+ Product Information
COMPOSITION
Each film-coated tablet contains:
- Nabumetone ...................................... 1000 mg
Excipients:
Microcrystalline cellulose (Avicel), sodium starch glycolate type A, PVP K30, sodium lauryl sulfate, magnesium stearate, hypromellose 606, hypromellose 615, macrogol 6000, talc, titanium dioxide.
DOSAGE FORM
Film-coated tablet.
White to off-white film-coated tablets with intact edges and surfaces.
PHARMACOLOGICAL PROPERTIES / USES (Nacofen)
Nabumetone is a non-acidic non-steroidal anti-inflammatory drug (NSAID) that relatively weakly inhibits prostaglandin synthesis.
It has minimal effect on the gastric mucosa and exhibits weak inhibition of collagen-induced platelet aggregation without affecting bleeding time.
After oral administration, nabumetone is rapidly metabolized in the liver into 6-methoxy-2-naphthylacetic acid (6-MNA), an active inhibitor of prostaglandin synthesis.
DOSAGE AND ADMINISTRATION (Nacofen)
General:
Use strictly as prescribed by a physician.
Adults
500 mg tablets:
- Recommended dose: 2 tablets (1 g) once daily at bedtime.
- In severe or persistent symptoms, an additional 1–2 tablets (500 mg – 1 g) may be taken in the morning.
750 mg tablets:
- Usual dose: 1 tablet once daily at bedtime.
- In severe, prolonged, or acute cases, an additional tablet may be taken in the morning.
Elderly:
- The daily dose should not exceed 2 tablets of 500 mg (1 g).
- In some cases, 1 tablet of 500 mg may be sufficient.
Method of administration:
Oral use. Swallow the tablet with water, during or after meals.
ADVERSE EFFECTS (Nacofen)
Common:
- Rash, pruritus, edema, hypertension
- Tinnitus, ear disorders
- Diarrhea, constipation, dyspepsia, gastritis
- Nausea, abdominal pain, flatulence
Uncommon:
- Drowsiness, dizziness, headache, paresthesia
- Anxiety, confusion, insomnia
- Visual disturbances, eye disorders
- Duodenal ulcer, gastrointestinal bleeding, gastric ulcer
- Black stools, vomiting, stomatitis, dry mouth
- Hypersensitivity, urticaria, sweating
- Dyspnea, respiratory disorders, epistaxis
- Muscle disorders, urinary disorders
- Fatigue, asthenia, elevated liver enzymes
Rare:
- Thrombocytopenia
- Renal failure, nephrotic syndrome
- Interstitial pneumonia, pancreatitis
- Anaphylactic shock, anaphylactic reactions
- Menorrhagia
- Hepatic failure, jaundice
- Severe skin reactions including toxic epidermal necrolysis, Stevens-Johnson syndrome
- Drug reaction with eosinophilia and systemic symptoms (DRESS)
- Erythema multiforme, angioedema, pseudo-anaphylaxis, alopecia
Frequency not known:
- Malaise, interstitial nephritis
- Purpura, depression, hallucinations
- Neutropenia, agranulocytosis, leukopenia
- Aplastic anemia, hemolytic anemia
PRESENTATION (Nacofen)
Dosage form: Film-coated tablets
Packaging:
Box of 1, 2, 3, 5, or 10 blisters x 10 tablets
Shelf life: 36 months from the date of manufacture
STORAGE
Store in a dry, cool, and clean place.
Protect from direct sunlight and temperatures above 30°C.
Keep out of reach of children.
