TRACAM-20 CAPSULE

Piroxicam B.P. 20mg  
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 questions, please ask your Pharmacist or 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 Tracam-20 capsule  is and what it is used for
2. Precautions and warning before you take Tracam-20 capsule
3. How to take Tracam-20 capsule
4. Possible side effects.
5. Symptoms and treatment of  over dosage
6. How to store Tracam-20 capsule
7. Further information

1. WHAT TRACAM-20 CAPSULE IS AND WHAT IT IS USED FOR 
Tracam-20 capsule contains a single active ingredient, Piroxicam.   Piroxicam belongs to a class of drugs known as NSAIDs (Non Steroidal Anti- Inflammatory Drugs). It is a non-narcotic analgesic and helps relief fever and pain due to swelling or inflammation of musculoskeletal origin. Piroxicam works in your body by inhibiting the synthesis of prostaglandins responsible for inflammation and pain.

2. PRECAUTIONS AND WARNING BEFORE YOU TAKE TRACAM-20 CAPSULE  

Contraindication:
• Do not take Tracam-20 capsule if you are allergic or hypersensitive to Piroxicam or any of the ingredients of Tracam-20 capsule.
• You have a history of bronchospasms or angioedema precipitated by aspirin or other NSAIDs. 

Pregnancy and lactation:
• Do not take Tracam-20 if you are in your late pregnancy or breast-feeding.

Take special care with Tracam-20 capsule if:
• You have impaired renal or hepatic function, peptic ulcer disease, GI disorders, cardiac disease, hypertension, or conditions predisposing to fluid retention.   

Stop taking Tracam-20 capsule:
• At the first sign of anemia (presenting as tiredness, fast heart beat or paleness of skin/lips/nails) as well as other unusual symptoms such as skin rash, pruritus or significant edema or weight gain, and seek immediate medical attention.

Driving or using machinery:
• Avoid hazardous activities requiring alertness until CNS effects are known.

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 TRACAM-20 CAPSULE 
• You should take one capsule of Tracam-20 daily or exactly as your Doctor or Pharmacist directs you. 

4. POSSIBLE SIDE EFFECTS
Like all medicines, Tracam-20 capsule 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, nephrotoxicity, blood dyscrasias, prolonged bleeding time, bronchospasms, rash, pruritus, and photosensitivity have been rarely reported.

Possible interactions with food and drugs
Food delays absorption of Tracam-20 while alcohol increases GI toxicity and decreases plasma levels. Tracam-20 may decrease effectiveness of antihypertensives and diuretics; increase adverse GI effects with anti-inflammatory drugs, corticosteroids and salicylates; increased toxicity with nifedipine, phenytoin and verapamil; and potentiate hypoglycemic effects of insulin or oral antidiabetics. Coadministration with aspirin reduces Piroxicam levels by about 20 percent.

Pharmacokinetics
Following single oral doses of 20 mg, Piroxicam is rapidly and fully absorbed, and eliminated with a mean plasma half life of about 45 hr. Mean peak concentrations are about 2micrigrams / ml after   single 20 mg doses and about 6 mcg / ml at steady state with 20 mg daily. Steady state is achieved within 7 to 12 days with no appreciable accumulation thereafter.

5. SYMPTOMS AND TREATMENT OF OVER DOSAGE  
Signs and symptoms of overdose include GI discomfort, nausea, vomiting, drowsiness, oliguria, peripheral edema, auditory disturbances. Treat overdose by inducing emesis with ipecac syrup followed by activated charcoal. Use gastric lavage if patient is unconscious or ipecac fails. Respiratory support and correction of fluid and electrolyte imbalances may also apply.

6. HOW TO STORE TRACAM-20 CAPSULE
Keep capsule out of reach or sight of children. Store below 300C and in the original package. Check expiry date on the label and do not use product if expired.  

7. FURTHER INFORMATION
Each Capsule contains 20mg of Piroxicam USP. The other ingredients in Tracam-20 capsule are: Sodium lauryl sulphate, Gelatin, Methyl paraben, Maize starch, Silicon dioxide, Talc and Magnesium Stearate.  
Presentation: Each box contains three (3) blisters of ten (10) capsules each.
Date of publication / review: Effective January, 2017, this publication is subject to review every two years and upon receipt of new product information.