Palladone SR Capsules
- Name:
Palladone SR Capsules
- 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: 12/03/19
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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 12 March 2019 PIL
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 6 - date of revision
Updated on 11 March 2019 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
Updates to sections 4.4. and 4.5 in line with CMDh wording regarding the concomitant use of benzodiazepines/benzodiazepine like products and opioids.
Updated on 11 March 2019 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
Updates to sections 4.4. and 4.5 in line with CMDh wording regarding the concomitant use of benzodiazepines/benzodiazepine like products and opioids.
Updated on 29 August 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 29 August 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
Addition of the following paragraphs to section 4.4 Special warnings and precautions for use, in relation to concomitant administration with benzodiazepines and endocrine effects
‘Risks of concomitant administration with benzodiazepines (and other CNS depressants)
Concomitant use of opioids, including Palladone SR capsules, with benzodiazepines may result in profound sedation, respiratory depression, coma, and death. Because of these risks, concomitant prescribing of opioids and benzodiazepines should be made only in patients for whom alternative treatment options are inadequate.
If a decision is made to prescribe Palladone SR capsules concomitantly with benzodiazepines, the lowest effective dosages and minimum durations of concomitant use should be chosen. Patients should be closely monitored for signs and symptoms of respiratory depression and sedation (see section 4.5).’
‘Opioids, such as hydromorphone, may influence the hypothalamic-pituitary-adrenal or –gonadal axes. Some changes that can be seen include an increase in serum prolactin, and decreases in plasma cortisol and testosterone. Clinical symptoms may manifest from these hormonal changes.’
Update to section 4.5 Interaction with other medicinal products and other forms of interaction, in relation to concomitant administration with drugs that depress the CNS:
Concomitant administration of hydromorphone with drugs that depress the CNS may lead to an increased risk of respiratory depression, profound sedation, coma and death. Drugs that depress the CNS include, but are not limited to: tranquillisers, anaesthetics (e.g. barbiturates), hypnotics and sedatives (incl. benzodiazepines), antipsychotics, antidepressants, antiemetics, antihistaminic drugs and other opioids, phenothiazines.
Update to section 5.1 Pharmacodynamic properties
Endocrine System reference to section 4.4 of the SPC added
Section 10 Date of Revision of the Text updated to 21.08.2018
Updated on 7 August 2018 PIL
Reasons for updating
- Change to section 3 - overdose, missed or forgotten doses
Updated on 7 August 2018 SmPC
Reasons for updating
- 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 4.9
'pneumonia aspiration' was added to section 4.9
Section 10
Date of revision updated to '04 May 2017'
Updated on 24 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 24 May 2017 SmPC
Reasons for updating
- 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 28 March 2017 PIL
Reasons for updating
- New PIL for new product
Updated on 28 March 2017 PIL
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 6 - date of revision
Updated on 15 March 2017 SmPC
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- 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 31 October 2016 SmPC
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 7 June 2016 SmPC
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 5.2 - Pharmacokinetic properties
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Flushing has been added to undesirable effects - frequency not known. (Facial flushing has been removed).
Section 5.1
The heading Endocrine System has been added.
The following has been added:
Hepatobiliary System
Opioids may induce biliary spasm
the heading Other Pharmacologic System
Updated on 27 May 2016 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to dosage and administration
Updated on 21 November 2014 SmPC
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 4.7 - 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 5.1 - Pharmacodynamic properties
- Change to section 5.3 - Preclinical safety data
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
2. Qualitative and Quantitative Composition (Text in red has been added)
For the full list of excipients see section 6.1
4.2 Posology and method of administration
Method of administration
The heading Posology has been added
The heading Paediatric population has replaced the heading Children
4.3 Contraindications
excipients listed in section 6.1
4.4 Special warnings and precautions for use (Text in bold has been deleted)
infirm has been deleted (first paragraph)
Hyperalgesia that will not respond to a further dose increase of hydromorphone may very rarely occur in
4.7 Effects on ability to drive and use machines Text in bold has been deleted.
If hydromorphone is combined with alcohol of other CNS depressant agents
4.8 Undesirable effects (Text in red has been added)
Has been changed and reformatted.
Details of reporting of suspected adverse reactions has been added.
4.9 Overdose (Text in bold has been deleted and text in red has been added)
The stomach should be emptied.
Controlled release delivery systems may have a prolonged action, which should be considered.
5.1 Pharmacodynamic properties (Text in red has been added)
Opioids may induce biliary spasm
5.3 Preclinical safety data
Has been changed and text added.
Updated on 13 November 2014 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to storage instructions
- Change to side-effects
- Change to drug interactions
- Change to information about drinking alcohol
- Change to information about pregnancy or lactation
Updated on 8 May 2014 SmPC
Reasons for updating
- Change to section 4.7 - Effects on ability to drive and use machines
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 1 February 2012 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 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 7 - Marketing authorisation holder
- 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
Hydromorphone has an abuse profile similar to other strong opioid agonists and may be sought and
abused by people with latent or manifest addiction disorders. There is potential for development of
psychological dependence
(addiction) to opioid analgesics, including hydromorphone. Palladone SR capsules, like all opioids, should be used with particular care in patients with a history of
alcohol and drug abuse.
The
content (pellets) of the prolonged release capsules must be swallowed whole, and not broken,
chewed or crushed. The administration of broken, chewed or crushed hydromorphone pellets leads to a
rapid release and absorption of a potentially fatal dose of hydromorphone
(see section 4.9).
Concomitant use of alcohol and
Palladone SR capsules may increase the undesirable
Section 4.7 Effects on ability to drive and use machines
"Hydromorpone may impair the ability to drive and use machines" has been added.
Section 4.8 Undesirable effects - Has been rewritten.
Section 4.9 Overdose
4.9. Overdose (changes in red)
Signs of hydromorphone toxicity and overdose include
miotic pupils, bradycardia, respiratory
depression, hypotension, somnolence progressing to stupor and coma. Circulatory failure and deepening
coma may occur in more severe cases and may
lead to a fatal outcome.
In unconscious patients with respiratory arrest intubation and assisted respiration may be required.
Naloxone 0.8 mg should be administered intravenously. This should be repeated at 2-3 minute intervals
as necessary, or by an infusion of 2 mg in 500 ml of sodium chloride solution or 5% w/v glucose solution
(0.004 mg ml
-1). The infusion should be run at a rate relative to the previous bolus doses administered
and should be in accordance with the patients response. The stomach should be emptied. Respiration
should be assisted if necessary. Fluid and electrolyte levels should be maintained.
Close monitoring (at least for 24 hours) is required, since the effect of the opioid antagonist is shorter
than that of hydromorphone, so that repeated occurrence of the signs of overdose like respiratory
insufficiency are to be expected.
5.1 Pharmacodynamic properties (the following has been added)
The effects are primarily analgesic, anxiolytic, antitussive and sedative. Moreover, mood swings, respiratory depression, reduced
gastrointestinal motility, nausea, vomiting and alteration of the endocrine and vegetative nervous system
may occur
.
Section 7 Marketing Authorisation Holder is now:
Mundipharma Pharmaceuticals Limited
Millbank House
Arkle Road
Sandyford
Dublin 18
Ireland
Section 8 Marketing Authorisation Numbers are now:
PA 1688/007/007-011
Updated on 26 January 2012 PIL
Reasons for updating
- Change to date of revision
- Change to marketing authorisation holder
- Change to side-effects
- Change to further information section
Updated on 8 September 2011 SmPC
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
Marketing Authorisation Holder is now
:Mundipharma Pharmaceuticals Limited
Millbank House
Arkle Road
Sandyford
Dublin 18
Ireland
Section 8
Marketing Authorisation Number is now:
PA 1688/007/007-011
Updated on 18 August 2011 PIL
Reasons for updating
- Change to marketing authorisation holder
Updated on 8 February 2011 PIL
Reasons for updating
- Change due to user-testing of patient information
Updated on 12 March 2010 SmPC
Reasons for updating
- Change to section 1 - Name of medicinal product
- 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
Section 6.1 Sodium lauryl sulphate changed to Sodium laurilsulfate
Updated on 1 April 2009 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to drug interactions
Updated on 31 March 2009 SmPC
Reasons for updating
- 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 4.8 - Undesirable effects
- 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 22 November 2007 SmPC
Reasons for updating
- Change to section 6.1 - List of excipients
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Microcrystalline cellulose
Hypromellose
Ethylcellulose
Colloidal anhydrous silica
Dibutyl sebacate
Capsule shells
Gelatin
Sodium lauryl sulphate
Titanium dioxide (E171)
In addition the capsule shells contain the following colours:
2 mg Quinoline yellow (E104)
4 mg Erythrosine (E127), Indigo Carmine (E132)
8 mg Erythrosine (E127)
16 mg Iron Oxide (E172)
24 mg Indigo Carmine (E132)
Black Printing ink
Shellac
Propylene glycol
Iron oxide (E172)
Updated on 22 November 2007 PIL
Reasons for updating
- Change of inactive ingredient
Updated on 31 May 2005 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
- Change to instructions about overdose
- Change to side-effects
- Change to drug interactions
- Change to information about drinking alcohol
- Change to date of revision
Updated on 17 May 2005 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 4.4 - 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
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 6.1 - List of excipients
- Change to section 6.2 - Incompatibilities
- 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)
Updated on 26 August 2004 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 24 June 2003 SmPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Product subject to medical prescription which may not be renewed (A)