Solpadeine Capsules

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Summary of Product Characteristics last updated on medicines.ie: 21/10/2019

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Chefaro Ireland Ltd

Chefaro Ireland Ltd

Company Products

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Medicine Name Beconase Hayfever Active Ingredients Beclometasone Dipropionate Monohydrate
Medicine Name Buttercup Bronchostop Berry Flavour Cough Pastilles Active Ingredients Thyme herb extract
Medicine Name Buttercup Bronchostop Cough Syrup Active Ingredients Marshmallow root extract, Thyme herb extract
Medicine Name Cetirizine dihydrochloride 10mg Film-coated Tablets Active Ingredients Cetirizine Dihydrochloride
Medicine Name Lyclear Creme Rinse Active Ingredients Permethrin
Medicine Name Metatone Tonic Active Ingredients Calcium glycerophosphate, Manganese glycerophosphate, Potassium glycerophosphate, Sodium glycerophosphate, Thiamine Hydrochloride (Vitamin B1)
Medicine Name Milk of Magnesia Active Ingredients Magnesium Hydroxide
Medicine Name NiQuitin 14 mg/24hrs transdermal patches Active Ingredients Nicotine
Medicine Name NiQuitin 21mg/24hrs transdermal patches Active Ingredients Nicotine
Medicine Name NiQuitin 7mg/24hrs transdermal patches Active Ingredients Nicotine
Medicine Name NiQuitin CLEAR 14 mg/24 hours transdermal patch Active Ingredients Nicotine
Medicine Name NiQuitin CLEAR 21 mg/24 hours transdermal patch Active Ingredients Nicotine
Medicine Name NiQuitin CLEAR 7 mg/24 hours transdermal patch Active Ingredients Nicotine
Medicine Name NiQuitin CLEAR transdermal patch Active Ingredients Nicotine
Medicine Name NiQuitin Mini 1.5mg mint lozenges Active Ingredients Nicotine resinate
Medicine Name NiQuitin Mini 4mg mint lozenges Active Ingredients Nicotine resinate
Medicine Name Paracetamol 500 mg Film-Coated Tablets (GSL) Active Ingredients Paracetamol
Medicine Name Paracetamol 500 mg Film-Coated Tablets (p) Active Ingredients Paracetamol
Medicine Name PrevAllergy Tablets Active Ingredients Cetirizine Dihydrochloride
Medicine Name Solpa-Extra Soluble Tablets Active Ingredients Caffeine, Paracetamol
Medicine Name Solpa-Plus tablets Active Ingredients Codeine Phosphate Hemihydrate, Paracetamol
Medicine Name solpa-plus with caffeine soluble tablets Active Ingredients Caffeine, Codeine Phosphate Hemihydrate, Paracetamol
Medicine Name Solpa-Sinus Film-coated Tablets Active Ingredients Paracetamol, Pseudoephedrine Hydrochloride
Medicine Name Solpadeine Capsules Active Ingredients Caffeine, Codeine Phosphate Hemihydrate, Paracetamol
1 - 0 of 33 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 21 October 2019 SmPC

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 PIL

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 4 May 2016 PIL

Reasons for updating

  • New PIL for new product

Updated on 4 May 2016 PIL

Reasons for updating

  • Change to appearance of the medicine

Updated on 22 March 2016 SmPC

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 22 March 2016 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Supply through pharmacy only

Updated on 18 March 2016 PIL

Reasons for updating

  • Change to name of manufacturer

Updated on 25 October 2014 SmPC

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 8 May 2014 PIL

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 SmPC

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 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: 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 6 February 2013 PIL

Reasons for updating

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

Updated on 8 February 2012 PIL

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 SmPC

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 SmPC

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 6 December 2010 SmPC

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 9 August 2010 PIL

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 3 August 2010 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 4.6 - 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 2 June 2009 PIL

Reasons for updating

  • Change of manufacturer

Updated on 26 August 2008 SmPC

Reasons for updating

  • Correction of spelling/typing errors

Legal category: Supply through pharmacy only

Updated on 15 July 2008 SmPC

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 PIL

Reasons for updating

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

Updated on 2 July 2008 SmPC

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 SmPC

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 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 3 August 2007 SmPC

Reasons for updating

  • Improved electronic presentation

Legal category: Supply through pharmacy only

Updated on 28 September 2006 SmPC

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 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 3 November 2005 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications

Legal category: Supply through pharmacy only

Updated on 7 October 2005 SmPC

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 SmPC

Reasons for updating

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

Legal category: Supply through pharmacy only

Updated on 5 August 2004 SmPC

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 4 July 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Supply through pharmacy only