Declofenac 25 mg - 30 Tablets

Analgesic, nonopioid; nonsteroidal anti-inflammatory drug (NSAID), used in the treatment of pain, ankylosing spondylitis, dysmenorrhea, gout, migraine, osteoarthritis and rheumatoid arthritis.

-Do not crush delayed-release or ER tablets. May administer IR formulations with food or milk to avoid gastric distress. - Suppository : Remove plastic film prior to insertion; insert well into the rectum; for best results, bowels should be empty prior to insertion

-Common: Edema, nausea , hypertension, diaphoresis , pruritus , skin rash, abdominal pain, constipation , diarrhea , duodenal ulcer, dyspepsia , flatulence , gastric ulcer, gastrointestinal hemorrhage, gastrointestinal perforation, heartburn, upper abdominal pain , vomiting, Increased liver enzymes, increased serum alanine aminotransferase , increased serum aspartate aminotransferase, dizziness , drowsiness , headache, back pain, musculoskeletal pain, tinnitus, increased serum creatinine ,renal function abnormality, sinusitis. -Less common: Acute myocardial infarction, cardiac arrhythmia, cardiac failure, flushing, hypotension, palpitations, syncope, tachycardia, vasculitis, alopecia, ecchymoses, erythema multiforme, exfoliative dermatitis, skin photosensitivity, Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria, hyperglycemia, weight changes, change in appetite, colitis, eructation, esophagitis, gastritis, glossitis, hematemesis, melena, pancreatitis, peptic ulcer, stomatitis, xerostomia, cystitis, dysuria, hematuria, oliguria, proteinuria, agranulocytosis, aplastic anemia, eosinophilia, hemolytic anemia, leukopenia, lymphadenopathy, pancytopenia, purpuric disease, rectal hemorrhage, thrombocytopenia, fulminant hepatitis, hepatic failure.

-Should not be taken by patients suffering from hypersensitivity to diclofenac (eg, anaphylactoid reactions, serious skin reactions) ; should not be given to patients with a history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other nonsteroidal anti-inflammatory drugs. -NSAIDs cause an increased risk of serious gastrointestinal inflammation, ulceration, bleeding, and perforation (may be fatal); elderly patients and patients with history of peptic ulcer disease and/or GI bleeding are at greater risk for serious gastrointestinal events. These events may occur at any time during therapy. - Platelet adhesion and aggregation may be decreased; may prolong bleeding time. -NSAID use may increase the risk of hyperkalemia, particularly in the elderly, diabetics, renal disease, and with concomitant use of other agents capable of inducing hyperkalemia (eg, ACE inhibitors). -Use the lowest effective dose for the shortest duration. Avoid or use with caution in patients at risk for cardiovascular disease, GI disease, kidney impairment, chronic liver disease. -In case of kidney diseases: creatinine clearance ≥60 mL/minute: No dosage adjustment necessary. creatinine clearance >30 to <60 mL/minute: No dosage adjustment necessary, however, use of analgesics other than nonsteroidal anti-inflammatory drugs may be preferred. creatinine clearance ≤30 mL/minute: Avoid use due to increased risk of acute kidney injury. -NSAIDs cause an increased risk of serious (and potentially fatal) adverse cardiovascular thrombotic events, including myocardial infarction and stroke. Risk may occur early during treatment and may increase with duration of use. -Incase of over dose be ready to tell or show what was taken, how much and when it happened, and seek immediate medical attention. For additional information call us on 16676. Always tell your physician your detailed medical history.

Store at room temperature.

-Agents with Antiplatelet Properties (e.g., P2Y12 inhibitors, NSAIDs, SSRIs, etc.): May enhance the antiplatelet effect of other Agents with Antiplatelet Properties. -Alcohol (Ethyl): May enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents. Specifically, the risk of gastrointestinal bleeding may be increased with this combination. -Angiotensin II Receptor Blockers: May enhance the adverse/toxic effect of Nonsteroidal anti-inflammatory agents. The combination may result in a significant decrease in renal function. -Angiotensin-Converting Enzyme Inhibitors: May enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents. -Anticoagulants: Agents with Antiplatelet Properties may enhance the anticoagulant effect of Anticoagulants. -Apixaban: Nonsteroidal Anti-Inflammatory Agentsmay enhance the adverse/toxic effect of Apixaban. Specifically, the risk of bleeding may be increased. -Beta-Blockers: Nonsteroidal Anti-Inflammatory Agents may diminish the antihypertensive effect of Beta-Blockers. -Bile Acid Sequestrants: May decrease the absorption of Nonsteroidal Anti-Inflammatory Agents. -Corticosteroids (Systemic): May enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents. -Digoxin: Nonsteroidal Anti-Inflammatory Agents may increase the serum concentration of Digoxin -Diosmin: May increase the serum concentration of Diclofenac. -Enoxaparin: Nonsteroidal Anti-Inflammatory Agents may enhance the anticoagulant effect of Enoxaparin. -Metformin: Nonsteroidal Anti-Inflammatory Agents may enhance the adverse/toxic effect of Metformin. -Multivitamins/Minerals ( Folate, Iron): May enhance the antiplatelet effect of Agents with Antiplatelet Properties. -Salicylates: Nonsteroidal Anti-Inflammatory Agents may enhance the adverse/toxic effect of Salicylates. An increased risk of bleeding may be associated with use of this combination.

-Maternal use of NSAIDs should be avoided beginning at 20 weeks' gestation. If NSAID use is necessary between 20 and 30 weeks' gestation, limit use to the lowest effective dose and shortest duration possible. -Nonopioid analgesics, including nonsteroidal anti-inflammatory drugs (NSAIDs), are preferred for breastfeeding patients who require pain control peripartum or for surgery outside of the postpartum period . NSAIDs may be used for the management of acute migraine in lactating patients; diclofenac is considered compatible with breastfeeding when a NSAID is required.

EL NASR