Difflam AB Sore Throat Lozenges Full Prescribing Information, Dosage & Side Effects | MIMS Malaysia

Full Prescribing Info

Contents

2,4-dichlorobenzyl alcohol, amylmetacresol.

Description

Composition: Each lozenge contains: 2,4-Dichlorobenzyl Alcohol 1.2 mg; Amylmetacresol 0.6 mg.
Difflam AB Sore Throat lozenges Orange: Orange coloured, round, biconvex lozenges having orange flavour with sweet taste.
Difflam AB Sore Throat lozenges Lemon: Yellow coloured, round, biconvex lozenges having lemon flavour with sweet taste.
Difflam AB Sore Throat lozenges Blackcurrant: Violet coloured, round, biconvex lozenges having blackcurrant flavour with sweet taste.
Difflam AB Sore Throat lozenges Honey Lemon: Brownish yellow coloured, round, biconvex lozenges having honey lemon flavour with sweet taste.

Action

Pharmacology: Pharmacodynamics: 2,4-Dichlorobenzyl Alcohol and Amylmetacresol are antiseptics and possess antibacterial (bactericidal and bacteriostatic), antifungal and antiviral properties as demonstrated in vitro. When the two active agents are combined, a synergistic antibacterial action is observed leading to a reduced combined dose.
In-vitro studies demonstrated killing effects against some sore throat causing organisms such as Streptococcus pyogenes, Staphylococcus aureus, Haemophilus influenza and Moraxella catarrhalis, at 1 minute contact time. An overall reduction in the oral bacterial load was also seen in one in-vivo study.
In-vitro antiviral action against enveloped viruses including influenza A virus, para-influenza virus, respiratory syncytial virus, cytomegalovirus and coronavirus has also been observed for both amylmetacresol and dichlorobenzyl alcohol as well as the combination of the two after 1-2 minutes’ contact.

Indications/Uses

For the symptomatic relief of mouth and throat infections.

Dosage/Direction for Use

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.

Overdosage

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

Contraindications

Hypersensitivity to any of the ingredients.

Special Precautions

Do not exceed the stated dose.
Not to be given to children under 6 years.
If symptoms persist, have not improved, or have worsened after 3 days, consult a doctor or healthcare professional.
Patients with rare hereditary problems of glucose-galactose malabsorption or sucrose-isomaltose insufficiency should not take this medicine.

Use In Pregnancy & Lactation

Pregnancy: There are no or limited amount of data from the use of amylmetacresol and 2,4-Dichlorobenzyl Alcohol.
As with all medicines care should be taken when using this product in pregnancy and medical advice sought if necessary.
Breast-feeding: It is unknown whether 2,4-Dichlorobenzyl Alcohol, amylmetacresol or metabolites are excreted in human milk.
A risk to the newborns/infants cannot be excluded.

Adverse Reactions

View ADR Monitoring Form

Hypersensitivity reactions, glossodynia, and oral discomfort.

Drug Interactions

No clinically significant interactions are known.

Storage

Store below 30°C, in a dry place.

MIMS Class

Preparations for Oral Ulceration & Inflammation

ATC Classification

R02AA03 – dichlorobenzyl alcohol ; Belongs to the class of antiseptics used in throat preparations.

Regulatory Classification