Dolobion
Analgesic .. Neurotropic vitamins
  • Dolobion® is a  combination of Diclofenac sodium¸ vitamin B1, B6 and B12.
  • Diclofenac belongs to a class of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs) that are used for the treatment of mild to moderate pain, fever, and inflammation.
  • Like all other vitamins, vitamin B1, B6 and B12 are essential nutrients, which the body cannot produce itself. The efficacy of the combined vitamins B1, B6 and B12 is superior to that of the individual vitamins alone. Furthermore, the combination of these vitamins with Diclofenac has an analgesic, anti-inflammatory and synergic neuro-regenerative effect, where the addition of B vitamins to Diclofenac increased its analgesic effect.
  • The effect of Dolobion® in disease of the nervous sys-tem involves compensation of accompanying vitamin B deficiencies and stimulation of natural healing processes in the nervous tissue.
  • Dolobion® tablet works by reducing the substances in the body that cause inflammation and pain, metabolizing carbohydrate thus maintains normal growth which produce antibodies and hemoglobin, by keeping blood sugar level in normal range. 

¤ Each film coated tablet of  Dolobion® contains :

  • diclofenac sodium             50mg
  • Thiamine nitrate ( vitamin B 1 )          50mg.
  • Pyridoxine hydrochloride  ( vitamin B6 )  50mg.
  • Cyanocobalamine (vitamin B12 )            1mg 

¤ Dolobion® is used in the following cases:

  • Degenerative forms of painful inflammatory and inflammatory activity of rheumatism, such as osteoarthritis, spondyloarthritis, chronic polyarthritis, ankylosing spondylitis, extra-articular rheumatism.
  • Neurolgical disorder and neuritis (neuropathy).
  • Back pain,tendonitis,frozen shoulder, musculoskeletal disorder and acut attack of gout disease.
  • Pain and paralysis in facial nerves (trigeminal neuralgia, facial paresis) .
  • Pain of in area of vertebrate column (cervical, lumber vertebrates) and other disorder in back and intercostal nerves.
  • Joint and bone surgery.

¤ Dolobion® should not be used in cases of: 

  • Known hypersensitivity to any of the active components.
  • In cases of asthma.
  • Alterations of hematopoiesis.
  • Esophagitis, gastritis, gastric and duodenal ulcer.
  • Children under 6 years.
  • Liver or kidney failure or in the elderly.
  • It should only be used after weighing the risk-benefit ratio in cases of inducible  porphyrias.
  • Leber's disease.
  • Urticaria.
  • Concomitant treatment of diclofenac with paracetamol may increase risk of renal complictions.
  • Alcohol, corticosteroids, corticotropin and potassium supplements together with diclofenac may increase the risk of gastrointestinal adverse effects, including ulceration and bleeding.
  • Concomitant treatment of Dolobion® with digoxin or lithium preparations may raise the serum levels of digoxin and lithium which lead to digoxin and lithium toxcitiy.
  • Dolobion® can reduce the action of diuretics and antihypertensive agents; with potassium-sparing diuretics, it can cause hyperkalemia
  • the hypoglycemic effect of oral sulfonylureas antidiabetic agents increases if adminstrated with Dolobion®.
  • Concomitant use of glucocorticoids and other anti-inflammatories increases the risk of gastrointestinal bleeding.
  • Acetylsalicylic acid reduces the serum concentration of diclofenac.
  • Administered Dolobion® in a 24-hour period with methotrexate, it
    raises methotrexate concentration.
  • Simultaneous use with anticoagulants requires convenient control of coagulation state in a preventive manner.
  • Patients  treated with L-dopa should not take preparations containing of vitamin B6.
  • Cefoperazon ,pilamycin and valproic acid can produce hypoprothrobinemia that, in addition to the inhibition  of platelets function produced by diclofenac,can lead to gastrointestinal ulceration or bleeding if coadminstrated.
  • colchicine with diclofenac can lead to gastrointestinal ulceration and bleeding.
  • cyclosporin and gold salt can cause inhibition activity of renal prostaglandin if adminstered with diclofenac which  may increase the risk of nephrotoxicity induced by these drug.
  • Because it contains a NSAID Dolobion® should not be administered during pregnancy unless the physician considers its administration as strictly necessary, in which case the loweast possible doses should be used due to the risk of inhibition of uterine contractions and early closure of the duct arteriosus.
  • The administration of therapeutic doses determines the presence in very small amounts of the drug in breast milk, therefore, there is a minimal risk of undesirable effects in the infant. 

¤ These side effects are possible but do not always occur.

  • Rarely, various gastrointestinal discomforts (nausea, vomiting, diarrhea) and exceptionally, gastrointestinal bleeding and exacerbation of ulcerative colitis may occur. Likewise, headache, dizziness, fatigue.
  • More rarely, tinnitus, insomnia, irritability or seizures may occur.
  • Rare cases of rashes or hives and, exceptionally, Stevens Johnson syndrome, alopecia or photosensitivity have been described.
  • Very isolated cases of acute renal failure, hematuria, nephrotic syndrome and interstitial nephritis have been reported.
  • Various degrees of liver dysfunction can occur, including icteric or anicteric hepatitis.
  • Occasionally, anemia, leukopenia, thrombocytopenia or pancytopenia and, less frequently, anaphylactoid reactions have been observed.د

 

overdose:

  • The patient's vital functions should be monitored carefully.
  • To decrease the absorption of the drug, gastric lavage or emesis induction should be performed.
  • the administration of antacids or alkalinizers of the urine can be used to increase the excretion of the drug.
  • The use of diuretics has not been proven effective in cases of diclofenac overdose. In contrast, hemodialysis can be effective in reducing serum concentrations of diclofenac.
  • In severe cases, volume expanders can be used to treat hypotension and diazepam for seizure control.
  • If a demonstrated hypoprothrombinemia occurs, vitamin K can be used intramuscularly.
  • Glucocorticoids should be used if there is an evidence of renal damage (interstitial nephritis or nephrotic syndrome), thrombocytopenia, hemolytic anemia and sever skin reaction due to hypersensitivity.
  • nephrotoxicity may ensue after prolonged taken of 200 mg of pyridoxine per day.
  • Dose for adults: Adults can take one Dolobion® tablet, 1 to 3 times daily or directed by physican.
  • Dose for children: Due to its high diclofenac content, it is not indicated in children under 6 years.
  • Dolobion® should be taken after food with a full glass of water. 
  • It is advisabl to monitor the liver and kidney function, as well as the blood cell count periodically when administered for prolonged periods.
  • Dolobion® should be administered with caution in geriatric patients. 
  • Close medical surveillance will be established in patients with a history of peptic acid disease, ulcerative colitis, Crohn's disease.
  • Dolobion® will be administered with caution in patients with compromised cardiac or renal function.
  • Patients who manifest vertiginous syndrome, drowsiness or other disorders related to the Central Nervous System should not drive vehicles or use machines as a preventive measure.
  • Use with caution in people with lactose intolerance.
  • Blister of 10 tablets, pack of 3 blisters. 
  • Store in a dry  place at a temperature below 25°C.