Novartis Flotac 75mg Diclofenac Cholestyramine, 20 Capsules

Product Name & Strength: Flotac 75 mg Capsules (Diclofenac colestyramine 145.6 mg equivalent to 75 mg diclofenac sodium).

Indications (Approved Uses): Symptomatic treatment of pain and inflammation in acute arthritis, including gout attacks; chronic arthritis, especially rheumatoid arthritis (chronic polyarthritis); ankylosing spondylitis and other inflammatory rheumatic diseases of the vertebral column; irritation in cases of osteoarthritis and spondylarthritis; inflammatory rheumatic soft-tissue diseases; and painful swelling or inflammation following injuries or surgery. It is also indicated for tumour pain, particularly when the skeleton is affected or in cases of inflammatory peritumoural oedema.

Contraindications (Safety Warnings): Contraindicated in patients with known hypersensitivity to the active substance or excipients, or those with a history of bronchospasm, asthma, rhinitis, or urticaria following the intake of acetylsalicylic acid or other NSAIDs. It must not be used by patients with unexplained haematopoietic disorders, active or past history of recurrent peptic ulcers or haemorrhage, gastrointestinal bleeding or perforation associated with previous NSAID therapy, active cerebrovascular bleeding, severe hepatic dysfunction, severe renal dysfunction (GFR <15 mL/min/1.73 m²), or severe heart failure (NYHA II-IV). It is also contraindicated in patients with ischaemic heart disease, peripheral arterial occlusive disease, cerebrovascular disease, and during the third trimester of pregnancy. It is not suitable for children or adolescents. Use with caution in patients with history of gastrointestinal disease (ulcerative colitis, Crohn's disease), hypertension, or existing cardiovascular risk factors.

Side Effects (Adverse Reactions): Common side effects include gastrointestinal symptoms such as nausea, vomiting, diarrhoea, dyspepsia, abdominal pain, flatulence, and constipation. Nervous system effects such as headache, dizziness, and drowsiness are also common. Other reactions include inflammatory skin changes, oedema, and hypertension. Serious but rare or very rare adverse reactions include gastrointestinal haemorrhage or perforation, myocardial infarction, cardiac failure, hepatitis, jaundice, acute kidney injury, anaemia, leukopenia, thrombocytopenia, and severe bullous skin reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis.

Nutritional Information (per capsule): Each hard capsule contains 145.6 mg diclofenac colestyramine (equivalent to 75 mg diclofenac sodium). Excipients include basic cation-exchange resin, titanium dioxide (E171), iron oxide yellow (E172), gelatine, medicinal charcoal, and magnesium stearate.

Instructions for Use / Dosage: For oral administration. Adults: The recommended dosage range is 1 up to a maximum of 2 capsules per day, divided into two single doses, depending on disease severity. For milder cases and long-term treatment, 1 capsule daily is often sufficient. The capsule must be swallowed whole with plenty of liquid and should not be divided. It is recommended to take with meals if the patient has a sensitive stomach.

Regulatory Information: NAFDAC Registration Number: A4-1921. Manufactured by: Novartis Pharma.