📌 COMPOSITION

Each dispersible tablet contains: Diclofenac Free Acid 46.5 mg equivalent to Diclofenac Sodium 50 mg.

📌 DESCRIPTION

Volenac 50 DT (Diclofenac) is a non-steroidal anti-inflammatory compound with analgesic, antipyretic and antirheumatic properties. It acts by inhibiting prostaglandin biosynthesis by decreasing the activity of Cyclo-oxygenase, resulting in decreased formation of prostaglandin, which plays a major role in inflammation, pain and fever. Volenac 50 DT has rapid onset of action which makes it suitable for treatment of acute pain and inflammation, and also convenient for those patients who have difficulty in swallowing tablets.

Volenac 50 DT is absorbed immediately after administration and after one hour it achieves maximum concentration if taken on an empty stomach. However, if taken with or immediately after a meal, it reduces 16% of the amount absorbed and 50% of the maximum concentration. 99.7% of Diclofenac is bound to serum proteins. Its half-life is 1-2 hours; it is then metabolized in the liver and excreted in the urine and bile. Diclofenac does not accumulate within the recommended dosage intervals.

📌 INDICATIONS

• Analgesic for mild to moderate pain such as (bursitis, trauma, fractures, postoperative pain and inflammation, dysmenorrhea, painful vertebral column syndromes, back pain, swelling and inflammation pain).
• Anti-inflammatory for (Rheumatoid arthritis, non-articular rheumatism, acute attacks of gout, ankylosing spondylitis and osteoarthritis).
• As an adjuvant in severe painful inflammatory infections of the ear, nose, or throat.

Note: The underlying disease should be treated with basic therapy as appropriate, as pain is an indicator of disease.

📌 DOSAGE & ADMINISTRATION

• Children over 14 years: 2 tablets* daily.
• Adults: 2-3 tablets* daily.
• Elderly and low body weight patients: It is preferable to give the lowest effective dose for two weeks only.

* Volenac 50 DT should preferably be taken before meals in one of the following three ways:

• 1) Dropping the tablet into a glass of water and stirring to aid dispersion, then swallowing the contents. It is advisable to rinse the remaining quantity in the glass with extra water and swallow again.
• 2) Putting the tablet in the mouth and swallowing the dispersed tablet gradually.
• 3) Swallowing directly with a quantity of water.

📌 RESTRICTIONS ON USE

Contraindications

• Hypersensitivity to Diclofenac.
• Active or history of recurrent gastric or intestinal ulcer, bleeding or perforation.
• Patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis, angioedema, or urticaria) in response to ibuprofen, aspirin, or other non-steroidal anti-inflammatory drugs.
• Congestive heart failure, ischemic heart disease, peripheral arterial disease or cerebrovascular disease.
• Perioperative pain in the setting of coronary artery bypass graft (CABG) surgery.
• Severe heart failure, hepatic failure, renal failure or history of acute porphyria.

Precautions

Volenac 50 DT should be used with caution and it is preferable to give the lowest effective dose in the following cases:

• Patients with impaired hepatic function: liver function tests should be done periodically during treatment.
• Patients with impaired renal function: renal function tests should be done periodically during treatment.
• Patients with defects of hemostasis, bleeding diathesis or hematological abnormalities.
• All patients who are receiving long-term treatment with non-steroidal anti-inflammatory agents should have regular monitoring of renal function, hepatic function and blood counts. This is particularly important in the elderly.
• Patients with mild, moderate or unstable high blood pressure or patients with edema should be under medical monitoring.

Use during Pregnancy and Lactation

• Should not be used during pregnancy, particularly in the last three months, because it may delay or prolong labor or prolong bleeding time and may cause complications for the baby.
• It passes into breast milk in small amounts, so should not be used during lactation.
• It is preferable to avoid use by women with impaired fertility and is not recommended for women attempting to conceive.

📌 DRUG INTERACTIONS

Volenac 50 DT should not be used with:

• Other NSAIDs including cyclo-oxygenase-2 (COX-2) selective inhibitors, corticosteroids and selective serotonin reuptake inhibitors (SSRIs) — may increase the risk of gastrointestinal ulceration or bleeding.
• Diuretics and antihypertensive agents (e.g. beta-blockers, angiotensin-converting enzyme (ACE) inhibitors) — may cause a decrease in their effect.
• Cardiac glycosides, Lithium, Methotrexate, Digoxin and Phenytoin — increase drug levels in the plasma.
• Cyclosporine and Zidovudine — may increase their toxicity and side effects.
• Mifepristone — NSAIDs should not be used for 8-12 days after taking mifepristone.
• Anticoagulants and antiplatelet agents — may increase the risk of bleeding.
• Quinolone antibacterial group — convulsions may occur due to an interaction between quinolones and NSAIDs.
• Colestipol and cholestyramine — Volenac 50 DT should be taken at least one hour before or 4 to 6 hours after administration because they affect its absorption.

📌 ADVERSE EFFECTS

The side effects of Volenac 50 DT are generally well tolerated. The reported adverse effects include gastrointestinal disturbances such as nausea, vomiting, diarrhea, dyspepsia, abdominal pain, flatulence and loss of appetite. Rarely, effects such as hypersensitivity, drowsiness, gastritis, ulcer, jaundice and urticaria may occur.

📌 OVERDOSAGE

There is no typical clinical picture associated with overdose of Diclofenac. If it occurs, treatment should include gastric lavage and activated charcoal, followed by supportive and symptomatic treatment for complications.

📌 STORAGE INSTRUCTIONS

• Store below 30°C in a dry place.
• Protect from light.

📌 PHARMACEUTICAL FORMS

Volenac 50 DT dispersible tablets: Pack of 20 tablets.