BENYLIN DRY COUGHS

Adults and Children aged 12 years and over:

Posology 10 ml syrup (15 mg dextromethorphan) 4 times a day. 3). The Elderly (over 65 years) As for adults above. 2). Method of Administration For oral use.

Adverse drug reactions (ADRs) identified during clinical trials and post- marketing experience with dextromethorphan 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, including isolated reports 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’.

System Organ Class (SOC) Frequency Adverse Drug Reaction (Preferred Term) Psychiatric Disorders Not known Not known Not known Not known Agitation Confusional state Drug dependence Insomnia Nervous System Disorders Not known Not known Not known Not known Dizziness Psychomotor hyperactivity Seizure Somnolence Respiratory, thoracic and mediastinal Disorders Not known Respiratory depression Gastrointestinal Disorders Not known Not known Not known Not known Not known Abdominal pain Diarrhoea Gastrointestinal disorder Nausea Vomiting Skin and Subcutaneous Tissue Disorders Not known Not known Not known Not known Angioedema Pruritus Rash Urticaria General disorders and administration site condition Unknown Drug withdrawal syndrome 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

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.

There have been no specific studies of this product in renal or hepatic dysfunction. Due to the extensive hepatic metabolism of dextromethorphan, caution should be exercised in the presence of hepatic impairment. 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. This product should not be taken with any other cough and cold medicines.

Use of dextromethorphan with alcohol or other CNS depressants may increase the effects on the CNS and cause toxicity in relatively smaller doses. While taking this product, patients should be advised to avoid alcoholic drinks and consult a healthcare professional prior to taking with central nervous system depressants.

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.