Artinil-K (75mg) 20 Tablets

(Diclofenac) belongs to a group of medicines called non- steroidal anti-inflammatory drugs (NSAIDs), which are used to treat pain and inflammation. Diclofenac, a phenyl acetic acid derivative, is chemically described as 2-[(2, 6-dichlorophenyl) amino] benzene acetic acid, monosodium salt. Diclofenac works by inhibiting cyclooxygenase-1 and -2, the enzymes that are responsible for production of a prostaglandin; (PG) G2, which is the precursor to other prostaglandins. These molecules have broad actions in the mechanism of pain and inflammation and the inhibition of production of these prostaglandins by diclofenac results in cure from inflammation and pain.

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Nonsteroidal anti-inflammatory drug (NSAID)

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Tablet

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The uses associated with this product include:

• Rheumatoid Arthritis
• Osteoarthritis
• Ankylosing Spondylitis
• Acute Gout
• Acute Musculo-Skeletal Disorders (e.g., Periarthritis, such as frozen shoulder)
• Tendinitis
• Tenosynovitis
• Bursitis

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Dose must be taken according to the doctor’s advice only; doses given below are suggested as supportive literature for better understanding in some areas of requirements. General Recommendations: Immediate release tablet dose: 50mg after every 8 -12 hours. Use the lowest effective dose of Diclofenac for the shortest duration necessary to control symptoms. Usual recommended dose is 75mg- 150mg daily in two or three divided doses. The maximum recommended daily dose is 150mg. Adult dose: For osteoarthritis and rheumatoid arthritis:Diclofenac potassium 50mg after every 8 hours 2 or 3 times a day. For menstrual Cramps: 50mg 3 times a day. Your doctor may direct you to take 100mg as the first dose only. For migraine headaches: Oral solution, one packet of 50mg as a single, one time dose, in 30-60 mL of water. For Ankylosing Spondylitis: 50mg orally after every 12 hours. Child dose: For Juvenile Idiopathic arthritis:Children of age 3 years and older: 2-3 mg/kg/day for up to 4 weeks.

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Consult your doctor for management of overdose. Overdose can cause symptoms such as headache, nausea, vomiting, epigastric pain, gastrointestinal bleeding, diarrhea, dizziness, disorientation, excitation, coma, drowsiness, sinnitus, fainting or convulsions. In the case of significant poisoning acute renal failure and liver damage are possible. Supportive measures and symptomatic treatment should be given for complications such as hypotension, renal failure, convulsions, gastrointestinal disorder, and respiratory depression. Activated charcoal may be considered after ingestion of a potentially toxic overdose, and gastric decontamination (e.g., vomiting, gastric lavage) after ingestion of a potentially life threatening overdose.

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In case you missed any dose, take the next dose as soon as you remember, but don't double your next dose to compensate for the missed one.

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Take this medicine with food to avoid the risks of gastro-intestinal bleeding.

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Diclofenac is contraindicated in patients with hypersensitivity to the active substance or any of the excipients, gastric or intestinal ulcer, bleeding or perforation, history of gastrointestinal bleeding or perforation relating to previous NSAID therapy, severe hepatic, renal or cardiac failure. Diclofenac should not be given to patients with the aspirin triad.

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The side effects that may occur include:

• Headache
• Dizziness
• Vertigo
• Nausea
• Vomiting
• Diarrhea
• Dyspepsia
• Abdominal Pain
• Flatulence
• Anorexia
• Elevated Serum Transaminases
• Rash
• Hypersensitivity Reactions
• Anaphylactic and Anaphylactoid Reactions (including hypotension and shock)
• Somnolence
• Tiredness
• Asthma (including dyspnea)
• Gastritis
• Gastrointestinal Hemorrhage
• Hematemesis
• Hemorrhagic Melaena
• Gastrointestinal Ulcer (with or without bleeding or perforation, sometimes fatal, particularly in the elderly)
• Hepatitis
• Jaundice
• Liver Disorder
• Urticaria
• Edema

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Ulceration and bleeding may occur even in the absence of previous GI tract symptoms. NSAIDs should be prescribed with extreme caution in those with a prior history of ulcer disease or gastrointestinal bleeding. Special care should be taken in treating this population in elderly people to avoid fatal Gastro-intestinal events. To minimize the potential risk for an adverse Gl event, the lowest effective dose should be used for the shortest possible duration. Treatment should be discontinued if clinical signs and symptoms consistent with liver disease develop, or if systemic manifestations occur (e.g., eosinophilia, rash, etc.). It can cross placenta, can cause birth defects and miscarriage due to cyclooxygenase-2 inhibition interfering with implantation. So its use must be monitored by registered medical practitioners.

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The drug interactions with diclofenac potassium include:

• Anticoagulants (e.g., warfarin) – Can increase the risk of bleeding.
• Other NSAIDs (e.g., ibuprofen) – Can increase the risk of gastrointestinal bleeding and ulceration.
• ACE Inhibitors (e.g., lisinopril) – Can reduce the antihypertensive effects of ACE inhibitors.

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Using tobacco products like cigarettes along with diclofenac may increase the risk of gastrointestinal (GI) side effects including peptic ulcers and GI bleeding. Taking with milk and food will help to avoid GI bleeding. Coffee and spicy food should be avoided along with use.

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Store at 25°C. Protect from sunlight and moisture.

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