Diclofenac Sodium, the active ingredient of Voren Plus
Gel, is a nonsteroidal drug that has anti-inflammatory and analgesic
Each gram contains:
Diclofenac Sodium ......................... 10mg
Pharmacology (Summary of Pharmacodynamics and Pharmacokinetics)
1. Diclofenac Sodium has analgesic and anti-inflammatory properties. It
inhibits cyclo-oxygenase which results in a marked reduction in
2. Voren Plus Gel is suitable for use in inflammatory and degenerative
rheumatic diseases, as well as for the treatment of post traumatic
inflammation and swelling.
3. Voren Plus Gel can be easily rubbed on the skin, and due to the aqueous
alcoholic base it exerts a soothing and cooling effects.
4. After percutaneous application of diclofenac gel, the maximum plasma
concentration of diclofenac was less than 10% of that reached after a
similar dose given by parenteral administration.
5. Local accumulation of diclofenac by direct transport or diffusion into
the knee joint seems unlikely.
6. After topical application fewer adverse effects are to be expected which
are otherwise related to the higher drug plasma levels reached after oral or
Topical treatment of inflammatory or pain conditions caused by chronic
rheumatoid arthritis, degenerative arthritis and soft tissue rheumatism.
Dosage and Administration
Depending on the size to be treated, apply sufficient amounts of Voren Plus
Gel 3 ~ 4 times daily on the affected areas and rub in gently. To be
dispensed on physician's prescription.
After assessing the risk/ benefit ratio in each individual patient, the
lowest effective dose for the shortest possible duration should be used.
Known hypersensitivity to diclofenac sodium, propylene glycol or to any
components of this product.
Precaution(s) / Warning(s):
1. Voren Plus Gel should be applied only to intact skin surfaces, and not to
skin wounds or open injuries. It should not be allowed to come into contact
with the eyes or with mucous membranes.
2. Safe use of this product during pregnancy and lactation has not been
established. Women who suspect pregnancy, pregnant women or nursing mothers
should not be given this product unless clearly needed.
3. NSAIDs may very rarely cause serious cutaneous adverse events such as
exfoliative dermatitis, toxic epidermal necrolysis (TEN) and StevensJohnson
Syndrome (SJS), which can be fatal and occur without warning. These serious
adverse events are idiosyncratic and are independent of dose or duration of
use. Patients should be advised of the signs and symptoms of serious skin
reaction and to consult their doctor at the first appearance of a skin rash
or any other sign of hypersensitivity.
4. When Voren Gel is applied to relatively large areas of skin and over a
prolonged period, the possibility of systemic side effects cannot be
completely excluded. In such cases, the product information on Voren should
5. Observational studies have indicated that non-selective NSAIDs may be
associated with an increased risk of serious cardiovascular events,
principally myocardial infarction, which may increase with dose or duration
of use. Patients with cardiovascular disease or cardiovascular risk of an
adverse cardiovascular event in patient taking NSAID, especially in those
with cardiovascular risk factors, the lowest effective dose should be used
for the shortest possible duration.
There is no consistent evidence that the concurrent use of aspirin
mitigates the possible increased risk of serious cardiovascular thrombotic
events associated with NSAID use.
6. NSAIDs may lead to the onset of new hypertension or worsening the
preexisting hypertension and patients taking anti-hypertensive with NSAIDs
may have an impaired anti-hypertensive response. Caution is advised when
prescribing NSAIDs to patients with hypertension. Blood pressure should be
monitored closely during initiation of NSAID treatment and at regular
7. Fluid retention and oedema have been observed in some patients taking
NSAIDs, therefore caution is advised in patients with fluid retention or
8. All NSAIDs can cause gastrointestinal discomfort and rarely serious,
potentially fatal gastrointestinal effects such as ulcers, bleeding and
perforation which may increase with dose or duration of use, but can occur
at any time without warning. Caution is advised in patients with risk
factors for gastrointestinal events e.g. the elderly, those with a history
of serious gastrointestinal events, smoking and alcoholism. When
gastrointestinal bleeding or ulceration occurs in patients receiving NSAIDs,
the drug should be withdrawn immediately. Doctors should warn patients about
signs and symptoms of serious gastrointestinal toxicity. The concurrent use
of aspirin and NSAIDs also increases the risk of serious gastrointestinal
No interactions have been reported.
RISK OF GI ULCERATION, BLEEDING AND PERFORATION WITH NSAID
toxicity such as bleeding, ulceration and perforation can occur at any
time, with or without warning symptoms, in patients treated with NSAID
therapy. Although minor upper GI problems (eg. dyspepsia) are common,
usually developing early in therapy, prescribers should remain alert for
ulceration and bleeding in patients treated with NSAIDs even in the
absence of previous GI tract symptoms.
Studies to date have not- identified any subset of patients not at risk
of developing peptic ulceration and bleeding. Patients with prior
history of serious adverse events and other risk factors associated with
peptic ulcer disease (eg. alcoholism, smoking,. and corticosteroid
therapy) are at increased risk. Elderly or debilitated patients seem to
tolerate ulceration or bleeding less than other individuals and account
for most spontaneous reports for fatal GI events.
Side Effect(s) / Adverse
Voren Plus Gel is usually well tolerated. Itching, reddening, smarting of
the skin, rashes or skin eruptions may occasionally occur.
Symptoms and Treatment for Overdosage, and Antidote(s)
In the event of significant systemic side effects occurring as a result of
improper use or accidental overdosage leg. children), general therapeutic
measures of the kind normally adopted to treat poisoning with non-steroidal
anti-inflammatory drugs should be resorted to.
3 years from the date of manufacture.
Keep in an airtight container. Store at temperature below 30°C. Protect from
light and moisture.
Product Description and Packing(s)
A colorless transparent gel
Aluminium tube of 20g, 45g and 50g.