מדינה: מלטה
שפה: אנגלית
מקור: Medicines Authority
AMYLMETACRESOL, DICHLOROBENZYL ALCOHOL, LEVOMENTHOL
Reckitt Benckiser Healthcare International Limited Thane Road, Nottingham NG90 2DB, United Kingdom
R02AA20
AMYLMETACRESOL 0.6 mg 2,4 DICHLOROBENZYL ALCOHOL 1.2 mg LEVOMENTHOL 8 mg
LOZENGE
AMYLMETACRESOL 0.6 mg 2,4 DICHLOROBENZYL ALCOHOL 1.2 mg LEVOMENTHOL 8 mg
OTC
THROAT PREPARATIONS
Withdrawn
2006-02-28
Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1. TRADE NAME OF THE MEDICINAL PRODUCT Strepsils Menthol and Eucalyptus 2. QUALITATIVE AND QUANTATIVE COMPOSITION Amylmetacresol BP 0.6mg 2,4-Dichlorobenzyl alcohol HSE 1.2mg Levomenthol natural or synthetic EP 8.0mg 3. PHARMACEUTICAL FORM A blue circular lozenge with a characteristic taste. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the symptomatic relief of mouth and throat infections, and nasal congestion. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults and children: One lozenge to be dissolved slowly in the mouth every 2-3 hours. 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. 4.5 INTERACTION WITH OTHER MEDICAMENTS AND OTHER FORMS OF INTERACTION No clinically significant interactions are known. Page 2 of 4 4.6 PREGNANCY AND LACTATION The safety of Strepsils Menthol and Eucalyptus during pregnancy and lactation has not been established, but 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 and soreness of the tongue are a possibility. 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 properties. Menthol has a mild local anaesthetic action on the throat and also relieves t קרא את המסמך השלם