Login

Solpadeine Capsules

*
Pharmacy Only: Non-prescription

Updated on 08 April 2021

File name

ie-spc-approved-08-04-2021.pdf

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Updated on 08 April 2021

File name

ie-pl-approved-08-04-2021.pdf

Reasons for updating

  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision

Updated on 18 January 2021

File name

ie-spc-Jan-2021.pdf

Reasons for updating

  • Change to section 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Updated on 29 May 2020

File name

ie-pl-clean_may_2020.pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 17 April 2020

File name

ie-spc-Mar-2020.pdf

Reasons for updating

  • Change due to harmonisation of SPC
  • Improved presentation of SPC
  • Change to improve clarity and readability
  • Updated inline with QRD template and/or excipient guideline

Legal category:Supply through pharmacy only

Updated on 17 April 2020

File name

ie-pl-Mar-2020.pdf

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 1 - what the product is used for
  • 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 - use in children and adolescents
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 2 - driving and using machines
  • Change to section 2 - excipient warnings
  • Change to section 3 - dose and frequency
  • Change to section 3 - use in children/adolescents
  • Change to section 3 - how to take/use
  • Change to section 3 - duration of treatment
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 5 - how to store or dispose
  • Change to section 6 - what the product contains
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision
  • Improved presentation of PIL

Updated on 21 October 2019

File name

ie-spc-approved-27-09-2019.pdf

Reasons for updating

  • Change to MA holder contact details

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Change of MAH address

Updated on 21 October 2019

File name

ie-mockup-pl-approved-27-9-2019.pdf

Reasons for updating

  • Change to MA holder contact details

Free text change information supplied by the pharmaceutical company

Change of the MAH address.

Updated on 04 May 2016

File name

PIL_11507_136.pdf

Reasons for updating

  • New PIL for new product

Updated on 04 May 2016

Reasons for updating

  • Change to appearance of the medicine

Updated on 22 March 2016

Reasons for updating

  • New SPC for new product

Legal category:Supply through pharmacy only

Updated on 22 March 2016

Reasons for updating

  • Change to section 3 - Pharmaceutical form

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

3 PHARMACEUTICAL FORM

 

Capsule, hard

Gelatin capsules with a red, opaque cap and a white, opaque body with ‘SOLPADEINE’ printed in black on both halves or plain on both halves.

Updated on 18 March 2016

Reasons for updating

  • Change to name of manufacturer

Updated on 25 October 2014

Reasons for updating

  • Change to section 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Update the SPC revision date to reflect the variation approval date

Updated on 08 May 2014

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to information about pregnancy or lactation
  • Change to date of revision

Updated on 30 April 2014

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • 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 4.6 - Pregnancy and lactation
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

The following sections of the SPC have been updated following the outcome of an Article 31 Referral for Codeine:$0$0$0$0Section 4.1 (therapeutic indications): Re-worded to include "indicated in patients older than 12 years". Minor typographical changes.$0$0Section 4.2 (Posology): Typographical changes. Explanation of the paediatric posology.$0$0Section 4.3 (Contraindications): Addition of 3 new contraindications (lactation, known CYP2D6 metabolisers and paediatric patients aged 0-18 years who undergo tonsillectomy and/or adenoidectomy for obstructive sleep apnoea syndrome)$0$0Section 4.4 (Special warnings & precautions for use): Addition of CYP2D6 and post-operative use in children information.$0$0Section 4.6 (Pregnancy & lactation): Amendment to contraindicate use in lactation.$0$0Section 5.1 (Pharmacodynamic properties): Codeine information update.$0$0Section 10 (Date of revision)$0

Updated on 20 August 2013

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:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 7 MAH Holder address changed from GSK Ireland to:

Chefaro Ireland Limited First Floor

Block A

The Crescent Building Northwood Office Park

Dublin 9

Ireland

Section 8 Marketing Authoriation Number to:

PA 1186/011/002

Section 10 Revision date to January 2013

Updated on 06 February 2013

Reasons for updating

  • Change to date of revision
  • Change to marketing authorisation holder

Updated on 08 February 2012

Reasons for updating

  • Change to information about pregnancy or lactation
  • Change to date of revision
  • Transfer of Marketing Authorisation Holder

Updated on 28 April 2011

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Correction of spelling/typing errors
  • Transfer of marketing authorisation holder

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

In section 4.3:  removal of contraindication
In section 4.4: Information about CYP2D6 and ultra-rapid metabolisers added.
In section 6.6: Update of information about the use of Sopladeine in breastfeeing.

Updated on 22 December 2010

Reasons for updating

  • Change to section 4.2 - Posology and method of administration

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

in section 4.2 the word 'tablet' was changed to 'capsule'

Updated on 06 December 2010

Reasons for updating

  • Change to section 4.2 - Posology and method of administration

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

change to the layout of section 4.2

Updated on 09 August 2010

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to drug interactions
  • Change to further information section
  • Change to date of revision
  • Change to improve clarity and readability
  • Change due to user-testing of patient information

Updated on 03 August 2010

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 4.6 - 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:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company



In section 4.2 (Posology and method of administration)

 

  • The text” and children aged 12 years and over” was added to the heading “Adults (including the elderly)”. The text underneath this was changed to, “the usual dose is two tablets three to four times in a 24 hour period as required.”
  • The text “under 12” was added to the heading “Children”. Underneath this the sentence “The product is not suitable for children under 12 years of age” was changed to “Not recommended in children under 12 years of age.”
  • Warning text was also added, advising the maximum number of tablets to be taken in 24hours, how often doses should be repeated and for how long the tablets should be taken without consulting a doctor. Warning on not to take with other paracetamol or codeine containing products was also added as was advice for those with renal and/or hepatic impairment.

In section 4.4 (Special warnings and precautions for use)

  • The first sentence advising care in those with severe renal or hepatic impairment was removed and replaced by text advising patients with such impairments to seek medical advice before use. A sentence was also added stating the increased risk of paracetamol-related liver damage in those with underlying liver disease.
  • In the next paragraph the final part of the last sentence was removed (i.e. “and those with inflammatory or obstructive bowel disorders.”)

 

  • In the next paragraph the advice that excessive intake of tea or coffee should be avoided was replaced with “Excessive intake of caffeine (e.g. tea, coffee and some canned drinks) should be avoided while taking this product.”
  • Two paragraphs were added after this precaution. The first detailed that those with inflammatory or obstructive bowel disorders or acute abdominal condition should consult a doctor before use. The second details that patients with a history of cholecystectomy should consult a doctor before use due to the risk of acute pancreatitis.
  • another paragraph was added detailing how prolonged use of painkillers for headaches may make them worse. Information was given on what should be done if this is suspected or experienced and also advice on how to diagnose this “medication over headache”.

Near the end of section 4.4 the following warning statements were added:

  • “This product should be used only when clearly necessary.”
  • “Do not take for more than 3 days without consulting a doctor.”
  • “Immediate medical advice should be sought in the event of overdosage because of the risk of irreversible liver damage.”
  • The phrase “Keep out of the reach of children” was changed to “Keep out of the reach and sight of children.”
  • The phrase “Do not take with other paracetamol containing medicines.” was replaced with “Do not take with other paracetamol or codeine containing products”
  • The text “Contains Carmoisine (E122). May cause allergic reactions.” was added.

In section 4.6 (Pregnancy and Lactation)

  • The opening paragraph detailing safety evidence in pregnancy was removed. Section 4.6 is now split by two subheadings (Pregnancy and Lactation). Underneath the Pregnancy subheading two paragraphs have been added detailing that use of this product should be avoided during pregnancy unless advised by a physician. Details on the fact that safety during pregnancy for paracetamol-caffeine-codeine has not been established relative to the possible adverse events is given and also details of the increased risk of spontaneous abortion due to caffeine consumption is given.
  • Underneath the second subheading, Lactation, all of the information previously listed in the SPC remains with the addition of the line “Although significant caffeine toxicity has not been observed in breastfed infants, caffeine may have a stimulating effect on the infant.”

In section 4.8 (Undesirable effects)

  • The text present at the moment has been deleted and replaced by information on classification of undesirable effects, including very common, common, uncommon, rare, very rare and not known. Information for undesirable effects for Paracetamol, Caffeine and Codeine was then tabulated by blood system, undesirable effect and frequency. Text has also been added under neat the tabulated undesirable effects of caffeine detailing the increase in risk for caffeine related adverse events when the product is combined with dietary caffeine.

In section 4.9 (Overdose)

  • The text present has been erased or reworded or broken up into different sections.
  • Now the text has been put into subheadings for Paracetamol, Codeine and Caffeine each of which is further broken up into two subheadings:

1.      Symptoms and signs

2.      Treatment.

  • For Paracetamol the Symptoms and signs now contains two paragraphs the first of which opens with the new text “Paracetamol overdose may cause liver failure.” Following on from this the text which was previously in the first paragraph of the old SPC beginning with “Ingestion of more than 12g paracetamol “and detailing what quantities of paracetamol can cause liver damage and what biochemical evidence may be present is given after this new opening sentence.
  • The second paragraph details all of the symptoms associated with paracetamol overdose, and how this paracetamol toxicity occurs.
  • In the Treatment subheading for paracetamol two paragraphs are given detailing that immediate medical attention should be sought. Advice is given on the appropriate treatments and timelines for which they may be effective (i.e. advice on N-acetylcysteine, oral methionine and activated charcoal).
  • For Codeine an opening sentence detailing that the effects of overdose would be subsumed by the effects of paracetamol overdose is given. In the Symptoms and Signs subheading what signs and symptoms to be expected are listed and in the Treatment section the appropriate treatments to be given are stated.
  • For Caffeine in the Symptoms and Signs subheading what signs and symptoms to be expected are listed and in the Treatment section details that no specific antidote for caffeine overdose is given but states that supportive measures such as beta adrenoreceptors should be used.

In section 10 (date of revision) the date was changed to July 2010.

 

 

 

 

 

 

Updated on 02 June 2009

Reasons for updating

  • Change of manufacturer

Updated on 26 August 2008

Reasons for updating

  • Correction of spelling/typing errors

Legal category:Supply through pharmacy only

Updated on 15 July 2008

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.6 - Pregnancy and lactation

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Changes to section 4.3:  The following text has been added.
Use of codeine containing products is contraindicated in mothers who are breastfeeding unless prescribed by a doctor.
Description of the change: contraindication in breastfeeding mothers.
 
Changes to section 4.6 - The following text has been deleted:
Insignificant levels of codeine also pass into breast milk. Available published data do not contraindicate breast feeding.
 
The following text has been added:
In nursing mothers, who are ultra-rapid metabolisers of codeine, higher than expected serum and breast milk morphine levels can occur. Morphine toxicity in babies can cause excessive somnolence, hypotonia, miosis and difficulty breastfeeding or breathing. In severe cases respiratory depression and death can occur. In severe cases, naloxone may be appropriate to reverse the effects. The lowest effective dose should be used, for the shortest possible time.
Nursing mothers should be informed about carefully monitoring the infant during treatment for any signs and/or symptoms of morphine toxicity such as increased drowsiness or sedation, difficulty breastfeeding, breathing difficulties, miosis and decreased tone, and seeking immediate medical care if such symptoms or signs are noticed. The nursing mother should be informed about monitoring for signs and symptoms of maternal opioid toxicity as well. Should such signs/symptoms be noted in mother or baby, the mother should immediately stop taking all codeine-containing medicines and seek medical advice.
Codeine-containing products must not be used while breastfeeding unless prescribed by a doctor.
Description of the change: addition of the safety warning for breastfeeding mothers.

Updated on 11 July 2008

Reasons for updating

  • Change to warnings or special precautions for use
  • Introduction of new pack/pack size

Updated on 02 July 2008

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.5 - Nature and contents of container
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Sections: 1, 2, 6.5, 9 and 10 (text changed) all are renewal changes

Updated on 18 February 2008

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

6.5 Nature and Contents of Containers:

"PVC/aluminium foil blister strip in a cardboard carton, containing 6, 12, 24, 36, 48, 60, 72 or 96 capsules" to be changed to "PVC/aluminium foil blister strip in a cardboard carton, containing 6, 12, 24, 32, 36, 48, 60, 72 or 96 capsules."

10 Date of revision of the text:

"September 2006" should be changed to "July 2007".

Updated on 27 August 2007

Reasons for updating

  • Improved electronic presentation

Updated on 03 August 2007

Reasons for updating

  • Improved electronic presentation

Legal category:Supply through pharmacy only

Updated on 28 September 2006

Reasons for updating

  • Change to section 6.1 - List of excipients

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 6.1

Printing ink:

Shellac

Black iron oxide (E172)

Propylene glycol

The following have been removed Soya lecithin, 2-ethoxyethanol and Dimethylpolysiloxane from section 6.1.

Updated on 19 September 2006

Reasons for updating

  • New PIL for medicines.ie

Updated on 03 November 2005

Reasons for updating

  • Change to section 4.1 - Therapeutic indications

Legal category:Supply through pharmacy only

Updated on 07 October 2005

Reasons for updating

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

Legal category:Supply through pharmacy only

Updated on 15 July 2005

Reasons for updating

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

Legal category:Supply through pharmacy only

Updated on 05 August 2004

Reasons for updating

  • Change to section 4.9 - Overdose
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Updated on 04 July 2003

Reasons for updating

  • New SPC for medicines.ie

Legal category:Supply through pharmacy only