Night Nurse Capsules *
Pharmacy Only: Non-prescription

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 29 July 2020

File name

ie-spc-nightcaps-gds8-approved-clean-181007EC_1596021902.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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 4.8 – Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text
  • Improved presentation of SPC

Legal category:Supply through pharmacy only

Updated on 29 July 2020

File name

ie-mockup-pl-nightcaps-gds8-approved-clean-181007EC_1596021164.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - driving and using machines
  • Change to section 2 - excipient warnings
  • Change to section 3 - use in children/adolescents
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision
  • Improved presentation of PIL

Updated on 29 July 2020

File name

ie-mockup-pl-nightliq-gds8-approved-clean-181007EC_1596021004.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 2 - driving and using machines
  • Change to section 2 - excipient warnings
  • Change to section 3 - use in children/adolescents
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision
  • Improved presentation of PIL

Updated on 04 September 2019

File name

ie-spc-nightnurse-clean-site transfer 181119EC - emc_1567587463.pdf

Reasons for updating

  • 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 04 September 2019

File name

ie-mockup-leaflet-site transfer 181119EC - emc_1567587195.pdf

Reasons for updating

  • Change to section 6 - what the product contains
  • Change to section 6 - manufacturer
  • Improved presentation of PIL
  • Addition of manufacturer
  • Change to date of revision

Updated on 21 August 2019

File name

IE_Capsules_Internal_1566378376.pdf

Reasons for updating

  • File format updated to PDF

Legal category:Supply through pharmacy only

Updated on 09 May 2018

File name

IE_Capsules_Internal.docx

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
  • Change to section 5.2 - Pharmacokinetic properties

Legal category:Supply through pharmacy only

Updated on 27 April 2018

File name

m1-3-1-SPC-161111AR Dextro Prac.docx.docx

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition

Legal category:Supply through pharmacy only

Updated on 23 February 2016

Reasons for updating

  • New SPC for new product

Legal category:Supply through pharmacy only

Updated on 23 February 2016

Reasons for updating

  • Change due to harmonisation of SPC

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

align with updated GDS

Updated on 22 February 2016

File name

PIL_8688_479.pdf

Reasons for updating

  • New PIL for new product

Updated on 22 February 2016

Reasons for updating

  • Change to date of revision

Updated on 26 January 2016

Reasons for updating

  • Change due to harmonisation of SPC

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Change Text: 4 Change(s) in the Summary of Product Characteristics, Labelling or Package Leaflet due to new

quality, pre-clinical, clinical or pharmacovigilance data

Updated on 26 January 2016

Reasons for updating

  • Change due to harmonisation of PIL

Updated on 22 December 2015

Reasons for updating

  • Change to section 6.1 - List of excipients

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

The change is due to HPRA notifying us of a slight discrepancy on section 6.1 for the printing ink components.

Updated on 22 July 2015

Reasons for updating

  • Change to warnings or special precautions for use

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 04 June 2015

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

·         In section 4.8 (undesirable effects), very serious skin reactions have been added.

Updated on 06 January 2015

Reasons for updating

  • Improved electronic presentation

Updated on 28 November 2013

Reasons for updating

  • Change to further information section

Updated on 15 May 2012

Reasons for updating

  • Change to storage instructions

Updated on 04 October 2011

Reasons for updating

  • Change to section 6.1 - List of excipients
  • 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

6.1     List of Excipients


b) Shell

Patent Blue V  (E131)
Erythrosine (E127)

Quinoline Yellow (E104)

Titanium Dioxide (E171)
Gelatin

Updated on 01 September 2011

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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

Section 1: Name expanded to include active ingredients
Section 2: Information expanded to include key excipients
Section 4.2: Expanded dosing information
Section 4.3 Increased detail and added contraindication for children under 16 years.
Section 4.4. Addition of cautions in children, elderly and those taking CNS depressants
Section 4.5 Increased detail, addition of new interactions.
Section 4.6 Increased detail.
Section 4.7 Expanded information.
Section 4.8: Added side effects in relation to promethazine and dextromethorphan. Added frequencies for side effects for promethazine and dextromethorphan.
Section 4.9: Added information on signs of overdose of promethazine and dextromethorphan and treatment information.

Updated on 02 September 2010

Reasons for updating

  • Change to further information section
  • Change to date of revision
  • Change due to user-testing of patient information

Updated on 13 July 2010

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

In section 4.8 (Undesirable effects), in the tabulated section for frequency anywhere "Unknown" is found it has been replaced by "Not known"

Updated on 10 August 2009

Reasons for updating

  • Change to date of revision

Updated on 03 October 2008

Reasons for updating

  • Change to section 4.3 - Contraindications
  • 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 4.8 - Undesirable effects

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 4.3   

 Known hypersensitivity to the active ingredients.Use in children under 2 years of age. Hepatic or renal impairment.

Use of dextromethorphan in patients taking monoamine oxidase inhibitors should be avoided as severe reactions have been reported.

 

Section 4.4    The following warnings were added:

Underlying liver disease increases the risk of paracetamol-related liver damage. Patients with severe renal or severe hepatic impairment should seek medical advice before treatment with paracetamol. The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease.
Consult your doctor if you are taking warfarin.

 

Section 4.5   

The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular use of paracetamol with increased risk of bleeding.

 

The hepatotoxicity of paracetamol may be potentiated by excessive intake of alcohol. 

 

Pharmacological interactions involving paracetamol with a number of other drugs have been reported.  In particular, the speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by cholestyramine.  These are considered to be of unlikely clinical significance in acute use at the dosage regimen proposed.

 

Promethazine may potentiate the action of alcohol and other centrally acting depressants, hypnotics and anxiolytics. MAOIs may enhance the antimuscarinic effects of antihistamines. 

 

Antihistamines have an added antimuscarinic effect with other antimuscarinic drugs including tricyclic antidepressants. Promethazine may interfere with immunologic urine pregnancy tests to produce false results.

 

Use of dextromethorphan in patients taking monoamine oxidase inhibitors should be avoided as severe reactions have been reported.

 

   

Section 4.6

Epidemiological studies of paracetamol have demonstrated no abnormalities during pregnancy, and hence it is not contraindicated.but patients should follow the advice of their doctor regarding its use. Paracetamol is excreted in breast milk but not in a clinically significant amount. Available published data do not contraindicate breast feeding There are also no known contraindications to the use of promethazine and dextromethorphan during pregnancy and lactation.  However, as with all medicines, the advice of a doctor should be sought before use of the product in pregnancy and lactation, and it should only be used when considered essential by the doctor.

 

 

Section 4.8

Skin rashes and other allergies occur occasionally with paracetamol.

Night Nurse can occasionally cause drowsiness, headache, dizziness, confusion, excitation, gastrointestinal disorders, bronchoconstriction and dyspnoea.

Adverse events associated with paracetamol from historical clinical trial data are both infrequent and from small patient exposure. Accordingly, events reported from extensive post-marketing experience at therapeutic/labeled dose and considered attributable are tabulated below by System Organ Class and frequency.  Frequencies are defined as: very common (>1/10), common (>1/100, <1/10), uncommon (>1/1000, <1/100), rare (>1/10,000, <1/1000) and very rare (<1/10,000) including isolated reports.

 

 

 

Paracetamol

           

System Organ Class

Adverse Event

Frequency

Blood and lymphatic system disorders

Thrombocytopaenia

Very rare (<1/10,000)

Immune system disorders

Hypersensitivity reactions, including skin rashes, angioedema and Stevens Johnson syndrome.

Anaphylaxis

Very rare (<1/10,000)

Respiratory, thoracic and mediastinal disorders

Aggravation of bronchospasm reported in asthmatic patients known to be sensitive to aspirin and other non-steroidal anti-inflammatory drugs

Very rare (<1/10,000)

Hepatobiliary

Liver dysfunction

Very rare (<1/10,000)

 

 

           

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

            Promethazine

            Adverse events may occasionally occur with promethazine. Clinical data is insufficient to reliably determine event frequencies.

 

System Organ Class

Adverse Event

Frequency

Nervous system disorders

Drowsiness

Psychomotor impairment

Disorientation

Restlessness

Headache

Unknown

Eye disorders

Blurred vision

Unknown

Gastrointestinal disorders

Gastrointestinal disturbance

Dry mouth

Unknown

Skin and subcutaneous system disorders

Rash

Photosensitivity

Unknown

Renal and urinary disorders

Urinary retention

Unknown

 

            Dextromethorphan 

Adverse events may occasionally occur with dextromethorphan. Clinical data is insufficient to reliably determine event frequencies.

 

System Organ Class

Adverse Event

Frequency

Nervous system disorders

Dizziness

 

Unknown

Respiratory, thoracic and mediastinal disorders

Bronchoconstriction

Dyspnoea

Unknown

Gastrointestinal disorders

Gastrointestinal disturbance

Unknown

Renal and urinary disorders

Urinary retention

Unknown

 

 

 

 

 

Updated on 03 October 2008

Reasons for updating

  • Correction of spelling/typing errors

Legal category:Supply through pharmacy only

Updated on 31 May 2007

Reasons for updating

  • Change to storage instructions

Updated on 21 February 2007

Reasons for updating

  • Change to section 6.1 - List of excipients
  • Change to section 6.4 - Special precautions for storage

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

6.1 List of Excipients

Printing Ink:

Shellac

Propylene Glycol

Black iron oxide (E172)

6.4 Special Precautions for Storage

Do not store above 25o C.

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 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Updated on 12 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