Boots Oral Antiseptic

1. Name Of The Medicinal Product

Boots Oral Antiseptic

2. Qualitative And Quantitative Composition

Active Ingredient	% w/v
Cetyl Pyridinium Chloride Ph Eur	0.025

3. Pharmaceutical Form

Mouthwash

4. Clinical Particulars

4.1 Therapeutic Indications

For the relief of mouth and throat infections.

For use after dental surgery and for daily oral hygiene.

4.2 Posology And Method Of Administration

For adults and children over six years, thoroughly rinse the mouth or gargle with at least 15ml (1 tablespoonful) 2 or 3 times a day.

Do not swallow.

Do not dilute. Product is ready for use.

4.3 Contraindications

Hypersensitivity to any of the ingredients, especially cetyl pyridinium chloride.

4.4 Special Warnings And Precautions For Use

Prolonged use of this preparation could lead to hypersensitivity to cetyl pyridinium.

If symptoms persist consult your doctor.

Keep all medicines out of the reach of children.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

No clinically significant interactions known.

4.6 Pregnancy And Lactation

The use of this preparation in pregnancy and lactation has not been studied but is unlikely to constitute a hazard.

4.7 Effects On Ability To Drive And Use Machines

No adverse effects are anticipated.

4.8 Undesirable Effects

Adverse effects are unlikely unless there is sensitivity to the ingredients, especially cetyl pyridinium which may cause nausea or vomiting.

4.9 Overdose

If accidentally swallowed in large quantities, signs of toxicity will include those associated with alcohol, sorbitol, menthol and cetyl pyridinium ingestion, including euphoria, slurred speech, nausea, vomiting, flatulence, diarrhoea and abdominal pain. Treatment includes stomach aspiration and lavage, supportive therapy should include keeping the patient warm. In children, overdosage could lead to hypoglycaemia, correct with dextrose.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Cetyl pyridinium chloride is a cationic disinfectant with gram, positive and negative activity which has been found to be of value in mouthwashes for treating superficial infections of the mouth and throat.

5.2 Pharmacokinetic Properties

Not applicable.

5.3 Preclinical Safety Data

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

6. Pharmaceutical Particulars

6.1 List Of Excipients

Cetomacrogol 1000 croda

Saccharin 550

Alcohol 96%

Sorbitol solution non cryst

Levomenthol natural or synthetic

Peppermint oil

Methyl salicylate

Sodium bicarbonate

Quinoline yellow 14031 anst

Blue 12401 anst

Purified water

6.2 Incompatibilities

None

6.3 Shelf Life

36 months

6.4 Special Precautions For Storage

None

6.5 Nature And Contents Of Container

White flint glass bottle with roll on pilfer proof aluminium cap with a PVDC faced expanded polyethylene liner or a triseal (LDPE/EPE/LDPE) liner.

Alternative cap: unfitted polypropylene cap with a tamper evident band.

A PET bottle with a polypropylene cap with expanded polyethylene liner.

Pack sizes: 30ml, 50ml, 75ml, 100ml, 150ml, 200ml, 210ml, 250ml, 300ml, 500ml.

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 00014/0277

9. Date Of First Authorisation/Renewal Of The Authorisation

Date of first grant: 18 November 1982

Date of last renewal: 18 November 1992

10. Date Of Revision Of The Text

August 1997