PHOPAIN TABLET

Each 600 mg Tablet contains Paracetamol B.P 325 mg 
Aspirin B.P 125 mg   
Caffeine B.P 30 mg

Read this leaflet carefully before you take the 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 Phopain tablet is and what it is used for:
2. Precautions and warning before you take Phopain tablet  
3. How to take Phopain tablet 
4. Possible side effects.
5. Symptoms and treatment of  over dosage
6. How to store Phopain tablet   
7. Further information

1. WHAT PHOPAIN TABLET IS AND WHAT IT IS USED FOR 
Phopain tablet is a proprietary medicine containing paracetamol, Aspirin and Caffeine as the active drugs. Paracetamol like aspirin is a non-narcotic analgesic which helps relief pain and fever. They relieve fever by modulating the heat regulating centre in the brain and relieve pain through the inhibition of prostaglandin synthesis and elevation of the pain threshold. Aspirin in addition inhibit the synthesis or action of agents that cause inflammation in the body. Aspirin at low doses inhibit platelet aggregation thus prolonging bleeding time but at high doses, this is negated. Caffeine is a mild CNS stimulant which enhances action of the other 2 drugs. 

2. PRECAUTIONS AND WARNING BEFORE YOU TAKE PHOPAIN TABLET
Take special care or caution with Phopain tablet if:   

• You have a history of chronic alcohol abuse, hepatic or CV disease, renal function impairment, angle closure glaucoma, increased intraocular pressure, hyperthyroidism, stenosing peptic ulcer or GI lesions, vitamin K deficiency, hypoprothrombinemia, asthma or COPD. 

Contraindication:
• Do not take Phopain tablet if you are allergic or hypersensitive to paracetamol, aspirin, caffeine or any of the ingredients of Phopain tablet.
• You have acute asthmatic attacks, G6PD deficiency, bleeding disorders such as hemophilia, NSAID induced sensitivity reactions or in children with chickenpox or flulike symptoms. 

Pregnancy and lactation
• Do not give Phopain tablet to pregnant or breast feeding mothers.

Stop Taking Phopain tablet:
• If a fever persist for 3days or more, or is recurrent. Seek medical attention immediately.

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 PHOPAIN TABLET
• Phopain tablet should be taken exactly as your Doctor or Pharmacist directs you.
• Doses should preferably be taken before meals, and on an empty stomach.

Dosage:
Phopain tablet should be taken according to body weight in 3- 4 divided doses daily, as needed. In the absence of body weight data, the following doses apply unless otherwise directed:
12 years and older: one tablet three to four times daily.
Adults:  two tablets three to four times daily.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Phopain tablet can cause side effects, although not everybody gets them. Side effects like jaundice, liver damage, hypoglycemia, rash, urticaria, anaphylaxis, angioedema, hemolytic anemia, blood dyscrasias, drowsiness, seizures, anorexia, tinnitus, hearing loss, Reye’s syndrome, Stevens - Johnson syndrome, toxic epidermal necrolysis and acute generalized exanthematous pustulosis have been rarely reported. Side effects are usually dose related. 

Possible interactions with food and drugs
Aminoglycosides, cisplatin, erythromycin, ethacrynic acid, furosemide or vancomycin may potentiate ototoxic effects. Antibiotics, steroids and other NSAIDs may potentiate adverse GI effects of Phopain while antacids and other urine alkalizers decrease aspirin blood levels. Anticoagulants and thrombolytics may potentiate platelet inhibiting effects of aspirin. Food delays and decreases absorption of Phopain while alcohol potentiates its adverse GI effects.

5. SYMPTOMS AND TREATMENT OF OVER DOSAGE
Signs and symptoms of overdose include GI discomfort, oliguria, acute renal failure, hyperthermia, EEG abnormalities, restlessness, metabolic acidosis with respiratory alkalosis, hyperpnoea and tachypnea. Treat overdose by inducing emesis with ipecac syrup followed by activated charcoal. Use gastric lavage if patient is unconscious or ipecac fails. Enhance renal excretion by alkalinizing with sodium bicarbonate. Sponging should be used if rectal temperature exceeds 40oc.

6. HOW TO STORE PHOPAIN TABLET
Keep tablet out of reach or sight of children and in the original package. Store product below 300C, away from light. Always check the expiry date on the label and do not use product if expired.  

7. FURTHER INFORMATION
In addition to Paracetamol, Aspirin and Caffeine, excipients present in Phopain tablet include: Povidone, microcrystalline cellulose, maize starch, citric acid, methyl paraben, erythrosine red, sodium starch glycolate, silicon dioxide, Talc and stearic acid.  

Date of publication / review: This publication is subject to review every two years (effective January, 2010) and upon receipt of new product information.