BELLS HEALTHCARE PAEDIATRIC SIMPLE LINCTUS BP 31.25 MG PER 5ML ORAL SOLUTION, SAINSBURYS CHILDRENS COUGH RELIEF 31.25 MG PER 5ML ORAL SOLUTION, BELLS HEALTHCARE CHILDRENS COUGH RELIEF 31.25 MG PER 5 ML ORAL SOLUTION, TESCO HEALTH CHILDRENS COUGH RELIEF 31 - summary of medicine characteristics

Summary of medicine characteristics - BELLS HEALTHCARE PAEDIATRIC SIMPLE LINCTUS BP 31.25 MG PER 5ML ORAL SOLUTION, SAINSBURYS CHILDRENS COUGH RELIEF 31.25 MG PER 5ML ORAL SOLUTION, BELLS HEALTHCARE CHILDRENS COUGH RELIEF 31.25 MG PER 5 ML ORAL SOLUTION, TESCO HEALTH CHILDRENS COUGH RELIEF 31

1. NAME OF THE MEDICINAL PRODUCT

Bell’s Healthcare Paediatric Simple Linctus BP 31.25 mg per 5 ml Oral Solution

Numark Paediatric Simple Linctus 31.25 mg/5 ml Oral solution

Bell’s Healthcare Children’s Cough Relief 31.25 mg per 5ml Oral Solution

Sainsbury’s Children’s Cough Relief 31.25 mg per 5ml Oral Solution

Tesco Health Children’s Cough Relief 31.25 mg per 5ml Oral Solution

Well Pharmaceuticals Children’s Cough Relief 31.25mg per 5ml 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.

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, glucosegalactose malabsorption or sucraseisomaltase insufficiency should not take this medicine.

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 breastfeeding.

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.

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. By reporting side effects you can help provide more information on the safety of this medicine.

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.

5.1 Pharmacodynamic properties

Pharmacotherapeutic Group: Acid Preparations

ATC Code: A09 AB

Citric acid is fever reducing.

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 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

None known

6.3 Shelf life

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