Numark Paediatric Simple Linctus 31.25 Mg/5 Ml Oral Solution
1
NAME OF THE MEDICINAL PRODUCT
Bells Healthcare Paediatric Simple Linctus BP 31.25mg per 5ml Oral Solution Numark Paediatric Simple Linctus 31.25 mg/5 ml Oral solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Citric Acid Monohydrate 31.25 mg/5 ml.
Excipients: Sucrose 4.4g per 5ml. For full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Oral Solution.
A clear, colourless liquid with the flavour of anise.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
The management of mild non-specific cough.
4.2 Posology and method of administration
CHILD 1 MONTH - 12 YEARS: 5 - 10ml 3 - 4 times daily.
Administration
For oral use.
4.3 Contraindications
Glucose malabsorption syndrome. Glucose intolerance due to sucrose or isomaltase deficiency. Hypersensitivity to any of the constituents.
Care should be taken in patients with Diabetes mellitus.
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 Fertility, pregnancy and lactation
Contact your doctor before taking this medicinal product if you are pregnant or breast-feeding.
4.7 Effects on ability to drive and use machines
None.
4.8 Undesirable effects
It is possible that citric acid ingested in large quantities or frequently may cause gastric irritation, or erosion of dental enamel.
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.yellowcard.mhra.gov.uk.
Overdose
4.9
There is no evidence that overdose is harmful.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Citric acid is fever reducing.
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
No relevant information additional to that already contained elsewhere in the SPC.
6 PHARMACEUTICAL PARTICULARS 6.1 List of excipients
Star Anise Oil Polysorbate 20 Sucrose Water Purified
6.2
Incompatibilities
6.3 Shelflife
3 years
6.4 Special precautions for storage
Store at a temperature not exceeding 25°C.
6.5 Nature and contents of container
100 ml, 200 ml and 500 ml in amber glass bottles with pilfer proof cap or child resistant cap.
500 ml, 1 litre and 2 litre high density polyethylene bottle with screw on cap. Not all packs may be marketed.
6.6 Special precautions for disposal
Not relevant.
7 MARKETING AUTHORISATION HOLDER
Bell, Sons and Co (Druggists) Ltd [Trading Style - Bell’s Healthcare] Gifford House,
Slaidburn Crescent Southport Merseyside PR9 9AL
8 MARKETING AUTHORISATION NUMBER(S)
PL 03105/0065
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
17th August 1998
10 DATE OF REVISION OF THE TEXT
08/08/2016