RHUMADIC PLUS Tablet

Indications & Dosage:

For treatment of pain or primary dysmenorrhea the recommended dosage is one tablet t.i.d.

For the relief of osteoarthritis the recommended dosage is one tablet b.i.d or t.i.d.

For the relief of rheumatoid arthritis the recommended dosage is one tablet b.i.d or t.i.d.

In patients taking Diclofenac or other NSAIDs, the most frequently reported adverse experiences occurring in approximately 1%25-10% of patients are:

Gastrointestinal experiences including: abdominal pain, constipation, diarrhea, dyspepsia, flatulence, gross bleeding/perforation, heartburn, nausea, GI ulcers (gastric/duodenal) and vomiting.

Abnormal renal function, anemia, dizziness, edema, elevated liver enzymes, headaches, increased bleeding time, pruritus, rashes and tinnitus.

Body as a whole: fever infection, sepsis

Cardiovascular system: congestive heart failure, hypertension, tachycardia, syncope

Digestive system: dry mouth, esophagitis, gastric/peptic ulcers, gastritis, gastrointestinal bleeding, glossitis, hematemesis, hepatits, jaundice.

Hemic and lymphatic system: ecchymosis, eosinophilia, leukopenia, melena, purpura, rectal bleeding, stomatitis, thrombocytopenia

Metabolic and nutritional: weight changes

Nervous system: anxiety, asthenia, confusion, depression, dream abnormalities, drowsiness, insomnia, malaise, nervousness, paresthesia, somnolence, tremors, malaise, nervousness, paresthesia, somnolence, tremors, vertigo

Respiratory system: asthma, dyspnea

Skin and appendages: alopecia, photosensitivity, sweating increased

Special senses: blurred vision urogenital system: cystitis, dysuria, hematuria, interstitial nephritis, orliguria/polyuria, proteinuria, renal failure.

Aspirin, Methotrexate, Cyclosporine, ACE inhibitors, Furosemide, Lithrium, Warfarin

Cardiovascular Thrombotic Events

Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, myocardial infarction, and stroke, which can be fatal.

Hypertension

NSAIDs can lead to onset of new hypertension or worsening of pre-existing hypertension, either of which may contribute to the increased incidence of CV events.

Congestive Heart Failure and Edema

Fluid retension and edema have been observed in some patients taking NSAIDs.

Renal Effects

Caution should be used when initiating treatment with Diclofenac sodium in patients with considerablet dehydration.

Hepatic Effects

Elevations of one or more liver tests may occur during therapy with Diclofenac sodium.

In late pregnancy, as with other NSAIDs, Cataflom should be avoided because it may cause premature closure of the ductus arteriosus.

General

Anemia is sometimes seen in patients receiving NSAIDs, including diclofenac sodium.

NSAIDs inhibit platelet aggregation and have been shown to prolong bleeding time in some patients.

Pre-existing Asthma: Patients with asthma may have aspirin sensitive asthma.

Diclofenac sodium is a nonsteroidal anti-inflammatory drug (NSAID) that exhibits anti-inflammatory, analgesic, and antipyretic activities in animal models. The mechanism of action of Diclofenac sodium, like that of other NSAIDs, is not completely understood but may be related to prostaglandin synthetase inhibition.

The main mechanism of action of paracetamol is considered to be the inhibition of cycloxygenase (COX), and recent findings suggest that it is highly selective for COX-2 Paracetamol is metabolised primarily in the liver, into non-toxic products.