Neuromeal® plus 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 Neuromeal® plus in disease of the nervous sys-tem involves compensation of accompanying vitamin B deficiencies and stimulation of natural healing processes in the nervous tissue. Neuromeal® plus 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.
Neuromeal® plus 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.
Dosage & Administration
Dose for adults: Adults can take one Neuromeal® plus 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.
Neuromeal® plus should be taken after food with a full glass of water .
-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.
Each film coated tablet of Neuromeal® plus contains :-
- diclofenac sodium 50 mg
- Thiamine nitrate ( vitamin B 1 ) 50 mg.
- Pyridoxine hydrochloride ( vitamin B6 ) 50 mg.
- Cyanocobalamine (vitamin B12 ) 1 mg
Neuromeal® plus 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
-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 Neuromeal® plus with digoxin or lithium preparations may raise the serum levels of digoxin and lithium which lead to digoxin and lithium toxcitiy .
-Neuromeal® plus 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 Neuromeal® plus
-Concomitant use of glucocorticoids and other anti-inflammatories increases the risk of gastrointestinal bleeding.
-Acetylsalicylic acid reduces the serum concentration of diclofenac.
-Administered Neuromeal® plus 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 Neuromeal® plus 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
-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.
-It is advisabl to monitor the liver and kidney function, as well as the blood cell count periodically when administered for prolonged periods.
-Neuromeal® plus 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.
-Neuromeal® plus 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.