Simple Linctus Sugar Free

Oral Solution

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. 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.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 **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)** | **Frequency** | **Adverse event** | | **Immune System Disorders** | Not known | Hypersensitivity | **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.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.

5.1 Pharmacodynamic properties Pharmacotherapeutic Group: Cough and Cold Preparations ATC Code: R055.2 Pharmacokinetic properties None stated5.3 Preclinical safety data None.

6.1 List of excipients Aniseed Flavour (contains propylene glycol) PHL-090803 Glycerol (E422) Liquid Maltitol (E965) (contains Sorbitol) Sodium Benzoate (E211) Purified water6.2 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°C6.5 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 and other handling Any unused product or waste material should be disposed of in accordance with local requirements.