Description:

Flotac 75mg Capsules is a modified-release (dual-release) nonsteroidal anti-inflammatory drug (NSAID) formulation combining diclofenac with cholestyramine (a bile acid sequestrant resin). The cholestyramine acts as a carrier for diclofenac resinate, enabling rapid initial absorption for quick pain relief and prolonged sustained release for extended action over several hours. It is indicated for the symptomatic treatment of pain and inflammation in conditions such as osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, acute musculoskeletal disorders, dysmenorrhea, gout flares, migraine, postoperative pain, and other inflammatory/painful states. The “Duo” or dual-release design improves tolerability (reduced GI irritation compared to standard diclofenac) while maintaining efficacy.

Prescription:

Prescription-only (POM / Rx required in Ghana; dispensed by pharmacies with a valid prescription from a doctor due to NSAID risks including gastrointestinal bleeding, cardiovascular events, and renal effects; not freely OTC for prolonged use).

Therapeutic Category:

Nonsteroidal Anti-Inflammatory Drug (NSAID) / Analgesic / Anti-inflammatory / Antipyretic (Modified-release diclofenac resinate with cholestyramine.

Active Ingredients/Composition:

• Active ingredient: Diclofenac cholestyramine (diclofenac resinate) 145.6 mg per capsule (equivalent to 75 mg diclofenac sodium or diclofenac base).
• Cholestyramine serves as the resin carrier for controlled release (no separate cholestyramine dose for lipid effects). Other ingredients (excipients, typical): Hard gelatin capsule shell, sugar spheres, hydroxypropyl cellulose, methacrylic acid copolymer, triethyl citrate, talc, titanium dioxide (E171), indigo carmine (E132), and other coating/polymer agents for dual-release pellets. Capsules are hard gelatin, often colored (e.g., blue/white or similar).

Vitamins: None.

Minerals: None.

Variant:

• Flotac 75mg Capsules (modified/dual-release, 20 capsules per pack common in Ghana). Related variants: Standard diclofenac formulations (e.g., immediate-release 50mg tablets, prolonged-release 100mg tablets, injections, or suppositories from Novartis or generics). No major variants beyond the 75mg dual-release capsule for Flotac.

Consume Type:

Oral – Hard capsule (swallow whole with water; do not crush, chew, or open to preserve modified-release mechanism).

Directions/Usage:

Take as prescribed by a doctor (lowest effective dose/shortest duration).

• Adults: Typically 1 capsule (75 mg) once or twice daily (maximum 150 mg/day), with or after food/milk to reduce stomach upset.
• Take at consistent times; do not exceed recommended dose.
• Duration: Short-term for acute pain; longer for chronic conditions with monitoring (e.g., blood pressure, stomach symptoms).
• If no improvement or worsening, consult doctor.

Common Side Effects: Common:

• Gastrointestinal: Indigestion, heartburn, nausea, abdominal pain, diarrhea, constipation.
• Central: Headache, dizziness, drowsiness.
• Other: Rash, edema (swelling), increased blood pressure, flushing. Rare/serious (seek immediate help): Stomach ulcers/bleeding (black stools, vomiting blood), severe allergic reactions (rash/swelling/breathing difficulty), heart attack/stroke signs (chest pain, shortness of breath), liver issues (jaundice), kidney problems, or severe skin reactions.

Package Type:

Blister packs (typically 10 capsules per strip, packs of 2×10 = 20 capsules; foil blisters in carton with patient information leaflet).

Storage Advice:

Store at room temperature (below 25–30°C) in a cool, dry place, away from direct sunlight, heat, and moisture. Keep in original packaging, tightly closed, and out of reach of children.

Safety Advice:

• Increased risk of serious cardiovascular (heart attack/stroke), gastrointestinal (ulcers/bleeding/perforation), and renal events—use cautiously in elderly, those with heart disease, hypertension, or ulcer history.
• Contraindicated if allergic to diclofenac/NSAIDs/aspirin (asthma triad), active peptic ulcer, severe heart/liver/kidney failure, post-CABG surgery, or third-trimester pregnancy (fetal harm).
• Caution in pregnancy/planning (avoid if possible), breastfeeding, or on anticoagulants/steroids.
• Avoid alcohol/other NSAIDs (increased bleeding risk).
• Inform doctor of all medications (interacts with diuretics, ACE inhibitors, etc.).
• If black stools, severe pain, swelling, or chest pain occurs, seek immediate help. Regular monitoring for long-term use.

Product Substitutes:

Similar diclofenac modified/prolonged-release 75mg capsules/tablets in Ghana:

• Other diclofenac 75mg ER generics (e.g., Diclofam, Voltaren Retard equivalents).
• Standard diclofenac 50mg/100mg tablets or injections.
• Alternatives: Ibuprofen, Naproxen, Celecoxib (COX-2 selective), Etoricoxib (consult doctor for risk profile). Widely available at pharmacies like Scab Pharmacy, Meldinpharma, Country Medical Pharmacy in Accra.

Manufacturer/Marketer:

Novartis Pharma

Country of Origin:

Switzerland