Skelan Forte

Relief of mild to moderate pain & inflammation including headache, migraine, backache, muscular aches, menstrual cramps, minor arthritis pain, toothache, & pain associated w/ common cold & flu. Fever reduction.

Adult 18-65 yr 1 tab every 8-12 hr. Elderly ≥65 yr 1 tab every 12 hr.

Should be taken with food: Take w/ a full glass of water.

Hypersensitivity to naproxen Na, aspirin, NSAIDs, & paracetamol. Patients w/ asthma, urticaria, or allergic reaction after taking NSAIDs; active peptic/duodenal/GI ulcers, bleeding or perforation related to previous NSAID therapy; active recurrent peptic ulcer/hemorrhage unrelated to previous NSAID therapy; cerebrovascular bleeding or other bleeding disorders; inflammatory bowel disease, chronic dyspepsia, congestive or atrophic gastritis; hyperkalemia; severe uncontrolled cardiac failure; severe liver impairment or severe active liver disease; severe renal impairment (CrCl <30 mL/min) or deteriorating renal disease. Perioperative pain in CABG surgery. Pregnancy (last trimester) & breastfeeding women.

Promptly w/draw treatment at the 1st signs & symptoms of anaphylactoid reactions; or upon 1st appearance of manifestations of any skin or hypersensitivity reactions. May mask signs & symptoms of underlying infectious disease. Do not concomitantly use w/ other naproxen- or naproxen Na-containing medicines; or other paracetamol-containing prep. Patients w/ rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. May interfere w/ urinary assays of 5-hydroxy indoleacetic acid. May impair judgment, thinking, or motor skills. Patients w/ hepatic or renal impairment. Not recommended in childn <18 yr. Elderly. Naproxen Na: Risk of serious CV thrombotic events eg, MI & stroke; onset of new HTN or worsening of pre-existing HTN; fluid retention, edema & heart failure; GI effects (eg, inflammation, ulceration, bleeding, upper or lower GIT perforation); renal papillary necrosis & other renal effects; hyperkalemia; borderline elevations of ≥1 liver enzymes; blurred &/or diminished vision; GUT effects (eg, hematuria, cystitis & other persistent urinary symptoms). Naproxen Na cannot be a substitute for corticosteroid, nor can it be used to treat corticosteroid insufficiency. May decrease platelet aggregation & prolong bleeding time. May increase urinary values of 17-ketogenic steroids due to naproxen interaction w/ m-dinitrobenzene used in assay (eg, Porter-Silber test). May delay or prevent rupture of ovarian follicles & result in reversible infertility. Naproxen use during early pregnancy may increase risk of miscarriage, cleft palate, gastroschisis & cardiac malfunction to the fetus. Paracetamol: Prolonged administration of large doses is associated w/ blood dyscrasias. Increased risk of metabolic acidosis in patients w/ low glutathione levels (eg, patients w/ sepsis). Patients w/ G6PD deficiency.

Constipation, headache, nausea. Naproxen Na: Heartburn, abdominal pain, peptic ulcer w/ or w/o bleeding. Dizziness, drowsiness, pruritus, ecchymoses, skin eruptions, tinnitus. Paracetamol: Insomnia, vomiting.

Naproxen Na: May compete for binding sites w/ albumin-bound drugs (eg, hydantoins, sulfonamides, sulfonylureas, coumarin-type anticoagulants, aspirin, & other NSAIDs). Increased risk of serious GI bleeding w/ anticoagulants/thrombolytic agents. May reduce the antihypertensive effects of ACE inhibitors, ARBs & β-blockers, & may increase the risk of renal dysfunction. Increased risk of bleeding & prolonged bleeding time w/ anti-platelet agents (eg, aspirin, clopidogrel, cilostazol, dipyridamole). Increased risk for serious GI events w/ aspirin & other NSAIDs (eg, ibuprofen, mefenamic acid, ketorolac, diclofenac). Increased risk of gastric mucosal damage w/ bisphosphonates. Delayed absorption w/ cholestyramine. Increased risk of GI ulceration or bleeding w/ corticosteroids & SSRIs (eg, fluoxetine, citalopram, sertraline). Increased risk of nephrotoxicity w/ ciclosporin & tacrolimus. Increased risk of pemetrexed-associated myelosuppression, nephrotoxicity, & GI toxicity w/ pemetrexed. Increased plasma conc & t_1/2 of digoxin. Reduced natriuretic effects of furosemide or thiazide diuretics. Increased risk of acute renal failure & hyperkalemia w/ diuretics. Increased risk of convulsions w/ quinolones. Increased lithium toxicity. Delayed absorption rate w/ antacids & sucralfate. Reduced t_1/2 w/ cimetidine, ranitidine, famotidine. Enhanced toxicity of MTX. Increased plasma levels w/ probenecid. Increased plasma levels & toxicity of zidovudine. Paracetamol: Increased risk of hepatotoxicity w/ alcohol, anticonvulsants (eg, barbiturates, carbamazepine, phenytoin) & enzyme-inducing agents (eg, amoxicillin + clavulanic acid, anticoagulants, ethanol, INH, zidovudine). Increased conc of chloramphenicol. Reduced absorption w/ cholestyramine. Accelerated absorption w/ drugs that increase gastric emptying eg, metoclopramide or domperidone. Reduced absorption w/ drugs that decrease gastric emptying w/ propantheline, antidepressants w/ anticholinergic properties, narcotic analgesics. May reduce AUC & t_1/2 of lamotrigine. Increased risk of bleeding w/ oral anticoagulants (eg, warfarin & other coumarins). Altered plasma conc & excretion w/ probenecid.

Analgesics (Non-Opioid) & Antipyretics / Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)

N02BE51 - paracetamol, combinations excl. psycholeptics ; Belongs to the class of anilide preparations. Used to relieve pain and fever.
M01AE02 - naproxen ; Belongs to the class of propionic acid derivatives of non-steroidal antiinflammatory and antirheumatic products.

Rx