Lemsip Dry Cough 0.25ml/5ml Oral Solution

Section 4.2 updated to include the below text:
Posology: the lowest effective dose should be used for the shortest duration necessary to relieve symptoms and a healthcare professional should be consulted if symptoms persist or worsen.
Children under 12 years changed to Childrens 1-12 years
Children ages less than 1 year: not suitable
Method of Administration: Oral

Section 4.3 amended from "none known" to
Hypersensitivity to the active substances or any of the excipients listed in Section 6.1.  Do not give to children under 1 year.

Section 4.4 updated to include:
Citrates should not be taken together with aluminium hydroxide or aluminium-containing antacids in patients with end-stage renal disease unless consulted with healthcare profession (see section 4.5).

Section 4.5 amended from "none known" to
The product may contain sufficient amounts of sugar to affect the control of diabetes. 
Intestinal absorption of aluminium ions may be enhanced by oral doses of citrates, increasing the toxicity of aluminium.

Section 4.6 updated to include:
Pregnancy: there are no or a limited amount of data from the use of glycerol, honey, citric acid monohydrate, terpeneless lemon oil and syrup in pregnant women.  As a precautionary measure, it is preferable to avoid the use of the product during pregnancy unless clearly necessary.  Consult a healthcare professional before use.  As with may other medicines this product should be avoided in the first three months of pregnancy.
Breastfeeding: No significant problems have been reported in breast-fed infants from mothers taking this product.  It is preferable to avoid the use of the product during lactation to avoid the use of the product during lactation unless the benefits outweight any risks.  A risk to the newborns/infnats cannot be excluded.  Consult a healthcare professional before use.
Fertility: There is no information on the effects of glycerol, honey, citric acid, monohydrate, terpeneless lemon oil and syrup on fertility.

Section 4.7 amended from "none known" to
This product has no negligible influence on the ability to drive and use machines

Section 4.8 amended from "none known" to
System Organ Class;  Immune System Disorders
Frequency; Not known
Adverse Events: Hypersensitivity

Reporting of suspected adverse reactions text added.

Section 4.9 amended to include
Symptoms: Serious side effects are not expected.  When taken orally, glycerol may cause headache, nausea and vomiting.  Diarrhoea, thirst, dizziness and mental confusion may occur less frequently.  Cardiac arrhythmias have been reported.  Citric acid ingested frequently or in large quantities may cause erosion of the teeth and have a local irritant action.  Overconsumption of sucrose is assocated with the formation of dental caries.
Management: Consult a healthcare professional.

Section 5.1 updated to include
Pharmacotherapeutic group: Respiratory System; Cough and Cold Preparations; Other cold preparations
ATC Code:  R05X
Citric acid monohydrate and the lemon oil. terpenless add to the sharpness of the product and enhance the flavour.

Section 5.2 amended from "not applicable" to:
Glycerol is readily absorbed from the gastrointestinal tract and undergoes extensive metabolism mainly in the liver; it may be used in the synthesis of lipids, metabolised to glucose or glycogen, or oxidised to carbon dioxide and water.  It is also excreted in the urine unchanged.
Sucrose is hydrolysed in the small intestine by the enzyme sucrose to glucose and fructose, which are then absorbed.
No relevant pharmacokinetic data are available for citric acid monohydrate, honey or terpeneless lemon oil.

Section 5.3 amended to read
There are no preclinical safety data or relevance to the consumer.

N/A