MST Continus Tablets

  • Name:

    MST Continus Tablets

  • Company:
    info
  • Active Ingredients:

    Morphine sulfate

  • 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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Summary of Product Characteristics last updated on medicines.ie: 1/10/2020

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Mundipharma Pharmaceuticals Limited - Formerly Napp Laboratories

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Company Products

Medicine NameActive Ingredients
Medicine Name Adizem-SR Capsules Active Ingredients Diltiazem Hydrochloride
Medicine Name ADIZEM-XL Capsules Active Ingredients Diltiazem Hydrochloride
Medicine Name BuTrans 15 microgram/hour transdermal patches Active Ingredients Buprenorphine
Medicine Name BuTrans transdermal patches Active Ingredients Buprenorphine
Medicine Name Flutiform 50 microgram/5 microgram, 125 microgram/5 microgram and 250 micorgram/10 microgram per metered dose pressurised inhalation, suspension. Active Ingredients Fluticasone Propionate, Formoterol fumarate dihydrate
Medicine Name Flutiform K-haler 50 microgram /5 microgram, 125 microgram /5 microgram per actuation pressurised inhalation, suspension. Active Ingredients Fluticasone Propionate, Formoterol fumarate dihydrate
Medicine Name Herzuma 150 mg and 420 mg powder for concentrate for solution for infusion Active Ingredients Trastuzumab
Medicine Name Invokana 100 mg and 300 mg film-coated tablets Active Ingredients Canagliflozin hemihydrate
Medicine Name MST Continus Suspension Active Ingredients Morphine sulfate
Medicine Name MST Continus Tablets Active Ingredients Morphine sulfate
Medicine Name Nyxoid 1.8 mg nasal spray Active Ingredients Naloxone Hydrochloride dihydrate
Medicine Name OxyContin prolonged release tablets Active Ingredients Oxycodone Hydrochloride
Medicine Name OxyNorm 10 mg/ml solution for Injection or Infusion Active Ingredients Oxycodone Hydrochloride
Medicine Name OxyNorm 50 mg/ml, solution for injection or infusion Active Ingredients Oxycodone Hydrochloride
Medicine Name OxyNorm Capsules Active Ingredients Oxycodone Hydrochloride
Medicine Name OxyNorm Concentrate Active Ingredients Oxycodone Hydrochloride
Medicine Name OxyNorm Dispersa 5, 10, 20 mg orodispersible tablets Active Ingredients Oxycodone Hydrochloride
Medicine Name OxyNorm liquid 1 mg/ml oral solution Active Ingredients Oxycodone Hydrochloride
Medicine Name PALLADONE Capsules Active Ingredients Hydromorphone Hydrochloride
Medicine Name Palladone SR Capsules Active Ingredients Hydromorphone Hydrochloride
Medicine Name Pelmeg 6 mg solution for injection in pre-filled syringe Active Ingredients Pegfilgrastim
Medicine Name PHYLLOCONTIN CONTINUS Tablets Active Ingredients Aminophylline Hydrate
Medicine Name SEVREDOL Tablets Active Ingredients Morphine sulfate
Medicine Name Targin 15 mg/7.5 mg and 30 mg/15 mg prolonged-release tablets Active Ingredients Naloxone Hydrochloride dihydrate, Oxycodone Hydrochloride
Medicine Name Targin 5/2.5mg, 10mg/5mg, 20mg/10mg and 40/20mg prolonged release tablets Active Ingredients Naloxone Hydrochloride dihydrate, Oxycodone Hydrochloride
1 - 0 of 30 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 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

$0Section 2:$0$0This sectionhas been updated to state ‘morphineequivalent to morphine sulfate’.$0$0Thesubheading ‘Excipients with known effect’has been added.$0$0 $0$0Section 4.2:$0$0The informationregarding route and method of administration has been moved to the end of thissection.$0$0Thesubheading ‘Posology’ has been added.$0$0Thesubheading ‘Children’ has beenupdated to ‘Paediatric population’.$0$0 $0$0Section 4.3:$0$0Theinformation regarding hypersensitivity to the active substance or any of theexcipients has been moved to the beginning of this section.$0$0 $0$0Section 4.4:$0$0Informationregarding the use of MST CONTINUS tablets pre- and postoperatively has beenadded.$0$0 $0$0Section 4.5:$0$0A referenceto section 4.3 has been added.$0$0 $0$0Section 4.6:$0$0The title ofthis section has been updated to ‘Fertility,pregnancy and lactation’.$0$0Thesubheadings ‘Pregnancy’ and ‘Breast-feeding’ have been added to thissection.$0$0Informationregarding prolonged use of morphine sulfate during pregnancy has been added.$0$0 $0$0Section 4.8:$0$0‘Allergic reaction’ has been updated to ‘Hypersensitivity’.$0$0‘Asthenic conditions’ has been updatedto ‘Asthenia, fatigue, malaise’.$0$0‘Drug withdrawal syndrome neonatal’ hasbeen added under ‘General disorders andadministration site conditions’ with a frequency of unknown.$0$0 $0$0Section 4.9:$0$0‘Pneumonia aspiration’ has been added asa sign of morphine toxicity and overdose.$0$0 $0$0Section 6.1:$0$0Thesubheading ‘Film-coat’ has been added.$0$0 $0$0Section 6.6:$0$0The title ofthis section has been updated to ‘Specialprecautions for disposal and other handling’.$0$0 $0$0Section 10:$0$0The date ofrevision of the text has been updated to 22 May 2017.$0

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.ie

Updated 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

typing/spelling corrected

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

Section 7
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

2.  Lactose now reads Lactose Anhydrous

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

Section 4.4 - severe broncial asthma added. There is a potential for development of psychological dependence statement added.
 
Section 4.5 general anaesthetics added, also other nervous system depressants including...and gabapentin added
 
Section 4.8 Dizziness (common sdie effect) added

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)