Solpadeine Tablets
*Company:
Chefaro Ireland DACStatus:
No Recent UpdateLegal Category:
Supply through pharmacy onlyActive Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 19 February 2021
File name
ie-spc-February-2021.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Supply through pharmacy only
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.pdf
Reasons for updating
- Change to name of medicinal product
Updated on 17 April 2020
File name
ie-spc-Mar-2020.pdf
Reasons for updating
- Change due to harmonisation of SPC
- Correction of spelling/typing errors
- 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 - marketing authorisation holder
- Change to section 6 - date of revision
- Correction of spelling/typing errors
- Improved presentation of PIL
- Change due to harmonisation of PIL
Updated on 17 January 2019
File name
ie-mockup-pl-jan-19.pdf
Reasons for updating
- Change to MA holder contact details
Updated on 09 January 2019
File name
ie-spc-jan-19.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Supply through pharmacy only
Updated on 11 April 2016
Reasons for updating
- New SPC for new product
Legal category:Supply through pharmacy only
Updated on 11 April 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
Tablet
White capsule shaped tablets, printed ‘Solpadeine’ in red on one side or plain on both the sides.
Updated on 24 March 2016
File name
PIL_11508_742.pdf
Reasons for updating
- New PIL for new product
Updated on 24 March 2016
Reasons for updating
- Change to name of manufacturer
Updated on 23 March 2016
Reasons for updating
- Change to name of manufacturer
Updated on 15 September 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
Updated on 14 May 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
Updated on 07 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 how the medicine works
- Change to date of revision
- Changes to therapeutic indications
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 1186/011/003
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 03 May 2011
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- Correction of spelling/typing errors
- Change to section 4.3 - Contraindications
- Transfer of marketing authorisation holder
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Section 4.4: Information about the CYP2D6 and ultra-rapid metabolisers removed
Section 4.6: Updated information about the use of Solpadeine tablets in breastfeeding added.
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 of special precautions for disposal
- 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 “under 12” was added to the heading “Children”
- Warning text was also added, advising the maximum number of tablets to be taken in 24hours 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
- 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 Carmosine (E 122). 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 with
- 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 13 July 2010
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
In section 1 (name of the medicinal product), the following text was added underneath “Solpadeine Tablets”; “Paracetamol 500mg, Codeine Phosphate Hemihydrate 8mg, Caffeine 30mg”
In section 2 (Qualitative and Quantitative Composition), the text “For excipients see6.1” was removed and replaced by “Excipients: contains Carmoisine (E122) For a full list of excipients, see section 6.1”.
In section 6.5 (Nature and contents of container), the following text was added: “Not all pack sizes may be marketed”.
In section 9 (Date of first authorisation/renewal of the authorisation), 29 October 2003 was replaced by 20 October 2008
In section 10 (Date of Revision of the text), January 2008 was replaced to November 2009.
Updated on 20 August 2008
Reasons for updating
- Improved electronic presentation
Legal category:Supply through pharmacy only
Updated on 11 July 2008
Reasons for updating
- Change to warnings or special precautions for use
- Change of active ingredient
Updated on 12 June 2008
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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
General Sale. Date of Rev March 2008 .
Updated on 22 May 2008
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
4.6 Pregnancy and Lactation has been deleted:
"Insignificant levels of codeine also pass into breast milk. Available published data do not contraindicate breast feeding."
Updated on 16 May 2008
Reasons for updating
- Change to warnings or special precautions for use
Updated on 18 February 2008
Reasons for updating
- Change to section 4.3 - Contraindications
- Change to section 4.6 - Pregnancy and lactation
- 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
4.3 Contraindications: The following sentence should be added to become the last sentence of section 4.3: "Use of codeine containing products is contraindicated in mothers who are breastfeeding unless prescribed by a doctor."
4.6 Pregnancy and lactation: The following 3 paragraphs should be added at the end of section 4.6:
"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."
4.9 Overdose: Following the first sentence in the third paragraph, which ends with "anorexia, and abdominal pain.", the following sentence should be added: "Liver damage may become apparent 12 to 48 hours after ingestion."
The following sentence should be deleted: "Liver damage results when excess quantities of a toxic metabolite (usually adequately detoxified by glutathione when normal doses of paracetamol are ingested) become irreversibly bound to liver tissue."
Following the sentence which reads "Cardiac arrhythmias and pancreatitis have been reported.", the following should be added: "Liver damage is possible in adults who have taken 10g or more of paracetamol. It is considered that excess quantities of toxic metabolite (usually adequately detoxified by glutathione when normal doses of paracetamol are ingested), become irreversibly bound to liver tissue."
10 Date of revision of the text:
"September 2005" should be changed to "January 2008".
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
- Change to section 6.1 - List of excipients
Legal category:Supply through pharmacy only
Updated on 12 May 2005
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 6.1 - List of excipients
Legal category:Supply through pharmacy only
Updated on 09 August 2004
Reasons for updating
- Improved electronic presentation
Legal category:Supply through pharmacy only
Updated on 05 August 2004
Reasons for updating
- Change to section 4.9 - Overdose
- Change to section 6.3 - Shelf life
- Change to section 10 - Date of revision of the text
Legal category:Supply through pharmacy only
Updated on 25 June 2003
Reasons for updating
- New SPC for medicines.ie
Legal category:Supply through pharmacy only