Night Nurse Cold Remedy
*Company:
Haleon Ireland LimitedStatus:
No Recent UpdateLegal Category:
Supply through pharmacy onlyActive Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 29 March 2023
File name
ie-working-pl-nightnurseliq-MAH-Haleon-clean-230325RE.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Company name change or merger
- Change to date of revision
Updated on 29 March 2023
File name
ie-working-spc-nightnurseliq-MAH-Haleon-clean-230325RE.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
- Company name change or merger
Legal category:Supply through pharmacy only
Updated on 20 September 2022
File name
NURSE_NIGHT LIQUID_Paracetamol_1000_mg_20_ml_Pr_Leaflet.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
Updated on 16 September 2022
File name
ie-spc-nightnurseliq-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 29 July 2020
File name
ie-spc-nightliq-gds8-approved-clean-181007EC.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 4.5 - 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-nightliq-gds8-approved-clean-181007EC.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 - use in children and adolescents
- 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 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 21 August 2019
File name
IENNLiquid.pdf
Reasons for updating
- File format updated to PDF
Legal category:Supply through pharmacy only
Updated on 28 May 2018
File name
IENNLiquid.docx
Reasons for updating
- New SPC for new product
Legal category:Supply through pharmacy only
Updated on 09 May 2018
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
Legal category:Supply through pharmacy only
Updated on 15 March 2018
File name
PIL_8690_237.pdf
Reasons for updating
- New PIL for new product
Updated on 15 March 2018
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 27 May 2016
Reasons for updating
- New SPC for new product
Legal category:Supply through pharmacy only
Updated on 27 May 2016
Reasons for updating
- 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
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
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 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
Updated on 06 January 2015
Reasons for updating
- Improved electronic presentation
Updated on 15 May 2012
Reasons for updating
- Change to warnings or special precautions for use
- Change to storage instructions
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 6.3 - Shelf life
- 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.
Section 6.3 Shelf life extended to 3 years.
Updated on 12 August 2010
Reasons for updating
- Change to warnings or special precautions for use
- Change to how the medicine works
- Change to date of revision
Updated on 12 July 2010
Reasons for updating
- 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 6.1 - List of excipients
- Change to section 6.5 - Nature and contents of container
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
In section 4.6 (Pregnancy and lactation) the phrase "..paracetamol have demonstrated no ill effects during pregnancy.." was changed to "...paracetamol have demonstrated no abnormalities during pregnancy.."
In section 4.8 (undesirable effects) where the frequency classification is listed as "Unknown" it has been changed to "Not known"
In section 6.1 (List of excipients), the exipient sodium benzoate has been removed and the excipients Ascorbic acid and Disodium Edetate have been added.
In section 6.5 (Nature and contents of container), the line "Contents: 160ml" has been changed to "Contents 100 or 160ml"
Updated on 17 August 2009
Reasons for updating
- Change to warnings or special precautions for use
Updated on 09 June 2009
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
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
Paracetamol-containing products should be given with caution to patients taking other drugs that affect the liver.
Underlying liver disease increases the risk of paracetamol-related liver damage. Patients with renal or 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.
Concomitant use of other paracetamol or decongestant-containing medicines, or alcohol should be avoided.
In patients with asthma or other respiratory disorders, glaucoma, urinary retention or cardiovascular problems the product should only be taken after consulting a doctor.
Night Nurse should only be used under medical supervision for persistent or chronic cough as occurs with smoking, asthma or emphysema, or where cough is accompanied by excessive secretions.
If symptoms persist, consult your doctor.
Patients who are taking other medication and/or are under the care of a physician, should consult their doctor before taking the product.
Do not exceed the recommended dose schedule.
Keep out of the reach of children.
Section 4.5
The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by colestyramine
The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular use of paracetamol with increased risk of bleeding. The hepatoxicity of paracetamol may be potentiated by excessive intake of alcohol
Promethazine may potentiate the action of alcohol and other centrally acting depressants, hypnotics and anxiolytics.
Use of dextromethorphan in patients taking monoamine oxidase inhibitors should be avoided as severe reactions have been reported.
MAOI 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.
Section 4.6
This product should only be used during pregnancy if considered essential by the physician
Epidemiological studies of paracetamol have demonstrated no ill effects during pregnancy,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 20 August 2008
Reasons for updating
- Improved electronic presentation
Updated on 18 August 2008
Reasons for updating
- 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 4.4 The sentence "Patients with rare glucose-galactose malabsorption should not take this medicine." was inserted as the third last line.
Section 6.1 “Sodium citrate" was inserted instead of "Sodium acid citrate", the excipients "Ascorbic Acid" and "Disodium Edetate" were included in the list and the excipient "Sodium benzoate" was removed from the list. "Medicated flavour oil" was included in the list instead of "Medicated flavour".
Section 6.5 the start of the first line was changed to "Amber glass or amber PET bottle..." instead of "Clear flint glass bottle..." and the contents changed to "100ml or 160ml" instead of "160ml".
Section 10 the date of revision of the text was changed to February 2008.
Updated on 12 August 2008
Reasons for updating
- Improved electronic presentation
Updated on 28 August 2007
Reasons for updating
- Improved electronic presentation
Updated on 21 February 2007
Reasons for updating
- Change to section 6.3 - Shelf life
- Change to section 6.4 - Special precautions for storage
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
6.3 Shelf Life
2 years
6.4 Special Precautions for Storage
Do not store above 25oC.
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 25 June 2003
Reasons for updating
- New SPC for medicines.ie
Legal category:Supply through pharmacy only