Panadol Extra

INDICATIONS

Contains paracetamol, which is an analgesic and antipyretic, and caffeine, an adjuvant to the analgesic effect of paracetamol.

Treatment of miId to moderate pain and relief of fever including:

  • Headache
  • Migraine
  • Muscle ache
  • Dysmennorhoea
  • Sore throat
  • Musculoskeletal pain
  • Fever and pain after vaccination
  • Pain after dental procedures/ tooth extraction
  • Toothache
  • Earache/Otalgia
  • Pain of osteoarthritis
  • Respiratory tract infections including cold and flu

PHARMACEUTICAL FORM

Tablets.
PACK SIZE
Box of 10 blisters x 12 tablets.

Active ingredients:
Paracetamol ................... 500 mg
Caffeine ........................... 65 mg

CONTRA-INDICATIONS

This product is contraindicated in patients with a previous history of hypersensitivity to paracetamol, caffeine or excipients.

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DOSAGE AND ADMINISTRATION

Adults (including the elderly) and children aged 12 years and over:
Oral administration only.
Do not exceed the stated dose.
The lowest dose necessary to achieve efficacy should be used with the shortest duration of treatment.
Minimum dosing interval: 4 hours.
1 or 2 tablets every 4 to 6 hours as required.
Maximum daily dose: 8 tablets; 4000 mg/520 mg (paracetamol/caffeine).

Children aged 7 to 12 years can take half to 1 caplet every 4-6 hours with water, as required. Do not exceed the maximum of 4 caplets in a 24-hour period. Do not use for more than 48 hours except on medical advice.i

Panadol Caplets with OPTIZORB Formulation are not recommended for use in children aged under 7 years.i

  • Panadol Extra

Also available:

More Information

  • Contains paracetamol.
  • Do not use with any other paracetamol-containing products. The concomitant use with other products containing paracetamol may lead to an overdose.
  • Paracetamol overdose may cause liver failure which may require liver transplant or lead to death.
  • Underlying liver disease increases the risk of paracetamol- related liver damage. Patients who have been diagnosed with liver or kidney impairment must seek medical advice before taking this medication.
  • Cases of hepatic dysfunction /failure have been reported in patients with depleted glutathione levels, such as those who are severely malnourished, anorexic, have a low body mass index or are chronic heavy users of alcohol or have sepsis.
  • In patients with glutathione depleted states, the use of paracetamol may increase the risk of metabolic acidosis.
  • If symptoms persist, medical advice must be sought. (If cold and flu symptoms persist for longer than 7 days, medical advice must be sought*.)
  • Excessive intake of caffeine (e.g., coffee, tea and some canned drinks) should be avoided while taking this product.
  • Keep out of sight and reach of children.
Paracetamol

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.

Caffeine

Caffeine can increase the elimination of lithium from the body. Concomitant use is therefore not recommended.

Pregnancy

Not recommended for use during pregnancy.
Paracetamol
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.
Caffeine
Caffeine is not recommended for use during pregnancy due to the possible increased risk of spontaneous abortion associated with caffeine consumption.

Lactation

Not recommended for use during breast feeding.
Paracetamol
Paracetamol is excreted in breast milk but not in a clinically significant amount at recommended dosages
Caffeine
Caffeine in breast milk may potentially have a stimulating effect on breast fed infants but significant toxicity has not been observed.

Post Marketing Data

Adverse events from historical clinical trial data are both infrequent and from small patient exposure. Accordingly, events reported from extensive post-marketing experience at therapeutic/labelled dose and considered attributable are tabulated below by MedDRA System Organ Class. Adverse reactions identified during post-marketing use are reported voluntarily from a population of uncertain size, the frequency of these reactions is unknown but likely to be very rare <1/10,000).

Body System
 Undesirable Effects
Paracetamol  
Blood and lymphatic system disorders  Thrombocytopenia
Immune System disorders  Anaphylaxis
Cutaneous hypersensitivity reactions including, among others, skin rashes, angioedema, Stevens Johnson syndrome and toxic epidermal necrolysis. 
Respiratory, thoracic and mediastinal Disorders  Bronchospasm in patients sensitive to aspirin and other NSAIDs
Hepatobiliary disorders  Hepatic dysfunction
Caffeine  
Central Nervous System  Dizziness, headache
Cardiac disorders  Palpitation
Psychiatric disorders  Insomnia, restlessness, anxiety and irritability, nervousness
Gastrointestinal Disorders  Gastrointestinal disturbances

When the recommended paracetamol-caffeine dosing regimen is combined with dietary caffeine intake, the resulting higher dose of caffeine may increase the potential for caffeine-related adverse effects.

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Always read the label before use.

If you want to get a superior quality medicine, please purchase medicine with certified stamp register number CAM R4 2712 IP-04 (Panadol 500), CAM R2 0011 IP-10 (Panadol Extra), CAM R2 0012 IP-10 (Panadol Cold&Flu) in pharmacy and sub-pharmacy with permits and logo issued by the ministry of Health. The advertisement is already approved by Health Authority. If any side effect from using this medicine, please report to department of Medicine via telephone no. 012 673 268/ 089 498 883 or Email pv.center@ezecome.com.kh or Website https://www.ddfcambodia.com/ and Contact Number from DKSH Company DKSH 067 555 752