SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Difflam 3 mg Lozenges, orange-honey flavour

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each lozenge contains 3 mg benzydamine hydrochloride (equivalent to 2.68 mg benzydamine).

Excipients: each lozenge contains 3073.53 mg Isomalt (E 953), 0.017 mg Sunset yellow (E 110).

For a full list of excipients, see section 6.1

3 PHARMACEUTICAL FORM

Lozenge.

Orange-yellow square-shaped lozenges, with a central cavity.

4    CLINICAL PARTICULARS

4.1    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.

4.2 Posology and method of administration

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.

Oropharingeal use.

Lozenge should be dissolved slowly in the mouth Do not swallow. Do not chew.

4.3 Contraindications

Known hypersensitivity to benzydamine or to any of the excipients.

4.4 Special warnings and precautions for use

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, appear feverish or have other symptoms, must therefore seek the advice of their doctor or dentist as appropriate.

The medicinal product contains Isomalt and patients with rare hereditary problems of fructose intolerance should not take this medicine.

The medicinal product contains Sunset yellow (E 110) which may cause allergic reactions.

4.5 Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed.

4.6 Fertility, Pregnancy and lactation

There are not adequate data from the use of benzydamine in pregnant and breastfeeding women. Excretion into breast milk has not been studied. Animal studies are insufficient with respect to effects on pregnancy and lactation (see section 5.3). The potential risk for humans is unknown.

Difflam should not be used during pregnancy and lactation.

4.7 Effects on ability to drive and use machines

Difflam has no influence on the ability to drive and use machine, when it is used at the recommended dose.

4.8 Undesirable effects

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).

Gastrointestinal disorders - Rare: Burning mouth, Dry mouth, Not known: Hypoaesthesia oral

Immune system disorders - Rare: Hypersensitivity reaction, Not known: Anaphylactic reaction.

Respiratory, thoracic, and mediastinal disorders - Very rare: Laryngospasm.

Skin and subcutaneous tissue disorders - Uncommon: Photosensitivity. Very rare: Angioedema.

4.9 Overdose

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.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: other agents for oral local treatment, ATC code: A01AD02.

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.

5.2 Pharmacokinetic properties

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.

The excretion occurs mainly in the urine and mostly in the form of inactive metabolites or conjugation products.

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.

5.3 Preclinical safety data

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.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Isomalt (E 953),

Citric acid, monohydrate,

Orange flavour,

Honey flavour,

Levomenthol,

Acesulfame potassium,

Quinoline yellow (E 104),

Sunset yellow (E 110).

6.2 Incompatibilities

Not applicable.

Shelf life

3 years.

6.4 Special precautions for storage

Do not store above 30°C.

Store in original package in order to protect from moisture.

6.5 Nature and contents of container

Each lozenge is wrapped in paraffin paper.

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

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

Not all pack sizes may be marketed.

6.6 Special precautions for disposal

No special requirements.

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

7 MARKETING AUTHORISATION HOLDER

MEDA PHARMACEUTICALS LIMITED SKYWAY HOUSE PARSONAGE ROAD, TAKELEY BISHOP'S STORTFORD CM22 6PU

8    MARKETING AUTHORISATION NUMBER(S)

PL 15142/0266

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

30/05/2013

DATE OF REVISION OF THE TEXT

26/09/2011