- NONSTEROIDAL ANTI-INFLAMMATORY DRUGS
- Pharmaceutical Form : Enteric coated tablets
- Composition : Diclofenac Sodium 50 mg - Vitamin B1 50 mg - Vitamin B6 50 mg - Vitamin B12 1mg
- Active Substance : Sodium diclofenac, vitamin B 1, vitamin B 6, Vitamin B 12
This product is a combination of three essential neurotropic vitamins: thiamine (vitamin B1), pyridoxine (vitamin B6) and Cyanocobalamin (vitamin B12) in high doses with diclofenac which is non-steroidal anti-inflammatory drugs (NSAIDS).
Thiamine, pyridoxine and cyanocobalamin have particular importance for the metabolism in the peripheral and central nervous system. In addition, it provides a synergistic effect to the action anti-nociceptive of diclofenac in mixed pain.
Vitamin B1: After oral administration, vitamin B1 is absorbed into the duodenum. After absorption by the intestinal mucosa, the Vitamin B1 is transported to the liver. Vitamin B1 is eliminated with a half-life of one hour.
Vitamin B6: Vitamin B6 is rapidly absorbed, especially in the gastrointestinal tract, and Transported to the organs and tissues. Vitamin B6 passes into the cerebrospinal fluid, is excreted in breast milk and crosses the placenta.
Vitamin B12: The absorption of vitamin B12 by the gastrointestinal tract is performed through two mechanisms. Vitamin B12 is predominantly excreted by bile, most of which is reabsorbed via enterohepatic circulation.
Diclofenac sodium: Diclofenac is rapidly and completely absorbed in the duodenum, reaching peak plasma concentrations after two or three hours. It is metabolized in the liver by Cytochrome P450 of the subfamily CYP2C. The metabolites are excreted in the urine (65%) and in the bile (35%). The Elimination half-life of is 1.2 to 2 hours.
Back pain, cervical pain, Braquialgia, radiculitis, peripheral neuropathies caused by several aetiologies, facial neuralgias, Trigeminal neuralgia, intercostals neuralgia, herpetic neuralgia, carpal tunnel syndrome, fibromyalgia, spondylitis.
- Hypersensitivity to any of the active ingredients or the excipients.
- polycythemia vera
- In patients with History of bronchospasm, asthma, allergic rhinitis or urticaria in relation to previous treatment with NSAIDS.
- Peptic ulcer, acute gastrointestinal bleeding or a history of peptic ulcer or Hemorrhage.
- Cerebrovascular hemorrhage syndrome or other severe hemorrhage.
- Renal insufficiency (creatinine clearance <30 ml/min).
- Severe liver failure (levels of ALT/AST > 30 times the upper limit).
- Severe heart failure (NYHA class IV).
- In children below 12 years of age, due to the high content of diclofenac.
- Vitamin b 12 should not be used in the early stage of leber’s disease (hereditary atrophy of the optic nerve).
Warnings and Precautions:
- Administration with other NSAIDS is not recommended.
- Gastrointestinal ulceration, bleeding or perforation may occur during treatment with diclofenac, without prior warning signs. The risk may be increased with the use of high doses or during prolonged treatments, as well as the use in elderly patients. Special caution is advised if it is used concomitantly with other medicinal products that increase the risk of ulceration or bleeding (such as corticosteroids, anticoagulants).
- In patients with cardiovascular disease, diclofenac may cause fluid retention or edema.
- The use of diclofenac, particularly at doses ≥ 100 mg / day and during prolonged treatments, may be associated with an increased risk of arterial thrombotic events, such as myocardial infarction or stroke. Careful monitoring is recommended, especially in patients with a history of cardiovascular disease.
- In patients with dehydration, diclofenac increases the risk of renal toxicity. Therefore, dehydration has to be avoided in patients receiving it.
- Special caution is recommended in patients with mild or moderate renal or hepatic insufficiency.
- Severe skin reactions may occur, particularly at the start of treatment. Therefore, diclofenac should only be administered in patients with acute intermittent porphyria or systemic lupus erythematous after careful evaluation of risk against benefit.
- Neuropathies have been described with prolonged administration (6 -12 months) of daily doses of more than 50 mg of pyridoxine. Therefore, regular monitoring during long-term treatment is recommended.
- The F.C.T contains lactose, therefore its use is not recommended in patients with rare hereditary diseases of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
Effects on ability to drive and operate machinery:
Patients who have visual disturbance, dizziness, drowsiness or other Disorders of the central nervous system during treatment with diclofenac should avoid driving vehicles and/or operate machinery.
Diclofenac has been shown to inhibit implantation and embryonic development in rats. Administered late in pregnancy may also cause premature closure of the ductus arteriosus. Diclofenac may induce embryopathy. Therefore, this medicinal product must not be used by pregnant women or women who may become pregnant during treatment.
Thiamine, pyridoxine, and cyanocobalamin are excreted into human milk, but the risks of an overdose for the baby are not known. Diclofenac has been found in human milk in small amounts. Therefore, this drug should not be used during breastfeeding.
Use in the elderly and in children:
Caution is advised when used in elderly, debilitated patients or those with low body weight, and the use of the lowest effective dose is recommended. Diclofenac is not indicated for children less than 14 years of age, except for cases of chronic juvenile arthritis.
- The effect of L-dopa can be reduced when pyridoxine is administered concomitantly; concomitant administration with of carbidopa with levodopa prevents this effect. Pyridoxine should not be administered at doses above 5 mg / day to patients receiving levodopa only.
- Pyridoxine antagonists such as isoniazid, cycloserine, penicillamine, and hydralazine may decrease the efficacy of pyridoxine.
- Because of reduced tubular reabsorption, thiamine elimination can be accelerated with the prolonged use of loop diuretics such as furosemide and therefore the blood level of thiamine may be reduced.
- Concomitant ingestion of other NSAIDs, glucocorticoids, or serotonin reuptake inhibitors may increase the risk of gastrointestinal ulceration and bleeding.
- Diclofenac may increase the efficacy of platelet aggregation inhibitors or anticoagulants such as warfarin, close monitoring is recommended.
- Diclofenac may increase serum digoxin, phenytoin, lithium, potassium-sparing diuretics, or methotrexate.
- NSAIDS should be discontinued 24 hr befor the administration of methotrexate in order to avoid increased plasma concentration of the cytotoxic agent.
- Diclofenac may increase the renal toxicity of cyclosporin.
- Diclofenac may decrease the efficacy of diuretics or anti-hypertensive agent.
- Medicines containing probenecid or sulfinpyrazone may prolong the excretion of diclofenac
- The absorption of vitamin b 12 in the gastrointestinal tract is reduced by the administration of the following drugs: aminoglycosides, colchicine, extended release potassium, aminosalicylic acid and its salt, anti-convulsive agent (phenytoin, phenobarbital and primodone), cobalt radiation in the small intestine and by excessive intake of alcohol for more than 2 weeks.
- Concomitant administration of chloramphinciol and vitamin b 12 may affect the hematopoietic response to vitamin.
Uncommon: exacerbation of ulcerative colitis or Crohn’s disease, gingivostomatitis, esophageal injury, glossitis and constipation.
Rare: certain hypersensitivity reactions (such as hypotension, edema, anaphylactic reactions) disorientation, insomnia, psychotic irritation, paresthesia, changes of sensitivity and memory, visual disorders, tinnitus, gastrointestinal ulceration, hemorrhage, perforation, changes of taste, hematuria, proteinuria, acute renal insufficiency.
Posology and method of administration:
1 tablet two to three times daily. The tablets should be swallowed whole with liquid, preferably after meals. It is recommended that the duration of treatment preferably, is as short as possible.
There have been cases of overdose with thiamine or cyanocobalamin. Sensory Neuropathy and other sensory neuropathic syndromes caused by the administration of high Doses of pyridoxine improve gradually with the discontinuation of vitamin. In the event of acute poisoning with diclofenac, symptomatic and supportive measures are recommended for complications such as hypotension, renal failure, convulsions, gastrointestinal irritation or respiratory insufficiency.
Storage conditions: Do not store above 30˚c
How supplied: 20-30 enteric coated tablets