Sugar Free Antiseptic Throat Drops Blackcurrant

1. Name Of The Medicinal Product

Boots Sore Throat Relief Lozenges Blackcurrant Flavour Sugar Free or Sugar Free Antiseptic Throat Drops Blackcurrant

2. Qualitative And Quantitative Composition

Active ingredient	mg/lozenge
Amylmetacresol BP	0.6

3. Pharmaceutical Form

Lozenge

4. Clinical Particulars

4.1 Therapeutic Indications

For the short-term symptomatic relief of sore throats.

4.2 Posology And Method Of Administration

For oral 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.

4.3 Contraindications

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 Interaction With Other Medicinal Products 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 the product during pregnancy or lactation.

4.7 Effects On Ability To Drive And Use Machines

No adverse effects are known.

4.8 Undesirable Effects

Occasionally hypersensitivity reactions and soreness of the tongue are a possibility.

4.9 Overdose

Slight 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

There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Isomalt

Maltitol liquid

Levomenthol

Anthocyanin (E163)

Blackcurrant Flavour

Malic acid

Aspartame

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

PVC/PVdC strip: 24 months

Bag: 36 months

6.4 Special Precautions For Storage

PVC/PVdC strip: Do not store above 25°C

Store in the original package

Bag: None

6.5 Nature And Contents Of Container

a) PVC/PVdC blister heat sealed to hard tempered aluminium foil:

Blister packed in cardboard carton.

b) Individually wrapped in laminate: Lozenges sealed in a cellophane bag and packed into a carton.

Pack sizes: 6, 8, 10, 12, 16, 18, 20, 24, 30, 32, 36

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

The Boots Company PLC

1 Thane Road West

Nottingham NG2 3AA

8. Marketing Authorisation Number(S)

PL 00014/0603

9. Date Of First Authorisation/Renewal Of The Authorisation

26 February 1998

10. Date Of Revision Of The Text

November 2003