Simple Linctus
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Simple Linctus Paediatric Sugar Free
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Citric Acid Monohydrate 31.25mg/5ml dose.
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 non productive (dry) coughs
4.2 Posology and method of administration
Oral.
Children’s Dosage 1 to 5 years: Give one 5ml spoonful.
6 to 12 years: Give two 5ml spoonfuls.
Repeat up to four times a day if necessary.
4.3 Contraindications
Hypersensitivity to any of the ingredients.
4.4 Special warnings and precautions for use
Keep out of the reach and sight of children
Consult a doctor if symptoms persist for more than 5 days
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
There are no or limited amount of data from the use of citric acid monohydrate in pregnant women.
Animal studies are insufficient with respect to reproductive toxicity (see section 5.3).
There is insufficient information on the excretion of citric acid monohydrate metabolities in human milk.
4.7 Effects on ability to drive and use machines
Simple Linctus Paediatric 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 ingredients. However, in the event treatment should be symptomatic.
5.1 Pharmacodynamic properties
Pharmacotherapeutic Group: Acid Preparations ATC Code: A09 AB
5.2 Pharmacokinetic properties
Citric acid is absorbed after oral administration. It is found naturally in the body and is widely distributed. It is metabolised to carbon dioxide and water in Kreb’s citric acid cycle. Citric acid is normally excreted in the urine in amounts ranging from 0.4 to 1.5g daily and this amount is not increased unless very large doses are administered.
5.3 Preclinical safety data
No data of relevance, which is additional to that included on other sections of the SPC.
6.1 List of excipients
Aniseed Flavour (contains propylene glycol) Glycerol (E422)
Liquid Maltitol Sodium Benzoate (E211)
Purified water
6.2 Incompatibilities
None.
6.3 Shelf life
36 months unopened, 3 months after first opening.
6.4 Special precautions for storage
Do not store above 25°C
The following additional phrases appear on the 2 litre pack: Do not store part full bottles.
Pre-pack in tightly closed dispensing containers once opened.
6.5 Nature and contents of container
200ml: Amber glass bottle with a 28mm Child-resistant cap with Tamper Evident band and
EPE/Saranex liner.
6.6 Special precautions for disposal
Any unused product or waste material should be dispersed of in accordance with local requirements.
7 MARKETING AUTHORISATION HOLDER
Thornton & Ross Ltd. Linthwaite Laboratories Huddersfield HD7 5QH.
8 MARKETING AUTHORISATION NUMBER(S)
PL: 00240/0362
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
26/08/2010
10 DATE OF REVISION OF THE TEXT
15/01/2015