Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.
* Keep this leaflet. You may need to read it again.
* If you have any further questions, ask your doctor or
pharmacist.
* This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them, even if their
signs of illness are the same as yours.
* If you get any side effects talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
See section 4.
1-DESCRIPTION:
An orange colored, round shaped, biconvex, enteric coated tablet,
plain on both the sides.
2-COMPOSITION:
Each film -coated tablet contains:
Diclofenac Sodium……………………………………………50 mg
Thiamine nitrate (B1)…………………………………………50 mg
Pyridoxine hydrochloride (B6) …………………………….50 mg
Cyanocobalamin(B12)………………………………………….1 mg
Excipients: Lactose Anhydrous, Maize Starch, Microcrystalline
Cellulose, PVPK 30, HPMC E 5, Maize Starch, Isopropyl Alcohol, HPMC E
15 B, Purified Talc, PEG 6000, Isopropyl Alcohol, Magnesium Stearate,
Colloidal Anhydrous Silica, Cross povidone.
HPMC E 15, HPMC E 5, PEG 6000, Sunset Yellow IH, Isopropyl Alcohol,
Methylene Chloride.
3-THERAPEUTIC INDICATIONS:
Analgesic, antineurotic, and anti-inflammatory. Back pain, neck pain,
arm pain, radiculitis, peripheral neuropathy of diverse etiology, facial
neuralgias, trigeminal neuralgia, intercostal neuralgia, herpetic
neuralgia, alcoholic neuropathy, diabetic neuropathy, carpal tunnel
syndrome, fibromyalgia, spondylitis.
4-PHARMACOLOGICAL PROPERTIES:
This product is a combination of three essential neurotropic vitamins:
Thiamine Nitrate (Vitamin B1), Pyridoxine Hydrochloride (Vitamin B6)
and Cyanocobalamin (Vitamin B12) in high doses with diclofenac
which is non-steroidal anti-inflammatory drugs (NSAIDS).
Thiamine Nitrate, Pyridoxine Hydrochloride 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 Sodium in mixed pain.
5-PHARMACOKINETICS:
Vitamin B1: After oral administration, vitamin B1 is absorbed into the
duodenum. After absorption by the intestinal mucosa, the Vitamin BI
is transported to the liver. Vitamin BI 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: 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.
6-CONTRAINDICATIONS:
-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).
-Pregnancy.
-In children below 12 years of age, due to the high content of
Diclofenac Sodium.
-Vitamin B 12 should not be used in the early stage of Leber’s disease
(hereditary atrophy of the optic nerve).
7- POSOLOGY
Depending on the severity of the disease, the recommended doses lies
between 2x1 and 3x1 tablets of Voltplus tablet, equivalent to 50 to 150
mg of diclofenac per day preferably after food. Patients may be
treated for long periods if this is considered necessary by their doctor.
Children under 6 years of age are definitely to be excluded from
therapy.
8-Drug Interactions:
Pyridoxine hydrochloride must not be given at doses higher than 5 mg
per day to patients being treated with levodopa alone. Treatment with
200 mg pyridoxine hydrochloride per day for one month produces
decreases of up to 50% in serum concentrations of phenobarbital and
phenytoin. If pyridoxine is given alongside cyclosporin, plasma
concentrations of the latter may be reduced. The absorption of
vitamin B12 in the gastrointestinal system may be reduced by
administration of the following: aminoglycosides, colchicine,
prolonged- release potassium-based products, amino salicylic acid
and its salts, anticonvulsants (phenytoin, phenobarbital, primidone),
irritation of the small intestine by cobalt, and by excessive alcohol
intake for periods of more than two weeks. The simultaneous
administration of neomycin and colchicine aggravates poor
absorption of vitamin B12. The simultaneous administration of
chloramphenicol and vitamin B12 can antagonize the hemopoietic
response to the vitamin. The simultaneous administration of
diclofenac with lithium-based products or digoxin or with
potassium-sparing diuretics can cause plasma elevations of these
drugs. Appropriate monitoring is recommended in such cases. The
concomitant use of other nonsteroidal anti-inflammatory can
increase the risk of undesirable side effects. Patients treated with
anticoagulants should be closely monitored. Nonsteroidals
anti-inflammatories should be discontinued 24 hours before initiating
treatment with methotrexate so as to avoid plasma elevations of the
cytostatic and the occurrence of toxic effects.
9-WARNINGS and PRECAUTIONS:
Administration with other NSAIDS is not recommended.
-Gastrointestinal ulceration, bleeding or perforation may occur during
treatment with Diclofenac Sodium, 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 Sodium may
cause fluid retention or edema.
-The use of Diclofenac Sodium, 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 Sodium 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 hepato-insufficiency.
- Severe skin reactions may occur, particularly at the start of
treatment. Therefore, Diclofenac Sodium 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
Hydrochloride. Therefore, regular monitoring during long-term
treatments recommended.
-It contains Lactose therefore, its use is not recommended in patients
with rare hereditary diseases of galactose intolerance, Lapp lactase
deficiency or glucose-galactose malabsorption.
10-SPECIFIC PATIENT POPULATIONS:
Pregnancy
Diclofenac Sodium 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 Sodium may induce embryopathy. Therefore, this
medicinal product must not be used by pregnant women or women
who may become pregnant during treatment.
Lactation
‘Thiamine Nitrate, Pyridoxine Hydrochloride and Cyanocobalamin are
excreted into human milk, but the risks of
an overdose for the baby is not known. Diclofenac Sodium has been
found in human milk in small amounts.
‘Therefore, this drug should not be used during breastfeeding.
Elderly and 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 Sodium is not
indicated for children less than 14 years of age, except for cases of
chronic juvenile arthritis.
11-ADVERSE REACTIONS:
They include: GI disturbances, dizziness, headache, and other central
nervous system disturbances, isolated cases of skin eruptions, rare
cases of hematuria, proteinuria, rare cases of liver function
disturbances, isolated cases of thrombocytopenia, leukopenia,
anemia, agranulocytosis, and rare severe hypersensitivity reactions.
12-STORAGE CONDITIONS:
keep out of reach of children. Store below 30°C. Protect from light.
This is a medicament:
- A medicament is a product which
affects your health and its consumption
contrary to instructions is dangerous for
you.
- Follow strictly the doctor's prescription,
the method of use and the instructions of
the pharmacist who sold the
medicament.
- The doctor and the pharmacist are the
experts in medicine, their benefits and
risks.
- Do not by yourself interrupt the period
of treatment prescribed.
- Do not repeat the same prescription
without consulting your doctor.
- Keep all medicaments out of reach of
children.
Council of Arab Health Ministers
Union of Arab pharmacists
Date of Revision: January 24, 2025
Diclofenac sodium, Thiamine nitrate, Pyridoxine
Hydrochloride, Cyanocobalamin Tablets)
Manufacturer:
LIVEALTH BIOPHARMA PVT. LTD. 862/1 G.I.D.C,
Makarpura, Vadodara – 390 010, India
Marketing Authorization Holder:
PI019/01
