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Pfizer Consumer Healthcare
9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24, Ireland
Telephone: +353 (0)1 467 6500
Fax: +353 (0)1 467 6501
Medical Information Direct Line: +353 (0)1 467 6627
Summary of Product Characteristics last updated on medicines.ie: 06/01/2015
SPC PARAEXTRA Hard Capsules

When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 06/01/2015 and displayed until Current
Reasons for adding or updating:
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   22-Dec-2014
Legal Category:   Supply through general sale

Free-text change information supplied by the pharmaceutical company
3. PHARMACEUTICAL FORM

Capsules, hard

Size 0, hard gelatin capsules with an opaque blue cap and an opaque yellow body, imprinted on both sections with “500/32”, containing a white, free flowing granule mix.

4.4 Special Warnings and Special Precautions for Use

• Caution should be exercised in patients with impairment of hepatic or renal function (avoid if severe). The hazards of overdose are greater in those with non-cirrhotic alcoholic liver disease.
• If symptoms persist, consult your doctor.
• Prolonged use without medical advice may be harmful.
• Do not exceed the stated dose.
• Do not take this medicine with other Paracetamol containing products.
• Immediate medical advice should be sought in the event of overdosage even if you feel well.
• Use only when clearly necessary.

Patients should be advised that Paracetamol may cause severe skin reactions. If a skin reaction such as skin reddening, blisters, or rash occurs, they should stop use and seek medical assistance right away.

4.8 Undesirable Effects

Skin and subcutaneous tissue disorders

Very Rare: Serious skin reactions (including severe cutaneous reactions such as Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis, and Acute Generalised Exanthematous Pustulosis) have been reported.

10. DATE OF (PARTIAL) REVISION OF THE TEXT

December 2014

Updated on 11/10/2013 and displayed until 06/01/2015
Reasons for adding or updating:
  • New SPC for new product
Date of revision of text on the SPC:  
Legal Category:   Supply through general sale

Free-text change information supplied by the pharmaceutical company
None provided

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Active Ingredients

 
  Paracetamol
  Caffeine