Product Name & Strength: Sanofi Fleming 625mg, 14 Tablets
Indications (Approved Uses): Approved for the treatment of mild to moderate bacterial infections caused by susceptible beta-lactamase-producing organisms. These include upper respiratory tract infections such as acute bacterial sinusitis and otitis media, lower respiratory tract infections including acute exacerbations of chronic bronchitis and community-acquired pneumonia, urinary tract infections (cystitis and pyelonephritis), skin and soft tissue infections, and dental infections.
Contraindications (Safety Warnings): This medication is strictly contraindicated in patients with a known history of hypersensitivity to penicillins, cephalosporins, or any other beta-lactam antibacterial agents. It must absolutely not be used in individuals with a history of co-amoxiclav-associated jaundice or hepatic dysfunction. It should be avoided in patients with suspected infectious mononucleosis (glandular fever) due to a high risk of developing an erythematous skin rash. Concomitant use with allopurinol increases the risk of allergic skin reactions, and it may interact with oral anticoagulants, requiring monitoring of prothrombin time.
Side Effects (Adverse Reactions): Known adverse reactions frequently include gastrointestinal disturbances such as diarrhoea, nausea, vomiting, and indigestion. Patients may also experience mucocutaneous candidiasis (oral or vaginal thrush), dizziness, and headache. Less common but severe reactions include elevated liver enzymes, cholestatic jaundice, hepatitis, reversible leucopenia, thrombocytopenia, and severe hypersensitivity or dermatological reactions including anaphylaxis, erythema multiforme, and Stevens-Johnson syndrome.
Active / Nutritional Information: Amoxicillin (formulated as amoxicillin trihydrate) 500 mg, Clavulanic acid (formulated as potassium clavulanate) 125 mg.
Instructions for Use / Dosage: For oral administration. The standard universal dosage for adults and children weighing 40 kg and over is typically one 625mg tablet taken two to three times daily, depending on the severity of the infection. The tablets should be swallowed whole with a glass of water at the start of a meal to minimise potential gastrointestinal intolerance. Always consult the physical package labelling for exact manufacturer dosage guidelines or follow the direct advice of a healthcare professional.
