Paraeze Hard Capsules

  • Name:

    Paraeze 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: 5/11/2019

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Pfizer Consumer Healthcare

Pfizer Consumer Healthcare

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Medicine Name Anadin Maximum Strength Capsules Active Ingredients Acetylsalicylic acid (Aspirin), Caffeine
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Medicine Name Nexium Control 20 mg gastro-resistant tablets Active Ingredients Esomeprazole magnesium trihydrate
Medicine Name Nexium Control Capsules 20mg Esomeprazole Active Ingredients Esomeprazole magnesium trihydrate
Medicine Name Paracetamol 500 mg Film Coated Tablets Active Ingredients Paracetamol
Medicine Name PARAEXTRA Hard Capsules Active Ingredients Caffeine, Paracetamol
Medicine Name Paraeze Hard Capsules Active Ingredients Caffeine, Paracetamol
Medicine Name Robitussin Chesty Cough Active Ingredients Guaifenesin
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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 5 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 section 6 - date of revision

Updated on 11 March 2019 PIL

Reasons for updating

  • Change to name of medicinal product

Updated on 11 March 2019 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product

Legal category: Supply through general sale

Updated on 4 October 2018 SmPC

Reasons for updating

  • File format updated to PDF

Legal category: Supply through general sale

Updated on 22 June 2018 SmPC

Reasons for updating

  • Previous version of SmPC reinstated

Legal category: Supply through general sale

Updated on 21 June 2018 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product

Legal category: Supply through general sale

Updated on 16 November 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Supply through general sale

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 aged 12 to 15 years take 1 capsule every 4 to 6 hours. A maximum of 4 doses in any given 24 hour period.   

Updated on 15 November 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 15 November 2017 PIL

Reasons for updating

  • Change to section 3 - dose and frequency

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 4.8 - Undesirable effects
  • Change to section 4.4 - Special warnings and precautions for use
  • 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 side-effects
  • Change to date of revision
  • Change to improve clarity and readability

Updated on 26 August 2013 SmPC

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • 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 (capsule)

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

Updated on 20 August 2013 PIL

Reasons for updating

  • Change to further information section

Updated on 26 March 2013 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number

Legal category: Supply through general sale

Free text change information supplied by the pharmaceutical company

7. MARKETING AUTHORISATION HOLDER

Pfizer Healthcare Ireland,
9 Riverwalk, National Digital Park,
Citywest Business Campus, Dublin 24.
Ireland.


8. MARKETING AUTHORISATION NUMBER

P.A. 822/168/1


Updated on 20 March 2013 PIL

Reasons for updating

  • Change to marketing authorisation holder

Updated on 14 June 2012 SmPC

Reasons for updating

  • Change to section 6.1 - List of excipients

Legal category: Supply through general sale

Free text change information supplied by the pharmaceutical company

6.1       List of Excipients

 

Maize Starch

Magnesium Stearate

Sodium Laurilsulfate

Croscarmellose Sodium

 

Capsule Shell

 

Gelatin

Purified water

Erythrosine

Patent blue V

Titanium dioxide

Quinoline Yellow

 

Printing Ink

Shellac

Titanium dioxide

Propylene glycol

Ammonium hydroxide

Simeticone

Iron oxide black (E172)

Updated on 11 June 2012 PIL

Reasons for updating

  • Change to further information section

Updated on 24 October 2011 SmPC

Reasons for updating

  • Change to section 6.1 - List of excipients

Legal category: Supply through general sale

Free text change information supplied by the pharmaceutical company

6.1 List of Excipients

Maize Starch
Magnesium Stearate
Sodium Laurilsulfate
Croscarmellose Sodium

Capsule Shell

Gelatin
Erythrosine
Patent blue V
Titanium dioxide
Quinoline Yellow

Printing Ink
Shellac
Titanium dioxide
Propylene glycol
Iron oxide black (E172)

Updated on 20 October 2011 PIL

Reasons for updating

  • Change to further information section

Updated on 11 March 2011 PIL

Reasons for updating

  • Change to improve clarity and readability
  • Change due to user-testing of patient information

Updated on 10 August 2010 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category: Supply through general sale

Free text change information supplied by the pharmaceutical company

7.         MARKETING AUTHORISATION HOLDER

 

                        Pfizer Consumer Healthcare Ltd,

                        Ramsgate Road, Sandwich,

                        Kent, CT13 9NJ,

                        United Kingdom.

(formally Wyeth Consumer Healthcare)

Updated on 9 August 2010 PIL

Reasons for updating

  • Change to marketing authorisation holder

Updated on 29 October 2008 PIL

Reasons for updating

  • Change to date of revision
  • Change to warnings or special precautions for use
  • Change to instructions about overdose

Updated on 18 September 2008 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.9 - Overdose
  • Change to section 9 - Date of renewal of authorisation

Legal category: Supply through general sale

Free text change information supplied by the pharmaceutical company

During recent renewal assessment Section 1, 4.4 and 4.9 of the SmPC were updated in line with EU guidance and current safety information.  

Updated on 13 September 2006 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category: Supply through general sale

Free text change information supplied by the pharmaceutical company

Update section 4.8: Delete 'any unexplained bruising or bleeding more easily than usual' and include 'High caffeine intake can result in tremor and palpitations'.

Updated on 15 March 2006 SmPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

Legal category: Supply through general sale

Updated on 23 September 2004 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 19 September 2003 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose

Legal category: Supply through general sale

Updated on 20 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Supply through general sale