Updated on 06/01/2015 and displayed until Current
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Change to section 3 - Pharmaceutical form
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Change to section 4.8 - Undesirable effects
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Change to section 4.4 - Special warnings and precautions for use
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Change to section 10 - Date of revision of the text
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| 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
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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
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Updated on 26/08/2013 and displayed until 06/01/2015
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Change to section 3 - Pharmaceutical form
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Change to section 10 - Date of revision of the text
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| Date of revision of text on the SPC: 09-Aug-2013 |
| Legal Category: Supply through general sale |
Free-text change information supplied by the pharmaceutical company
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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.
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Updated on 26/03/2013 and displayed until 26/08/2013
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Change to section 7 - Marketing authorisation holder
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Change to section 8 - MA number
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| Date of revision of text on the SPC: 15-Mar-2013 |
| Legal Category: Supply through general sale |
Free-text change information supplied by the pharmaceutical company
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| 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
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Updated on 14/06/2012 and displayed until 26/03/2013
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Change to section 6.1 - List of excipients
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| Date of revision of text on the SPC: 31-May-2012 |
| Legal Category: Supply through general sale |
Free-text change information supplied by the pharmaceutical company
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| 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)
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Updated on 24/10/2011 and displayed until 14/06/2012
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Reasons for adding or updating:
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Change to section 6.1 - List of excipients
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| Date of revision of text on the SPC: 06-Oct-2011 |
| Legal Category: Supply through general sale |
Free-text change information supplied by the pharmaceutical company
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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)
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Updated on 10/08/2010 and displayed until 24/10/2011
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Reasons for adding or updating:
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Change to section 7 - Marketing authorisation holder
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| Date of revision of text on the SPC: 30-Jun-2010 |
| Legal Category: Supply through general sale |
Free-text change information supplied by the pharmaceutical company
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7. MARKETING AUTHORISATION HOLDER
Pfizer Consumer Healthcare Ltd,
Ramsgate Road, Sandwich,
Kent, CT13 9NJ,
United Kingdom.
(formally Wyeth Consumer Healthcare)
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Updated on 18/09/2008 and displayed until 10/08/2010
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Change to section 1 - Name of medicinal product
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Change to section 4.4 - Special warnings and precautions for use
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Change to section 4.9 - Overdose
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Change to section 9 - Date of renewal of authorisation
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| Date of revision of text on the SPC: 09/2008 |
| Legal Category: general sale |
Free-text change information supplied by the pharmaceutical company
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| 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.
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Updated on 13/09/2006 and displayed until 18/09/2008
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Change to section 4.8 - Undesirable effects
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| Date of revision of text on the SPC: 08/2006 |
| Legal Category: general sale |
Free-text change information supplied by the pharmaceutical company
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| 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'.
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Updated on 15/03/2006 and displayed until 13/09/2006
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Change to section 6.5 - Nature and contents of container
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Updated on 19/09/2003 and displayed until 15/03/2006
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Change to section 4.1 - Therapeutic indications
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Change to section 4.3 - Contraindications
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Change to section 4.4 - Special warnings and precautions for use
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Change to section 4.8 - Undesirable effects
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Change to section 4.9 - Overdose
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Updated on 20/06/2003 and displayed until 19/09/2003
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