DIFFLAM Lozenge Ref.[6245] Active ingredients: Benzydamine

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. Once of the minor hydrolysis products is phenylalanine That may be harmful for people with phenylketonuria.
• Isomalt: and patients with rare hereditary problems of fructose intolerance should not take this medicine.

No interaction studies have been performed.

Pregnancy

There are no or limited amount of data from the use of benzydamine in pregnant women, and animal studies are insufficient with respect to reproductive toxicity (see section 5.3).

Difflam should not be used during pregnancy.

Breast-feeding

There is insufficient information on the excretion of benzydamine in animal 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

Not Known: Anaphylactic reaction, Hypersensitivity reactions

Respiratory, thoracic, and mediastinal disorders

Very rare: Laryngospasm

Gastrointestinal Disorders

Rare: Burning mouth, Dry mouth

Not known: Hypoaesthesia oral

Skin and subcutaneous tissue disorders

Uncommon: Photosensitivity

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. 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.

Not applicable.