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 acts by inhibiting prostaglandin biosynthesis by decreasing

the activity of Cyclo- oxygenase and results in decreased formation of prostaglandin, which plays a

major role in inflammation, pain and fever. Volenac 50 DT has rapid onset of action which make it

suitable for treatment of acute pain and inflammation also convenient for those patients who have

difficulty in swallowing tablets.

Volenac 50 DT absorbed immediately after administration and after one hour it achieves maximum

concentration if it’s taken on empty stomach but if it’s taken with or immediately after meal it reduce

16% of the amount absorbed and 50% of the maximum concentration. Serum protein bind with

99.7% of Diclofenac, its half-life 1-2 hours then metabolized in the liver and excreted in the urine and

the bile. Diclofenac does not accumulated 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 sever painful inflammatory infections of the ear, nose, or throat.

Note : underlying disease should be treated with basic therapy as appropriate.

DOSAGE & ADMINISTRATION :

Children over 14 years: 2 tablets* daily.

Adults : 2-3 tablets* daily .

Elderly and low body weight patients : It prefers to give the lowest effective dose for two weeks

only.

* It prefers to take Volenac 50 DT befor the meals in one of the following three ways :

1) Dropping the tablet in a glass of water and stirring to aid dispersion then swallow and it is

advisable to rinse the remained quantity in the glass with extra quantity of water and swallow again.

2) Putting the tablet in the mouth then swallow the dispersed tablet gradually.

3) Swallowing directly with quantity of water.

RESTRICTIONS ON USE :

Contraindications

• Hypersensitivity to the 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 the coronary artery bypass graft (CABG) surgery.

• Severe heart failure, hepatic failure, renal failure or history of acute porphyria.

Precautions

Volenac 50 DT used with caution and prefer to give the lowest effective dose in the following cases:

- Patients with impairment hepatic function, liver function test should be done periodically during

treatment.

- Patients with impairment renal function, renal function test 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,

renal function, hepatic function and blood counts should be monitored particularly important in the

elderly.

- Patients with mild, mediated or unstable high blood pressure or patients with odema should be used

under medical monitoring.

Use during Pregnancy and lactation

- Should not be used during pregnancy particularly at the last three months because it may delay or

prolong labor or prolong bleeding time and may cause complications on the baby.

- It passes into breast milk in small amounts so should not be used during lactation.

- It prefers to stop use by female with impair fertility and is not recommended in 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 (SSRls) 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 level in the

plasma.

● Cyclosporine and Zidovudine : may increase the toxicity and their side effects.

● Mifepristone : NSAIDs should not be used for 8-12 days after using mifepristone

● Anti-coagulants and anti-platelet agents: could 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 the absorption of Volenac 50 DT .

ADVERSE EFFECTS :

The side effects of Volenac 50 DT are 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.

OVERDOSE:

There is no typical clinic picture associated with overdose with diclofenac if it happens should be

cure with gastric lavage and treatment with active charcoal and then supportive and systemic

treatment should be done for complication.

STORAGE INSTRUCTIONS :

Store below 30oC, in a dry place.

Protect from light.

PRESENTATIONS :

Volenac 50 DT : Pack of 20 Tablets.