Simple Linctus Sugar Free
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Simple Linctus Sugar Free
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Citric acid monohydrate (E330) 125mg per 5ml.
Excipients: Each 5ml contains Liquid Maltitol 4.2g For full list of excipients see section 6.1
3 PHARMACEUTICAL FORM
Oral Solution
4 CLINICAL PARTICULARS
4.1 Therapeutic Indications
For relief of the symptoms of coughs.
4.2 Posology and method of administration
Oral.
Recommended doses
Adults, the elderly and children over 12 years: one 5ml spoonful, repeated up to four times per day.
Children under 12 years: not recommended.
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients.
4.4 Special warnings and precautions for use
This medicinal product is not recommended for the use in children below the age of 12 years due to lack of data on safety and efficacy.
Patients with rare hereditary problems of fructose intolerance should not take this medicine.
4.5 Interaction with other medicinal products and other forms of interaction
None known.
4.6 Pregnancy and lactation
No adverse effects are known for the product, however as with all medicines use should be avoided during pregnancy unless recommended by a doctor.
4.7 Effects on ability to drive and use machines
Simple Linctus Sugar Free has no influence on the ability to drive and use machines.
4.8 Undesirable effects
There are no known side effects from using this medicine when used as directed, however, if you notice any side effects, stop use and consult a doctor or pharmacist.
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 due to the low concentrations of the active substance, however in the event of an overdose, treatment should be symptomatic.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic Group: Cough and Cold Preparations ATC Code: R05
5.2 Pharmacokinetic properties
None stated
Preclinical safety data
5.3
None.
6.1 List of excipients
Aniseed Flavour (contains propylene glycol) PHL-090803 Glycerol (E422)
Liquid Maltitol Sodium Benzoate (E211)
Purified water
6.2 Incompatibilities
Not Applicable.
6.3. Shelf life
36 months unopened. Discard 2 months after first opening.
6.4 Special precautions for storage
Do not store above 25°C
6.5 Nature and contents of container
200ml: Amber glass bottle with plastic cap and liner or white 28mm cap with tamper
evident band and EPE Saranex liner
6.6 Special precautions for disposal
Any unused product or waste material should be disposed of in accordance with local requirements.
L.C.M. Ltd
Linthwaite Laboratories
Huddersfield
HD75QH
8 MARKETING AUTHORISATION NUMBER(S)
PL 12965/0050
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
02/07/2010
10 DATE OF REVISION OF THE TEXT
16/03/2015