BENYLIN DRY COUGHS NIGHT

Posology Adults and children aged 12 years and over:

Patients may start with two 5 ml spoonfuls at bedtime followed by two 5 ml spoonfuls every 6 hours. Or two 5 ml spoonfuls four times a day. Do not take more than 4 doses (1 dose = two 5 ml spoonfuls) in 24 hours. 3).

The Elderly:

Normal adult dosage is appropriate, [See Pharmacokinetics in the Elderly]. 2). 2). Method of administration For oral use

Adverse drug reactions (ADRs) identified during clinical trials and post- marketing experience with Dextromethorphan/Diphenhydramine/Menthol are included in the table below by System Organ Class (SOC).

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) ADRs are presented by frequency category based on 1) incidence in adequately designed clinical trials or epidemiology studies, if available, or 2) when incidence cannot be estimated, frequency category is listed as ‘Not known’.

4) Hallucination Nervous System Disorders Very Common Common Common Common Common Rare Rare Rare Not known Somnolence Dizziness Headache Paradoxical stimulation Psychomotor impairment Extrapyramidal disorder Seizure Tremor Paraesthesia Eye Disorders Common Blurred vision Ear and Labyrinth Disorders Uncommon Tinnitus Cardiac Disorders Rare Rare Not known Arrhythmia Palpitations Tachycardia Vascular Disorders Rare Hypotension Respiratory, Thoracic and Mediastinal Disorders Common Not known Not known Not known Increased viscosity of bronchial secretion Chest discomfort Nasal dryness Respiratory depression Gastrointestinal Disorders Common Common Not known Not known Not known Not known Dry Mouth Gastrointestinal disorder Abdominal pain Diarrhoea Nausea Vomiting Hepatobiliary Disorders Rare Liver Disorder Skin and Subcutaneous Tissue Disorders Uncommon Not known Not known Not known Rash Angioedema Pruritus Urticaria Renal and Urinary Disorders Common Not known Urinary retention Dysuria General Disorders and Administration Site Conditions Common Not known Asthenia Drug withdrawal syndrome Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

This product may cause drowsiness. This product should not be used to sedate a child. Patients with the following conditions should not use this product, unless directed by a physician: acute or chronic asthma, a persistent or chronic cough such as occurs with chronic bronchitis or emphysema, or where cough is accompanied by excessive secretions.

Diphenhydramine should be used with caution by individuals with susceptibility to angle-closure or with prostatic hypertrophy, urinary retention. 2). Drug dependence, tolerance and potential for abuse For all patients, prolonged use of this product may lead to drug dependence (addiction), even at therapeutic doses.

, major depression). Drug withdrawal syndrome The drug withdrawal syndrome is characterised by some or all of the following: restlessness, lacrimation, rhinorrhoea, yawning, perspiration, chills, myalgia, mydriasis and palpitations.

Other symptoms may also develop including irritability, agitation, anxiety, hyperkinesia, tremor, weakness, insomnia, anorexia, abdominal cramps, nausea, vomiting, diarrhoea, increased blood pressure, increased respiratory rate or heart rate.

Serotonin Syndrome Serotonergic effects, including the development of a potentially life- threatening serotonin syndrome, have been reported for dextromethorphan with concomitant administration of serotonergic agents, such as selective serotonin re-uptake inhibitors (SSRIs), drugs which impair metabolism of serotonin (including monoamine oxidase inhibitors (MAOIs)) and CYP2D6 inhibitors.

Serotonin syndrome may include mental-status changes, autonomic instability, neuromuscular abnormalities, and/or gastrointestinal symptoms. If serotonin syndrome is suspected, treatment with this medicine should be discontinued. Use of dextromethorphan with alcohol or other CNS depressants may increase the effects on the CNS and cause toxicity in relatively smaller doses.

1. 5). 5). 5). Dextromethorphan should not be given to patients in, or at risk of developing respiratory failure. Not to be used in children under the age of 12 years.