Benylin Children's Dry Coughs
*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 23 January 2022
File name
402552081_Benylin__child_dry_LN513603_EMEA_2021_00028311_002_r2.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 6 - date of revision
Updated on 23 January 2022
File name
ie-spc v13 benylin childrens dry cough 2195.pdf
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
Updated on 06 January 2022
File name
ie-pl-benylin-child-dry-2109 (2).pdf
Reasons for updating
- Improved presentation of PIL
Updated on 26 October 2021
File name
ie-pl-proposed-clean-benylin-childrens-dry-2109-Sep2021.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 3 - overdose, missed or forgotten doses
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 26 October 2021
File name
ie-spc-v12-Benylin Children's Dry Cough-2109.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- 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
Updated on 03 May 2021
File name
ie-leaflet-proposed-benylin-childrens-dry-2094.pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
Updated on 03 May 2021
File name
ie-spc V11 Benylin Children's Dry Cough 2094.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 6.1 - List of excipients
- Change to section 10 - Date of revision of the text
Legal category:Supply through pharmacy only
Updated on 23 October 2020
File name
ie-pl-proposed-benylin-child-dry-2058.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 17 June 2019
File name
ie-spc V10 Benylin Children's Dry Cough 1648.pdf
Reasons for updating
- File format updated to PDF
Legal category:Supply through pharmacy only
Updated on 04 April 2018
Reasons for updating
- New SPC for new product
Legal category:Supply through pharmacy only
Updated on 04 April 2018
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
Free text change information supplied by the pharmaceutical company
PA Transfer from McNeil Healthcare (Ireland) Ltd to Johnson & Johnson (Ireland) Ltd. Change in PA number. Note the address and contact details remain the same.
Updated on 03 April 2018
File name
PIL_9179_71.pdf
Reasons for updating
- New PIL for new product
Updated on 03 April 2018
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
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_9179_697.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 14 February 2014
Reasons for updating
- 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
A spoon with a 5 ml and 2.5 ml measure is supplied with the pack.
Updated on 10 February 2014
Reasons for updating
- Change to dosage and administration
Updated on 31 January 2014
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 4.8 - Undesirable effects
- 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
The following has been added:
Do not use to make a child sleepy.
Excitability may occur.
Do not use with any other product containing diphenydramine, even one used on skin.
Diphenhydramine may enhance the sedative effects of central nervous system depressants including alcohol, sedatives, and tranquilizers. While taking this product, avoid alcoholic beverages and consult a healthcare professional prior to taking with central nervous system depressants.
Patients with the following conditions should be advised to consult a physician before using diphenhydramine and menthol:
· A respiratory condition such as emphysema, chronic bronchitis, or acute or chronic bronchial asthma.
· Glaucoma
Patients with rare hereditary problems of fructose intolerance should not take this medicine.
This medicinal product contains 5 vol % ethanol (alcohol), i.e. up to 200mg per 5ml equivalent to 5ml beer, 2ml wine per 5ml. This can be harmful for those suffering from alcoholism. The ethanol content should be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver or kidney disease or epilepsy.
This medicinal product contains 16.47 mg sodium per 5ml. This should be taken into consideration by those on a controlled sodium diet.
Section 4.6:
'Fertility' added to title.
'or lactation' added to sentence as follows:
This product should not be used during pregnancy or lactation unless considered essential by the physician.
Section 4.8:
Completley re-written, many additionl side effects added plus frequency etc.
Adverse drug reactions (ADRs) identified during Post marketing experience with diphenhydramine and menthol are included in Table 1.
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, including isolated reports
Not known (cannot be estimated from the available data)
Table 1 Adverse Drug Reactions Identified During Post-Marketing Experience with Diphenhydramine/ Menthol Frequency Category Estimated from Clinical Trials or Epidemiology Studies*
|
Body system |
Incidence |
Reported adverse event |
|
Psychiatric disorders |
Not known |
Confusional state Irritability Hallucination Nervousness |
|
Nervous system disorders |
Very common |
Somnolence |
|
Common |
Dizziness |
|
|
Not known |
Agitation Coordination abnormal Convulsion Headache Insomnia Paraesthesia Sedation Tremor |
|
|
Eye disorders |
Not known |
Vision blurred |
|
Ear and labyrinth disorders |
Not known |
Tinnitus |
|
Cardiac disorders |
Not known |
Hypotension Palpitations Tachycardia |
|
Respiratory, thoracic and mediastinal disorders |
Not known |
Chest discomfort Dry throat Nasal dryness |
|
Gastrointestinal disorders |
Common |
Dry mouth
|
|
Not known |
Constipation Diarrhoea Dyspepsia Nausea Vomiting |
|
|
Skin and subcutaneous tissue disorders |
Not known |
Pruritus Rash Urticaria |
|
Renal and urinary disorders |
Not known |
Urinary retention |
|
General disorders and administration site conditions |
Common |
Asthenia |
(*) Frequency category based on clinical trials with single-ingredient diphenhydramine.
Section 4.9:
Symtoms section re-written with more detail and split out with seprate infomration for each active ingredient. Treatment section not changed.
Diphenhydramine
Mild to Moderate Symptoms: Somnolence, anticholinergic syndrome (hyperexia, mydriasis, flushing, fever, tachycardia, dry mouth, urinary retention, decreased bowel sounds, agitation confusion and hallucinations), mild hypertension, nausea and vomiting are common after overdose. Cerebral stimulation in children and occasionally in adults, insomnia, nervousness, tremors, epileptiform convulsions may occur.
Severe Symptoms: Effects may include delirium, psychosis, seizures, coma, hypotension, QRS widening, and ventricular dysrhythmias (including torsades de pointe), but are generally only reported in adults after large ingestions. Rhabdomyolysis and renal failure may rarely develop in patients with prolonged agitation, coma, or seizures. Death may occur as a result of respiratory failure or circulatory collapse.
Menthol
Excessive use of menthol may lead to abdominal pain, vomiting, flushed face, dizziness, weakness, tachycardia, stupor, and ataxia.
Sectiosn 5.1, 5.2 and 5.3:
More detail added.
Updated on 21 July 2011
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
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Section 4.2:
Removal of indication for use in children under 6 years of age.
Addition of maximum daily dose information
Addition of extra warnings:
Use only when simple measures have failed to provide adequate relief.
Use for more than 5 consecutive days is not recommended
Section 4.3
CI in children under 6.
Section 4.4
Children 2 to 6 years: Not more than 3 doses should be given in any 24 hours.
changed to:
Children 6 to 12 years: Not more than 3 doses should be given in any 24 hours.
Consult a pharmacist or other healthcare professional before use in children under 6 years.
changed to:
Consult a pharmacist or other healthcare professional before use in children under 12 years.
Updated on 21 July 2011
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
- Change to dosage and administration
Updated on 06 April 2011
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
Updated on 16 November 2010
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
Updated on 01 October 2010
Reasons for updating
- Change due to user-testing of patient information
Updated on 04 January 2010
Reasons for updating
- 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
Updated on 25 August 2008
Reasons for updating
- Change to marketing authorisation holder
Updated on 05 June 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 24 August 2007
Reasons for updating
- Correction of spelling/typing errors
Legal category:Supply through pharmacy only
Updated on 13 October 2006
Reasons for updating
- Change of manufacturer
Updated on 28 October 2004
Reasons for updating
- New PIL for medicines.ie
Updated on 16 June 2003
Reasons for updating
- New SPC for medicines.ie
Legal category:Supply through pharmacy only