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GLYCERIN LEMON AND HONEY WITH GLUCOSE AND IPECACUANHA

Active substance(s): GLYCEROL / IPECACUANHA LIQUID EXTRACT / GLYCEROL / IPECACUANHA LIQUID EXTRACT / GLYCEROL / IPECACUANHA LIQUID EXTRACT

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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.

4.3

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

PHARMACEUTICAL PARTICULARS

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
HD7 5QH

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

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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