It is recommended that you also refer to http://www.medicines.ie as the Summary of Product Characteristics may have been updated since this copy was printed.

Reckitt Benckiser Ireland Limited

Reckitt Benckiser Ireland Limited

Summary of Product Characteristics last updated on medicines.ie: 21/6/2017

Lemsip Dry Cough 0.25ml/5ml Oral Solution

1. NAME OF THE MEDICINAL PRODUCT

Lemsip Dry Cough 0.25ml/5ml Oral Solution

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each 5ml oral solution contains 0.25ml Glycerol.

Excipients: Contains 3.31g of sucrose, 0.05ml of ethanol and 6.5mg of parabens per 5ml oral solution

For a full list of excipients see section 6.1.

3. PHARMACEUTICAL FORM

Oral solution.

Clear yellow solution, with characteristic lemon odour.

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

For the symptomatic relief of dry tickly coughs and sore throats.

4.2 Posology and method of administration

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.

Adults and children over 12: Two 5ml spoonfuls, three or four times daily.

Children 1-12 years: One 5ml spoonful, three or four times daily.

Children aged less than 1 year: Not suitable (see section 4.3)

No special dose is required for elderly patients.

Method of Administration:

Oral

4.3 Contraindications

Hypersensitivity to the active substances or any of the excipients listed in section 6.1

Do not give to children under 1 year.

4.4 Special warnings and precautions for use

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

Contains 3.31g of sucrose per 5ml dose. This should be taken into account in patients with diabetes mellitus.

Contains parabens. May cause allergic reactions (possibly delayed).

This medicinal product contains a small amount of ethanol (alcohol) less than 100mg per dose.

Citrates should not be taken together with aluminium hydroxide or aluminium-containing antacids in patients with end-stage renal disease unless consulted with healthcare professional (see section 4.5)

4.5 Interaction with other medicinal products and other forms of interaction

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.

4.6 Use in pregnancy and lactation

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 many other medicines, this product should be avoided in the first three months of pregnancy.

Breast-feeding

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 outweighs any risks. A risk to newborns/infants 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.

4.7 Effects on ability to drive and use machines

This product has no or negligible influence on the ability to drive and use machines.

4.8 Undesirable effects

Adverse events which have been associated with glycerol, honey, citric acid, monohydrate, terpeneless lemon oil and syrup are given below, tabulated by system organ class and frequency.

Frequencies are defined as: Very common (≥1/10); Common (≥1/100 and <1/10); Uncommon (≥1/1000 and <1/100); Rare (≥1/10,000 and <1/1000); Very rare (<1/10,000); Not known (cannot be estimated from the available data). Within each frequency grouping, adverse events are presented in order of decreasing seriousness.

System Organ Class

Frequency

Adverse Events

Immune System Disorders

Not known

Hypersensitivity

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. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail:medsafety@hpra.ie

4.9 Overdose

Symptoms

Overdosage is unlikely but if it does occur 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 associated with the formation of dental caries.

Management

Consult a healthcare professional. Treatment consists of general supportive therapy and may include gastric lavage.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Respiratory System; Cough and Cold Preparations; Other Cold Preparations

ATC Code: R05X

Glycerol, honey and syrup acts as a demulcent and provides a soothing medium for an irritated throat.

Citric acid monohydrate and the lemon oil, terpeneless add to the sharpness of the product and enhance the flavour.

5.2 Pharmacokinetic properties

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.

5.3 Preclinical safety data

There are no preclinical safety data of relevance to the consumer.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Honey

Syrup

Citric acid monohydrate

Terpeneless lemon oil

Ethanol (96%)

Sodium parabens mixture

Water, purified.

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

Three years.

6.4 Special precautions for storage

Do not store above 25°C.

6.5 Nature and contents of container

Amber glass bottles with a polypropylene cap with a polyethylene tamper-evident band with expanded polyethylene wad. Pack sizes: 100 ml, 150ml and 200 ml.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

No special requirements.

7. MARKETING AUTHORISATION HOLDER

Reckitt Benckiser Ireland Limited

7 Riverwalk

Citywest Business Campus

Dublin 24

Ireland

8. MARKETING AUTHORISATION NUMBER(S)

PA 979/25/1

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of First Authorisation: 7th April, 2006

Date of last renewal: 7th April 2011

10. DATE OF REVISION OF THE TEXT

12 June 2017

It is recommended that you also refer to http://www.medicines.ie as the Summary of Product Characteristics may have been updated since this copy was printed.