Diclofenac sodium B.P. 50mg
Read all of this leaflet carefully before you take this medicine.
• Keep this leaflet. You many need to read it again.
• If you have further question, please ask your Pharmacist or your Doctor.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
In this leaflet:
1. What Tradiclo-50 Tablet is and what it is used for
2. Precautions and warning before you take Tradiclo-50 Tablet
3. How to take Tradiclo-50 Tablet
4. Possible side effects.
5. Symptoms and treatment of over dosage
6. How to store Tradiclo-50 Tablet
7. Further information
1. WHAT TRADICLO-50 TABLET IS AND WHAT IT IS USED FOR
Tradiclo-50 tablet is a proprietary medicine containing the active drug Diclofenac sodium. Diclofenac belongs to a class of drugs known as Non Steroidal Anti-Inflammatory Drugs (NSAID). It is non-narcotic and helps relief fever and pain due to swelling or inflammation of musculoskeletal origin. Tradiclo-50 relief fever by modulating the heat regulation centre in the brain. It relief pain through the inhibition of prostaglandin synthesis.
2. PRECAUTIONS AND WARNING BEFORE YOU TAKE TRADICLO-50 TABLET
Take special care or caution with Tradiclo-50 Tablet if:
• You have a history of peptic ulcer disease, impaired renal or hepatic function, cardiac disease, hypertension, fluid retention or known coagulation defects.
Stop Taking Tradiclo-50:
At the first sign of GI ulceration symptoms like epigastric pain and black or tarry stools as well as other unusual symptoms such as skin rash, pruritus or significant edema or weight gain, and seek immediate medical attention.
Contraindication:
• Do not take Tradiclo-50tablet if you are allergic or hypersensitive to the active drug or any of the ingredients of Tradiclo-50 tablet.
• You have a history of asthma, hepatic porphyria and bronchospastic reaction to aspirin or other NSAIDs.
Pregnancy and lactation:
• Do not take Tradiclo-50tablet if you are in your late pregnancy or breast-feeding.
Taking other Medicines:
• Please inform your Pharmacist or Doctor if you are taking or about to take any other medicine, including those obtained without a prescription.
3. HOW TO TAKE TRADICLO-50 TABLET
• You should take the tablet exactly as your Doctor or Pharmacist directs you.
• Tablets should be taken with meals or milk to avoid GI upset, but if rapid or maximum absorption is desired, they can be taken either I hour before or 2 hours after meals.
Dosage:
Adults: 50 mg P.O two to three times daily.
4. POSSIBLE SIDE EFFECT
Like all medicines, Tradiclo-50 can cause side effects, although not everybody gets them. Side effects like dizziness, fluid retention, edema, angioedema, tinnitus, nausea, epigastria distress, dyspepsia, occult blood loss, peptic ulceration, hepatotoxicity, acute renal failure, cystitis, blood dyscrasias, bronchospasms, rash, pruritus, photosensitivity, Stevens - Johnson syndrome have been rarely reported.
Possible interactions with food and drugs
Food delays the rate but not the extent of absorption. Tradiclo-50 should not be used together with aspirin or beta blockers. Concurrent use of Tradiclo-50 with cyclosporine, digoxin, methotrexate, diuretics, insulin, oral antidiabetics, lithium, phenytoin, and warfarin would require close monitoring by your physician.
5. SYMPTOMS AND TREATMENT OF OVER DOSAGE
Signs and symptoms of overdose may include anxiety, dizziness, edema, fluid retention, tinnitus, abdominal cramps, bullous eruption and acute renal failure. Supportive and symptomatic treatment may include induction of vomiting or gastric lavage. Treatment with activated charcoal or dialysis may also be appropriate.
6. HOW TO STORE TRADICLO-50 TABLET
Keep tablet out of reach or sight of children. Store product below 300c and in the original package. Check the expiry date on the label. Do not use product if the expiry date has passed.
7. FURTHER INFORMATION
Each Tablet contains 50mg of Diclofenac sodium. The other ingredients in Tradiclo-50 tablet are: Sodium lauryl sulphate, mannitol, povidone, methyl paraben, maize starch, starch glycolate, silicon dioxide, Talc and Magnesium Stearate.
Date of publication / review: Effective June, 2014, this publication is subject to review every two years and upon receipt of new product information.