Palladone SR Capsules *
Pharmacy Only: Prescription

Updated on 18 February 2022

File name

spc_1645191573.pdf

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • 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 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling

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

Free text change information supplied by the pharmaceutical company

Section 1: Addition of hard to product name.

Section 4.3: Addition of Severe bronchial asthma, minor wording and format changes.

Section 4.4: Addition of Central sleep apnoea, Constipation and Head injury.  Re-wording and format changes. Addition of wording for sodium content.

Section 4.5: Rewording and typographical changes.

Section 4.8: Addition of Sleep apnoea syndrome, updating to current MedDRA terms where necessary, correcting typographical errors. Update to adverse event reporting text.

Section 5.1: Editorial changes.

Section 5.2: Additional detail of distribution and elimination added.

Section 6.5: Addition of statement that not all pack sizes may be marketed.

Section 6.6: Correction of title according to QRD template.

Updated on 18 February 2022

File name

pil_1645191443.pdf

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 - pregnancy, breast feeding and fertility
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - manufacturer

Free text change information supplied by the pharmaceutical company

Section 2 (Do not take…):  addition of severe asthma.

Section 2 (warnings & precautions): addition of sleep apnoea, constipation and editorial changes. Addition of information about sodium content.

Section 2 (pregnancy) additional information about withdrawal syndrome in new-born infants.

Section 4 (possible side effects): Addition of sleep apnoea and editorial changes.

Section 4 (reporting side effects): Update of contact details for reporting side effects.

Section 6 (contents of the pack): Manufacturer change.

Updated on 12 March 2019

File name

ie-pl-cleanpalladoneallprcen_medicines_ie_1552398182.pdf

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

File name

ie-spc-cleanpalladone2_4__16_24_mgprcen_for_medicines_ie_1552316116.pdf

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

File name

ie-spc-cleanpalladone13mg_26mg_for_medicines_ie_1552315876.pdf

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

File name

Approved_package_leaflet_clean_Palladone-SR for medicines_ie_1535553570.pdf

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

File name

Approved_SPC_clean_Prolonged_Release_Capsules_combined for medicines_ie_1535553466.pdf

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 07 August 2018

File name

PIL-2188197-04052017153327-636295088108537500_1533653165.pdf

Reasons for updating

  • Change to section 3 - overdose, missed or forgotten doses

Updated on 07 August 2018

File name

IPHA_IE_combined_SmPC_Palladone-SR_prolonged_release_capsules_-_CCDS_V14_update_1533651942.pdf

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

Reasons for updating

  • New SPC for new product

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

Updated on 24 May 2017

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

File name

PIL_8261_172.pdf

Reasons for updating

  • New PIL for new product

Updated on 28 March 2017

Reasons for updating

  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 6 - date of revision

Updated on 15 March 2017

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

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 07 June 2016

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

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

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

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 08 May 2014

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 01 February 2012

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

Reasons for updating

  • Change to date of revision
  • Change to marketing authorisation holder
  • Change to side-effects
  • Change to further information section

Updated on 08 September 2011

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

Reasons for updating

  • Change to marketing authorisation holder

Updated on 08 February 2011

Reasons for updating

  • Change due to user-testing of patient information

Updated on 12 March 2010

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 01 April 2009

Reasons for updating

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

Updated on 31 March 2009

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

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

Reasons for updating

  • Change of inactive ingredient

Updated on 31 May 2005

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

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

Reasons for updating

  • New PIL for medicines.ie

Updated on 24 June 2003

Reasons for updating

  • New SPC for medicines.ie

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