Summary of Product Characteristics (SmPC) - Simple linctus
1 NAME OF THE MEDICINAL PRODUCT
Simple Linctus
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Citric Acid Monohydrate BP 125mg per 5ml.
Excipients with known effects
Sucrose 4g per 5ml.
For the full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Linctus
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 Contra-Indications
None Known.
4.4 Special Warnings and Special Precautions For Use
Keep out of the reach of children.
Not suitable for children under 12 years.
This product contains 4g of sucrose per dose. To be taken into account in people with diabetes mellitus. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
This medicine contains less than 1mmol sodium (23 mg) per 5ml dose, that is to say essentially ‘sodium-free’. This medicine contains 2.5mg sodium benzoate per 5ml dose.
4.5 Interactions 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
None known.
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 ingredients, however, in the event, treatment should be symptomatic.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic Properties
None stated.
5.2 Pharmacokinetic Properties
None stated.
5.3 Preclinical Safety Data
None.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Anise flavour (contains propylene glycol)
Sodium benzoate (E211)
Glycerol (E422)
Purified water
Syrup (sucrose)
6.2 Incompatibilities
None.
6.3 Shelf life
36 months unopened. Discard 2 months after first opening.
6.4 Special Precautions for Storage
Store below 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 Instructions for Use, Handling and Disposal
None.
7. MARKETING AUTHORISATION HOLDER
L.C.M. Ltd
Linthwaite Laboratories
Huddersfield
HD7 5QH
8. MARKETING AUTHORISATION NUMBER(S)
PL 12965/0032
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
21.04.1999
10 DATE OF REVISION OF THE TEXT
07/09/2020