Indications:
Inflammatory and degenerative forms of rheumatism: rheumatoid arthritis, juvenile
heumatoid arthritis, ankylosing spondylitis, osteoarthritis and spondylarthritis. Painful
syndromes of the vertebral column.
Non-articular rheumatism. aNS\
Acute attacks of gout. .\11
Post-traumatic and postoperative pain, inflammation, and swelling, e.g. following
dental or orthopaedic surgery.
Painful and/or inflammatory conditions in gynaecology, e.g. primary dysmenorrhoea or
adnexitis.
As an adjuvant in severe painful inflammatory infections of the ear, nose, or throat, e.g.
pharyngotonsillitis, otitis. In keeping with general therapeutic principles, the underlying
disease should be treated with basic therapy, as appropriate. Fever alone is not an
indication

Restrictions on use:
Contraindications
Gastric or intestinal ulcer; Known hypersensitivity to the activ \Substance.,Iiike Cher
non-steroidal anti-inflammatory agents, Voltic is also contrain4eated in pan s in
whom attacks of asthma, urticaria, or acute rhinitis are precipitated-d&aeatiValicylic
acid or other drugs with prostaglandin synthesis inhibiting activity.
Precautions
Careful diagnosis and close medical surveillance is imperative in patients with
symptoms indicative of gastrointestinal disorders or a history suggestive of gastric or
intestinal ulceration, in patients with ulcerative colitis or Crohn's disease, and in patients
suffering from impaired hepatic function. Gastrointestinal bleeding or
ulceration/perforation generally have more serious consequences in the elderly. They
9 5
can occur at any time during treatment, with or without warning%frenptomS`
previous history.
In the rare cases where gastrointestinal bleeding or ulceration occurs in patients
receiving Voltic, the drug should be withdrawn. Owing to the importance of
prostaglandins in maintaining renal blood flow, particular caution is called for in
patients with impaired cardiac or renal function, the elderly, patients being treated with
diuretics, and patients with substantial extracellular volume depletion from any cause,
e.g. before or after major surgery. Monitoring of renal function is recommended as a
precautionary measure when using Voltic in such cases. Discontinuation of therapy is
usually followed by recovery to the pretreatment state. Caution is indicated in the
elderly on basic medical grounds. In particular, it is recommended that the lowest
effective dosage be used in frail elderly patients or those with a low bodyweight.
As with other NSAIDs, values of one or more liver enzymes may increase during
treatment with Voltic. Although this has been observed with diclofenac in clinical
studies and may occur in around 15% of patients, it is rarely accompanied by clinical
symptoms. The clinical significance of this phenomenon is unknown. In the majority of
cases, increases are borderline. Occasionally (in 2.5%) the increases observed were
moderate.
(>3-‹ 8 times the upper limit of normal), while the incidence of marked increases (> 8
times the upper limit of normal) remained around 1%. In the above-mentioned clinical
studies, liver enzyme elevations were accompanied by clinically apparent liver damage
in 0.5% of cases.
The enzyme elevations were generally reversible on discontinuation of the drug. As
with other NSAIDs, hepatic function should be monitored regularly during long-term
treatment with Voltic. If abnormal liver function tests persist or worsen, if clinical signs
or symptoms consistent with liver disease (e.g. hepatitis) develop, or if other
manifestations occur (e.g. eosinophilia, rash, etc.), Voltic should be discontinued. In
addition to liver enzyme elevations, there have been reports of rare cases of severe
hepatic reactions, including jaundice, and isolated cases of fultninant hepatitis with a
fatal course. Hepatitis may occur without prodromal symptoms. Caution is called for
when using Voltic in patients with hepatic porphyria, since it may trigger an attack.
During prolonged treatment with Voltic, as with other NSAIDs, monitoring of the blood
count is recommended.
Like other NSAIDs, Voltic may temporarily inhibit platelet aggregation. Patients with
defects of haemostasis should be carefully monitored.
As with other NSAIDs, allergic reactions, including anaphylactic/anaphylactoid
reactions, can also occur without earlier exposure to the drug.
Like other NSAIDs, Voltic may mask the signs and symptoms of infection due to its
pharmacodynamic properties.
Note
Patients experiencing dizziness or other central nervous system disturbances, including
visual disturbances, should not drive or operate machinery.
Pregnancy and lactation
1st and 2nd trimesters: Pregnancy category B. Studies in animals have not indicated
any risk to the fetus, but no controlled studies have been carried out in pregnant women,
3rd trimester: Pregnancy category D.
Owing to the possibility of uterine inertia and/or premature closure of the ductus
arteriosus, Voltic should not be used.

Dosage and administration:
Adults
The recommended initial daily dosage is 100-150 mg. In milder cases, as well as for
long-term therapy, 75-100 mg daily is usually sufficient. The total daily dosage should
be divided into 2-3 doses.
In primary dysmenorrhoea the daily dosage should be individually adjusted and is
generally 50-150 mg. Initially a dose of 50-100 mg should be given and, if necessary,
raised in the course of several menstrual cycles up to a maximum of 200 mg/day.
Treatment should be started upon appearance of the first symptoms and, depending on
the symptomatology, continued for a few days. The tablets should be swallowed whole
with liquid, preferably before meals.
Children
Children aged 1 year or over should be given 0.5-2 mg/kg bodyweight daily, in 2-3
divided doses, depending on the severity of the disorder. For treatment of juvenile
rheumatoid arthritis the daily dosage can be raised up to a maximum of 3 mg/kg, in
divided doses.
Owing to the high content of active substance, a Voltic tablet :4-50-,
recommended for use in children

Undesirable effects
Gastrointestinal tract
Occasional: epigastric pain, other gastrointestinal disorders such as nausea, vomiting,
diarrhoea, abdominal cramps, dyspepsia, flatulence, anorexia.
Rare: gastrointestinal bleeding (haematemesis, melaena, bloody diarrhoea), gastric or
intestinal ulcer with or without bleeding or perforation.
Isolated cases: aphthous stomatitis, glossitis, oesophageal lesions, diaphragm-like
intestinal strictures, lower gut disorders such as nonspecific haemorrhagic colitis and
exacerbation of ulcerative colitis or Crohn's disease; constipation, pancreatitis,
exacerbation of haemorrhoids.
Central (and peripheral) nervous system Occasional: headache, dizziness, vertigo.
Rare: drowsiness.
Isolated cases: sensory disturbances, including paraesthesias, memory disturbances,
disorientation, insomnia, irritability, convulsions, depression, anxiety, nightmares,
tremor, psychotic reactions, aseptic meningitis.
Special senses
Isolated cases: disturbances of vision (blurred vision, diplopia),
tinnitus, taste disturbances.
Skin
Occasional: rashes.
Rare; urticaria.
Isolated cases: bullous eruptions, eczema, erythema multiforme, SkVeps Johnson
syndrome, Lyell's syndrome (acute toxic epidermolysis), erythroderma- (eVoliatiVe
dermatitis), loss of hair, photosensitivity reaction, purpura, including allergic purpura.
Kidney
Rare: oedema.
Isolated cases: acute renal failure, haematuria, proteinuria, interstitial nephritis,
nephrotic syndrome, papillary necrosis.
Liver
Frequent: elevation of serum aminotransferase enzymes (SOOT, SGPT), occasionally
moderate (>3 times the upper limit of normal) or marked (>8 times the upper limit of
normal). Rare; hepatitis with or without jaundice, in isolated cases fulminant. Stood
Isolated cases: thrombocytopenia, leucopenia, agranulocytosis, haemolytic anaemia,
aplastic anaemia.
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(Y2
Hypersensitivity
Rare: hypersensitivity reactions such as asthma, systemic anaphylac c/anaphy lactoid
reactions including hypotension.
Isolated cases: vasculitis, pneumonitis.
Cardiovascular system
Isolated cases: palpitation, chest pain, hypertension, congestive heart failure.

Store at 15 - 25 °C and protect from moisture.