Childrens 3 Months Plus Simple Cough linctus, Infant sugar free Simple Cough linctus, Boots Cough syrup 3 Months Plus, Infant Simple Cough linctus 3 Months Plus – Summary of Product Characteristics (SmPC) for healthcare professionals

1 NAME OF THE MEDICINAL PRODUCT

Infant Simple Cough Linctus 3 Months Plus or Infant Sugar Free Simple Cough Linctus or Children's 3 Months Plus Simple Cough Linctus or Boots Cough Syrup 3 Months Plus.

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

3 PHARMACEUTICAL FORM

Syrup

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

For the relief of dry tickly coughs.

4.2 Posology and Method of Administration

For oral administration.

Children 3 months – 1 year:

Children 1 to 5 years:

Children under 3 months:

one 5ml spoonful three to four times a day. two 5ml spoonfuls three to four times a day. not recommended.

4.3 Contra-Indications

Hypersensitivity to any of the ingredients.

Not recommended for children under 3 months.

If symptoms persist for more than 3 days consult your doctor.

Keep all medicines out of the reach of children.

4.5 Interactions with other Medicinal Products and other Forms of Interaction

No clinically significant drug interactions.

4.6 Pregnancy and Lactation

The safety of this product during pregnancy and lactation has not been established but is not thought to constitute a hazard.

4.7 Effects on Ability to Drive and Use Machines

No adverse effects known.

4.8 Undesirable effects

Immune system disorder: hypersensitivity reactions, including anaphylaxis.

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.

4.9 Overdose

Overdosage with this product may possibly cause diarrhoea. Treatment should be symptomatic.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Glycerin has demulcent properties and may possibly block sensory cough receptors in the respiratory tract.

5.2 Pharmacokinetic Properties

None stated.

5.3 Pre-clinical Safety Data

Not applicable.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Maltitol liquid

Hydroxyethylce­llulose

Sodium Benzoate

Citric Acid Monohydrate

Sodium Citrate

Apple flavouring 5112OIE

Purified Water

6.2 Incompatibilities

None stated.

6.3 Shelf-Life

36 months.

Do not store above 25°C. Keep tightly closed.

6.5 Nature and Content of Container

1) Bottle amber PET with polypropylene child resistant closure fitted with expanded polythene liner.

Pack size: 150 ml, 100ml

2) Bottle amber glass with polypropylene child resistant closure fitted with an expanded polyethylene liner.

Pack size 100, 125 or 150ml.

6.6 Instructions for Use, Handling and Disposal

Not applicable.

7 MARKETING AUTHORISATION HOLDER

The Boots Company PLC

1 Thane Road West

Nottingham

NG2 3AA

Trading as: BCM

8 MARKETING AUTHORISATION NUMBER(S)

PL 00014/0500