Lofnac Gel, 30g

Product Name & Strength: Lofnac Gel (Diclofenac Diethylamine 1.16% w/w, Linseed oil 3.00% w/w, Methyl Salicylate 10.00% w/w, Menthol 5.00% w/w), 30 g.

Indications (Approved Uses): Indicated for the local symptomatic relief of pain and inflammation in trauma of the tendons, ligaments, muscles, and joints (e.g., due to sprains, strains, and bruises); localised forms of soft tissue rheumatism; and for the relief of pain in non-serious arthritic conditions.

Contraindications (Safety Warnings): Contraindicated in patients with or without chronic asthma in whom attacks of asthma, urticaria, or acute rhinitis are precipitated by acetylsalicylic acid (aspirin) or other non-steroidal anti-inflammatory drugs (NSAIDs). It must not be used by patients with a hypersensitivity to diclofenac, aspirin, other NSAIDs, or any of the excipients. It is strictly contraindicated during the third trimester of pregnancy, in children and adolescents aged less than 14 years, and with the concomitant use of other diclofenac-containing products or oral NSAIDs. It should only be applied to intact, non-diseased skin and must not be applied to skin wounds or open injuries. Avoid contact with the eyes or mucous membranes. Major potential drug interactions (if systemically absorbed) include lithium, digoxin, anticoagulants, antidiabetic agents, ciclosporin, methotrexate, quinolone antimicrobials, diuretics, mifepristone, and antihypertensives.

Side Effects (Adverse Reactions): Usually well tolerated, though local irritation, erythema, pruritus, or dermatitis (including contact dermatitis) may occasionally occur. Common side effects include rash and eczema. Rare or very rare side effects include bullous dermatitis, photosensitivity reactions, hypersensitivity (including urticaria), angioneurotic oedema, pustular rash, and asthma.

Nutritional Information (per 1 g): Diclofenac diethylamine 1.16% w/w (equivalent to diclofenac sodium 1.00% w/w), linseed oil 3.00% w/w, methyl salicylate 10.00% w/w, menthol 5.00% w/w, carbomer 940, disodium edetate, butylated hydroxytoluene, propylene glycol, benzyl alcohol, isopropyl alcohol, hydrogenated castor oil (polyoxyl 40), triethanolamine, polysorbate 80, butylated hydroxyanisole, citric acid monohydrate, purified water.

Instructions for Use / Dosage: For topical administration. Adults and children 14 years and over: Rub the gel gently into the skin. Depending on the size of the affected site to be treated, the required amount of gel should be applied 3 to 4 times a day. Wash hands after application unless they are the site being treated. If symptoms do not improve by day 7, or if they worsen within the first 7 days, a consultation with a doctor is recommended. Do not use for more than 14 days unless recommended by a doctor. The usual adult dosage may be used in the elderly.

Regulatory Information: NAFDAC Registration Number: 04-7092. Manufactured by: Gopaldas Visram & Company Ltd.