Colpermin Gastro-Resistant Capsules
*Company:
KenvueStatus:
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 16 February 2023
File name
ie-pil-clean-colpermin.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 11 July 2022
File name
ie-mockup-pl-clean-colpermin-2248.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 07 July 2021
File name
ie-spc-clean-2136.pdf
Reasons for updating
- Change to section 3 - Pharmaceutical form
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 10 - Date of revision of the text
Legal category:Supply through pharmacy only
Updated on 07 July 2021
File name
ie-mockup-pl-colpermin-2136.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 12 March 2020
File name
ie-spc-clean-1640.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
- Change to section 10 - Date of revision of the text
Legal category:Supply through pharmacy only
Updated on 12 March 2020
File name
ie mockup pl colpermin 1640.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 27 September 2019
File name
ie-mockup-pil-clean-1665.pdf
Reasons for updating
- 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 5 - how to store or dispose
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
Updated on 27 September 2019
File name
ie-spc V8 CPA02 1665.pdf
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 4.6 - Pregnancy and lactation
- Change to section 10 - Date of revision of the text
Legal category:Supply through pharmacy only
Updated on 17 June 2019
File name
ie-spc V7 CPA02 1400 Colpermin June 2015.pdf
Reasons for updating
- File format updated to PDF
Legal category:Supply through pharmacy only
Updated on 07 August 2015
Reasons for updating
- New SPC for new product
Legal category:Supply through pharmacy only
Updated on 07 August 2015
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Reporting of Suspected Adverse Reactions.
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail:medsafety@hpra.ie.
Updated on 21 July 2015
File name
PIL_9327_51.pdf
Reasons for updating
- New PIL for new product
Updated on 21 July 2015
Reasons for updating
- Addition of information on reporting a side effect.
Updated on 04 November 2013
Reasons for updating
- Correction of spelling/typing errors
Updated on 15 October 2013
Reasons for updating
- 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 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Added: This product should not be taken by patients known to be allergic to peanut and / or soya (See section 4.3)
Section 4.8:
Re-written in MedRA format and side effects added:
Side effects: Heartburn, hypersensitivity to menthol, erythematous skin rash, headache, bradycardia, muscle tremor, ataxia, arthralgia and dry mouth. This may occur in conjunction with alcohol.
changed to:
Post marketing data:
Adverse drug reactions (ADRs) identified during post-marketing experience with Peppermint Oil are included in the table below. The frequencies are provided according to the following convention:
Very common ≥1/10
Common ≥1/100 and <1/10
Uncommon ≥1/1,000 and <1/100
Rare ≥1/10,000, and <1/1,000
Very rare <1/10,000
Not known (cannot be estimated from the available data)
|
Adverse Drug Reactions Identified During Post-Marketing Experience with Peppermint Oil Frequency Category Estimated from adequately designed clinical trials or epidemiology studies |
|
|
SOC |
|
|
Frequency category |
Adverse Event Preferred Term |
|
Immune System Disorders |
|
|
Not known |
Hypersensitivity** |
|
Nervous System Disorders |
|
|
Not known |
Burning sensation mucosal |
|
Gastrointestinal System Disorders |
|
|
Not known |
Anorectal discomfort |
|
Not known |
Dyspepsia |
|
Not known |
Gastrooesophageal reflux |
|
Not known |
Nausea |
|
Not known |
Vomiting |
|
** Individual intolerance as well as allergic reactions may occur. These may include erythematous skin rash, headache, bradycardia, muscle tremor, ataxia, arthralgia and dry mouth. This may occur in conjunction with alcohol. |
|
Section 4.9:
Added: The most commonly reported symptoms of overdose are severe nausea, vomiting, abdominal pain, vertigo, ataxia, drowsiness and coma.
Section 51. to 5.3 updated with more detail
Updated on 17 September 2013
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
Updated on 04 June 2013
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
4.2 Posology and Method of Administration
Children: There is not any experience of Colpermin therapy in children.
Adults: One capsule three times a day, taken 30-60 minutes before food with a small quantity of water. The capsules should not be taken immediately after food.
The dose may be increased to two capsules, three times a day when discomfort is more severe.
The capsules should be taken until symptoms resolve, usually within one or two weeks. At times when symptoms are more persistent, the capsules can be continued for longer periods of not longer than 2 to 3 months per course.
CHANGED TO:
4.2 Posology and Method of Administration
Adults and children 15 years and over:
One capsule three times a day, taken 30-60 minutes before food with a small quantity of water. The capsules should not be taken immediately after food.
The dose may be increased to two capsules, three times a day when discomfort is more severe.
Children under 15 years:
There is no experience of Colpermin Capsules in children under the age of 15 years.
The capsules should be taken until symptoms resolve, usually within one or two weeks. At times when symptoms are more persistent, the capsules can be continued for longer periods of not longer than 2 to 3 months per course.
Updated on 23 September 2011
Reasons for updating
- Change due to user-testing of patient information
Updated on 19 August 2011
Reasons for updating
- Change to packaging
Updated on 12 May 2011
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 6.1 - List of excipients
- Change to section 6.4 - Special precautions for storage
- Change to section 6.5 - Nature and contents of container
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
2. 'Arachis oil' details added.
6.1 Componenets of excipient Eudragit added
6.4 Full description of storage conditions in line with BP added
6.5 More detaisl added.
Updated on 10 May 2011
Reasons for updating
- Change of trade or active ingredient name
- Change to further information section
Updated on 13 August 2010
Reasons for updating
- Correction of spelling/typing errors
Updated on 25 August 2008
Reasons for updating
- Change of manufacturer
- Change to marketing authorisation holder
Updated on 11 January 2008
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Updated on 28 August 2007
Reasons for updating
- Change to section 4.3 - Contraindications
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
This product should not be used in patients who are hypersensitive to any of its ingredients, including menthol and arachis oil (peanut oil).
Updated on 31 March 2006
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 6.1 - List of excipients
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - MA number
Legal category:Supply through pharmacy only
Updated on 31 March 2006
Reasons for updating
- Change to further information section
Updated on 07 January 2005
Reasons for updating
- New PIL for medicines.ie
Updated on 29 December 2003
Reasons for updating
- Change to section 10 - Date of revision of the text
Legal category:Supply through pharmacy only
Updated on 15 August 2003
Reasons for updating
- New SPC for medicines.ie
Legal category:Supply through pharmacy only
Updated on 10 July 2003
Reasons for updating
- New SPC for medicines.ie
Legal category:Supply through pharmacy only