MST Continus Suspension

  • Name:

    MST Continus Suspension

  • 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: 17/06/19

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Summary of Product Characteristics last updated on medicines.ie: 17/6/2019

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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 Levact 25mg and 100 mg powder for concentrate for solution for infusion Active Ingredients Bendamustine Hydrochloride
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
1 - 0 of 31 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 17 June 2019 PIL

Reasons for updating

  • 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 - manufacturer
  • Change to section 6 - date of revision

Updated on 17 June 2019 SmPC

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 - 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

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Updates to SPC following approval of Morphine PSUSA/00010549/201710 assessment outcome 

Updated on 3 April 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 3 April 2018 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 3 April 2018 SmPC

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 5.1 - Pharmacodynamic properties
  • 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 4.4$0$0The text below was added tosection 4.4 of the SPC:$0$0‘Concomitant use of benzodiazepines and opioids may result in sedation,respiratory depression, coma and death. Because of these risks, concomitantprescribing of sedative medicines such as benzodiazepines or related drugs withopioids should be reserved for patients for whom alternative treatment optionsare not possible. $0$0If a decision is made to prescribe benzodiazepines concomitantly withopioids, the lowest effective dose should be used, and the duration oftreatment should be as short as possible (see also general dose recommendationin section 4.2). $0$0The patients should be followed closely for signs and symptoms ofrespiratory depression and sedation. In this respect, it is stronglyrecommended to inform patients and their environment to be aware of thesesymptoms (see section 4.5).’$0$0This text below was also added tosection 4.4 of the SPC:$0$0‘Opioids, such as morphine sulfate, may influence thehypothalamic-pituitary-adrenal or –gonadal axes. Some changes that can be seeninclude in serum prolactin, and decreases in plasma cortisol, oestrogen andtestosterone in association with inappropriately low or normal ACTH, LH or FSHlevels. Clinical symptoms may be manifest from these hormonal changes. $0$0Section 4.5$0$0‘Morphine potentiates the effects of central nervous system depressantsincluding tranquilisers, general anaesthetics, phenothiazines, hypnotics,sedatives, muscle relaxants and antihypertensives. Interactive effectsresulting in respiratory depression, hypotension, profound sedation, or comamay result if these drugs are taken in combination with the usual doses of morphine.’This text was replaced by the text below:$0$0‘The concomitant use of sedative medicines such as benzodiazepines orrelated drugs such with opioids increases the risk of sedation, respiratorydepression, coma and death because of the additive CNS depressant effect. Thedosage and duration of concomitant use should be limited (see section 4.4). $0$0Drugs that depress the CNS include, but are not limited to: otheropioids, anxiolytics, hypnotics and sedatives (including benzodiazepines),antipsychotics, antidepressants, general anaesthetics, phenothiazines, musclerelaxants and antihypertensives. $0$0Section 5.1$0$0Opioids, such as morphinesulfate, may influence the hypothalamic-pituitary-adrenal or –gonadal axes.Some changes that can be seen include in serum prolactin, and decreases inplasma cortisol, oestrogen and testosterone in association with inappropriatelylow or normal ACTH, LH or FSH levels. Clinical symptoms may be manifest fromthese hormonal changes.’ This text has been replaced by the text below:$0$0‘Opioids may affect the hypothalamic pituitary adrenal and hypothalamicpituitary gonadal system resulting in adrenal insufficiency or hypogonadismrespectively (see section 4.4)’$0$0Section 10$0$0The date of revision was updatedto read ‘08 March 2018’$0

Updated on 3 April 2018 PIL

Reasons for updating

  • 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 6 - date of revision

Updated on 30 May 2017 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • 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

$0Section 4.4:$0$0‘Controlled release’ has been updated to‘prolonged release’.$0$0‘Very rarely’ has been removed as adescription of the frequency of hyperalgesia.$0$0Thedescription of how the medicine must be taken has been updated to include ‘or sprinkled on to soft food’.$0$0 $0$0Section 4.6:$0$0‘There are no or limited amount of data fromthe use of morphine in pregnant women’ has been added to the beginning ofthis section.$0$0Informationregarding the prolonged use or morphine 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‘Controlled release’ has been updated to‘prolonged release’.$0$0 $0$0Section 10:$0$0The date ofrevision has been updated to 22 May 2017.$0

Updated on 30 May 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 14 October 2016 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.6 - Pregnancy and lactation
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • 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



Previous text

Changes made in updated text

 

Throughout the entire document the spelling of ‘Sulphate’ has been corrected to ‘Sulfate’.

 

Section 2: Addition of ‘Each sachet contains’ and of ‘Excipients with known effect’ information; rewording of final sentence

Morphine equivalent to Morphine Sulphate 20, 30, and 60 mg

For excipients see 6.1

 

Each sachet contains Morphine equivalent to Morphine Sulfate 20, 30, and 60 mg.

Excipients with known effect:

Ponceau 4R (E124)

For the full list of excipients, see section 6.1

 

Section 3: Moving of ‘Pink granules’ to the end of the section

Pink granules

Prolonged release granules for oral suspension

 

Prolonged release granules for oral suspension

Pink granules

 

Section 4.2: Addition of ‘Posology’ subtitle; replacement of ‘Children’ with ‘Paediatric Population’’; moving of ‘Method of Administration’ information to the end of the section.

Posology

Adults:

A patient presenting with severe pain, uncontrolled by weaker opioids (e.g. dihydrocodeine) should normally be started on 30 mg 12 hourly. Patients previously on normal release oral morphine should be given the same total daily dose as MST CONTINUS suspension but in divided doses at 12-hourly intervals.

Increasing severity of pain will require an increased dosage of the suspension.  Higher doses should be made, where possible in 30-50% increments as required.  The correct dosage for any individual patient is that which is sufficient to control pain with no, or tolerable, side effects for a full 12 hours.  It is recommended that the 200 mg strength is reserved for patients who have already been titrated to a stable analgesic dose using lower strengths of morphine or other opioid preparations.

Patients receiving MST CONTINUS suspension in place of parenteral morphine should be given a sufficiently increased dosage to compensate for any reduction in analgesic effects associated with oral administration.  Usually such increased requirement is of the order of 100%.  In such patients individual dose adjustments are required.

Paediatric Population:

The use of MST CONTINUS suspension in children has not been extensively evaluated.  For children with severe cancer pain, a starting dose in the range of 0.2 to 0.8 mg morphine per kg bodyweight 12 hourly is recommended.  Doses should then be titrated as for adults. 

Post-operative pain:

MST CONTINUS suspension is not recommended in the first 24 hours post-operatively or until normal bowel function has returned; thereafter it is suggested that the following dosage schedule be observed at the physician's discretion:

(a)  MST CONTINUS suspension 20 mg 12 hourly to patients under 70 kg

(b)  MST CONTINUS suspension 30 mg 12 hourly to patients over 70 kg

(c)  Elderly - a reduction in dosage may be advisable in the elderly

(d)  Children - not recommended

Supplemental parenteral morphine may be given if required but with careful attention to the total dosages of morphine, and bearing in mind the prolonged effects of morphine in this controlled release formulation.

Method of Administration

20, 30 & 60 mg strengths: The contents of one sachet should be mixed with at least 10 ml water or sprinkled on to soft food, for example yogurt.

The prolonged release granules must be suspended whole and ingested immediately, but not be broken, chewed or crushed. The administration of broken, chewed or crushed morphine granules leads to a rapid release and absorption of a potentially fatal dose of morphine (see section 4.9, Overdose).

MST CONTINUS suspension should be used at 12-hourly intervals.  The dosage is dependent upon the severity of the pain, the patient's age and previous history of analgesic requirements.

 

Section 4.3: Rewording

Hypersensitivity to any of the constituents (see section 6.1).

 

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

 

Section 4.6: Addition of the subtitles ‘Pregnancy’ and ‘Breastfeeding’

Pregnancy

MST CONTINUS Suspension is not recommended during pregnancy and labour due to the risk of neonatal respiratory depression. 

Breast-feeding

Administration to nursing mothers is not recommended as morphine is excreted in breast milk.  Withdrawal symptoms may be observed in the new born of mothers undergoing chronic treatment.

Section 4.8: Addition of information on how to report a side effect.

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

Section 6.5: Addition of ‘Not all pack sizes may be marketed’

 

Pack type:  Surlyn lined, laminated aluminium foil sachets coated with polyethylene and clay coated Kraft paper.

Pack size: Boxboard cartons of 10, 20, 30, 60 sachets or medical sample packs of up to 14 sachets.

Not all pack sizes may be marketed.

 

Section 6.6: Rewording of title

Instructions for use, handling and disposal

Special precautions for disposal and other handling

 

Updated on 9 October 2012 SmPC

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 4.8 - Undesirable effects
  • 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

 

 

4.3  Contraindications    

(see section 6.1)  has been added.

 

4.4  Special Warnings and precautions for use - (bold text has been added)

Use with caution in patients with impaired respiratory function, severe bronchial asthma,......

 

Hyperalgesia that will not respond to a further dose increase of morphine sulphate may very rarely occur in particular in high doses. A morphine sulphate dose reduction or change in opioid may be required.

There is potential for development of psychological dependence (addiction) to opioid analgesics, including morphine.

There is potential for development of psychological dependence (addiction) to opioid

The contents of the controlled release sachets (granules) must be suspended whole and drunk immediately after (See section 4.2), but not be broken, crushed or chewed.  The administration of broken, chewed or crushed morphine (granules) leads to a rapid release and absorption of a potentially fatal dose of morphine (see section 4.9).

 

4.5  Interaction with other medicinal products and other forms of interaction

(Bold text has been added)

Morphine potentiates the effects of central nervous system depressants including tranquillisers, general anaesthetics, phenothiazines, hypnotics, sedatives, ....

In a study involving healthy volunteers (N = 12), when a 60 mg controlled-release morphine capsule was administered 2 hours prior to a 600 mg gabapentin capsule, mean gabapentin AUC increased by 44% compared to gabapentin administered without morphine. Therefore, patients should be carefully observed for signs of CNS depression, such as somnolence, and the dose of gabapentin or morphine should be reduced appropriately.

4.8  Undesirable effects

This section has been reformatted

4.9  Overdose

(Bold text has been added)

Signs of morphine toxicity and overdose are drowsiness, pin-point pupils, skeletal muscle flaccidity, bradycardia, respiratory depression and hypotension, somnolence and central nervous system depression which can progress to stupor or coma.

Oral activated charcoal (50g for adults, 1 g/kg for children) may be considered if a substantial amount has been ingested within one hour, provided the airway can be protected.

 

The following text has been deleted:

Gastric contents may need to be emptied as this can be useful in removing unabsorbed drug, particularly when a modified release formulation has been taken.

 

 

Updated on 19 September 2012 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to drug interactions
  • Change to date of revision

Updated on 19 September 2012 PIL

Reasons for updating

  • New PIL for new product

Updated on 19 January 2012 PIL

Reasons for updating

  • Change to marketing authorisation holder
  • Discontinuation of one or more strengths

Updated on 16 January 2012 SmPC

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 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • 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)

Free text change information supplied by the pharmaceutical company

Section 1

100 and 200 mg strengths have been deleted.

Section 2

100 and 200  mg strengths have been deleted.

Section 4.2

100 and 200 mg strengths have been deleted.

Section 7

Marketing Authorisation holder is now
Mundipharma Pharmaceuticals Limited
Millbank House
Arkle Road
Sandyford
Dublin 18
Ireland

Section 8

PA  number is now PA 1688/4/8-10

Section 9

100 and 200 mg strengths have been deleted

Section 10

Date of Revision of the Text - December 2011


Updated on 24 May 2011 SmPC

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 suspension may increase the undesirable effects of MST CONTINUS suspension; concomitant use should be avoided." has been added.

Section 4.5
Morphine potentiates the effects of tranquillisers, anaesthetics, phenothiazines, hypnotics, sedatives, muscle relaxants and antihypertensives. Interactive effects resulting in respiratory depression, hypotension, profound sedation, or coma may result if these drugs are taken in combination with the usual doses of morphine. The word 'alcohol' has been removed from this sentence.

"Alcohol may enhance the pharmacodynamic effects of MST CONTINUS suspension; 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 3 May 2011 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Corrections to section 4.4

"Pre-operative administration of MST CONTINUS suspension is not recommended" has been removed.
"convulsive disorders" has been changed to convulsion disorders.
"and in patients with" has been added before "raised intracranial pressure" in the first sentence.

Updated on 24 August 2009 PIL

Reasons for updating

  • Change due to user-testing of patient information

Updated on 15 March 2007 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to date of revision
  • Change to side-effects
  • Change to drug interactions

Updated on 15 March 2007 SmPC

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 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)

Free text change information supplied by the pharmaceutical company

Section 4.2 Posology Controlled release granules statement about potentially fatal dose of morphine
 
Section 4.2 epilepsy added, Ponceau 4R statement added and use in caution in further disorders added
 
Section 4.5 Medicines that block action of Acetylcholine statment added. riframpicin statement added and concomitant use of ritonavir added.

Section 4.8 undesirable effects tabulated and listed according to organ class
 
 

Updated on 26 August 2004 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 23 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Product subject to medical prescription which may not be renewed (A)