DIFFLAM

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.

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).

System-Organ Class Frequency Undesirable effect Immune system disorders Not Known Anaphylactic reaction, Hypersensitivity reaction Respiratory, thoracic, and mediastinal disorders Very rare Laryngospasm Rare Burning mouth, Dry mouth Gastrointestinal Disorders Not known Hypoaesthesia oral Uncommon PhotosensitivitySkin and subcutaneous tissue disorders Very rare Angioedema 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. uk/yellowcard or search for MHRA yellow car in the Google Play or Apple App Store.

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.

Difflam contains: - 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.

- Mint Fragrance with Benzyl Alcohol, Citronellol, d- Limonene, Eugenol, Geraniol, Linalool and Lemon Fragrance with Benzyl Alcohol, Citral, Citronellol, d-Limonene, Geraniol, Linalool. These may cause allergic reactions. g. contact dermatitis) or irritation to the eyes and mucous membranes.

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