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Panadol Night Film-coated tablets, Paracetamol 500mg

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Pharmacy Only: Non-prescription

Updated on 22 September 2023

File name

working-ie-spc-panadolnight-MAH-clean-230922RE.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Updated on 22 September 2023

File name

working-ie-leaflet-panadol-night-PA0678-039-008-MAH-230922RE.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 20 September 2022

File name

ie-mockup-panadol night-proposed-220511SKDJ.pdf

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink

Updated on 16 September 2022

File name

ie-spc-panadolnight-PRAC update-clean-220511SKDJ.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

Legal category:Supply through pharmacy only

Updated on 20 August 2020

File name

ie-spc-panadolnight-crsf-200418EM-clean Approved Aug 2020.pdf

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

Legal category:Supply through pharmacy only

Updated on 29 May 2020

File name

ie-mockup-pl-panadolnight-200320em.pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 04 November 2019

File name

ie-spc-panadolnight-GDSv7-180702GB-cleanv4.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.9 - Overdose
  • Change to section 5.3 - Preclinical safety data

Legal category:Supply through pharmacy only

Updated on 04 November 2019

File name

ie-mockup-pl-panadolnight-GDSv7-180702GB.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects

Updated on 15 July 2019

File name

m1-3-1-spc-171207LC.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration

Legal category:Supply through pharmacy only

Updated on 03 September 2018

File name

ie-mockup-leaflet-678-39-8.pdf

Reasons for updating

  • Change to section 2 - use in children and adolescents

Updated on 03 September 2018

File name

ie-spc-678-39-8-clean.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Paediatric posology changes

Updated on 22 April 2016

File name

PIL_8693_346.pdf

Reasons for updating

  • New PIL for new product

Updated on 22 April 2016

Reasons for updating

  • Change to MA holder contact details

Updated on 10 July 2015

Reasons for updating

  • New SPC for new product

Legal category:Supply through pharmacy only

Updated on 10 July 2015

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 7

Marketing Authorisation Holder address updated to:

12 Riverwalk,

Citywest Business Campus,

Dublin 24,

Ireland

Updated on 13 March 2015

Reasons for updating

  • Change to section 4.1 - Therapeutic indications

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 4.1 Removal of neuralgia

Updated on 12 March 2015

Reasons for updating

  • Change to, or new use for medicine

Updated on 15 February 2013

Reasons for updating

  • Change to name of manufacturer

Updated on 14 June 2011

Reasons for updating

  • Change to improve clarity and readability

Updated on 12 August 2010

Reasons for updating

  • Change to further information section
  • Change to date of revision

Updated on 02 July 2010

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

  • In section 4.2  (Posology and method of administration), for adults, further text detailing the elderly and children over 12 was added. Additional information on consuming other paracetamol containing products was added including a statement not to exceed 4000mg in 24hr period and also information on time between doses. Information on maximum daily dose of this product and for how many nights to take without seeing a doctor, and not to exceed the daily dose was added. Also information on not to be taken by the elderly with confusion was added, as well as a warning of possible sedation and excitation in the elderly. A subheading “children under 12 years” was also added.

 

  • In section 4.4  (Special warnings and precautions for use), text detailing that antihistamines should be used with caution in certain conditions was removed and replaced by information on caution in those with underlying liver diseases due to paracetamol toxicity and also information on various conditions, including epilepsy, where caution should be exercised. Warnings on length of time of which the product should be taken without seeing a doctor was added. Warning on concurrent use of alcohol, drugs which cause sedation such as hypnotics, monoamine oxidase inhibitors, tricyclic antidepressants and antimuscarinics was also added. Also advice on to use with caution in the elderly was added. “Keep out of sight and reach of children” was added.

 

  • In section 4.5 (Interactions with other medicaments and other forms of interactions), details of diphenhydramine’s enhanced sedative effect with other certain compounds was removed, including the enhanced antimuscarinic effect which may occur when antihistamines are taken with antimuscarincs. Information on the enhanced anticoagulant effect of coumarins with prolonged paracetamol use was added. The potentiating sedative effect that diphenhydramine may have on other sedatives was added.  Also the enhanced anticholinergic effect of monoamine oxidase inhibitors as well as other anticholinergics was added. Information regarding the fact that diphenhydramine is an inhibitor of cytochrome P450 isoenzymes and the effect this may have was also given.

 

  • In section 4.6  (Pregnancy and lactation) the information regarding inadequate safety evidence of diphenhydramine but epidemiological evidence for paracetamol was removed. A subheading for pregnancy was added and details regarding its use during pregancacy and human and animal studies for paracetamol and lack of available data for diphenhydramine were given. Another subheading for lactation was added and a detail regarding inadequate safety data for diphenhydramine was added and also information on paracetamol use was given.

 

  • In section 4.7(Effects on ability to drive and use machinery), “Patients should be advised not to drive or operate machinery if affected by drowsiness” was removed and warnings on symptoms which may affect a patient’s ability to drive or operate machinery was added.
  • In section 4.8 (Undesirable effects),text detailing adverse effects of both diphenhydramine and paracetamol and also the side effects associated with these, including adverse effects in an overdose situation was removed and replaced by information on classification of undesirable effects, including very common, common, uncommon, rare, very rare and not known. Then for paracetamol, text detailing the collection of information for adverse events is given and this information was then tabulated by blood system, undesirable effect and frequency. For diphenhydramine text is given detailing the MeDRA System Organ Class in which the adverse effects are tabulated (i.e. by blood system, undesirable effect and frequency).
  • In section 4.9 (overdose), the manner in which the information regarding paracetamol overdose has been rearranged. The SPC now has a heading for “Paracetamol” and then a subheading for “Symptoms and signs” which details the amount of paracetamol which constitutes an overdose the symptoms which can be expected and the pharmacological reason for the overdose. There is then a heading for “Treatment” followed by details of what should be done and what treatments are available. A heading for Diphenhydramine Hydrochloride has been added followed by a subheading for “Symptoms and signs” which details the signs and symptoms. Another subheading for “Treatment” has been added followed by details on what treatments are available.

 

  • In section 10 (Date of revision of text) the date was changed to April 2010.

Updated on 15 December 2009

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.1 - List of excipients
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

section 2 - statment 'contains lactose' added
section 3 - tablets description changed
section 4.4 - lactose warning
section 6.1 - composition of tablet coating changed
section 6.6 - packaging changed

Updated on 10 August 2009

Reasons for updating

  • Change to date of revision

Updated on 20 August 2008

Reasons for updating

  • Improved electronic presentation

Updated on 27 October 2006

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 6.1 - List of excipients

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

3 PHARMACEUTICAL FORM

Film coated tablets

Green film coated capsule shaped tablets "PN" embossed on one side.

6.1 List of excipients

Maize starch

Pregelatinised starch

Potassium sorbate

Povidone K25

Talc

Stearic acid

Magnesium stearate

Croscarmellose sodium

Hypromellose

Mastercote green FA 1507 containing:

Quinoline yellow (E104)

Patent Blue (E131)

                          Titanium Dioxide (E171)

Updated on 24 September 2004

Reasons for updating

  • New PIL for medicines.ie

Updated on 09 August 2004

Reasons for updating

  • Change to section 4.9 - Overdose
  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Updated on 20 August 2003

Reasons for updating

  • Improved electronic presentation

Legal category:Supply through pharmacy only

Updated on 26 June 2003

Reasons for updating

  • New SPC for medicines.ie

Legal category:Supply through pharmacy only