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FLANZEN-D:

 
 
 
   
   
   
 
    
 
 
   Abridged Prescribing Information
     
     
 
  Composition
   
  Each tablet of FLANZEN-D contains:
  Diclofenac sodium. . .50 mg
  Serratiopeptidase. . .10 mg
   
   
  Therapeutic Indications & Usage
   
 
FLANZEN-D is indicated for:
   
 
  • Trauma Surgery: In sports injuries, sprains, laceration, fractures, dislocation and osteoarthritis etc.

  • Surgery: To reduce post-operative edema at injection sites, internal tissue edema and inflammation caused at post-operative handling.

  • Plastic Surgery: For diminishing post-operative edema, restoring micro-circulation at the site of graft and minimizing risk of graft rejection along with reduction in pain.

  • Infections: Facilitating mucolysis in sinuses, ear cavities and coupled with anti-inflammatory activity in upper respiratory tract affections helps in faster resolution, better antimicrobial availability in infected tissues and faster cures.

  • Dermatology: Particularly useful in acutely painful inflamed dermatoses.

  • Dentistry: Helps better control over dental infections and inflammation.

  • Obstetrics & Gynecology: The anti-inflammatory and anti-edema activity helps in resolution of post-partum hematomas, breast engorgements and pregnancy-related thrombophlebitis.
   
   
  Contraindications
   
 
FLANZEN-D is contraindicated in those who are hypersensitive to its ingredients.
   
   
  Precaution & Warnings
   
 
Diclofenac (in FLANZEN-D) should be administered with caution in patients with acid-peptic disease, impaired renal or liver functions, blood dyscrasias, and in patients with hypersensitivity to aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs).
   
  FLANZEN-D should be used in pregnant women and nursing mothers only if absolutely required. Data on safety and efficacy of diclofenac / serratiopeptidase (FLANZEN-D) in children is not adequate.
   
  Since serratiopeptidase can enhance the action of anticoagulants, FLANZEN-D must be coadministered with due precaution.
   
   
  Adverse Reactions
   
 
The most common side effects of diclofenac (in FLANZEN-D) are gastric pain, nausea, vomiting and diarrhea; rarely peptic ulcer and gastrointestinal bleeding occur. Infrequently, hypersensitivity reactions, malaise, change in appetite and weight, and eye disorders are possible due to diclofenac (in FLANZEN-D). Neurological reactions possible include headache, drowsiness, insomnia, irritability and mood disturbances. Diclofenac (in FLANZEN-D) can rarely cause hepatitis, renal dysfunction and blood dyscrasias.
   
 
Serratiopeptidase (in FLANZEN-D) can cause hypersensitivity reactions such as rash or redness, besides gastrointestinal side effects like anorexia, abdominal discomfort, nausea and vomiting.
   
   
  Drug Interactions:
   
 
Concomitant use of diclofenac (in FLANZEN-D) with aspirin, methotrexate, digoxin, cyclosporin, triamterene and lithium is not advocated due to possibility of drug interaction. If coadministered with anticoagulants, serratiopeptidase (FLANZEN-D) can increase the anticoagulative action.
   
   
  Recommended Dosage & Administration
   
  ADULTS: 1 FLANZEN-D Tablet three times daily 1-2 hours after meals.
   
   
  Presentations
   
  FLANZEN-D Tablets: Blisters of 10s.
   
 
 
 
   
 
         
 
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