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SIMPLE LINCTUS PAEDIATRIC B.P.

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SUMMARY OF PRODUCT CHARACTERISTICS
1

NAME OF THE MEDICINAL PRODUCT
Simple Linctus Paediatric BP

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Citric Acid Monohydrate 31.25mg/5ml dose.
Excipients: Sucrose (Syrup) 4.3g per 5ml, Ethanol (Alcohol) 1.5vol%
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 reach of children.
Consult a doctor if symptoms persist for more than 5 days
Contains 1.5vol% ethanol (alcohol) i.e. up to 118mg per 10ml dose, equivalent
to 3ml beer and of 1ml wine per dose. Harmful if suffering from alcoholism.
To be taken into account in pregnant or breast feeding women, children and
high-risk groups such as patients with liver disease, or epilepsy.

Patients with rare hereditary problems of fructose intolerance, glucosegalactose malabsorption or sucrase-isomaltase insufficiency should not take
this medicine.
Also contains 8.6g of sucrose per 10ml. This should be taken into account in
patients with diabetes.

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
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.

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.

6.1

List of excipients
Chloroform
Aniseed Oil
Alcohol 96%
Glycerin (E422)
Purified Water
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 /

10

09/09/1993

DATE OF REVISION OF THE TEXT
11/09/2014

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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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