Skip to Content

The originating document has been archived. We cannot confirm the completeness, accuracy and currency of the content.

GLYCERINE LEMON AND HONEY LINCTUS

PDF options:  View Fullscreen   Download PDF

PDF Transcript

SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Glycerin Lemon and Honey Expectorant

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5ml contains:
Squill Elixir BP 0.5ml
Ipecacuanha Liquid Extract BP 0.02ml
Citric Acid Mononydrate BP 0.025mg
Tolu Syrup BP 0.5ml

3

PHARMACEUTICAL FORM
Expectorant

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
For soothing sore throats or tickly coughs.

4.2

Posology and method of administration
Dose (Taken Orally): To be sipped and swallowed slowly 3 or 4 times a day
Not recommended for children under 6 years old.
For children 6 to 12 years old:
One 5ml spoonful three or four times a day (sipped and swallowed slowly)
For Adults:
Two 5ml spoonful three or four times a day (sipped and swallowed slowly)

4.3

Contraindications
Impaired renal function, impaired hepatic function, cardiac disorders,
moderate to severe respiratory insufficiency, alcoholism and raised intracranial
pressure.
Hypersensitivity to any of the actives/excipients.
During pregnancy
Not recommended for children under 3 years.

4.4

Special warnings and precautions for use
The product contains ipecac and squill both of which are cardioactive and
hence should not be used in patients receiving anti-arrhythmic therapy. This
product cotains sugar.Dental hygiene after each dose is recommended and it is
best avoided by diabetic patients. The stated dose should not be exceeded and
if symptoms persist or deteriorate after 5 days of treatment, a doctor should be
consulted.

4.5

Interaction with other medicinal products and other forms of interaction
Theoretical risk of interaction with anti-arrhythmic drugs through this is
unlikely at recommended doses.

4.6

Fertility, pregnancy and lactation
Avoid use during pregnancy.
Squill: There is a documented abortifacient effect. It also modulates the
menstrual cycle.

4.7

Effects on ability to drive and use machines
None.

4.8

Undesirable effects
Gastric irritation, nausea and vomiting. Occasionally moderate to severe
diarrhoea can occur if hypersensitive to squill.

4.9

Overdose
Symptoms of overdose are similar to other undesirable effects stated above but
more exaggerated. When taken in large doses, blood diarrhoea, musocal
erosion and albuminuria can occur. If symptoms and signs due to squill
dominate, the clinical picture resembles dioxin toxicity. Fluid and electrolyte
balance together with ECG should be monitored and other symptomatic and
supportive measures should be provided.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Pharmacotherapeutic group: Cold and Cough expectorant
ATC code: R0SCA04
At the levels which they are present in this product the Squill Elixir and the
Ipecacuanha Liquid Extract act as expectorants due to their irritant effect on the
gastric mucosa.
The Citric Acid is present for its cooling properties. It has been used as a cooling
drink to relieve thirst if fever.
Tolu Syrup has mild antiseptic properties and some expectorant action however it is
normally considered as flavour.

5.2

Pharmacokinetic properties
The alkaloids from the Ipecacuanha and the glyco sides from the quill are
absorbed by the gastric mucosa, metabolised and excreted in the urine and
faeces. Emetine being the slowest of the ingredients to be metabolised.

Citric Acid is absorbed and oxidised in the body to Carbondioxide and water.
The balsamic acids of the Tolu are absorbed, metabolised and excreted in the
urine and faeces.

5.3

Preclinical safety data
None stated.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Compound Tartrazine Solution
Lemon Oil
Glycerol
Purified Honey
Portable Water
Syrup

6.2

Incompatibilities
None.

6.3

Shelf life
3 years.

6.4

Special precautions for storage
None.

6.5

Nature and contents of container
Glass bottles (100ml), (200ml).

6.6

Special precautions for disposal

7

MARKETING AUTHORISATION HOLDER
Activase Pharmaceuticals Limited,
11 Boumpoulinas, 3rd Floor,
P.C. 1060
Nicosia.
Cyprus

8

MARKETING AUTHORISATION NUMBER(S)
PL 28444/0058

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
28/02/2008

10

DATE OF REVISION OF THE TEXT
16/01/2012

+ Expand Transcript

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.

Hide