Summary of medicine characteristics - BOOTS SORE THROAT RELIEF LOZENGES LEMON FLAVOUR
1 NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For the short-term symptomatic relief of sore throats.
4.2. Posology and Method of Administration
Adults, elderly and children over 12 years: One throat drop to be sucked when required up to a maximum of 8 throat drops in 24 hours.
Children 5 – 12 years: One throat drop to be sucked when required up to a maximum of 4 throat drops in 24 hours.
Children under 5 years: Not suitable.
For oral administration.
4.3. Contra-indications
Hypersensitivity to any of the ingredients.
4.4. Special Warnings and Precautions for Use
Keep all medicines out of the reach of children. Do not exceed the stated dose.
If symptoms persist or worsen see your doctor.
4.5. Interactions with other Medicaments and other forms of Interaction
No clinically significant interactions are known.
4.6. Pregnancy and Lactation
The safety of this product has not been established during pregnancy and lactation, but is not expected to constitute a hazard. As with all drugs try to avoid taking them during pregnancy or lactation.
4.7. Effects on Ability to Drive and Use Machines
No adverse effects are known.
4.8. Undesirable Effects
Occasional hypersensitivity reactions and soreness of the tongue are a possibility.
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 http://www.mhra.gov.uk/yellowcard
4.9. Overdose
4.9. OverdoseSlight overdosage should not present a problem other than gastrointestinal discomfort. Treatment should be symptomatic. In cases of severe overdosage, empty the stomach by gastric lavage. Administer a saline laxative and activated charcoal by mouth.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Amylmetacresol has antiseptic properties.
5.2. Pharmacokinetic Properties
No data available.
5.3. Preclinical Safety Data
5.3. Preclinical Safety DataThere are no pre-clinical data of relevance to the prescriber which are additional to that already included.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Terpeneless Lemon Oil
Star Anise Oil
Levomenthol Natural or Synthetic
Dry Matter Liquid Sugar Demineralised
or Glucose Syrup Liquid
Malic Acid
Beta Carotene
6.2. Incompatibilities
None stated.
6.3 Shelf life
PVC/PVDC Blister: 24 months
Laminate wrapper/Cellophane Bag/Carton: 18 months
6.4 Special precautions for storage
PVC/PVdC blister: Do not store above 25°C. Store in the original package.
Laminate wrapper/Cellophane bag/Carton: None.
6.5 Nature and contents of container
A card carton containing push through PVC/PVdC blisters heat-sealed to hard-tempered aluminium foil.
Pack sizes: 16, 24 lozenges
or a card carton, having a cellophane inner bag containing lozenges individually wrapped in laminate.
Pack size: 20 lozenges
6.6. Instruction for use and handling
None stated.
7. MARKETING AUTHORISATION HOLDER
The Boots Company PLC
1 Thane Road West
Nottingham
NG2 3AA
8. MARKETING AUTHORISATION NUMBER
8. MARKETING AUTHORISATION NUMBERPL 00014/0214
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
3 November 1978 / 11 April 1995