Description
COMPOSITION :
Each enteric-coated caplet contains 25 mg and 50 mg Diclofenac sodium.
PHARMACOLOGY :
Prostanac is a nonsteroidal compound with pronounced antirheumatic, anti – inflammatory, analgesic properties. Diclofenac
sodium is well absorbed in the gastrointestinal tract. Plasma peak level will be achieved within 2 hours after administration.
Largest portion is excreted in urine and smaller portion in bile.
INDICATIONS :
Inflammations
Degenerative forms of rheumatism ; rheumatoidarthritis, ankylosing spondylitis, osteoarthritis, spondylarthritis, etc.
Nonarticular rheumatism.
CONTRAINDICATIONS :
Peptic ulcer.
Known hypersensitivity to diclofenac sodium.
Patients in whom attacks of asthma, urticaria or acute rhinitis are precipitated by acetylsalicylic acid or by other drugs
with prostaglandin synthetase-inhibiting activity.
Not to be used for children.
ADVERSE REACTIONS :
Gastrointestinal Tract : Occasional: epigastric pain, other gastrointestinal disorders, eg nausea, vomiting, diarrhea,
abdominal cramps, dyspepsia, flatulence, anorexia. Rare gastrointestinal bleeding, haematemesis, melaena, peptic
ulcer with or without bleeding or perforation, bloody diarrhoea, pancreatitis. Isolated cases : lower gut disorders, eg
nonspecific haemorrhagic colitis and exacerbation of ulcerative colitis or Crohn’s proctocolitis; aphthous stomatitis,
glossitis, oesophageal lesions, constipation.
Central Nervous System :
Occasional : headache, dizziness or vertigo
Rare : drowsiness
Isolated cases : disturbances of sensation including paraesthesia, memory disturbances, disorientation, disturbances of
vision (blurred vision, diplopia, impaired hearing, tinnitus, insomnia, irritability, convulsions, depression, anxiety,
nightmares, tremor, psychotic reactions, taste alteration disorders.
Skin :
Occasional : rashes or skin eruptions
Rare : urticaria
Isolated cases : bullous eruptions, eczema, erythema multiforme, Stevens-Johnson syndrome, Lyell’s syndrome (acute
toxic epidermolysis), erythroderma (ex-foliative dermatitis), loss of hair, photosensitivity reaction, purpura, including
allergic purpura.
Kidney :
Isolated cases : acute renal failure, urinary abnormalities, eg haematuria, proteinuria, interstitial nephritis, nephrotic
syndrome, papillary necrosis.
Liver :
Occasional : Elevation of serum aminotransferase enzymes (SGOT, SGPT).
Rare : Hepatitis with or without jaundice.
Isolated cases : fulminant hepatitis.
Blood :
Isolated cases : thrombocytopenia, leukopenia, anaemia, (haemolytic anaemia, aplastic anaemia), agranulocytosis.
Hypersensitivity :
Rare : Hypersensitivity reaction, eg asthma, anaphylactic/anaphylactoid systemic including hypotension.
PRECAUTIONS :
Symptoms / history of gastrointestinal disease impaired hepatic, cardiac or renal function.
Can not be used in patients in the 1st trimester of pregnancy and lactation.
The treatment with diclofenac sodium must be discontinued if peptic ulcer is evident.
Care must be taken in elderly patients and low body weight.
Central nervous disturbances can influence the ability to drive and use machines.
DOSAGE :
Adult : Initially 100 – 150 mg daily in divided dose, followed by 75 – 100 mg daily in divided doses.
STORAGE :
Keep in a cool and dry place.
PACKING :
Box of 5 x 10’s caplets.
PROSTANAC – 25 : Reg.No.DKL 9221005907A1
PROSTANAC – 50 : Reg.No.DKL 9221005907B1
On Doctors Prescription Only.
