Panadol Optizorb: Each caplet contains 500mg paracetamol, pregelatinised starch, magnesium stearate, carnauba wax, calcium carbonate, alginic acid, blend of sodium parabens, crospovidone, povidone (K-25), colloidal anhydrous silica and opadry white.
Pharmacology: Pharmacodynamics: Mechanism of Action: Paracetamol is an analgesic and antipyretic. Its mechanism of action is believed to include inhibition of prostaglandin synthesis, primarily within the central nervous system.
Pharmacodynamic Effects: The lack of peripheral prostaglandin inhibition confers important pharmacological properties such as the maintenance of the protective prostaglandins within the gastrointestinal tract.
Paracetamol is, therefore, particularly suitable for: patients with a history of disease or patients taking concomitant medication, where peripheral prostaglandin inhibition would be undesirable (such as, for example, those with a history of gastrointestinal bleeding or the elderly).
In two dental pain studies conducted in patients following surgical removal of third molars, pain relief was observed at a median time of 15 minutes following administration of the 1000mg dose of Panadol Tablets with Optizorb.
Panadol Tablets with Optizorb demonstrated superior pain relief at 1000 mg dose compared to placebo and to Panadol Tablets with Optizorb at 500mg dose. Panadol Tablets with Optizorb at the 500 mg dose also demonstrated superior efficacy compared to placebo.
Pharmacokinetics: Absorption: Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract.
Distribution: Binding to the plasma proteins is minimal at therapeutic concentrations.
Metabolism: Paracetamol is metabolised in the liver and excreted in the urine mainly as glucuronide and sulphate conjugates.
Elimination: Less than 5% is excreted as unmodified paracetamol.
Paracetamol is rapidly absorbed from the gastrointestinal tract and is distributed into most body tissues. Binding to plasma proteins is minimal at therapeutic concentrations. Paracetamol is metabolised in the liver and excreted in the urine mainly as glucuronide and sulphate metabolites - less than 5% is excreted as unmodified paracetamol. The mean plasma half life is about 2.3 hours.
Paracetamol Tablets with Optizorb contain a disintegrant system which optimises tablet dissolution compared to standard paracetamol tablets.
Human scintigraphy data demonstrate that Paracetamol Tablets with Optizorb generally start to disintegrate by 5 minutes post dose. Human pharmacokinetic data demonstrate that paracetamol can generally be detected in plasma by 10 minutes. Human pharmacokinetic data demonstrate that early absorption of paracetamol (fraction of dose over the first 60 minutes) is 32% greater from Paracetamol Tablets with Optizorb compared to standard paracetamol tablets (p<0.0001). There is also less between-subject and less within- subject variability (p<0.0001) in early absorption of paracetamol from Paracetamol Tablets with Optizorb compared to standard paracetamol tablets.
Human pharmacokinetic data demonstrate that maximum plasma concentration of paracetamol is reached at least 25% faster for Paracetamol Tablets with Optizorb compared to standard paracetamol tablets in fasted and fed states (p < 0.01). Total extent of absorption of paracetamol from Paracetamol Tablets with Optizorb is equivalent to that from standard paracetamol tablets.
Paracetamol is an analgesic and an antipyretic.
Relief of fever.
Relief of headache, migraine, sore throat, fever and toothache.
Panadol: Adults including elderly and children aged 12 years and over: 1-2 tablets 4-6 hourly. Maximum Dose: 8 tablets in 24 hours.
Panadol Optizorb: Do not exceed the stated dose.
The lowest dose necessary to achieve efficacy should be used for the shortest duration of treatment.
Minimum dosing interval: 4 hours.
Maximum daily dose: 4000mg (8 tablets).
Adults (including the elderly) and children aged 12 years and over: 1 to 2 caplets (500mg to 1000mg paracetamol), taken every 4 to 6 hours as required. Max: 8 caplets in 24 hours.
Children 6 to 11 years: No more than 4 doses in any 24-hour period.
Maximum duration of continued use without medical advice: 3 days.
Maximum daily dose: 60mg/kg to be administered in divided doses of 10-15 mg/kg throughout the 24-hour period.
Children 6 to 8 years: ½ caplet (250mg).
Children 9 to 11 years: 1 caplet (500mg).
Children under 6 years: Not recommended for children under the age of 6 years.
Renal Impairment: Patients who have been diagnosed with renal impairment must seek medical advice before taking this medication. The restrictions related to the use of paracetamol products in patients with renal impairment are primarily a consequence of the paracetamol content of the drug (see Precautions).
Hepatic Impairment: Patients who have been diagnosed with liver impairment must seek medical advice before taking this medication. The restrictions related to the use of paracetamol products in patients with hepatic impairment are primarily a consequence of the paracetamol content of the drug (see Precautions).
Route of Administration: Oral administration only.
If the patient takes more of the medicine than they should, seek medical advice immediately even if the patient do not have any symptoms because of the risk of liver failure.
Symptoms and Signs: Paracetamol overdose may cause liver failure which can lead to liver transplant or death. Acute pancreatitis has been observed, usually with hepatic dysfunction and liver toxicity.
Treatment: Immediate medical management is required in the event of overdose, even if symptoms of overdose are not present.
If overdose is confirmed or suspected, seek immediate advice from National Poison Centre and refer patient to nearest Emergency Medical Centre for management and expert treatment. This should happen even in patients without symptoms or signs of overdose due to the risk of delayed liver damage.
Administration of N-acetylcysteine or methionine may be required.
National Poison Centre (Phone: +604-657 0099, Website: www.prn.usm.my, Email: prnnet@usm.my).
Do not use if the patient is allergic to paracetamol or any of the other ingredients in the product.
This preparation contains PARACETAMOL. Do not take any other paracetamol containing medicines at the same time.
Do not take more than the recommended dose as it may cause serious harm to the patient's liver.
Check with the doctor before use if the patient: Have liver or kidney problems; Are underweight or malnourished; Regularly drink alcohol.
The patient may need to avoid using this product altogether or limit the amount of paracetamol that the patient takes.
Check with the doctor before use if the patient: Have a severe infection, are severely malnourished, severely underweight or are a chronic heavy alcohol user as this may increase the risk of metabolic acidosis. Signs of metabolic acidosis include: Deep, rapid, difficult breathing; Feeling sick (nausea), being sick (vomiting); Loss of appetite.
Contact a doctor immediately if the patient gets a combination of these symptoms.
Please see a doctor if the patient's symptoms do not improve.
Always read and follow the label.
Allergy Alert: Paracetamol may cause severe skin reactions. Symptoms may include skin reddening, blisters and rash. These could be signs of a serious condition. If these reactions occur, stop use and seek medical assistance right away. Each caplet contains Paracetamol 500mg, 0.2% w/w sodium parabens (preservative).
Sodium methyl-, sodium ethyl- and sodium propylparahydroxybenzoates (E219, E215, E217) may cause allergic reactions (possible delayed).
Effects on Ability to Drive and Use Machine: Unlikely to cause an effect on ability to drive and use machines.
Pregnancy: As with the use of any medicine during pregnancy, pregnant women should seek medical advice before taking paracetamol. The lowest effective dose and shortest duration of treatment should be considered.
Lactation: Paracetamol is excreted in breast milk but not in a clinically significant amount at recommended dosages. Available published data do not contraindicate breastfeeding.
Stop taking this medicine and tell a doctor immediately if: the patient experience allergic reactions such as skin rash or itching, sometimes with breathing problems or swelling of the lips, tongue, throat or face.
The patient experience a skin rash or peeling, or mouth ulcers.
The patient have previously experienced breathing problems with aspirin or non-steroidal anti-inflammatories, and experience a similar reaction with this product.
The patient experience unexplained bruising or bleeding.
These reactions are rare.
From post marketing data, the reactions as follows are very rare: Thrombocytopaenia, Anaphylaxis, cutaneous hypersensitivity reactions including, among others, skin rashes, angioedema, Stevens-Johnson syndrome and Toxic Epidermal Necrolysis, Bronchospasm in patients sensitive to aspirin and other NSAIDs, Hepatic dysfunction.
Before taking this medicine, make sure the patient consult a doctor if they are taking warfarin or similar medicines used to thin the blood. The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular daily use of paracetamol with increased risk of bleeding; occasional doses have no significant effect.
N02BE01 - paracetamol ; Belongs to the class of anilide preparations. Used to relieve pain and fever.
Panadol Optizorb caplet 500 mg
144's;36's
Panadol tab 500 mg
150's;30's
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