Palladone SR Capsules

  • Name:

    Palladone SR Capsules

  • Company:
    info
  • Active Ingredients:

    Hydromorphone Hydrochloride

  • 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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Summary of Product Characteristics last updated on medicines.ie: 11/3/2019

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Mundipharma Pharmaceuticals Limited - Formerly Napp Laboratories

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Company Products

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Medicine Name ADIZEM-XL Capsules Active Ingredients Diltiazem Hydrochloride
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Medicine Name BuTrans transdermal patches Active Ingredients Buprenorphine
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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
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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 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

The date of revision of the text has been updated to 31 March 2017.$0$0$0

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

$0Current text: in black$0$0Updated text: in red$0$0Removed text: crossed through$0$0Added text: in bold$0$0$0$0Section 4.6:$0$0$0$0Withdrawal symptoms may be observed in the newborn of mothers undergoing chronic treatment.$0$0$0$0$0Withdrawal symptoms may be observed in the newborn of mothers undergoing chronic treatment. Prolonged use of hydromorphone during pregnancy can result in neonatal withdrawal syndrome.$0$0$0$0$0Section 10:$0$0 $0$0The date of revision has been updated to 21 February 2017.$0

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

In section 4.8 (undesirable effects), neonatal drug withdrawal syndrome has been added under 'General disorders and administration site conditions' with the frequency 'unknown'.

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

Section 4.8

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

In section 4.7 if hydromorphone is combined with alcohol or with CNS depressant agents.   "with alcohol"  has been added

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

Section 4.4 Sepcial warnings and precautions for use - changes highlighted in red

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

Section 7

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 1. Palladone® SR capsules changed to 'prolonged release capsules'

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

Section 4.2 updated to include administrative details.
Section 4.3 updated to include with hypoxia or elevated carbon dioxide levels in the blood, and Palladone SR capsules are not recommended for preoperative use or within the first 24 hours postoperatively. After this time, they should be used with caution particularly following abdominal surgery.
Section 4.4 updated to include further warnings and precautions for use
Section 4.5 updated to include barbituates and anti emetics
Section 4.8 updated to include further side effects

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

6.2 Change to list of excipients now reads:
 
                Capsule contents

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)