
Because of poor systemic absorption ofniflumic acid from intact skin following topical application, NIFLUMA cream or gel can be used during pregnancy and lactation if indicated and as directed by the physician.

PRECAUTIONS & WARNINGS:
NIFLUMA cream or gel should be applied only to intact skin surfaces (not to open wounds or injuries). It should not be allowed to come into contact with eyes or with mucous membranes.

OVERDOSAGE AND TREATMENT:
Not applicable with topical preparations (cream or gel).
INSTRUCTIONS TO PATIENTS:
If undue skin irritation develops or increases, discontinue the cream or gel application and consult the physician.

PACKING:
A tube containing 20 g or 40 g of NIFLUMA cream or gel.

STORAGE:
Keep the cream at a temperature below 30°C & the gel at a temperature below 25°C.
Keep out of reach of children.