Colpermin Gastro-Resistant Capsules

  • Name:

    Colpermin Gastro-Resistant Capsules

  • Company:
    info
  • Active Ingredients:

    Peppermint Oil

  • Legal Category:

    Supply through pharmacy only

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 12/03/20

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Summary of Product Characteristics last updated on medicines.ie: 12/3/2020

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Johnson & Johnson (Ireland) Ltd

Johnson & Johnson (Ireland) Ltd

Company Products

Medicine NameActive Ingredients
Medicine Name ACTIFED 30 mg/1.25 mg per 5 ml Syrup Active Ingredients Pseudoephedrine Hydrochloride, triprolidine hydrochloride
Medicine Name ACTIFED 60 mg / 2.5 mg Tablets Active Ingredients Pseudoephedrine Hydrochloride, triprolidine hydrochloride
Medicine Name Arret 2mg Hard Capsules Active Ingredients Loperamide Hydrochloride
Medicine Name Benylin Children's Chesty Coughs Active Ingredients Guaifenesin
Medicine Name Benylin Children's Dry Coughs Active Ingredients Diphenhydramine Hydrochloride, Levomenthol
Medicine Name Benylin Cough Medicine Syrup Active Ingredients Diphenhydramine Hydrochloride, Levomenthol
Medicine Name Benylin Day and Night Tablets Active Ingredients Diphenhydramine Hydrochloride, Paracetamol, Pseudoephedrine Hydrochloride
Medicine Name Benylin Dry Coughs Syrup Active Ingredients Dextromethorphan Hydrobromide, Diphenhydramine Hydrochloride, Levomenthol
Medicine Name Benylin Dual Action Dry Syrup Active Ingredients Dextromethorphan Hydrobromide, Pseudoephedrine Hydrochloride, triprolidine hydrochloride
Medicine Name Benylin Four Flu Tablets Active Ingredients Diphenhydramine Hydrochloride, Paracetamol, Pseudoephedrine Hydrochloride
Medicine Name Benylin Non- Drowsy for Chesty Coughs Active Ingredients Guaifenesin, Levomenthol
Medicine Name BENYLIN Non-Drowsy Dry Coughs, Syrup Active Ingredients Dextromethorphan Hydrobromide
Medicine Name Benylin Phlegm Cough plus Decongestant Syrup Active Ingredients Guaifenesin, Pseudoephedrine Hydrochloride
Medicine Name Benylin Phlegm Cough Syrup Active Ingredients Guaifenesin, Levomenthol
Medicine Name Calpol 120mg/5ml Infant Oral Suspension Active Ingredients Paracetamol
Medicine Name Calpol Infant 120mg/5ml Sugar Free Oral Suspension (Bottle & Sachets) Active Ingredients Paracetamol
Medicine Name CALPOL Six Plus 250mg/5ml Oral Suspension Active Ingredients Paracetamol
Medicine Name CALPOL SIX PLUS 250mg/5ml SUGAR/COLOUR FREE ORAL SUSPENSION Active Ingredients Paracetamol
Medicine Name CALPOL Six Plus Fastmelts 250 mg Paracetamol OrodispersibleTablets Active Ingredients Paracetamol
Medicine Name Colpermin Gastro-Resistant Capsules Active Ingredients Peppermint Oil
Medicine Name Daktarin 2% w/w Cream Active Ingredients Miconazole nitrate
Medicine Name Daktarin 2% w/w Cutaneous Powder Active Ingredients Miconazole nitrate
Medicine Name DAKTARIN 20mg/g Oral Gel Active Ingredients Miconazole
Medicine Name Imodium 2 mg Capsules Active Ingredients Loperamide Hydrochloride
Medicine Name Imodium Instants 2mg Orodispersible Tablets Active Ingredients Loperamide Hydrochloride
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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 12 March 2020

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

Updated on 12 March 2020 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 27 September 2019 PIL

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

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

Updated on 17 June 2019

Reasons for updating

  • File format updated to PDF

Updated on 7 August 2015

Reasons for updating

  • New SmPC for new product

Legal category: Supply through pharmacy only

Updated on 7 August 2015 SPC

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

Added to 4.8:

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 PIL

Reasons for updating

  • New PIL for new product

Updated on 21 July 2015 PIL

Reasons for updating

  • Addition of information on reporting a side effect.

Updated on 4 November 2013 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 15 October 2013 SPC

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

Section 4.4:

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 PIL

Reasons for updating

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

Updated on 4 June 2013 SPC

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 PIL

Reasons for updating

  • Change due to user-testing of patient information

Updated on 19 August 2011 PIL

Reasons for updating

  • Change to packaging

Updated on 12 May 2011 SPC

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

1. Full pahramceutical form added to name
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 PIL

Reasons for updating

  • Change of trade or active ingredient name
  • Change to further information section

Updated on 13 August 2010 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 25 August 2008 PIL

Reasons for updating

  • Change of manufacturer
  • Change to marketing authorisation holder

Updated on 11 January 2008 SPC

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

Change from Pfizer Consumer Health, Pottery Road, Dun Loaghaire, Co.Dublin to McNeil Healthcare, Airton Road Tallaght, Dublin 24.

Updated on 28 August 2007 SPC

Reasons for updating

  • Change to section 4.3 - Contraindications

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 4.3:

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 SPC

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 PIL

Reasons for updating

  • Change to further information section

Updated on 7 January 2005 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 29 December 2003 SPC

Reasons for updating

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

Legal category: Supply through pharmacy only

Updated on 15 August 2003 SPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Supply through pharmacy only

Updated on 10 July 2003 SPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Supply through pharmacy only