GLYCERIN LEMON AND HONEY WITH GLUCOSE AND IPECACUANHA
Active substance(s): GLYCEROL / IPECACUANHA LIQUID EXTRACT
NAME OF THE MEDICINAL PRODUCT
Glycerin Lemon and Honey with Glucose and Ipecacuanha
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
For a full list of excipients see section 6.1
A soothing preparation for relief of the symptoms of coughs and sore throats.
Posology and method of administration
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.
Patients in shock, at risk of seizure, or with cardiovascular disorders.
Hypersensitivity to any of the ingredients.
Children under 12 years of age.
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
Interactions with other medicinal products and other forms of interaction
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.
Effects on ability to drive and use machines
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:
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.
Glycerol acts as a demulcent to soothe the passage of the upper respiratory
Ipecacuanha has a reflex expectorant action as a result of its irritant action on
the respiratory tract.
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
Pre-clinical safety data
List of excipients
Lemon soluble essence
Citric acid monohydrate
200ml: 24 months unopened
Special precautions for storage
Store below 25°C.
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.
Instructions for Use, Handling and Disposal
MARKETING AUTHORISATION HOLDER
MARKETING AUTHORISATION NUMBER(S)
DATE OF FIRST AUTHORISATION/RENEWAL OF THE
DATE OF REVISION OF THE TEXT
Source: Medicines and Healthcare Products Regulatory Agency
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