Benylin Cough Medicine Syrup

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 21/05/18

files-icon(Click to Download)
Summary of Product Characteristics last updated on medicines.ie: 17/6/2019

Click on this link to Download PDF directly

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
1 - 0 of 66 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 17 June 2019 SmPC

Reasons for updating

  • File format updated to PDF

Legal category: Supply through pharmacy only

Updated on 25 May 2018 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Legal category: Supply through pharmacy only

Updated on 21 May 2018 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 7 August 2015 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Supply through pharmacy only

Updated on 7 August 2015 SmPC

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 29 August 2013 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • 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 6.6 - Special precautions for disposal and other handling
  • 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

Additions are underlined and deletions are crossed through:

Section 4.4 Special Warnings and Precautions for Use

 

Do not use with any other product containing diphenhydramine, even one used on skin (see Section 4.5).

 

Patients with moderate to severe renal or hepatic dysfunction should exercise caution when using this product (see Pharmacokinetics Section 5.2).

 

This product contains diphenhydramine and therefore should not be taken by individuals with narrow-angle glaucoma or symptomatic prostatic hypertrophy unless directed by a doctor.

Patients with the following conditions should be advised to consult a physician before using BENYLIN Cough Medicine:

 

·      Persistent  or chronic cough such as occurs with smoking, asthma or emphysema or where cough is accompanied by excessive secretions

·      Narrow angle glaucoma

·      Prostatic enlargement (hyperplasia/hypertrophy) with residual urine formation

 

This product may act as a cerebral stimulant in children and occasionally in adults.  Symptoms of overdosage include insomnia, nervousness, hyperpyrexia, tremors and epileptiform convulsions.  Large doses of antihistamines may precipitate attacks in epilepsy (see Section 4.9).

 

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 (see Section 4.5).

This product may cause  drowsiness (see Section 4.8).

 

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insuffucuency should not take this medicine.

 

Benylin Cough Medicine should not be used for persistent  or chronic cough such as occurs with smoking asthma or emphysema or where cough is accompanied by excessive secretions, unless directed by a physician.

 

This product contains Ponceau 4R (E214) red colouring which may cause allergic reactions.

 

This product contains 16.61mg of sodium per 5ml. This should be taken into consideration by those on a controlled sodium diet.

 

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.

Section 4.5 Interactions with other medicinal products and other forms of interaction

 

CNS Depressants: This product contains diphenhydramine and therefore may potentiate the effects of alcohol and other central nervous system depressants including opiod analgesics, anticonvulsants, antidepressants, antihistamines, antiemetics, antipsychotics, antixiolytic sedatives and hypnotics..

 

Antimuscarinic drugs: As diphenhydramine possesses some anti-cholinergic activity, the effects of anti-cholinergics (e.g. some psychotropic drugs and atropine) may be potentiated by this product giving rise to tachycardia, mouth dryness, gastrointestinal disturbances (e.g. colic), urinary retention and headache.

 

MAOIs: Not to be used in patients taking MAOIs or within 14 days of stopping treatment as there is a risk of serotonin syndrome.

Section 4.6 Fertility, Pregnancy and lactation

 

Although diphenhydramine has been in widespread use for many years without ill consequence, it is known to cross the placenta and has also been detected in breast milk. Menthol is also excreted in breast milk.  Benylin Cough Medicine should not be used during pregnancy or lactation unless considered essential by a doctor.


Section 4.8 Undesirable effects

 

Side effects associated with the use of Benylin Cough Medicine are uncommon.

 

Diphenhydramine may cause drowsiness; dizziness; gastrointestinal disturbance; dry mouth, nose and throat; difficulty in urination, headache or rash.

 

Diphenhydramine

Data from several clinical trials are available with a total population of 936 people treated with diphenhydramine where adverse events were assessed. Additionally, adverse events reported in post-marketing are included.

 

Post-marketing Data:

Adverse drug reactions (ADRs) identified during post-marketing experience with Diphenhydramine / Menthol are included in table below.

The frequencies are provided according to the following convention: Very common (³1/10); Common (³1/100 and < 1/10); Uncommon (³1/1,000 and <1/100); Rare (³1/10,000, <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 Diphenhydramine / Menthol, Frequency Category Estimated from Clinical Trials or Epidemiology Studies*

System Organ Classification

Frequency category

Adverse Event Preferred Term

 

 

Psychiatric Disorders

 

Uncommon

Confusional state

Uncommon

Irritability

Uncommon

Hallucination

Uncommon

Nervousness

 

 

Nervous System Disorders

 

Uncommon

Agitation

Uncommon

Coordination abnormal

Uncommon

Convulsion

Common

Dizziness

Uncommon

Headache

Uncommon

Insomnia

Uncommon

Paraesthesia

Uncommon

Sedation

Common

Somnolence

Uncommon

Tremor

 

 

Eye Disorders

 

Uncommon

Vision blurred

 

 

Ear and Labyrinth Disorders

 

Uncommon

Tinnitus

 

 

Cardiac Disorders

 

Uncommon

Hypotension

Uncommon

Palpitations

Uncommon

Tachycardia

 

 

Respiratory, Thoracic and Mediastinal Disorders

 

Uncommon

Chest discomfort

Uncommon

Dry throat

Uncommon

Nasal dryness

 

 

Gastrointestinal Disorders

 

Uncommon

Constipation

Uncommon

Diarrhoea

Common

Dry Mouth

Uncommon

Dyspepsia

Uncommon

Nausea

Uncommon

Vomiting

 

 

Skin and Subcutaneous Tissue Disorders

 

Uncommon

Pruritus

Uncommon

Rash

Uncommon

Uriticaria

 

 

Renal and Urinary Disorders

 

Uncommon

Urinary retention

 

 

General Disorders and Administration site conditions

 

Common

Asthenia§

* Frequency category based on clinical trials with single-ingredient diphenhydramine.

§ Adverse drug reaction only reported in one clinical trial.

 

Menthol

 

Adverse reactions to menthol at the low concentration present are not anticipated.


Section 4.9 Overdose

 

Diphenhydramine

 

Symptoms and signs

 

Mild to Moderate Symptoms Drowsiness, anticholinergic syndrome (hyperpyrexia, mydriasis, flushing, fever, tachycardia, dry mouth, urinary retention, decreased bowel sounds, agitation confusion and hallucinations), mild hypertension, nausea and vomiting are common after overdose.

 

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.With higher doses, and particularly in children, symptoms of CNS excitation including insomnia, nervousness, tremors and epileptiform convulsions may appear; with massive doses, coma or cardiovascular collapse may follow.

 

Menthol

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

 

Treatment

 

Treatment of overdose should be symptomatic and supportive.  Measures to promote rapid gastric emptying (with syrup of ipecac-induced emesis or gastric lavage) and, in cases of acute poisoning, the use of activated charcoal, may be useful.  The intravenous use of physostigmine may be efficacious in antagonising severe anticholinergic symptoms.


Section 5.1 Pharmacodynamic properties

 

Diphenhydramine HCl

ATC Code: R06AA52 Pharmacotherapeutic Group: Antihistamines for systemic use, Aminoalkyl ethers

Diphenhydramine possesses antitussive, antihistaminic, anticholinergic properties.  Experiments have shown that the antitussive effect (resulting from an action on the brainstem) is discrete from its antihistaminic effect.  The duration of activity of diphenhydramine is between 4 and 8 hours.

Diphenhydramine is a potent antihistamine and antitussive with concurrent anticholinergic and sedative properties. Experiments have shown that the antitussive action is discrete from H1-rececptor blockade and is located in the brain stem. The duration of activity of diphenhydramine is between 4 and 8 hours. The sedative mechanism for diphenhydramine is thought to result from antagonism of central histamine and cholinergic receptors. The time course for sedation following a 50 mg oral dose was associated with higher plasma concentrations, and was significantly different from placebo during the first three hours following administration. The pharmacodynamics of sedation was correlated with peak concentrations of drug occurring during absorption and the alpha distribution phase.

Menthol

Menthol has mild local anaesthetic and decongestant properties. The mechanism by which menthol may act as an antitussive may be related to a strong stimulant effect on cold receptors in the larynx in the absence of cold air. It has been noted that substances which produce a hot sensation in the airway may stimulate the cough reflex, while menthol, which produces a cold sensation, has the opposite effect.

Section 5.2 Pharmacokinetic properties

 

 

Diphenhydramine

Absorption

Diphenhydramine is well absorbed from the gastrointestinal tract, reaching peak plasma concentrations from 47-153 ng/mL between 1.5 and 4 hours after a single 50-mg dose in adults. After multiple oral doses of 50 mg diphenhydramine HCl four times during each day to four subjects, minimum diphenhydramine plasma concentrations at steady state on the third day ranged from 57-150 ng/mL. Diphenhydramine and menthol are well absorbed from the gut following oral administration.  Peak serum levels of diphenhydramine following a 50 mg oral dose are reached at between 2 and 2.5 hours.

 

Distribution

Diphenhydramine is widely distributed throughout the body, including the CNS. The pharmacokinetics of diphenhydramine follows a two-compartment model in which the distribution or alpha phase is apparent over the first eight to ten hours. The volume of distribution adjusted by body weight is large for diphenhydramine at 14.0 L/kg (38%) for adults, 16.0 (32%) for adolescents, and 19.5 (28%) for children. Diphenhydramine is highly protein bound, with free drug concentrations of 24.0 ± 1.9% ng/mL and 14.8 ± 1.5% ng/mL measured in Asian and Caucasian plasma. In adults with liver disease, protein binding is lower, although the volume of distribution is comparable to healthy adults Following a 50 mg oral dose of diphenhydramine, the volume of distribution is in the range 3.3 – 6.8 L/kg, and it is some 78% bound to plasma proteins.

 

Metabolism and elimination

Diphenhydramine undergoes extensive first pass metabolism with an absolute bioavailability of 72% ± 8%. It is extensively metabolized in the liver by demethylation to N-demethyl diphenhydramine (DMDP), and the extent of DMDP measured in plasma is highly correlated with the clearance of diphenhydramine. DMDP is subsequently demethylated to N,Ndidemethyl diphenhydramine. Because only the latter, minor metabolic pathway of N,N-didemethylation appears to be mediated by cytochrome P450 2D6, diphenhydramine disposition in humans is not determined by CYP2D6 activity. Rather, clinical pharmacokinetics data suggest that diphenhydramine may be an inhibitor of CYP2D6 without being extensively metabolized by this cytochrome P450 isozyme. N,Ndidemethyl diphenhydramine is further metabolized by oxidative deamination to diphenylmethoxyacetic acid..  Two successive N-dimethylations occur, with the resultant amine being oxidised to a carboxylic acid.  Values for plasma clearance of a 50 mg oral dose of diphenhydramine lie in the range 600 – 1300 ml/min, and the terminal elimination half-life lies in the range 3.4 – 9.3 hours.  Little unchanged drug is excreted in the urine.  Menthol is hydroxylated in the liver by microsomal enzymes to p-methane-3,8 diol.  This is then conjugated with glucuronide and excreted both in urine and bile as the glucuronide.

 

Elimination

Mean beta elimination half-life from 8.5 and 11.5 hours in adults have been reported in studies in which blood is sampled up to 24 to 72 hours. The half-life is increased to 13.6 ± 4.2 h in the elderly and to 15.2 ± 1.5 h in adults with liver cirrhosis. Little unchanged drug is excreted in the urine.

Mean oral clearances for adults after a 25- and 50-mg dose are 1041 and 1029 mL/min, respectively, having coefficients of variation of 40% and 35%. Oral clearance is about 50% lower in elderly adults. Oral clearance is 691 mL/min (32%) for children ages 2 to 11 years, and is 1251 mL/min (43%) for adolescents’ ages 12 to 17 years.

 

The elderly

Pharmacokinetic studies indicate no major differences in distribution or elimination of dipenhydramine compared to younger adults.

 

Renal dysfunction

The results of a review on the use of diphenhydramine in renal failure suggest that in moderate to severe renal failure, the dose interval should be extended by a period dependent on glomerular filtration rate (GFR).

 

Hepatic dysfunction

After intravenous administration of 0.8 mg/kg diphenhydramine, a prolonged shelf-life was noted in patients with chronic liver disease which correlated with the severity of the disease.  However, the mean plasma clearance and apparent volume of distribution were not significantly affected.

 

Menthol

 

Absorption

Menthol is highly lipid soluble and, when taken orally, is rapidly absorbed from the small intestine.

Distribution

There is insufficient data on the distribution of menthol.

Metabolism

In humans, menthol is partially metabolized to menthol glucuronide by rapid conjugation. Animal studies in rats have demonstrated that menthol then undergoes extensive enterohepatic recirculation after being cleaved from the glucuronide conjugate and reabsorbed in the small intestine . The reabsorbed menthol is then subsequently metabolized by oxidative processes in the liver. There is support for this model in humans as well because menthol has been shown to be oxidized by CYP2A6 in human liver microsomes.

Elimination

A study in humans has demonstrated that approximately 50% of a menthol dose is excreted in the urine as menthol glucuronide. Other studies in rats have shown that menthol glucuronide is excreted in both the bile and the urine, but with the bile containing the majority of menthol glucuronide and with the urine also containing various oxidation products.

Section 6.6 Instructions for Use/Handling Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product properties

 

No special requirements.

 

 

Any unused product or waste material should be disposed of in accordance with local requirements.



Updated on 22 August 2013 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to date of revision

Updated on 21 July 2011 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 1 October 2010 PIL

Reasons for updating

  • Change due to user-testing of patient information

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 pharmacy only

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 8 September 2009 PIL

Reasons for updating

  • Change to date of revision
  • Change to dosage and administration

Updated on 20 April 2009 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.1 - List of excipients
  • Change to section 6.5 - Nature and contents of container
  • Change to section 9 - Date of renewal of authorisation

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Renewal changes:
 
Inclusion of e numbers  where applicable
Inclusion of additional container closure system
Inclusion of active ingredients in the product name
Update to revision date

Updated on 13 November 2008 SmPC

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

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

Updated on 19 May 2008 PIL

Reasons for updating

  • Change to marketing authorisation holder

Updated on 11 March 2008 SmPC

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 to the name of the MAH from Pfizer Consumer Healthcare, Pottery Road Dun Laoghaire, Co. Dublin to McNeil Healthcare (Ireland) Limited, Airton Road, Tallaght, Dublin 24

Updated on 12 September 2005 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 16 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Supply through pharmacy only