Simple Linctus
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Simple Linctus BP
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Citric Acid Monohydrate 125mg/5ml equivalent to 114.29mg/5ml Anhydrous Citric Acid.
3 PHARMACEUTICAL FORM
Oral Solution
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For the management of a mild non-specific cough
4.2 Posology and method of administration
Adults: One or two 5ml teaspoonfuls three or four times daily
4.3 Contraindications
Should not be used in patients with glucose malabsorption syndrome or glucose intolerance.
Should not be used in patients with glucose-galactose intolerance syndrome.
Should not be used in patients with sucrase-isomaltase deficiency
4.4 Special warnings and precautions for use
Contains 3.95g of sucrose per 5ml dose. Care should be taken with patients who suffer from diabetes mellitus. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
This medicinal product contains 6.3 vol % ethanol (alcohol, 96%), i.e. up to 505mg per 10ml dose, equivalent to 12ml beer, 5ml wine per dose. Harmful for those suffering from alcoholism. To be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease or epilepsy.
4.5 Interaction with other medicinal products and other forms of interaction
Citric acid may interact with Potassium Tartrate, Carbonates and Bicarbonates which therefore should not be administered at the same time.
4.6 Pregnancy and lactation
Not applicable
4.7 Effects on ability to drive and use machines
Not applicable
4.8 Undesirable effects
Not Applicable
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
It is possible that Citric Acid ingested in large quantities or frequently may cause gastric irritation, or erosion of dental enamel.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Not applicable
5.2 Pharmacokinetic properties
Citric Acid Monohydrate is absorbed from the gastrointestinal tract. Sucrose is hydrolysed in the small intestine by the enzyme sucrase and converted to dextrose and levulose, which are then absorbed.
5.3 Preclinical safety data
Not applicable
PHARMACEUTICAL PARTICULARS
6
6.1 List of excipients
Colour 1508 Red (Anstead) (E123) Glycerol (E422)
Chloroform Ethanol (96%)
Sugar (Mineral Water Grade)
Star Anise Oil
6.2 Incompatibilities
Not applicable
6.3 Shelf life
36 months
6.4 Special precautions for storage
Do not store above 25°C
6.5 Nature and contents of container
100ml, 200ml and 500ml III Amber glass bottles with pilfer proof cap.
500ml, 1L and 2L High Density Polyethylene with tamper evident cap.
6.6 Special precautions for disposal
No special instruction
7 MARKETING AUTHORISATION HOLDER
Pinewood Laboratories Limited Trading as: Pinewood Healthcare
Ballymacarbry
Clonmel
Co Tipperary
8 MARKETING AUTHORISATION NUMBER(S)
PL 04917/0011
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
24th May 2005
10 DATE OF REVISION OF THE TEXT
27/05/2015