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Voren Plus GelVoren Plus Gel

Diclofenac Sodium, the active ingredient of Voren Plus Gel, is a nonsteroidal drug that has anti-inflammatory and analgesic activity.

Ingredient(s)
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 prostaglandin synthesis.
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 parenteral administration.

Indication(s)
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.

Contraindication(s):
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 be consulted.

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 intervals thereafter.

7. Fluid retention and oedema have been observed in some patients taking NSAIDs, therefore caution is advised in patients with fluid retention or heart failure.

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 adverse events.

Drug Interactions
No interactions have been reported.

WARNINGS
RISK OF GI ULCERATION, BLEEDING AND PERFORATION WITH NSAID

Serious GI 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 Reaction(s)
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.

Shelf-Life
3 years from the date of manufacture.

Storage Condition(s)
Keep in an airtight container. Store at temperature below 30C. Protect from light and moisture.

Product Description and Packing(s)

A colorless transparent gel Aluminium tube of 20g, 45g and 50g.

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