PARAEXTRA Hard Capsules

  • Name:

    PARAEXTRA Hard Capsules

  • Company:
    info
  • Active Ingredients:

    Caffeine, Paracetamol

  • Legal Category:

    Supply through general sale

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 04/11/19

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Summary of Product Characteristics last updated on medicines.ie: 4/11/2019

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Pfizer Consumer Healthcare

Pfizer Consumer Healthcare

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Medicine Name Paracetamol 500 mg Film Coated Tablets Active Ingredients Paracetamol
Medicine Name PARAEXTRA Hard Capsules Active Ingredients Caffeine, Paracetamol
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1 - 0 of 14 items.Total: Infinity pages

When a pharmaceutical company changes any document, 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 4 November 2019 SmPC

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text

Legal category: Supply through general sale

Updated on 4 November 2019 PIL

Reasons for updating

  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 6 - what the product contains
  • Change to date of revision

Updated on 8 October 2018 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 4 October 2018 SmPC

Reasons for updating

  • File format updated to PDF

Legal category: Supply through general sale

Updated on 7 June 2018 PIL

Reasons for updating

  • Improved presentation of PIL

Updated on 16 November 2017 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration

Legal category: Supply through general sale

Free text change information supplied by the pharmaceutical company

 Adolescents (12-15 years) to take 1 capsule repeated every 4 to 6 hours. A maximum of 4 doses in any given 24 hours period.  

Updated on 16 November 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Supply through general sale

Updated on 15 November 2017 PIL

Reasons for updating

  • Change to section 3 - dose and frequency

Updated on 15 November 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 24 June 2015 PIL

Reasons for updating

  • Change to name of manufacturer

Updated on 6 January 2015 SmPC

Reasons for 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

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 31 December 2014 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to date of revision
  • Change to improve clarity and readability

Updated on 11 October 2013 SmPC

Reasons for updating

  • New SPC for new product

Legal category: Supply through general sale

Free text change information supplied by the pharmaceutical company

None provided

Updated on 9 October 2013 PIL

Reasons for updating

  • New PIL for new product