LEMOCALM DRY COUGH

Adults and children aged 12 years and over:

Posology: Take 10 mg-20 mg every 4-6 hours (1-2 spoonful of 5 ml), up to a maximum of 80 mg/day. Do not exceed the 4 daily intakes. 3). Elderly (over 65 years) As for adults above. 2). Do not exceed the stated dose.

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/Unknown (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) Agitation Nervous System Disorders Not known Not known Not known Not known Seizure Dizziness Psychomotor hyperactivity Somnolence Respiratory, thoracic and mediastinal Disorders Not known Respiratory depression Gastrointestinal Not known Abdominal pain Disorders Not known Not known Not known Not known 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 conditions 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.

Causes of chronic cough should be excluded if symptoms are persistent. Any accompanying symptoms should be actively sought and appropriately investigated/ treated. Stop use and ask your healthcare professional if your cough lasts more than 7 days, comes back or is accompanied by a fever, rash or persistent headache.

These could be signs of serious conditions. There have been no specific studies of Dextromethorphan in renal or hepatic dysfunction. Due to the extensive hepatic metabolism of dextromethorphan, caution should be exercised in the presence of hepatic impairment.

Cases of dextromethorphan abuse and dependence have been reported. Caution is particularly recommended for adolescents and young adults as well as in patients with a history of drug abuse or psychoactive substances. Dextromethorphan is metabolised by hepatic cytochrome P450 2D6.

The activity of this enzyme is genetically determined. About 10% of the general population are poor metabolisers of CYP2D6. Poor metabolisers and patients with concomitant use of CYP2D6 inhibitors may experience exaggerated and/or prolonged effects of dextromethorphan.

5). This product should be used with caution in atopic children due to histamine release. This product should not be taken with any other cough and cold medicine. 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. Drug dependence, tolerance and potential for abuse For all patients, prolonged use of dextromethorphan may lead to drug dependence (addiction), even at therapeutic doses.

1. - Dextromethorphan should not be given to patients in, or at risk of developing respiratory failure (for example during an acute asthma attack or in patients with Chronic Obstructive Pulmonary Disease). 5). 5). 5) or medications for depression, psychiatric, or emotional conditions or Parkinson’s disease.

- 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.