PALLADONE Capsules *
Pharmacy Only: Prescription

Updated on 11 February 2022

File name

spc_1644588439.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 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

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, update to wording of galactose intolerance statement.

Section 4.5: Rewording and typographical changes.

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

Section 5.1: Editorial changes.

Section 5.2: Additional detail of distribution and elimination added.

Section 5.3: Editorial changes.

Updated on 11 February 2022

File name

pil_1644588297.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 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - what the product looks like and pack contents

Free text change information supplied by the pharmaceutical company

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

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

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

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

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

Updated on 12 March 2019

File name

ie-pl-cleanpalladoneallcapen_medicines_ie_1552397969.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 6 - date of revision

Updated on 11 March 2019

File name

ie-spc-cleanpalladone13mg_26mg_for_medicines_ie_1552315692.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_Capsules_English_Palladone_for_medicines_ie_1535552639.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_Palladone_Capsules_combined_for_medicines_ie_1535552475.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 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 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 which 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 and alcohol. ‘

 

 

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

Approved_package_leaflet_clean_Capsules_English_Palladone_1533652545.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_IR_capsules_-__CCDS_V14_update_1533651822.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' added to section 4.9

Section 10

Date of revision updated to 04 May 2017

Updated on 28 March 2017

File name

PIL_8259_508.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

  • New SPC for new product

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

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$0$0Section 4.6:$0$0$0$0$0Withdrawal symptoms may be observed in the newborn of mothers undergoing chronic treatment.$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$0$0The date of revision has been updated to 21 February 2017.$0

Updated on 03 February 2017

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • 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 3 (pharmaceutical form), details regarding the appearance of Palladone 2.6 mg capsules have been added.

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 5.1 - Pharmacodynamic properties

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

Free text change information supplied by the pharmaceutical company

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 4.8 – 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)

Excipients with known effect:

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 


4.8 Undesirable effects (Text in red has been added)

Has been changed and reformatted.

Details of reporting of suspected adverse reactions has been added.

5.1  Pharmacodynamic properties (Text in red has been added)

Opioids may induce biliary spasm

5.3  Preclinical safety data

Has been changed and added to.

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 01 February 2012

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
  • Change to section 5.1 - Pharmacodynamic properties
  • 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 4.4  Special warnings and precautions for use (changes in red)

Hydromorphone has an abuse profile similar to other strong opioid agonists. Hydromorphone 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.

Sectin 4.8 Undesirable effects - has been rewritten

Section 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 administered

 

and should be in accordance with the patient's 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.

 

 

 

Section 5.1  Pharmacodynamic properties (changes in red)

 

Like morphine, hydromorphone is a μ1 selective full opioid agonist. The pharmaceutical actions of

hydromorphone and morphine do not differ significantly. Hydromorphone and related opioids produce

their major effects on the central nervous system and bowel.

 

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:

PA 1688/007/001-2

 

Updated on 26 January 2012

Reasons for updating

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

Updated on 17 February 2011

Reasons for updating

  • 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 7.  Has been changed from

Napp Pharmaceuticals Ltd
Cambridge Science Park
Milton Road

Cambridge CB4 0GW

UK

to

Mundipharma Pharmaceuticals Limited

Millbank House

Arkle Road

Sandyford

Dublin 18

Updated on 16 February 2011

Reasons for updating

  • Change to marketing authorisation holder

Updated on 11 October 2010

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to storage instructions
  • Change to information about pregnancy or lactation

Updated on 08 December 2009

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • 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 4.8 had been set out in a different way with the frequency categories listed at the beginning of the section and not repeated throughout.

Section 6.1  Sodium lauryl sulphate has been replaced with sodium laurilsulfate

Section 10  Date of last renewal added.

Updated on 01 April 2009

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change of contraindications

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,
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

6.1 List of excipients has changed, now reads
 

           Capsule contents:

            Microcrystalline cellulose

            Lactose (anhydrous)

 

            Gelatin             

              Erythrosine (E127)

            Iron oxide yellow (E172)

            Titanium dioxide (E171)

            Sodium lauryl sulphate  

 

            Black Printing ink:

            Shellac

            Propylene glycol

            Iron oxide (E172)

Updated on 22 November 2007

Reasons for updating

  • Change of inactive ingredient

Updated on 26 January 2006

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • 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 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 16 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 26 June 2003

Reasons for updating

  • New SPC for medicines.ie

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