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RANSOMS GLYCERIN LEMON & HONEY LINCTUS

Active substance(s): CITRIC ACID MONOHYDRATE / GLYCEROL / HONEY / LEMON OIL-TERPENELESS / SYRUP

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Transcript
SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Ransom’s Glycerin, Lemon & Honey Linctus or Morrisons Glycerin Lemon & Honey
Linctus

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION
Glycerol 5.0% v/v
Honey 10.0% w/v
Citric Acid Monohydrate 0.5% w/v
Lemon Oil Terpeneless 0.01% v/v
Syrup 75.0% v/v
For excipients, see 6.1.

3.

PHARMACEUTICAL FORM
Oral solution

4.

CLINICAL PARTICULARS

4.1

Therapeutic indications
The symptomatic treatment of coughs and sore throats.

4.2

Posology and method of administration
For oral administration
Adults and the elderly
Two 5 ml spoonfuls to be taken 3 or 4 times daily.
Children over 1 year
One 5 ml spoonful to be taken 3 or 4 times daily.

Not recommended for infants under 1 year.

4.3

Contraindications
Hypersensitivity to any of the ingredients.
Patients with rare hereditary problems or fructose intolerance, glucosegalactose malabsorption or sucrase-isomaltase insufficiency should not take
this medicine.
Not recommended for infants under 1 year.

4.4

Special warnings and precautions for use
This product is not suitable for use by diabetics.
If symptoms persist, consult your doctor.

4.5

Interactions with other medicinal products and other forms of interaction
None known.

4.6

Pregnancy and lactation
As with many other medicines, this product should be avoided in the first three
months of pregnancy and during lactation unless the benefits outweigh any
risks. No significant problems have been reported in breast-fed infants from
mothers taking the product.

4.7

Effects on ability to drive and use machines
None.

4.8

Undesirable effects
None anticipated at the recommended dosage.

4.9

Overdose
Overdosage is unlikely but if it does occur then treatment consists of general
supportive therapy and may include gastric lavage.

5.

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
ATC Code: R05X Other Cold Combination Preparations
The glycerol, honey and syrup act as demulcents and provide a soothing
medium for an irritated throat.
The citric acid monohydrate and the lemon oil, terpeneless both add to the
sharpness of the product and enhance the flavour.

5.2

Pharmacokinetic properties
Glycerol B.P.
It is readily absorbed from the intestine and metabolised to carbon dioxide and
glycogen.
Honey, Citric Acid Monohydrate B.P. and Lemon Oil, Terpeneless B.P.
Little is reported in the literature on the pharmacokinetics of these substances.
Syrup B.P.
Syrup B.P. is a 66.7% w/w solution of sucrose in water; Sucrose is hydrolysed
by enzymes in the mouth and in the gastrointestinal tract to glucose and
fructose.

5.3

Preclinical safety data
No relevant data.

6.

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Ethanol (96%)
Nipasept Sodium (a mixture of the sodium salts of methyl-, ethyl- and propyl4-hydroxybenzoate)
Water, potable

6.2

Incompatibilities
No major incompatibilities have been reported.

6.3

Shelf life
36 months.

6.4

Special precautions for storage
Do not store above 25ºC.

6.5

Nature and contents of container
Amber glass bottle with a plastic “J” cap or
Amber glass bottle with a metal roll-on pilfer proof closure (ROPP) with
plastic liner in a carton . Plastic dosage cup supplied.
Pack size: 100 ml and 200 ml.
Not all pack sizes may be marketed.

6.6

Instructions for use/handling
None.

7.

MARKETING AUTHORISATION HOLDER

Wise Pharmaceuticals Limited
Hani Wells Business Park
Unit 7
Hardicker Street
Manchester
M19 2RB
United Kingdom

8.

MARKETING AUTHORISATION NUMBER
PL 18374/0013

9.
DATE OF FIRST AUTHORISATION/RENEWAL OF
AUTHORISATION
9th March 2005

10

DATE OF REVISION OF THE TEXT
09/03/2005

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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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