Adults and Elderly:
Relief of all grades of pain and inflammation in a wide range of conditions, including:
(i) arthritic conditions: rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, acute gout,
(ii) acute musculo-skeletal disorders such as periarthritis (for example frozen shoulder),
tendinitis, tenosynovitis, bursitis,
(iii) other painful conditions resulting from trauma, including fracture, low back pain, sprains,
strains, dislocations, orthopaedic, dental and other minor surgery.
Children (aged 1-12 years): Juvenile chronic arthritis (25mg tablet only).

Undesirable effects may be minimized by using the lowest effective dose for the shortest
duration necessary to control symptoms (see section 4.4 Special warnings and precautions for
use).
For oral administration
75-150mg daily in two or three divided doses.
The recommended maximum daily dose of Voltic is 150mg.
Special populations
Elderly
Although the pharmacokinetics of diclofenac are not impaired to any clinically relevant extent in
elderly patients, nonsteroidal anti-inflammatory drugs should be used with particular caution in
such patients who generally are more prone to adverse reactions. In particular it is recommended
that the lowest effective dosage be used in frail elderly patients or those with a low body weight
(see also precautions) and the patient should be monitored for GI bleeding during NSAID
therapy.

Renal impairment
Diclofenac is contraindicated in patients with severe renal impairment (see section 4.3). No
specific studies have been carried out in patients with renal impairment; therefore, no specific
dose adjustment recommendations can be made. Caution is advised when administering
diclofenac to patients with mild to moderate renal impairment (see section 4.3 and 4.4).
Hepatic impairment
Diclofenac is contraindicated in patients with severe hepatic impairment (see section 4.3). No
specific studies have been carried out in patients with hepatic impairment; therefore, no specific
dose adjustment recommendations can be made. Caution is advised when administering
diclofenac to patients with mild to moderate hepatic impairment (see section 4.3 and 4.4).
Paediatric population
Children (aged 1-12 years): 1-3mg/kg per day in divided doses (25mg only).

Hypersensitivity to the active substance or any of the excipients.  Active, gastric or intestinal ulcer, bleeding or perforation.  History of gastrointestinal bleeding or perforation, relating to previous NSAID therapy.  Active or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding).  Last trimester of pregnancy (see section 4.6 Pregnancy and lactation).  Severe hepatic, renal or cardiac failure (see section 4.4 Special warnings and precautions for use).  Like other non-steroidal anti-inflammatory drugs (NSAIDs), diclofenac is also contraindicated in patients in whom attacks of asthma, angioedema, urticaria or acute rhinitis are precipitated by ibuprofen, acetylsalicylic acid or other nonsteroidal antiinflammatory drugs.  Established congestive heart failure (NYHA II-IV), ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease.

General
Undesirable effects may be minimised by using the lowest effective dose for the shortest
duration necessary to control symptoms (see section 4.2 Posology and method of
administration and GI and cardiovascular risks below).
The concomitant use of diclofenac with systemic NSAIDs including cyclooxygenase-2
selective inhibitors should be avoided due to the absence of any evidence demonstrating
synergistic benefits and the potential for additive undesirable effects (see section 4.5
Interactions with other medicaments and other forms of interaction).
Caution is indicated in the elderly on basic medical grounds. In particular, it is
recommended that the lowest effective dose be used in frail elderly patients or those with a
low body weight (see section 4.2 Posology and Method of administration).
As with other nonsteroidal anti-inflammatory drugs including diclofenac , allergic reactions,
including anaphylactic/anaphylactoid reactions, can also occur without earlier exposure to
the drug (see section 4.8 Undesirable effects).
Like other NSAIDs, diclofenac may mask the signs and symptoms of the infection due to its
pharmacodynamic properties.
Voltic 50 mg gastro-resistant tablets contain lactose and therefore are not recommended for
patients with rare hereditary problems of galactose intolerance, severe lactase deficiency or
glucose-galactose malabsorption.
Gastrointestinal effects:
Gastrointestinal bleeding (haematemesis, melaena) ulceration or perforation which can be
fatal has been reported with all NSAIDs including diclofenac and may occur at any time
during treatment, with or without warning symptoms or a previous history of serious GI
events. They generally have more serious consequences in the elderly. If gastrointestinal
bleeding or ulceration occurs in patients receiving diclofenac, the drug should be withdrawn.
As with all NSAIDs, including diclofenac close medical surveillance is imperative and
particular caution should be excised when prescribing diclofenac in patients with symptoms
indicative of gastrointestinal disorders, or with a history suggestive of gastric or intestinal
ulceration, bleeding or perforation (see section 4.8 Undesirable effects). The risk of GI
bleeding, ulceration or perforation is higher with increasing NSAID doses including
diclofenac, and in patients with a history of ulcer, particularly if complicated with
haemorrhage or perforation.

The elderly have increased frequency of adverse reactions to NSAIDs especially
gastrointestinal bleeding and perforation which may be fatal (see section 4.2 Posology and
method of administration).
To reduce the risk of GI toxicity in patients with a history of ulcer, particularly if
complicated with haemorrhage or perforation, and in the elderly, the treatment should be
initiated and maintained at the lowest effective dose.
Combination therapy with protective agents (e.g. misoprostol or proton pump inhibitors)
should be considered for these patients, and also for patients requiring concomitant use of
medicinal products containing low dose acetylsalicylic acid (ASA/aspirin or medicinal
products likely to increase gastrointestinal risk. (See section 4.5 Interactions with other
medicaments and other forms of interaction).
Patients with a history of GI toxicity, particularly when elderly, should report any unusual
abdominal symptoms (especially GI bleeding).
Caution is recommended in patients receiving concomitant medications which could
increase the risk of ulceration or bleeding, such as systemic corticosteroids, anticoagulants
such as warfarin, selective serotonin-reuptake inhibitors (SSRIs) or anti-platelet agents such
as acetylsalicylic acid (see section 4.5 Interaction with other medicaments and other forms
of interaction).
Close medical surveillance and caution should be exercised in patients with ulcerative
colitis, or with Crohn's disease as these conditions may be exacerbated (see section 4.8
Undesirable effects).
Hepatic effects:
Close medical surveillance is required when prescribing Voltic to patients with impairment
of hepatic function as their condition may be exacerbated.
As with other NSAIDs, including diclofenac, values of one or more liver enzymes may
increase. During prolonged treatment with diclofenac, regular monitoring of hepatic
function is indicated as a precautionary measure.
If abnormal liver function tests persist or worsen, clinical signs or symptoms consistent with
liver disease develop or if other manifestations occur (eosinophilia, rash), Voltic should be
discontinued.
Hepatitis may occur with diclofenac without prodromal symptoms.

Caution is called for when using diclofenac in patients with hepatic porphyria, since it may
trigger an attack.
Renal effects:
As fluid retention and oedema have been reported in association with NSAIDs therapy,
including diclofenac, particular caution is called for in patients with impaired cardiac or
renal function, history of hypertension, the elderly, patients receiving concomitant treatment
with diuretics or medicinal products that can significantly impact renal function, and those
patients with substantial extracellular volume depletion from any cause, e.g. before or after
major surgery (see section 4.3 Contraindications). Monitoring of renal function is
recommended as a precautionary measure when using diclofenac in such cases.
Discontinuation therapy is usually followed by recovery to the pre-treatment state.
Skin effects:
Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson
syndrome and toxic epidermal necrolysis, have been reported very rarely in association with
the use of NSAIDs, including diclofenac (see section 4.8 Undesirable effects). Patients
appear to be at the highest risk of these reactions early in the course of therapy: the onset of
the reaction occurring in the majority of cases within the first month of treatment. Voltic
should be discontinued at the first appearance of skin rash, mucosal lesions or any other
signs of hypersensitivity.
SLE and mixed connective tissue disease:
In patients with systemic lupus erythematosus (SLE) and mixed connective tissue disorders
there may be an increased risk of aseptic meningitis (see section 4.8 Undesirable effects).
Cardiovascular and cerebrovascular effects:
Patients with significant risk factors for cardiovascular events (e.g. hypertension,
hyperlipidaemia, diabetes mellitus, and smoking) should only be treated with diclofenac
after careful consideration. As the cardiovascular risks of diclofenac may increase with dose
and duration of exposure, the shortest duration possible and the lowest effective daily dose
should be used. The patient's need for symptomatic relief and response to therapy should be
re-evaluated periodically.
Appropriate monitoring and advice are required for patients with a history of hypertension
and/or mild to moderate congestive heart failure as fluid retention and oedema have been
reported in association with NSAID therapy including diclofenac.

Clinical trial and epidemiological data consistently point towards increased risk of arterial
thrombotic events (for example myocardial infarction or stroke) associated with the use of
diclofenac, particularly at high dose (150mg daily) and in long term treatment.
Patients with uncontrolled hypertension, congestive heart failure, established ischaemic
heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be
treated with diclofenac after careful consideration.
Haematological effects:
During prolonged treatment with diclofenac, as with other NSAIDs, monitoring of the blood
count is recommended.
Diclofenac may reversibly inhibit platelet aggregation (see anticoagulants in section 4.5
Interaction with other medicaments and other forms of interactions). Patients with defects of
haemostasis, bleeding diathesis or haematological abnormalities should be carefully
monitored.
Pre-existing asthma:
In patients with asthma, seasonal allergic rhinitis, swelling of the nasal mucosa (i.e. nasal
polyps), chronic obstructive pulmonary diseases or chronic infections of the respiratory tract
(especially if linked to allergic rhinitis-like symptoms), reactions on NSAIDs like asthma
exacerbations (so called intolerance to analgesics / analgesics asthma), Quincke's oedema or
urticaria are more frequent than in other patients. Therefore, special precaution is
recommended in such patients (readiness for emergency). This is applicable as well for
patients who are allergic to other substances, e.g. with skin reactions, pruritus or urticaria.
Like other drugs that inhibit prostaglandin synthetase activity, diclofenac sodium and other
NSAIDs can precipitate bronchospasm if administered to patients suffering from, or with a
previous history of bronchial asthma.
Female fertility:
The use of diclofenac may impair female fertility and is not recommended in women
attempting to conceive. In women who may have difficulties conceiving or who are
undergoing investigation of infertility, withdrawal of Voltic should be considered (see
section 4.6 Pregnancy and Lactation).

The following interactions include those observed with diclofenac gastro-resistant tablets
and/or other pharmaceutical forms of diclofenac.
Lithium: If used concomitantly, diclofenac may increase plasma concentrations of lithium
Monitoring of the serum lithium level is recommended.
Digoxin: If used concomitantly, diclofenac may raise plasma concentrations of digoxin.
Monitoring of the serum digoxin level is recommended.
Diuretics and antihypertensive agents: Like other NSAIDs, concomitant use of
diclofenac with diuretics and antihypertensive agents (e.g. beta-blockers, angiotensin
converting enzyme (ACE) inhibitors may cause a decrease in their antihypertensive effect
via inhibition of vasodilatory prostaglandin synthesis.
Therefore, the combination should be administered with caution and patients, especially the
elderly, should have their blood pressure periodically monitored. Patients should be
adequately hydrated and consideration should be given to monitoring of renal function after
initiation of concomitant therapy periodically thereafter, particularly for diuretics and ACE
inhibitors due to the increased risk of nephrotoxicity.
Drugs known to cause hyperkalemia: Concomitant treatment with potassium-sparing
diuretics, ciclosporin, tacrolimus or trimethoprim may be associated with increased serum
potassium levels, which should therefore be monitored frequently (see section 4.4 Special
warnings and precautions for use).
Anticoagulants and anti-platelet agents: Caution is recommended since concomitant
administration could increase the risk of bleeding (see section 4.4 Special warnings and
precautions for use). Although clinical investigations do not appear to indicate that
diclofenac has an influence on the effect of anticoagulants, there are isolated reports of an
increased risk of haemorrhage in patients receiving diclofenac and anticoagulant
concomitantly (see section 4.4 Special warnings and precautions for use). Therefore, to be
certain that no change in anticoagulant dosage is required, close monitoring of such patients
is required. As with other nonsteroidal anti-inflammatory agents, diclofenac in a high dose
can reversibly inhibit platelet aggregation.
Other NSAIDs including cyclooxygenase-2 selective inhibitors and corticosteroids: Coadministration
of diclofenac with other systemic NSAIDs or corticosteroids may increase
the risk of gastrointestinal bleeding or ulceration. Avoid concomitant use of two or more
NSAIDs (see section 4.4 Special warnings and precautions for use).
Selective serotonin reuptake inhibitors (SSRIs): Concomitant administration of SSRI's
may increase the risk of gastrointestinal bleeding (see section 4.4 Special warnings and

precautions for use).
Antidiabetics: Clinical studies have shown that diclofenac can be given together with oral
antidiabetic agents without influencing their clinical effect. However there have been
isolated reports of hypoglycaemic and hyperglycaemic effects necessitating changes in the
dosage of the antidiabetic agents during treatment with diclofenac. For this reason,
monitoring of the blood glucose level is recommended as a precautionary measure during
concomitant therapy.
Methotrexate: Diclofenac can inhibit the tubular renal clearance of methotrexate hereby
increasing methotrexate levels. Caution is recommended when NSAIDs, including
diclofenac, are administered less than 24 hours before treatment with methotrexate, since
blood concentrations of methotrexate may rise and the toxicity of this substance be increase.
Cases of serious toxicity have been reported when methotrexate and NSAIDs including
diclofenac are given within 24 hours of each other. This interaction is mediated through
accumulation of methotrexate resulting from impairment of renal excretion in the presence
of the NSAID.
Ciclosporin: Diclofenac, like other NSAIDs, may increase the nephrotoxicity of ciclosporin
due to the effect on renal prostaglandins. Therefore, it should be given at doses lower than
those that would be used in patients not receiving ciclosporin.
Tacrolimus: Possible increased risk of nephrotoxicity when NSAIDs are given with
tacrolimus. This might be mediated through renal antiprostagladin effects of both NSAID
and calcineurin inhibitor.
Quinolone antibacterials: Convulsions may occur due to an interaction between
quinolones and NSAIDs. This may occur in patients with or without a previous history of
epilepsy or convulsions. Therefore, caution should be exercised when considering the use of
a quinolone in patients who are already receiving an NSAID.
Phenytoin: When using phenytoin concomitantly with diclofenac, monitoring of phenytoin
plasma concentrations is recommended due to an expected increase in exposure to
phenytoin.
Colestipol and cholestyramine: These agents can induce a delay or decrease in absorption
of diclofenac. Therefore, it is recommended to administer diclofenac at least one hour before
or 4 to 6 hours after administration of colestipol/ cholestyramine.
Cardiac glycosides: Concomitant use of cardiac glycosides and NSAIDs in patients may
exacerbate cardiac failure, reduce GFR and increase plasma glycoside levels.

Mifepristone: NSAIDs should not be used for 8-12 days after mifepristone administration
as NSAIDs can reduce the effect of mifepristone.
Potent CYP2C9 inhibitors: Caution is recommended when co-prescribing diclofenac with
potent CYP2C9 inhibitors (such as voriconazole), which could result in a significant
increase in peak plasma concentrations and exposure to diclofenac due to inhibition of
diclofenac metabolism.

Pregnancy
Pregnancy Category C in first & second Trimester and Pregnancy Category D in third trimester
if < 30 weeks Category C; if > 30 weeks Category D.
Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the
embryo/foetal development. Data from epidemiological studies suggest an increased risk of
miscarriage and or cardiac malformation and gastroschisis after use of a prostaglandin synthesis
inhibitor in early pregnancy. The absolute risk for cardiovascular malformation was increased
from less than 1% up to approximately 1.5%.
The risk is believed to increase with dose and duration of therapy. In animals, administration of
a prostaglandin synthesis inhibitor has shown to result in increased pre-and post-implantation
loss and embryo-foetal lethality.
In addition, increased incidences of various malformations, including cardiovascular, have been
reported in animals given a prostaglandin synthesis inhibitor during organogenetic period. If
diclofenac is used by a woman attempting to conceive, or during the 1st trimester of pregnancy,
the dose should be kept as low and duration of treatment as short as possible.
During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the
foetus to:
- cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary
hypertension)
- renal dysfunction, which may progress to renal failure with oligo-hydroamniosis
The mother and the neonate, at the end of the pregnancy, to:
- possible prolongation of bleeding time, an anti-aggregating effect which may occur even at
very low doses

- inhibition of uterine contractions resulting in delayed or prolonged labour
Consequently, Voltic is contraindicated during the third trimester of pregnancy.
Lactation
Like other NSAIDs, diclofenac passes into breast milk in small amounts. Therefore Diclofenac
should not be administered during breastfeeding in order to avoid undesirable effects in the
infant (see section 5.2 Pharmacokinetic properties).
Female fertility:
As with other NSAIDs, the use of diclofenac may impair female fertility and is not
recommended in women attempting to conceive. In women who may have difficulties
conceiving or who are undergoing investigation of infertility, withdrawal of diclofenac should
be considered. See section 4.4 Special warnings and precautions for use, regarding female
fertility.

Patients who experience visual disturbances, dizziness, vertigo, somnolence, central nervous
system disturbances, drowsiness or fatigue while taking NSAIDs should refrain from driving
or operating machinery.

Adverse reactions are ranked under the heading of frequency, the most frequent first, using the
following convention: very common: (>1/10); common (≥ 1/100, <1/10); uncommon (≥
1/1,000, <1/100); rare (≥1/10,000, <1/1000); very rare (<1/10,000); not known: cannot be
estimated from available data.
The following undesirable effects include those reported with other short-term or long-term
use.

 

Symptoms
There is no typical clinical picture resulting from diclofenac over dosage. Over dosage can
cause symptoms such as headache, nausea, vomiting, epigastric pain, gastrointestinal
bleeding, diarrhoea, dizziness, disorientation, excitation, coma, drowsiness, tinnitus, fainting
or convulsions. In the case of significant poisoning acute renal failure and liver damage are
possible.
Therapeutic measures
Management of acute poisoning with NSAIDs, including diclofenac, essentially consists of
supportive measures and symptomatic treatment. Supportive measures and symptomatic
treatment should be given for complications such as hypotension, renal failure, convulsions,
gastrointestinal disorder, and respiratory depression.
Special measures such as forced diuresis, dialysis or haemo-perfusion are probably of no
help in eliminating NSAIDs, including diclofenac, due to high protein binding and extensive
metabolism.
Activated charcoal may be considered after ingestion of a potentially toxic overdose, and
gastric decontamination (e.g. vomiting, gastric lavage) after ingestion of a potentially life

threatening overdose.

Pharmacotherapeutic group
Nonsteroidal anti-inflammatory drugs (NSAIDs).
ATC Code: M01AB05
Mechanism of action
Diclofenac is a nonsteroidal agent with marked analgesic/anti- inflammatory properties. It is
an inhibitor of prostaglandin synthetase, (cyclo-oxygenase).
Diclofenac sodium in vitro does not suppress proteoglycan biosynthesis in cartilage at
concentrations equivalent to the concentrations reached in human beings.

Absorption
Absorption is complete but onset is delayed until passage through the stomach, which may
be affected by food which delays stomach emptying. The mean peak plasma diclofenac
concentration reached at about 2 hours (50mg dose produces 1.48 ± 0.65μg/ml (1.5μg/ml ≡
5μmol/l)).
Bioavailability
About half of the administered diclofenac is metabolised during its first passage through the
liver ("first-pass" effect), the area under the concentrations curve (AUC) following oral
administration is about half that following an equivalent parenteral dose.
Pharmacokinetic behaviour does not change on repeated administration. Accumulation does
not occur, provided the recommended dosage intervals are observed.
The plasma concentrations attained in children given equivalent doses (mg/kg, b.w.) are
similar to those obtained in adults. (25mg tablet only)

Distribution
The active substance is 99.7% protein bound, mainly to albumin (99.4%).
Diclofenac enters the synovial fluid, where maximum concentrations are measured 2-4
hours after the peak plasma values have been attained. The apparent half-life for elimination
from the synovial fluid is 3-6 hours. Two hours after reaching the peak plasma values,
concentrations of the active substance are already higher in the synovial fluid than they are
in the plasma and remain higher for up to 12 hours.
Diclofenac was detected in a low concentration (100 ng/mL) in breast milk in one nursing
mother. The estimated amount ingested by infant consuming breast milk is equivalent to a
0.03 mg/kg/day dose (see section 4.6 Pregnancy and lactation).
Metabolism
Biotransformation of diclofenac takes place partly by glucuronidation of the intact molecule,
but mainly by single and multiple hydroxylation and methoxylation, resulting in several
phenolic metabolites, most of which are converted to glucuronide conjugates. Two phenolic
metabolites are biologically active, but to a much lesser extent than diclofenac.
Elimination
The total systemic clearance of diclofenac in plasma is 263 ± 56 mL/min (mean value ±
SD). The terminal half-life in plasma is 1-2 hours. Four of the metabolites, including the two
active ones, also have short plasma half-lives of 1-3 hours.
About 60% of the administered dose is excreted in the urine in the form of the glucuronide
conjugate of the intact molecule and as metabolites, most of which are also converted to
glucuronide conjugates. Less than 1% is excreted as unchanged substance. The rest of the
dose is eliminated as metabolites through the bile in the faeces.
Characteristics in patients
Elderly: No relevant age-dependent differences in the drug's absorption, metabolism, or
excretion have been observed, other than the finding that in five elderly patients, a 15 minute
iv infusion resulted in 50% higher plasma concentrations than expected with young healthy
subjects.
Patients with renal impairment: In patients suffering from renal impairment, no
accumulation of the unchanged active substance can be inferred from the single-dose
kinetics when applying the usual dosage schedule. At a creatinine clearance of <10 mL/min,

the calculated steady-state plasma levels of the hydroxy metabolites are about 4 times higher
than in normal subjects. However, the metabolites are ultimately cleared through the bile.
Patients with hepatic disease: In patients with chronic hepatitis or non-decompensated
cirrhosis, the kinetics and metabolism of diclofenac are the same as in patients without liver
disease.

None stated.

Lactose Anhydrous
Microcrystalline Cellulose
Maize Starch
Povidone
Croscarmellose Sodium
Silicon Dioxide Colloidal
Magnesium Stearate
Purified water
Acryl-eze Yellow (Premixed coating material)

Not applicable.

2 years.

Do not store above 30°C, protect from moisture.

Primary: Alu-PVC/PVDC Blister.
Secondary: 2 blisters of 10 tablets each are packed in a carton along with PIL

No special requirements.
Any unused product or waste material should be disposed of in accordance with local
requirements.