Composition
Each capsules contains:
- Paracetamol BP 500mg
- Diclofenac sodium BP 50mg
- Caffeine (anhydrous) BP 30mg
Experiments
Lactose monohydrate, colloidal anhydrous silica, magnesium stearate, size "0" EHG capsule. Approved color used in hard Gelatin capsule shell.
Pharmacology
RONFIT FORTE has combination of Paracetamol, Diclofenac Sodium &, Caffeine. Diclofenac sodium has potent anti-inflammatory, analgesic and antipyretic actions. The mechanism of actions is inhibition of the enzyme cyclo-oxygenase in the pathway of prostaglandin (PG) synthesis. PGs are known to be associated with inflammation. Its ability to inhibit prostaglandin synthesis is involved in its anti-inflammatory activity, as well as contributes to its efficacy in relieving pain related to inflammation and primary dysmenorrheal. With regard to its analgesic effect, Diclofenac Sodium is not a narcotic analgesic.
Paracetamol has analgesic and anti-pyretic properties due to its ability to inhibit prostaglandin synthesis. Paracetamol produces analgesia by elevation of the pain threshold and antipyresis through action on the hypothalamic heat-regulating center.
Caffeine is structurally related to other methylxanthines, theophylline and theobromine.
These include:
(1) stimulation of the respiratory center
(2) increased minute ventilation
(3) decreased threshold to hypercapnia
(4) increased response to hypercapnia
(5) increased skeletal muscle tone
(6) decreased diaphragmatic fatigue
(7) increased metabolic rate
(8) increased oxygen consumption.
Indication
RONFIT FORTE is indicated in the treatment of painful rheumatic disorders such as rheumatoid arthritis, osteoarthritis, ankylosing spondylitis and acute gout. Acute musculoskeletal disorders and soft tissue inflammation such as periarthritis, sprains, strains, tenosynovitis, bursitis, pain in fractures and dislocation. Relief of pain and inflammation associated with orthopedic, dental, gynecological and other minor surgical procedures.
Dosage
Adults, elderly and children over 12 years of age:
1 Capsule two or three times daily. Not recommended for children under 12 years of age or as directed by the physician.
Contra-Indication: RONFIT FORTE is contra indicated in patients having hypersensitivity to any ingredients of formulation.
Caution: Many causes severe liver function damage. Patients suffering from liver or kidney disease should take paracetamol under medical supervision. Consult a doctor if no relief is obtained from the recommended dosage. Do not use continuously for more than 10 days without consulting a doctor.
Side effects: Redness of the rectal mucous membranes, Allergic reactions, Exanthema, urticaria, Liver damage, increase in creatinine, abdominal pain, constipation, diarrhea, dyspepsia, flatulence, gross bleeding/perforation, heartburn, nausea, ulcers and vomiting. Abnormal renal function, anemia, dizziness, edema, elevated liver enzymes, headache, increased bleeding time, pruritus, rashes and tinnitus, Fever, infection, sepsis, congestive heart failure, hypertension, tachycardia, syncope, dry mouth, esophagitis, gastric/peptic ulcers, gastritis, gastrointestinal bleeding, glossitis, hematemesis, hepatitis, jaundice, ecchymosis, eosinophilia, leukopenia, melena, purpura, rectal bleeding, stomatitis, thrombocytopenia, anxiety, asthenia, confusion, depression, dream abnormalities, drowsiness, insomnia, malaise, nervousness, paresthesia, somnolence, tremors, vertigo, asthma, dyspnea, alopecia, photosensitivity, sweating increased, blurred vision, cystitis, dysuria, hematuria, interstitial nephritis, oliguria/polyuria, proteinuria, renal failure.
Pregnancy Teratogenic Effects
Pregnancy Category C:
There are no adequate and well-controlled studies in pregnant women.
Because of the known effects of nonsteroidal anti-inflammatory drugs on the fetal cardiovascular system (closure of ductus arteriosus), use during pregnancy (particularly late pregnancy) should be avoided.
Nursing Mothers: Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from diclofenac sodium and paracetamol tablets, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Pediatric Use: Safety and effectiveness in pediatric patients have not been established.
Drug Interactions
Aspirin: concomitant administration can result in lower plasma concentration, peak plasma levels and AUC values.
Digoxin, Methotrexate, Cyclosporin: Diclofenac Sodium may affect renal prostaglandins and increase the toxicity of certain drugs. Ingestion of Diclofenac Sodium may increase serum concentrations of digoxin and methotrexate and increase cyclosporine nephrotoxicity.
Lithium: Diclofenac Sodium decreases lithium renal clearance and increase to insulin or oral hypoglycemic agents.
Diuretics: Diclofenac Sodium can inhibit the activity of diuretics. Concomitant treatment with potassium-sparing diuretics may be associated with increased serum potassium levels.
Cholestyramine: Reduces absorption of Paracetamol.
Activated charcoal: Administered immediately reduces absorption of Paracetamol.
Domperidone & metoclopramide: Enhance absorption of Paracetamol.
Alcohol: Chronic excessive ingestion of alcohol potentiates hepatoxicity of Paracetamol.
Zidovudine: Effects of zidovudine may be decreased.
Known Symptoms of Overdosage and Particulars of its Treatment
Overdose can cause symptoms such as vomiting, gastrointestinal hemorrhage, diarrhea, dizziness, tinnitus or convulsions. In the event of significant poisoning, acute renal failure and liver damage are possible.
Management of acute poisoning with NSAIDs essentially consists of supportive measures and symptomatic treatment. These should be given for complications such as hypotension, renal failure, convulsions, gastrointestinal disorder and respiratory depression.
Special measures such as forced diuresis, dialysis or hemoperfusion are probably of no help in eliminating NSAIDS due to the high protein binding and extensive metabolism.
Activated charcoal may be considered in case of a potentially toxic overdose, and gastric decontamination (e.g. vomiting, gastric lavage) in case of a potentially life- threatening overdose.
Storage: Store in a dry place below 30°C. Protect from light.
Keep medicines out of reach and sight of children.
Shelf life: 36 Months
Presentation: 2x10 Capsules
Date of Publication: May 2021
Date of Review: Every three years
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