Benylin Non- Drowsy for Chesty Coughs

  • Name:

    Benylin Non- Drowsy for Chesty Coughs

  • Company:
    info
  • Active Ingredients:

    Guaifenesin, Levomenthol

  • Legal Category:

    Supply through general sale

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 05/06/18

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Summary of Product Characteristics last updated on medicines.ie: 17/6/2019

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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) Active Ingredients Paracetamol
Medicine Name Calpol Infant 120mg/5ml Sugar Free Oral Suspension (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 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 17 June 2019 SmPC

Reasons for updating

  • File format updated to PDF

Legal category: Supply through general sale

Updated on 5 June 2018 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation number

Updated on 5 June 2018 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)

Legal category: Supply through general sale

Updated on 29 July 2015 PIL

Reasons for updating

  • New PIL for new product

Updated on 29 July 2015 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 10 March 2015 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text

Legal category: Supply through general sale

Free text change information supplied by the pharmaceutical company

Section 4.4 - information on excipients added

Section 4.6 updated as follows:

Pregnancy

There are no or limited amounts of data from the use of Guaifenesin in pregnant women.  Animal studies are insufficient with respect to reproductive toxicity (see section 5.3). Benylin Non-Drowsy Chesty Coughs is not recommended during pregnancy and in women of childbearing potential not using contraception.

 

Breastfeeding

Guaifenesin is excreted in breast milk in small amounts.  There is insufficient information on the effects of Guaifenesin in newborns/infants.  A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Benylin Non-Drowsy Chesty Coughs therapy, taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.

 

Fertility
There is insufficient information available to determine whether guaifenesin has the potential to impair fertility

Section 4.7 - updated as follows:
It is not expected that this product would interfere with the ability to drive or operate machinery


Section 4.8 updated as follows & HPRA details for AE reporting added:

Body System (SOC)

Frequency

Adverse Drug Reaction

(Preferred Term)

Immune system Disorders

Not known

Hypersensitivity (including Pruritus and Urticaria)

 

Gastrointestinal Disorders

Not known

Not known

Not known

Not known

Abdominal pain upper

Diarrhoea

Nausea

Vomiting

 

Skin and Subcutaneous Tissue Disorders

Not known

Rash



Section 4.9 updated as follows:

Symptoms and signs

 

Guaifenesin

The symptoms and signs of overdose may include gastro-intestinal discomfort, nausea and somnolence. When taken in excess, Guaifenesin may cause renal calculi.

 

Menthol

Excessive use of menthol may lead to abdominal pain, vomiting, flushed face, dizziness, weakness, tachycardia, stupor, and ataxia

Updated on 10 March 2015 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Supply through general sale

Updated on 9 March 2015 PIL

Reasons for updating

  • Change to side-effects

Updated on 1 October 2010 PIL

Reasons for updating

  • Change due to user-testing of patient information

Updated on 21 September 2009 PIL

Reasons for updating

  • Change to dosage and administration

Updated on 14 September 2009 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 10 - Date of revision of the text

Legal category: Supply through general sale

Free text change information supplied by the pharmaceutical company

Section 4.2:

Indication for use in children under 12 removed.

Section 4.3:

Contraindication not to use in children under 12 added.

Section 10:

Changed to June 2009

Updated on 13 November 2008 SmPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

Legal category: Supply through general sale

Free text change information supplied by the pharmaceutical company

Addition of HDPE plastic cap with PE-Alu-PET wad material.

Updated on 25 August 2008 PIL

Reasons for updating

  • Change to marketing authorisation holder

Updated on 5 June 2008 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category: Supply through general sale

Free text change information supplied by the pharmaceutical company

Change in MAH from Pfizer Consumer Healthcare, Pottery Road, Dun Laoghaire to McNeil Healthcare Ireland Limited, Airton Road, Tallaght, Dublin 24.

Updated on 19 May 2008 PIL

Reasons for updating

  • Change to marketing authorisation holder

Updated on 12 September 2005 PIL

Reasons for updating

  • New PIL for new product

Updated on 11 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Supply through general sale