Strepsils

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

AMYLMETACRESOL, DICHLOROBENZYL ALCOHOL

Available from:

Reckitt Benckiser Healthcare International Limited Thane Road, Nottingham NG90 2DB, United Kingdom

ATC code:

R02AA20

INN (International Name):

AMYLMETACRESOL 0.6 mg 2,4 DICHLOROBENZYL ALCOHOL 1.2 mg

Pharmaceutical form:

LOZENGE

Composition:

AMYLMETACRESOL 0.6 mg 2,4 DICHLOROBENZYL ALCOHOL 1.2 mg

Prescription type:

OTC

Therapeutic area:

THROAT PREPARATIONS

Authorization status:

Withdrawn

Authorization date:

2006-02-28

Summary of Product characteristics

Page 1 of 3 
SUMMARY OF PRODUCT CHARACTERISTICS 

1. 
NAME OF THE MEDICINAL PRODUCT 

Strepsils 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Amylmetacresol BP 
0.6mg 
2,4-Dichlorobenzyl alcohol HSE 
1.2mg 

3. 
PHARMACEUTICAL FORM 

A red circular lozenge. 

4. 
CLINICAL PARTICULARS 

4.1 
THERAPEUTIC INDICATIONS 

For the symptomatic relief of mouth and throat infections. 

4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 

For oral administration. 

Adults and children (over 6 years old):  
One lozenge to be dissolved slowly in the mouth every 2-3 hours
up to a maximum 
of 12 lozenges in 24 hours. 

Not suitable for children under 6 years. 

Elderly:  There is no need for dosage reduction in
the elderly. 

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. 

If symptoms persist consult your doctor. 

4.5 
INTERACTIONS WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS
OF INTERACTION 

No clinically significant interactions are known. 

Page 2 of 3 

4.6 
PREGNANCY AND LACTATION 

The safety of Strepsils Original Flavour has not been
established, but is not expected 
to constitute a hazard. 

4.7 
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES 

No adverse effects are known. 

4.8 
UNDESIRABLE EFFECTS 

Occasional hypersensitivity reactions. 

4.9 
OVERDOSE 

Overdosage should not present a problem other than gastrointestinal
discomfort.  
Treatment should be symptomatic. 

5. 
PHARMACOLOGICAL PROPERTIES 

5.1 
PHARMACODYNAMIC PROPERTIES 

2,4-Dichlorobenzyl alcohol and amylmetacresol
have antiseptic properties. 

5.2 
PHARMACOKINETIC PROPERTIES 

None available. 

5.3 
PRECLINICAL SAFETY DATA 

None available. 

6. 
PHARMACEUTICAL PARTICULARS 

6.1 
LIST OF EXCIPIENTS 

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