Search The Medical Knowledge Base

Drug Details

Hedex Extra

• Presentation
  Tablet. Hedex Extra/Solpadeine Headache Tablets are white film-coated, capsule shaped tablets printed with “HEDEX EXTRA” on one side and plain on the reverse or printed with “EP500” on one side and plain on the reverse or printed with “Headache” on one side and plain on the reverse.
• Description
  Each tablet contains Paracetamol Ph.Eur. 500.0 mg and Caffeine Ph.Eur. 65.0 mg.
• Indications
  

  Hedex Extra is a mild analgesic and antipyretic formulated to give extra pain relief. The tablets are recommended for the treatment of most painful and febrile conditions, for example, headache, including migraine, backache, toothache, rheumatic pain and dysmenorrhoea, and relief of the symptoms of colds, influenza and sore throat.

• Adult Dosage
  

  Adults:

  Two tablets up to four times daily.

  Do not exceed 8 tablets in 24 hours.

  Elderly:

  As for adults.

  Children:

  Not recommended for children under 12 years.

  Method of Administration

  Hedex Extra Tablets are for oral administration only.

• Contra Indications
  

  Hypersensitivity to paracetamol, caffeine or any of the other constituents.

• Special Precautions
  

  Care is advised in the administration of paracetamol to patients with renal or hepatic impairment. The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease.

  Excessive intake of caffeine (e.g. coffee, tea and some canned drinks) should be avoided while taking this product.

  Do not exceed the stated dose.

  Patients should be advised to consult their doctor if their headaches become persistent.

  Patients should be advised not to take other paracetamol-containing products concurrently.

  If symptoms persist consult your doctor.

  Keep out of the reach and sight of children.

  Pack Label:

  Immediate medical advice should be sought in the event of an overdose, even if you feel well. Do not take with any other paracetamol-containing products.

  Patient Information Leaflet:

  Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage.

• Interactions
  

  The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by colestyramine. 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.

• Adverse Drug Reactions
  

  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 system class. Due to limited clinical trial data, the frequency of these adverse events is not known (cannot be estimated from available data), but post-marketing experience indicates that adverse reactions to paracetamol are rare and serious reactions are very rare.

  Post marketing data 

  Body System	Undesirable effect
  Blood and lymphatic system disorders	Thrombocytopenia Agranulocytosis
  Immune system disorders	Anaphylaxis Cutaneous hypersensitivity reactions including skin rashes, angiodema and Stevens Johnson syndrome/toxic epidermal necrolysis
  Respiratory, thoracic and mediastinal disorders	Bromchospasm*
  Hepatobiliary disorders	Hepatic dysfunction

  * There have been cases of bronchospasm with paracetamol, but these are more likely in asthmatics sensitive to aspirin or other NSAIDs.

  Caffeine
  Central Nervous system	Nervousness Dizziness
  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 such as insomnia, restlessness, anxiety, irritability, headaches, gastrointestinal disturbances and palpitations.