ROBITUSSIN DRY COUGH MEDICINE

Oral administration.

Adults, the elderly and children over 12 years:

One 10ml measure up to four times daily.

Children under 12 years:

Do not use Medical advice should be sought before use in patients with severe renal impairment. See Warnings and Precautions.

The following convention has been utilised for the classification of the frequency of adverse reactions: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1,000, <1/100), rare (≥1/10,000, <1/1,000), very rare (<1/10,000), not known (cannot be estimated from available data).

Whenever possible, adverse reactions observed in clinical trials and those reported from post-marketing experience at therapeutic/labelled doses have been presented separately. These reactions are tabulated by MedDRA System Organ Class (SOC).

The following adverse events have been observed in clinical trials with dextromethorphan.

Gastrointestinal Disorders:

Gastrointestinal upset, nausea, vomiting, abdominal discomfort Nervous System Disorders: Dizziness, drowsiness, mental confusion Adverse reactions identified during post-marketing use are listed below. As these reactions are reported voluntarily from a population of uncertain size, the frequency of these reactions is unknown.

g. rash, urticaria, angioedema) General Disorders and Administration Site Conditions: Frequency 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.

Should not be used with other cough and cold medicines. Patients suffering from chronic cough as occurs with smoking, asthma or patients suffering from an acute asthma attack, chronic bronchitis, and emphysema, or where cough is accompanied by excessive secretions should be advised to consult a Healthcare Professional before use.

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. Medical advice should be sought before taking dextromethorphan in patients with: severe renal impairment. Concomitant use of other cough and cold medicines should be avoided. Concomitant use of alcohol should be avoided.

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). Caution is particularly recommended for adolescents and young adults as well as in patients with a history of drug abuse or psychoactive substances.

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.

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.

Hypersensitivity to any of the ingredients. Taking a prescription selective serotonin reuptake inhibitor (SSRI), or other medications for depression, psychiatric, or emotional conditions, or Parkinson's disease. Do not use if you are taking or have taken in the past two weeks, monoamine oxidase inhibitors (MAOI’s), usually used to treat depression.

If you are not sure if your prescription medication contains one of these medicines, ask a doctor or pharmacist before taking this product. 5). Use in children under 12 years. g. those with chronic obstructive airways disease or pneumonia, or during an asthma attack or an exacerbation of asthma).