Strepsils Orange with Vitamin C 100mg

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

AMYLMETACRESOL, ASCORBIC ACID, 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 ASCORBIC ACID 100 mg 2,4 DICHLOROBENZYL ALCOHOL 1.2 mg

Pharmaceutical form:

LOZENGE

Composition:

AMYLMETACRESOL 0.6 mg ASCORBIC ACID 100 mg 2,4 DICHLOROBENZYL ALCOHOL 1.2 mg

Prescription type:

OTC

Therapeutic area:

THROAT PREPARATIONS

Authorization status:

Authorised

Authorization date:

2006-02-28

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS 

1. 
TRADE NAME OF THE MEDICINAL PRODUCT 

Strepsils Orange with Vitamin C 100mg 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Amylmetacresol BP 0.6mg 
2,4-Dichlorobenzyl Alcohol HSE 1.2mg 
Vitamin C, (Ascorbic Acid, Sodium Ascorbate Equivalent to
EP) 100.0mg 

3. 
PHARMACEUTICAL FORM 

Orange flavoured and coloured 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 

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. 

For oral administration. 

4.3 
CONTRAINDICATIONS 

Hypersensitivity to any of the ingredients. 

4.4 
SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE 

Keep all medicines out of the reach of children. 

If symptoms persist consult your doctor.
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4.5 
INTERACTION WITH OTHER MEDICAMENTS AND OTHER
FORMS OF INTERACTION 

No clinically significant interactions are known. 

4.6 
PREGNANCY AND LACTATION 

The safety of Strepsils Orange with Vitamin
C 100mg has not been 
established, but it is not considered to constitute a hazard. 

4.7 
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES 

No adverse effects are known. 

4.8 
UNDESIRABLE EFFECTS 

Occasionally hypersensitivity reactions. 

4.9 
OVERDOSE 

Overdosage should not present a problem other than
gastrointestinal 
discomfort. 

Treatment should be symptomatic. 

5. 
PHARMACOLOGICAL PARTICULARS 

5.1 
PHARMACODYNAMIC PROPERTIES 

2,4-Dichlorobenzyl alcohol and
amylmetacresol have antiseptic prop