Sevredol 20 mg tablets
*Company:
Mundipharma Pharmaceuticals Limited - Formerly Napp LaboratoriesStatus:
UpdatedLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 28 November 2024
File name
ie-spc-sevredol-20 mg-clean.pdf
Reasons for updating
- Change to section 4.9 - Overdose
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
4.9 Overdose
Signs of morphine toxicity and overdose are drowsiness, pin-point pupils, skeletal muscle flaccidity, bradycardia, hypotension respiratory depression, pneumonia aspiration, somnolence and central nervous system depression which can progress to stupor or coma. Death may occur from respiratory failure. Circulatory failure and deepening coma may occur in more severe cases. Overdose can result in death. Rhabdomyolysis progressing to renal failure has been reported in opioid overdose.
Toxic leukoencephalopathy has been observed with morphine overdose.
Treatment of morphine overdose:
Primary attention should be given to the establishment of a patent airway and institution of assisted or controlled ventilation.
10 DATE OF REVISION OF THE TEXT
27th November 2024
Updated on 28 November 2024
File name
ie-pl-sevredol-clean.pdf
Reasons for updating
- Change to section 3 - overdose, missed or forgotten doses
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
3 How to take Sevredol tablets
If you take more Sevredol tablets than you should
Call your doctor or hospital straight away as you may need emergency treatment in hospital. People who have taken an overdose may feel very sleepy, sick, dizzy, get a brain disorder (known as toxic leukoencephalopathy) or get pneumonia from inhaling vomit or foreign matter (symptoms include breathlessness, cough and fever). People who have taken an overdose may also have breathing difficulties leading to unconsciousness, or even death. When seeking medical attention make sure that you take this leaflet and any remaining tablets with you to show to the doctor.
This leaflet was last revised in March November 2024.
Updated on 28 May 2024
File name
IE_Sevredol_PIL (Clean)-v4[IE Reporting].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 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Updated on 28 May 2024
File name
IE_Sevredol 20 mg_SmPC (Clean).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 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 29 March 2023
File name
sevredol-smpc-20mg-clean.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
IE MAH Address Change
Updated on 29 March 2023
File name
sevredol-pil-clean.pdf
Reasons for updating
- New PIL for new product
Free text change information supplied by the pharmaceutical company
IE MAH Address Change