MST Continus Tablets
- Name:
MST Continus Tablets
- Company:
Mundipharma Pharmaceuticals Limited - Formerly Napp Laboratories
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may not be renewed (A)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 25/04/19
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Mundipharma Pharmaceuticals Limited - Formerly Napp Laboratories
Company Products
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 1 October 2020
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
Free text change information supplied by the pharmaceutical company
Section 4.4: Addition of PRAC mandated warnings regarding concomitant use with oral P2Y12 inhibitor antiplatelet therapy.
Section 4.5: Addition of PRAC mandated text describing interaction between morphine and P2Y12 inhibitors.
Updated on 18 June 2019
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
Free text change information supplied by the pharmaceutical company
Correction to section 5.1 'Endocrine System'
Updated on 25 April 2019 PIL
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 3 - overdose, missed or forgotten doses
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 25 April 2019
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 4.8 – 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
Free text change information supplied by the pharmaceutical company
Update to SPC in line with PSUSA/00010549/201710 recommendations
Updated on 10 July 2018 PIL
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 1 - what the product is used for
- 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 3 - overdose, missed or forgotten doses
- Change to section 4 - possible side effects
- Change to section 5 - how to store or dispose
- Change to section 6 - date of revision
Updated on 30 May 2017
Reasons for updating
- New SmPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 30 May 2017 SPC
Reasons for updating
- 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 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 6.1 - List of excipients
- Change to section 6.6 - Special precautions for disposal and other handling
- 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
Updated on 14 August 2015 SPC
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.8
The following has been added
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ieUpdated on 12 August 2015 PIL
Reasons for updating
- New PIL for new product
Updated on 12 August 2015 PIL
Reasons for updating
- Addition of information on reporting a side effect.
Updated on 16 September 2013 PIL
Reasons for updating
- Change to further information section
Updated on 16 September 2013 SPC
Reasons for updating
- Change to section 6.1 - List of excipients
- 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
6.1. List of excipients
(Text in red has been added)
Tablet core has been deleted
Hypromellose (E464) (except for 10 mg)
Polyvinyl alcohol (10 mg only)
Macrogol 400 (except for 10 mg)
Macrogol 3350 (10 mg only)
Updated on 10 June 2013 SPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.4 Special warnings and precautions for use
The following has been added
Hyperalgesia that will not respond to a further dose increase of morphine sulphate may very rarely occur, particularly in high doses. A morphine sulphate dose reduction or change in opioid may be required.
Abuse of oral dosage forms by parenteral administration can be expected to result in serious adverse events, which may be fatal.
Typo has been corrected suspension has been replaced with tablets.
Section 4.8 Undesirable effects
This section has been re-written.
Section 4.9 Overdose (Text in red has been added)
Signs of morphine toxicity and overdoseage are pin-point pupils, skeletal muscle flaccidity, bradycardia, respiratory depression, and hypotension,and somnolence and central nervous system depression which can progress to stupor or coma. Circulatory failure and deepening coma may occur in more severe cases. Overdosagee can result in death. Rhabdomyolysis progressing to renal failure has been reported in opioid overdoseage.
Overdosage has been replaced with overdose in some places in this section.
“Gastric contents may need to be emptied as this can be useful in removing unabsorbed drug, particularly when a prolonged release formulation has been taken.” Has been deleted.
Updated on 3 June 2013 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to instructions about overdose
- Change to side-effects
Updated on 13 February 2012 SPC
Reasons for updating
- Correction of spelling/typing errors
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 19 January 2012 PIL
Reasons for updating
- Change to date of revision
- Change to marketing authorisation holder
Updated on 17 January 2012 SPC
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - MA number
- 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
Change of MA Holder
Mundipharma Pharmaceuticals Limited
Millbank House
Arkle Road
Sandyford
Dublin 18
Ireland
Section 8
Change of MA number
PA 1688/4/1-6
Updated on 31 May 2011 PIL
Reasons for updating
- Change to information about drinking alcohol
Updated on 24 May 2011 SPC
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 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
Section 4.4 "Concomitant use of alcohol and MST CONTINUS tablets may increase the undesirable effects of MST CONTINUS tablets; concomitant use should be avoided." has been added.
Section 4.5
Morphine potentiates the effects of tranquillisers, general anaesthetics, phenothiazines, other central nervous system depressants including hypnotics or sedatives, muscle relaxants, antihypertensives and gabapentin. "alcohol has been removed from this sentence.
"Alcohol may enhance the pharmacodynamic effects of MST CONTINUS tablets; concomitant use should be avoided. " has been added.
Updated on 24 May 2011 PIL
Reasons for updating
- Change to information about drinking alcohol
Updated on 6 January 2011 PIL
Reasons for updating
- Deletion of a pack size
Updated on 24 November 2010 SPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 6.1 - List of excipients
- 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
6.1 Lactose now reads Lactose Anydrous
Updated on 25 October 2010 PIL
Reasons for updating
- Addition of information on alternative format leaflets
Updated on 22 October 2010 PIL
Reasons for updating
- Addition of information on alternative format leaflets
Updated on 2 September 2009 PIL
Reasons for updating
- Deletion of a pack size
Updated on 17 February 2009 SPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- 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
Updated on 19 September 2008 PIL
Reasons for updating
- Change to improve clarity and readability
Updated on 11 April 2008 SPC
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
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
The following sections have been rewritten 4.2, 4.4, 4.5, 4.8, 4.9, 5.1
Updated on 11 April 2008 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to information about pregnancy or lactation
- Change to instructions about overdose
- Change to further information section
- Change to side-effects
- Change to storage instructions
Updated on 30 January 2006 PIL
Reasons for updating
- Change of contraindications
- Change to storage instructions
- Change to date of revision
Updated on 26 January 2006 SPC
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.1 - List of excipients
- Change to section 6.2 - Incompatibilities
- Change to section 6.4 - Special precautions for storage
- Change to section 6.5 - Nature and contents of container
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 9 - Date of renewal of authorisation
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 26 August 2004 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 3 July 2003 SPC
Reasons for updating
- Change to section 4.1 - Therapeutic indications
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 26 June 2003 SPC
Reasons for updating
- Improved electronic presentation
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 25 June 2003 SPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Product subject to medical prescription which may not be renewed (A)