SIMPLE LINCTUS B.P.

Active substance: CITRIC ACID MONOHYDRATE

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SUMMARY OF PRODUCT CHARACTERISTICS
1

NAME OF THE MEDICINAL PRODUCT
Simple Linctus B.P.
Moss Pharmacy Simple Linctus B.P.
VM Morrison Supermarkets PLC Simple Linctus B.P. Cough Liquid

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Citric Acid Monohydrate B.P. 125mg/5 ml dose
For excipents, see 6.1

3

PHARMACEUTICAL FORM
Oral Solution

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
For the relief of the symptoms of cough.

4.2

Posology and method of administration
For oral use.
Adults and the elderly

5 ml 3 to 4 times a day.
Children under 12 years

A paediatric version of this product us available and is recommended for
children under 12 yeas.

4.3

Contraindications
No significant contraindications have been reported; however it should be note
that the sucrose content is 76% and the product may be unsuitable for the
diabetic patient

4.4

Special warnings and precautions for use
None.

4.5

Interaction with other medicinal products and other forms of interaction
No significant interactions have been reported.

4.6

Fertility, pregnancy and lactation
No significant problems have been reported either with pregnant women or
with nursing mothers who are breast feeding; however, as with many other
medicines, its use, especially in the first 3 months of pregnancy, is
recommended only when the benefits outweigh any risks.

4.7

Effects on ability to drive and use machines
None known.

4.8

Undesirable effects
No significant other undesirable effects have been reported.

4.9

Overdose
Overdosage is unlikely to present a significant risk but if it does occur then the
treatment consists of general supportive therapy and may include gastric
lavage.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Citric acid monohydrate imparts a sharp taste to the product which acts as a
demulcent; though it may be a placebo effect some patients believe that
preparations, such as Simple Linctus B.P., relieve a dry tickling cough.

5.2

Pharmacokinetic properties
Citric acid monohydrate is metabolised to carbon dioxide and water in the
Krebs cycle.

5.3

Preclinical safety data
No relevant data.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Nipasept sodium
Water, Potable
Amaranth
Chloroform
Ethanol 96%
Anise Oil
Glycerol
Syrup

6.2

Incompatibilities
Though the product is acidic in nature and may exhibit incompatibilities with
alkaline products and constituents no significant major incompatibilities have
been reported.

6.3

Shelf life
36 months.

6.4

Special precautions for storage
Do not store above 250C.

6.5

Nature and contents of container
2000 ml Dispensing packs
Plastic bottle with plastic screw cap with an aluminium faced EPE liner.
500 ml dispensing pack
Plastic bottle with a wadless plastic screw cap.
100 ml and 200 ml patients and OTC packs
Amber glass bottle with a plastic “Jay cap” closure.
Not all pack sizes may be marketed.

6.6

Special precautions for disposal
None.

7

MARKETING AUTHORISATION HOLDER
Wise Pharmaceuticals Ltd
Hani Wells Business Park,
Unit 7, Hardicker Street,
Manchester
M19 2RB
United Kingdom

8

MARKETING AUTHORISATION NUMBER(S)

PL 18374/0027

9
DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
9th March 2005

10

DATE OF REVISION OF THE TEXT
20/09/2006

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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