DIFFLAM Lozenge Ref.[6245] Active ingredients: Benzydamine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: Mylan Products Ltd., Station Close, Potters Bar, Hertfordshire, EN6 1TL, UK

Therapeutic indications

Difflam is indicated in adults and children over 6 years of age, for symptomatic local treatment for the relief of pain and irritation of mouth and throat.

Posology and method of administration

Posology

Adults and children over 6 years of age

One lozenge 3 times a day.

The treatment must not exceed 7 days.

Paediatric population

Children 6-11 years of age

The medicinal product should be administered under adult supervision.

Children below 6 years of age

Due to the type of the pharmaceutical form, the administration should be restricted to children of more than 6 years of age.

Method of administration

For oropharingeal use.

Lozenge should be dissolved slowly in the mouth.

Do not swallow. Do not chew.

Overdose

Symptoms

No overdosage with the lozenge formulation has been reported. However, very rarely in children excitation, convulsions, sweating, ataxia, tremor and vomiting have been reported after the oral administration of benzydamine dosages about 100 times higher than those of the lozenge.

Management

In the event of acute overdosage only symptomatic treatment is possible; the stomach should be emptied by inducing vomiting or by gastric lavage, and the patient carefully observed and given supportive treatment. Adequate hydration must be maintained.

Shelf life

4 years.

Special precautions for storage

Do not store above 25°C.

Store in original package in order to protect from moisture.

Nature and contents of container

Lozenge is wrapped in paraffin paper.

Ten lozenges are wrapped together in printed polyethylene-paper-aluminium trilaminated material.

Each pack contains 20 or 30 lozenges (two or three packets of ten lozenges each).

Not all pack size may be marketed.

Special precautions for disposal and other handling

No special requirements.

Any unused product or waste material should be disposed of in accordance with local requirements.

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.