Morrisons Glycerin Lemon & Honey Linctus
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, glucose-galactose 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.
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 BP.
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
Ethanol (96%)
Nipasept Sodium (a mixture of the sodium salts of methyl-, ethyl- and propyl-4-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 25°C.
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.
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