SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Glycerin Lemon and Honey with Glucose and Ipecacuanha

2.    QUALITATIVE AND QUANTITATIVE COMPOSITION

Each 5ml of solution contains:-Glycerol 1.36g

Ipecacuanha Liquid Extract 0.01ml

Excipients: Each 5ml contains 2.436g of Syrup (sucrose) and 280.0mg of Liquid Glucose

For a full list of excipients see section 6.1

3.    PHARMACEUTICAL FORM Oral Solution

4.    CLINICAL PARTICULARS

4.1.    Therapeutic indications

A soothing preparation for relief of the symptoms of coughs and sore throats.

4.2 Posology and method of administration

Oral.

Recommended doses

Adults and children over 12 years: two 5ml spoonfuls.

May be repeated every four hours if required. Not more than 4 doses should be given in any 24 hours.

The product may be taken for up to 5 days, following which, if symptoms persist, medical advice should be sought.

Contraindications

Patients in shock, at risk of seizure, or with cardiovascular disorders. Hypersensitivity to any of the ingredients.

Children under 12 years of age.

4.4 Special warnings and precautions for use

Keep all medicines out of the reach and sight of children.

Not suitable for use in diabetics.

Do not give to children under 12 years

Do not exceed the stated dose

Do not take with any other cough and cold medicine

4.5. Interactions with other medicinal products and other forms of interaction

None known.

4.6. Pregnancy and lactation

No adverse effects are considered likely if this product is used in the above conditions, however, as with all medicines, its use should be avoided unless recommended by a doctor.

4.7. Effects on ability to drive and use machines

None known.

4.8.    Undesirable effects

None anticipated at the recommended dosage.

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 the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

4.9.    Overdose

Overdose with this preparation is unlikely to occur, however, large doses of glycerin may cause thirst, headache, nausea, vomiting, diarrhoea, hyperglycaemia, dehydration, dizziness and mental confusion. Cardiac arrhythmias have been reported. Treatment should be symptomatic.

Large doses of ipecacuanha may irritate the gastrointestinal tract, and give rise to nausea, persistent bloody vomiting or bloody diarrhoea.

Mucosal erosions of the entire gastrointestinal tract have been reported. Overdosage is unlikely as a result of the emetic action of ipecacuanha, however, if emetine is absorbed in sufficient amounts it may have adverse effects on the heart, such as conduction abnormalities or myocardial infarction. These symptoms may also be combined with dehydration due to vomiting, and may cause vasomotor collapse followed by death.

Acute overdosage of ipecacuanha should be treated with activated charcoal to delay absorption. Prolonged vomiting should be controlled by intramuscular injection of anti-emetics. Supportive measures should be taken to correct fluid and electrolyte imbalance and cardiac effects.

5. PHARMACOLOGICAL PROPERTIES

5.1.    Pharmacodynamic properties

Glycerol acts as a demulcent to soothe the passage of the upper respiratory tract.

Ipecacuanha has a reflex expectorant action as a result of its irritant action on the respiratory tract.

5.2.    Pharmacokinetic properties

Glycerol is readily absorbed from the intestine and is metabolised to carbon dioxide and glycogen.

Emetine one of the major alkaloids of ipecacuanha is excreted or metabolised slowly.

5.3.    Pre-clinical safety data

None known.

6.1 List of excipients

Lemon soluble essence Syrup

Purified water Lemon juice Citric acid monohydrate Honey

Liquid glucose

6.2. Incompatibilities

None stated.

6.3.    Shelf life

200ml: 24 months unopened

6.4.    Special precautions for storage

Store below 25°C.

6.5.    Nature and content of container

Amber glass bottle with polypropylene cap or white 28mm Child-resistant cap with Tamper Evident band and EPE/Saranex Liner.

6.6.    Instructions for Use, Handling and Disposal

None.

7. MARKETING AUTHORISATION HOLDER

L.C.M. Ltd

Linthwaite Laboratories

Huddersfield

HD75QH

8.    MARKETING AUTHORISATION NUMBER(S)

PL 12965/0014

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

30/03/1994

10    DATE OF REVISION OF THE TEXT

02/01/2015