When a pharmaceutical company changes an SPC or PIL, 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.
6.1 List of Excipients
b) Shell
Patent Blue V (E131) Erythrosine (E127)
Quinoline Yellow (E104)
Titanium Dioxide (E171) Gelatin
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 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.
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
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
Hepatobiliary
Liver dysfunction
Promethazine
Adverse events may occasionally occur with promethazine. Clinical data is insufficient to reliably determine event frequencies.
Nervous system disorders
Drowsiness
Psychomotor impairment
Disorientation
Restlessness
Headache
Unknown
Eye disorders
Blurred vision
Gastrointestinal disorders
Gastrointestinal disturbance
Dry mouth
Skin and subcutaneous system disorders
Rash
Photosensitivity
Renal and urinary disorders
Urinary retention
Dextromethorphan
Adverse events may occasionally occur with dextromethorphan. Clinical data is insufficient to reliably determine event frequencies.
Dizziness
Bronchoconstriction
Dyspnoea
Printing Ink:
Shellac
Propylene Glycol
Black iron oxide (E172)
6.4 Special Precautions for Storage
Do not store above 25o C.