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McNeil Healthcare (Ireland) Ltd

Airton Road, Tallaght, Dublin 24, Ireland
Telephone: +353 1 466 5200
Fax: +353 1 466 5316


Summary of Product Characteristics last updated on medicines.ie: 07/08/2015
SPC Benylin Cough Medicine


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1. NAME OF THE MEDICINAL PRODUCT

Benylin Cough Medicine Syrup

Diphenhydramine hydrochloride 14 mg

Levomenthol 1.1 mg


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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each 5 ml contains:

Diphenhydramine hydrochloride 14 mg

Levomenthol 1.1 mg

Each 5ml also contains:

Glucose Syrup 3.49mg

Sucrose 1.0g

Ethanol 0.26ml

Ponceau 4R (E124) 0.25mg

Sodium 16.42mg

For a full list of excipients, see section 6.1


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3. PHARMACEUTICAL FORM

Syrup.

Clear red syrup with a taste characteristic of menthol.


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4. CLINICAL PARTICULARS

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4.1 Therapeutic indications

(a) Properties

Fixed combination of anti-histamine with anti-tussive activity and carminative.

(b) Indications for use

In the symptomatic relief of non-productive cough and of allergic conditions and reactions.


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4.2 Posology and method of administration

For oral use.

Adults and children over 12 years:

One or two 5 ml spoonfuls three to four times daily.

Not recommended for children under 12 years. [see section 4.3]


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4.3 Contraindications

Benylin Cough Medicine is contra-indicated in individuals hypersensitive to the active ingredients.

Benylin cough Medicine should not be used in children under the age of 12 years.


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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 Section 5.2).

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.

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.


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4.5 Interaction 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..

Antimuscaranic 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.


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.


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4.7 Effects on ability to drive and use machines

This product may cause drowsiness and patients receiving it should not drive or operate machinery unless it has been shown that their physical and mental capacity remains unaffected.


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4.8 Undesirable effects

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 (≥1/10); Common (≥1/100 and < 1/10); Uncommon (≥1/1,000 and <1/100); Rare (≥1/10,000, <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.

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.


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4.9 Overdose

Symptoms and signs

Diphenhydramine

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.


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5. PHARMACOLOGICAL PROPERTIES

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5.1 Pharmacodynamic properties

Diphenhydramine HCl

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

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.


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5.2 Pharmacokinetic properties

Diphenhydramine HCl

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.

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.

Metabolism

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.

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.


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5.3 Preclinical safety data

Mutagenicity

The results of a range of tests suggest that neither diphenhydramine or menthol have mutagenic potential.

Carcinogenicity

There is insufficient information to determine the carcinogenic potential of diphenhydramine or menthol, although such effects have not been associated with these drugs in animal studies.

Teratogenicity

The results of a number of studies suggest that the administration of either diphenhydramine or menthol does not produce any statistically significant teratogenic effects in rats, rabbits and mice.

Fertility

There is insufficient information to determine whether diphenhydramine has the potential to impair fertility, although a diminished fertility rate has been observed in mice in one study.


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6. PHARMACEUTICAL PARTICULARS

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6.1 List of excipient(s)

Sodium citrate

Ethanol 96%

Citric acid monohydrate

Saccharin sodium

Glycerol

Sucrose

Glucose syrup

Sodium benzoate (E211)

Caramel (E150)

Concentrated Raspberry Essence

Ponceau 4R (E 124)

Purified Water


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6.2 Incompatibilities

Not applicable


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6.3 Shelf life

3 years


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6.4 Special precautions for storage

Do not store above 30°C. Keep the medicine tightly closed in the original container.


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6.5 Nature and contents of container

30 ml, 125 ml, 300 ml round amber glass bottle with aluminium roll on pilfer proof (ROPP) cap or a 3 piece plastic child resistant, tamper evident closure fitted with a polyester faced wad or polyethylene/expanded polyethylene laminated wad.

Not all pack sizes may be marketed.


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6.6 Special precautions for disposal and other handling

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


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7. MARKETING AUTHORISATION HOLDER

McNeil Healthcare (Ireland) Limited

Airton Road

Tallaght

Dublin 24

Ireland


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8. MARKETING AUTHORISATION NUMBER(S)

PA 823/17/1


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9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

1st April 1979 / 1st April 2009


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10. DATE OF REVISION OF THE TEXT

June 2015



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Active Ingredients

 
   Diphenhydramine Hydrochloride
   Levomenthol