- benzydamine hydrochloride
This information is intended for use by health professionals
Difflam 3 mg Lozenges, lemon flavour
Each lozenge contains 3 mg of benzydamine hydrochloride equivalent to 2.68 mg benzydamine.
Excipients with known effects: each lozenge contains 3183 mg of Isomalt (E 953) and 3.26 mg of Aspartame (E 951)
For the full list of excipients, see section 6.1
Yellow-green square-shaped lozenges, with a central cavity.
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.
Adults and children over 6 years of age: one lozenge 3 times a day.
The treatment must not exceed 7 days.
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.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Benzydamine use is not advisable in patient with hypersensitivity to salicylic acid or other NSAIDs.
Bronchospasm may be precipitated in patients suffering from or with a previous history of bronchial asthma. Caution should be exercised in these patients.
In a minority of patients, buccal/pharyngeal ulceration may be caused by serious disease processes. Patients whose symptoms worsen or do not improve within 3 days, or who appear feverish or have other symptoms, must therefore seek the advice of their doctor or dentist as appropriate.
- Aspartame: aspartame is hydrolysed in the gastrointestinal tract when orally ingested. One of the major hydrolysis products is phenylalanine that may be harmful for people with phenylketonuria.
- Isomalt: patients with rare hereditary problems of fructose intolerance should not take this medicine.
No interaction studies have been performed.
There are no or limited amount of data from the use of benzydamine in pregnant womenand animal studies are insufficient with respect to reproductive toxicity (see section 5.3).
Difflam should not be used during pregnancy.
There is insufficient information on the excretion of benzydamine in human milk.
Difflam should not be used during breast-feeding.
Difflam has no or negligible influence on the ability to drive and use machines, when it is used at the recommended dose.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness
The following rate values have been used: Very common (≥ 1/10), Common (≥ 1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000) and Very rare (<1/10,000), not known (cannot be estimated from the available data).
Immune system disorders
Anaphylactic reaction, Hypersensitivity reaction
Respiratory, thoracic, and mediastinal disorders
Burning mouth, Dry mouth
Skin and subcutaneous tissue disorders
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA yellow car in the Google Play or Apple App Store.
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.
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.
Pharmacotherapeutic group: other throat preparations, ATC code: R02AX03.
Clinical efficacy and safety
Clinical studies demonstrate that benzydamine is effective in relieving suffering from localised irritation processes of the mouth and pharynx. In addition, benzydamine possesses a moderate local anaesthetic effect.
The absorption through the mucosa of the mouth and pharynx was demonstrated by the presence of measurable quantities of benzydamine in the human plasma.
About 2 hours after the 3 mg lozenge administration, benzydamine peak plasma values of 37.8 ng/ml with an AUC of 367 ng/ml*h were observed. However, these levels are not sufficient to produce pharmacological systemic effects.
When locally applied benzydamine has been shown to accumulate in inflamed tissues where it reaches effective concentrations because of its capacity to penetrate the epithelial lining.
Biotransformation and elimination
The excretion occurs mainly in the urine and mostly in the form of inactive metabolites or conjugation products.
Development and peri-post natal toxicity was seen in reproductive toxicity studies in rats and rabbits at plasma concentration much higher (up to 40 times) than those observed after a single therapeutic oral dose. No teratogenic effects were seen in those studies. Available kinetic data do not allow to establish the clinical relevance of the reproductive toxicity studies. As the preclinical studies had shortcomings and therefore are of restricted value, they do not provide additional information relevant for the prescriber beyond that included in other sections of the SPC.
Isomalt (E 953),
Aspartame (E 951),
Citric acid, monohydrate,
Quinoline yellow (E 104),
Indigotin dye (E 132).
Do not store above 25°C.
Store in original package in order to protect from moisture.
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.
No special requirements.
Any unused product or waste material should be disposed of in accordance with local requirements.
Mylan Products Ltd.,
Station Close, Potters Bar,
Hertfordshire, EN6 1TL, UK
Date of first authorisation: 25/11/2004
Date of latest renewal: 06/08/2010
Building 4, Trident Place, Mosquito Way, Hatfield, Hertfordshire, AL10 9UL
+44 (0)1707 853 000
+44 (0)1707 853 000
+44 (0)1707 853 000 select option 2
+44 (0)1707 853 000 select option 2