Learning scenario

Difflam^™ 3 mg Lozenges (benzydamine hydrochloride) Lemon and Orange-Honey flavour
Presentation: Difflam 3 mg Lozenges, contains 3mg of benzydamine hydrochloride equivalent to 2.68 mg of benzydamine. 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. Dosage and Administration: : For oropharyngeal use. Adults and children over 6 years of age: one lozenge 3 times a day. Lozenge should be dissolved slowly in the mouth. Do not swallow. Do not chew. The treatment must not exceed 7 days. Contraindication: Hypersensitivity to the active substance or to any of the excipients. Warnings and Precautions: Benzydamine use is not advisable in patients 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 lozenges contain: Aspartame and Isomalt; aspartame is hydrolysed to phenylalanine which may be harmful for people with phenylketonuria. Isomalt is unsuitable for patients with rare hereditary problems of fructose intolerance and so should not take this medicine. Interactions: Not Known Pregnancy and lactation: Difflam Lozenges should not be used in pregnancy or lactation. Undesirable effects: Serious (frequency not known): Anaphylactic reaction which can be potentially life-threatening, Hypersensitivity reactions, Hypoaesthesia oral. (Uncommon): Photosensitivity, (Rare): Burning mouth, Dry mouth, (Very rare): Laryngospasm, Angioedema. Basic price (UK): RRP 20 lozenges £7.59 Product licence number: Lemon flavour PL 60682/0011, Orange-Honey flavour PL 60682/0013. Legal Category: P.

Difflam^™ 0.15 % w/v Spray (benzydamine hydrochloride)
Presentation: Difflam^™ Spray contains benzydamine hydrochloride 0.15% w/v. Each metered dose pump spray delivers approximately 175mcl per puff. Indications: Difflam^™ Spray is a locally acting analgesic and anti-inflammatory treatment for the throat and mouth. It is especially useful for the relief of pain in traumatic conditions such as following surgical removal of tonsils or the use of a naso-gastric tube; dental surgery. Dosage and administration: Adults and elderly: 4 to 8 puffs, 1½ to 3 hourly. Children aged 6-12: 4 puffs, 1½ to 3 hourly. Children under 6: One puff per 4kg body weight, up to a maximum 4 puffs, 1½ to 3 hourly. Contra-indications: Patients with known hypersensitivity to ingredients. Warnings and Precautions: Not advisable in patients with hypersensitivity to acetylsalicylic 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. The small amount of alcohol in this medicine will not have any noticeable effects. Some inactive ingredients may cause allergic reactions. Avoid contact with the eyes. Interactions: None known. Pregnancy and lactation: Difflam^™ Spray should not be used in pregnancy or lactation unless considered essential by the physician. There is no evidence of a teratogenic effect in animal studies. Undesirable effects: Serious (frequency not known): Anaphylactic reaction which can be potentially life-threatening. Hypersensitivity reactions. Angioedema (Uncommon): Oral tissue numbness or ‘stinging’ sensations in the mouth may occur which may disappear on continuing treatment. (Very rare): pruritus, rash, urticaria, photosensitivity reaction, laryngospasm / bronchospasm. Prescribers should consult the Summary of Product Characteristics in relation to side-effects. Special precautions for storage: Do not store above 30°C. Do not refrigerate or freeze. Keep out of reach of children. Basic price (UK): RRP 30ml spray £8.49. Marketing Authorization number: PL 60682/0016 Legal category: P.

Difflam^™ Sore Throat Rinse & Difflam^™ Oral Rinse (benzydamine hydrochloride)
Presentation: Difflam^™ Sore Throat Rinse & Difflam^™ Oral Rinse contain benzydamine hydrochloride 0.15% w/v. Presented as a gargle/oral rinse in a 200ml and 300ml glass bottle respectively. Indications: Locally acting analgesic and anti-inflammatory treatment for the relief of painful inflammatory conditions of the throat including pharyngitis. Dosage and administration: Rinse or gargle with 15ml (using measuring cup provided) every 1½-3 hours as required. Expel solution from the mouth after use. If stinging occurs the rinse may be diluted with water. Uninterrupted treatment should not exceed seven days, except under medical supervision. It is not suitable for children aged 12 years or under. Contra-indications: Patients with hypersensitivity to ingredients. Warnings and Precautions: Not advisable in patients with hypersensitivity to acetylsalicylic 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. The small amount of alcohol in this medicine will not have any noticeable effects. Some inactive ingredients may cause allergic reactions. Avoid contact with the eyes. Interactions: None known. Pregnancy and lactation: Difflam^™ Sore Throat Rinse should not be used in pregnancy or lactation unless considered essential by the physician. There is no evidence of a teratogenic effect in animal studies. Undesirable effects: Serious (frequency not known): Anaphylactic reaction which can be potentially life-threatening. Hypersensitivity reactions. Angioedema (Uncommon): Oral tissue numbness or 'stinging' sensations in the mouth may occur. (Very rare): pruritus, rash, urticaria, photosensitivity reaction, laryngospasm/bronchospasm. Prescribers should consult the Summary of Product Characteristics in relation to side-effects. Basic price (UK): RRP Difflam^™ Sore Throat Rinse 200ml bottle £8.99 Difflam^™ Oral Rinse 300ml bottle £11.19 Product licence number: Difflam^™ Sore Throat Rinse PL 60682/0014 & Difflam^™ Oral Rinse PL 60682/0015 Legal category: P
Marketing Authorisation Holder: Cooper Consumer Health B.V. Verrijn Stuartweg 60, 1112AX Diemen – The Netherlands. Date of preparation of Essential information: August 2025 Ref number: MAT-DIF-00077

The SmPC for this product, including adverse reactions, precautions, contra-indications, and method of use can be found at: Find product information about medicines and from from Cooper Consumer Health B.V., Verrijn Stuartweg 60, 1112 AX Diemen, The Netherlands.

Please continue to report suspected adverse drug reactions with any medicine or vaccine to the MHRA through the Yellow Card Scheme. It is easiest and quickest to report adverse drug reactions online via the Yellow Card Scheme website: Yellow Card | Making medicines and medical devices safer or search for MHRA Yellow Card in the Google Play or Apple App Store. Alternatively, you can report via some clinical IT systems (EMIS/SystemOne/Vision/MiDatabank) or by calling the Commission on Human Medicines (CHM) free phone line: 0800-731-6789. Adverse reactions/events should also be reported to MAH at e-mail address: vigilanceglobal@cooperconsumerhealth.com