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DYSMEN:

 
 
 
   
   
   
 
    
 
 
   Abridged Prescribing Information
     
     
 
  Composition
   
  Each tablet of DYSMEN contains:
  Mefenamic Acid. . .250 mg
  Dicyclomine HCl. . . 10 mg
   
   
  Therapeutic Indications & Usage
   
 
DYSMEN is indicated for symptomatic relief of colics such as intestinal, biliary and ureteric, as well as for spasmodic dysmenorrhea.
   
   
  Contraindications
   
 
DYSMEN should not be used in patients who have previously exhibited hypersensitivity to its ingredients, or another NSAID. It is contraindicated in presence of active ulceration or chronic inflammation of either the upper or lower gastrointestinal (GI) tract, preexisting renal disease and in third trimester of pregnancy due to mefenamic acid.
   
 
On account of its dicyclomine content, DYSMEN is also contraindicated in obstructive uropathy, obstructive disease of the GI tract, severe ulcerative colitis, reflux esophagitis, unstable cardiovascular status in acute hemorrhage, glaucoma and myasthenia gravis.
   
  DYSMEN is strictly not advocated for small children less than 6 months, and during lactation.
   
  DYSMEN Injection is not meant for intravenous use.
   
   
  Precautions
   
 
DYSMEN should be administered during the first 6 of pregnancy only if strictly required. Mefenamic acid (in DYSMEN) should be co-administered with caution along with oral anti-coagulants.
   
 
Dicyclomine (in DYSMEN) is to be advocated with caution in autonomic neuropathy, hepatic or renal disease, ulcerative colitis, hyperthyroidism, hypertension, coronary heart disease, congestive heart failure, cardiac tachyarrhythmia, hiatal hernia and known / suspected prostatic hypertrophy.
   
 
DYSMEN must be coadministered with caution along with anticholinergics, or drugs having anticholinergic activity, and prokinetics on account of its dicyclomine content.
   
   
 
Warnings
 
 
Mefenamic acid (in DYSMEN) can cause reduced renal blood flow in presence of impaired renal function, heart failure, liver dysfunction, in those taking concomitant diuretics, and in the elderly. Since dicyclomine (in DYSMEN) can produce drowsiness and blurred vision, patients must be warned not to engage in activities requiring mental alertness, such as operating a motor vehicle or other machinery or performing hazardous work while taking DYSMEN.
   
 
In presence of high environmental temperature, heat prostration can occur with dicyclomine (in DYSMEN) use resulting in fever and heat stroke due to decreased sweating. If symptoms occur as these DYSMEN must be discontinued and supportive measures instituted.
   
   
  Adverse Reactions
   
 
The most frequently reported adverse reactions associated with the use of mefenamic acid (in DYSMEN) are diarrhea, nausea with or without vomiting, and abdominal pain. Other GI reactions less frequently reported include anorexia, pyrosis, flatulence and constipation. GI ulceration with and without hemorrhage can also occur with mefenamic acid (in DYSMEN).
   
 
Mefenamic acid (in DYSMEN) can cause hypersensitivity reactions; central nervous disturbances like drowsiness, dizziness, nervousness, headache, blurred vision, insomnia; and hematopoietic disturbances.
   
 
As with other NSAIDs, renal failure, including papillary necrosis, is a possibility with mefenamic acid (in DYSMEN) administration. Eye complaints, mild hepatic toxicity, perspiration, and an increased need for insulin in diabetics are possible consequences of mefenamic acid (in DYSMEN) administration.
   
 
Dicyclomine (in DYSMEN) can cause GI disturbances, central nervous symptoms, hypersensitivity reactions and other skin eruptions, palpitations, tachycardia, apnea, dyspnea, asphyxia, decreased sweating, nasal stuffiness or congestion, sneezing, throat congestion, impotence, suppression of lactation, blurred vision and other eye complaints.
   
 
  Drug Interactions:
   
 
Dicyclomine (in DYSMEN) can interact with other anticholinergic agents, or drugs having anti-cholinergic activity and prokinetics.
   
   
  Recommended Dosage & Administration
   
 
ADULTS: 1 DYSMEN Tab tid, or as prescribed.
   
 
ELDERLY CHILDREN: ½-1 DYSMEN Tab tid, or as prescribed.
   
  Therapy should not exceed one week.
   
   
  Presentations
   
  DYSMEN Tablets: Blisters of 10s.
   
 
 
 
   
 
         
 
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