S
1. Name Of The Medicinal Product
Simple Linctus Sugar Free
2. Qualitative And Quantitative Composition
Simple Linctus Sugar Free: Citric Acid Monohydrate 125 mg/5 ml equivalent to 114.29mg/5ml Anhydrous Citric Acid.
3. Pharmaceutical Form
Clear Pink Sugar Free Syrup
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 5 ml spoonful orally 3-4 times daily.
Children: Not appropriate
4.3 Contraindications
Not known
4.4 Special Warnings And Precautions For Use
This medicine contains maltitol liquid. Patients with rare hereditary problems of fructose intolerance should not take this medicine.
This medicinal product contains small amounts of ethanol (alcohol), less than 100mg per 5ml dose
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
None Known
4.6 Pregnancy And Lactation
No data available
4.7 Effects On Ability To Drive And Use Machines
Not applicable
4.8 Undesirable Effects
Not Applicable
4.9 Overdose
Sufficient prolonged overdose of citric acid may cause erosion of the teeth and have a local irritant action.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Absorption: Citric Acid Monohydrate is absorbed after oral administration.
Distribution: Citric Acid is found naturally in the body and is widely distributed, about 70% of the citric acid in the body is in hard bone and this accounts for 1.5% of bone content.
Metabolic Reactions: It is an important intermediate in carbohydrate metabolism and its major role is in the tricarboxylic acid cycle (Krebs citric acid cycle); it is metabolised to carbon dioxide and water.
Excretion: 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. The urinary excretion of citric acid is increased in alkaline urine
5.2 Pharmacokinetic Properties
Not applicable
5.3 Preclinical Safety Data
None stated
6. Pharmaceutical Particulars
6.1 List Of Excipients
Glycerol (E422)
Sodium Carboxymethylcellulose
Sodium Benzoate (E211)
Saccharin Sodium (E954)
Lycasin 80/55 (E965)
Ethanol (96%)
Anise Oil
Chloroform
Natural Red DI (E163)
Purified Water
6.2 Incompatibilities
Not appropriate
6.3 Shelf Life
2 years
6.4 Special Precautions For Storage
Do not Store above 25°C.
6.5 Nature And Contents Of Container
Amber glass bottles with pilfer screw closure
High density Polyethylene with screw on closure
Pack sizes of 100ml, 125ml, and 200ml for Amber Glass Bottles
Pack size of 2000ml for High Density Polyethylene dispensary pack.
6.6 Special Precautions For Disposal And Other Handling
As with all medicines.
7. Marketing Authorisation Holder
Pinewood Laboratories Limited
Ballymacarbry
Clonmel
Co Tipperary
8. Marketing Authorisation Number(S)
PL 04917/0006
9. Date Of First Authorisation/Renewal Of The Authorisation
28 August 1991
10. Date Of Revision Of The Text
November 2008
Simple Linctus Sugar Free Pinewood Healthcare
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