Summary of Product Characteristics (SmPC) - Simple linctus paediatric
1 NAME OF THE MEDICINAL PRODUCT
Simple Linctus Paediatric
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Citric Acid Monohydrate 31.25mg/5ml dose.
Excipient(s) with known effect:
Sucrose (Syrup) 4.4g/5ml dose
Sodium Benzoate(E211) 2.5mg/5ml dose
For the 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
Dose
Children:
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
Known hypersensitivity to any of the ingredients
4.4 Special warnings and precautions for use
Keep out of the sight and reach of children.
Consult a doctor if symptoms persist for more than 5 days
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Excipient warnings:
This medicine contains 4.4g of sucrose per 5ml. This should be taken into account in patients with diabetes mellitus.
This medicine contains 2.5mg sodium benzoate per 5ml dose.
This medicine contains less than 1mmol sodium (23mg) per 5ml dose, that is to say essentially ‘sodium-free’.
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 metabolites in human milk.
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
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 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Anise flavour (contains propylene glycol (E1520))
Sodium benzoate (E211)
Glycerol (E422)
Purified Water
Sucrose (Syrup)
6.2 Incompatibilities
None
6.3 Shelf life
36 months unopened, 3 months after first opening
6.4 Special precautions for storage
Store below 25ºC
6.5 Nature and content of container
200ml: Amber glass bottle with a white 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 disposed of in accordance with local requirements.
7 MARKETING AUTHORISATION HOLDER
Thornton & Ross Ltd.
Linthwaite Laboratories
Huddersfield
HD7 5QH
8 MARKETING AUTHORISATION NUMBER(S)
PL 00240/6427R
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
16/06/1988 / 09/09/1993
10 DATE OF REVISION OF THE TEXT
21/10/2020