Morrisons Cough Linctus Oral Solution
1. NAME OF THE MEDICINAL PRODUCT
Menthodex Cough Mixture Bell’s Healthcare Cough Linctus Oral Solution Gordons Cough & Cold Linctus Morrisons Cough Linctus Oral Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Name of the active substance(s); each 5ml contains
Ammonium Chloride 100.0 mg
Sodium Citrate 50.0 mg
Levomenthol 7.75 mg
Squill Tincture 0.001 ml
Excipient(s) with known effect: methyl hydroxybenzoate E218 Each 10 ml dose contains 3.2 g sucrose and less than 100mg ethanol
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral Solution
4. CLINICAL PARTICULARS
4.1. Therapeutic indications
For the symptomatic relief of colds, sore throats, irritating and chesty coughs.
4.2. Posology and method of administration
Oral administration
Adults: two 5 ml spoonfuls
Children (7-14 years): One 5 ml spoonfuls
Dose may be repeated three times a day and at bedtimes
4.3.
Contra-indications
Care should be taken when given to patients with impaired renal function or hypersensitivity to any of the active ingredients.
4.4 Special warnings and precautions for use
Shake bottle.
If symptoms persist consult your doctor.
This medicinal product contains small amounts of ethanol (alcohol), less than 100mg per 10ml dose.
Contains sucrose and glucose. This should be taken into account inpatients with diabetes mellitus. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Contains 10.0 mg methyl hydroxybenzoate E218 per 10 ml dose; may cause allergic reactions (possibly delayed).
4.5 Interaction with other medicinal products and other forms of interaction
No interactions studies have been performed.
Contains alcohol and should be avoided in patients taking other medicines known to interact with alcohol (e.g. metronidazole)
4.6. Pregnancy and lactation
No evidence that this medicine adversely affects pregnancy, however, as with all medicines it is recommended that Menthodex is not taken during pregnancy.
4.7 Effects on ability to drive and use machines
No studies on the effects on the ability to drive or operate machines have been performed. Contains alcohol. See Section 2.
4.8 Undesirable effects
Nausea and vomiting have been reported on taking large doses of some ingredients. 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
5
5.1
5.2.
5.3.
6
6.1
Overdose
It is possible that excessive overdosing may produce nausea and vomiting.
If this occurs, no further action should be necessary except to withdraw medication.
PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties
Pharmacotherapeutic group: other cold preparations ATC code: R05X Ammonium Chloride acts as an expectorant.
Sodium citrate possesses demulcent properties and helps to relieve irritable coughs.
Squill possess some expectorant properties.
Levomenthol acts as flavouring and helps to relieve symptoms of catarrh.
Pharmacokinetic properties
Ammonium chloride is absorbed from the gastro-intestinal tract and is finally excreted in the urine.
Sodium citrate is absorbed in the gastro-intestinal tract and is finally excreted in the urine.
Preclinical safety data
There is no preclinical data available specific to the product.
PHARMACEUTICAL PARTICULARS
List of excipients
Eucalyptus Oil Star Anise Oil Ethanol Sucrose Glucose Caramel E150c
Methyl Hydroxybenzoate E218 Liquid Extract of Horehound Tolu Tincture Water, purified
6.2. Incompatibilities
None known
6.3. Shelf life
36 months in unopened bottle.
6.4. Special precautions for storage
Do not store above 25°C
6.5. Nature and contents of container
White or amber glass bottles with ROPP closure and steran wads. 60 ml, 100 ml, 150 ml, 200 ml.
6.6. Instructions for use/handling
Shake before use.
7. MARKETING AUTHORISATION HOLDER
Bell, Sons and Co.
Gifford House
Slaidbum Crescent Southport Merseyside PR9 9AL
8. MARKETING AUTHORISATION NUMBER(S)
PL 03105/0045
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of grant 19 September 1986 Date of renewal 19 November 1993
10 DATE OF REVISION OF THE TEXT
06/04/2016