Night Nurse Capsules

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 04/09/19

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Summary of Product Characteristics last updated on medicines.ie: 4/9/2019

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GlaxoSmithKline Consumer Healthcare (Ireland) Ltd

GlaxoSmithKline Consumer Healthcare (Ireland) Ltd

Company Products

Medicine NameActive Ingredients
Medicine Name Andrews Liver Salts Effervescent Powder Active Ingredients Citric Acid (Anhydrous), Magnesium sulfate (dihydrate), Sodium Hydrogen Carbonate
Medicine Name Corsodyl Aniseed 0.2% w/v Mouthwash Active Ingredients Chlorhexidine digluconate
Medicine Name Corsodyl 1% w/w Dental Gel Active Ingredients Chlorhexidine digluconate
Medicine Name Corsodyl Mint 0.2% w/v Mouthwash Active Ingredients Chlorhexidine digluconate
Medicine Name Day Nurse Capsules Active Ingredients Paracetamol, Pholcodine, Pseudoephedrine Hydrochloride
Medicine Name Duofilm Cutaneous Solution Active Ingredients Lactic Acid, Salicylic Acid
Medicine Name Eurax 10% w/w Cream Active Ingredients Crotamiton
Medicine Name Excedrin 250 mg /250 mg /65 mg film-coated tablets Active Ingredients Aspirin, Caffeine, Paracetamol
Medicine Name Flixonase Allergy Relief Nasal Spray Active Ingredients Fluticasone Propionate
Medicine Name Lamisil 1% w/w Cream Active Ingredients Terbinafine hydrochloride
Medicine Name Lamisil AT Cream Active Ingredients Terbinafine hydrochloride
Medicine Name Lamisil Once 1% cutaneous solution Active Ingredients Terbinafine hydrochloride
Medicine Name Nicotinell Cool Mint 2mg medicated chewing gum Active Ingredients Nicotine-polacrilin
Medicine Name Nicotinell Cool Mint 4mg medicated chewing gum Active Ingredients Nicotine-polacrilin
Medicine Name Nicotinell Fruit 2mg medicated chewing-gums Active Ingredients Nicotine-polacrilin
Medicine Name Nicotinell Fruit 4mg Medicated Chewing-Gums Active Ingredients Nicotine-polacrilin
Medicine Name Nicotinell Mint 1mg Compressed Lozenges Active Ingredients nicotine bitartrate dihydrate
Medicine Name Nicotinell Mint 2mg compressed Lozenges Active Ingredients nicotine bitartrate dihydrate
Medicine Name Nicotinell TTS 10, 7 mg/24 hour Transdermal Patch Active Ingredients Nicotine
Medicine Name Nicotinell TTS 20, 14 mg/24 hour Transdermal Patch Active Ingredients Nicotine
Medicine Name Nicotinell TTS 30, 21 mg/24 hour Transdermal Patch Active Ingredients Nicotine
Medicine Name Night Nurse Capsules Active Ingredients Dextromethorphan Hydrobromide, Paracetamol, Promethazine hydrochloride
Medicine Name Night Nurse Cold Remedy Active Ingredients Dextromethorphan Hydrobromide, Paracetamol, Promethazine hydrochloride
Medicine Name Oilatum Cream Active Ingredients Light Liquid Paraffin, White Soft Paraffin
Medicine Name Oilatum Emollient 63.4% w/w Bath Additive Active Ingredients Light Liquid Paraffin
1 - 0 of 52 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 September 2019 SmPC

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 4 September 2019 PIL

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 SmPC

Reasons for updating

  • File format updated to PDF

Legal category: Supply through pharmacy only

Updated on 9 May 2018 SmPC

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 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition

Legal category: Supply through pharmacy only

Updated on 23 February 2016 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Supply through pharmacy only

Updated on 23 February 2016 SmPC

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 PIL

Reasons for updating

  • New PIL for new product

Updated on 22 February 2016 PIL

Reasons for updating

  • Change to date of revision

Updated on 26 January 2016 PIL

Reasons for updating

  • Change due to harmonisation of PIL

Updated on 26 January 2016 SmPC

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 22 December 2015 SmPC

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 PIL

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 10 July 2015 SmPC

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 4 June 2015 SmPC

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 6 January 2015 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 28 November 2013 PIL

Reasons for updating

  • Change to further information section

Updated on 15 May 2012 PIL

Reasons for updating

  • Change to storage instructions

Updated on 4 October 2011 SmPC

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 1 September 2011 SmPC

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 2 September 2010 PIL

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 SmPC

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 PIL

Reasons for updating

  • Change to date of revision

Updated on 3 October 2008 SmPC

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 3 October 2008 SmPC

Reasons for updating

  • Correction of spelling/typing errors

Legal category: Supply through pharmacy only

Updated on 31 May 2007 PIL

Reasons for updating

  • Change to storage instructions

Updated on 21 February 2007 SmPC

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 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 9 August 2004 SmPC

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 SmPC

Reasons for updating

  • Improved electronic presentation

Legal category: Supply through pharmacy only

Updated on 26 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Supply through pharmacy only