Summary of Product Characteristics Updated 16-Nov-2020 | Thornton & Ross Ltd
Simple Linctus Sugar Free
Citric acid monohydrate (E330) 125mg per 5ml.
Excipients with known effects
Excipients: Each 5ml contains:
Liquid Maltitol (E965) 4.2g (contains Sorbitol 840mg)
Sodium benzoate (E211) 2.5mg
For the full list of excipients see section 6.1
For relief of the symptoms of coughs.
Adults, the elderly and children over 12 years: one 5ml spoonful, repeated up to four times per day.
Children under 12 years: not recommended.
Hypersensitivity to the active substance or to any of the excipients.
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.
This medicine contains 840mg sorbitol in each 5ml dose. Patients with hereditary fructose intolerance (HFI) should not take/be given this medicinal product.
This medicine also contains 4.2g of maltitol liquid (E965) per 5ml dose. Patients with rare hereditary problems of fructose intolerance should not take this medicine.
This medicine contains less than 1mmol sodium (23mg) per 5ml dose, that is to say essentially 'sodium-free'. This medicine contains 2.5mg sodium benzoate per 5ml dose.
No adverse effects are known for the product, however as with all medicines use should be avoided during pregnancy unless recommended by a doctor.
Simple Linctus Sugar Free has no influence on the ability to drive and use machines.
Tabulated list of adverse reaction(s)
Adverse reactions frequency are defined using the following convention:
Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
System organ class (MedDRA)
Immune System Disorders
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 or search for MHRA Yellow Card in the Google Play or Apple App Store.
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.
Pharmacotherapeutic Group: Cough and Cold Preparations
ATC Code: R05
Aniseed Flavour (contains propylene glycol) PHL-090803
Liquid Maltitol (E965) (contains Sorbitol)
Sodium Benzoate (E211)
36 months unopened. Discard 2 months after first opening.
Do not store above 25°C
Amber glass bottle with plastic cap and liner or white 28mm cap with tamper evident band and EPE Saranex liner
Any unused product or waste material should be disposed of in accordance with local requirements.
Linthwaite, Huddersfield, West Yorks, HD7 5QH
+44 (0) 1484 848164