Summary of Product Characteristics (SmPC) - 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
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
Active ingredient % v/v ml/5ml
Glycerol Ph Eur 15.0 0.75
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: one 5ml spoonful three to four times a day. Children 1 to 5 years: two 5ml spoonfuls three to four times a day. Children under 3 months: not recommended.
4.3 Contra-Indications
Hypersensitivity to any of the ingredients.
4.4 Special Warnings and Special Precautions for Use
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 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.
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.
6.4 Special Precautions for Storage
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
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
11/01/2007
10 DATE OF REVISION OF THE TEXT
14/07/2015