Summary of Product Characteristics (SmPC) - Difflam Orange-honey Flavour 3 mg lozenges
1 NAME OF THE MEDICINAL PRODUCT
Difflam orange-honey flavour 3 mg Lozenges
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each lozenge contains 3 mg of benzydamine hydrochloride equivalent to 2.68 mg benzydamine.
Excipients with known effects: each lozenge contains 3073.53 mg of Isomalt (E 953) and 0.017 mg of Sunset yellow (E 110).
Fragrance containing allergens - Citral, Citronellol, d-Limonene, Geraniol, Linalool (present in Orange and Honey Flavours).
For the 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
Posology
Adults and children over 6 years of age: one lozenge 3 times a day.
The treatment must not exceed 7 days.
Pediatric 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.
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
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, or who appear feverish or have other symptoms, must therefore seek the advice of their doctor or dentist as appropriate.
Difflam contains:
- Isomalt: patients with rare hereditary problems of fructose intolerance should not take this medicine.
- Sunset yellow (E 110): may cause allergic reactions.
Fragrance with Citral, Citronellol, d-Limonene, Geraniol and
Linalool. These 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
Pregnancy
There are no clinical data from the use of Difflam during pregnancy.
During the third trimester of pregnancy, systemic use of prostaglandin synthetase inhibitors may induce cardiopulmonary and renal toxicity in the fetus. At the end of the pregnancy prolonged bleeding time in both mother and child may occur, and labour can be delayed.
It is not known if the systemic Diffalm exposure reached after topical administration can be harmful to an embryo/fetus.
Therefore, Difflam should not be used during pregnancy unless clearly necessary. If used, the dose should be kept as low and duration of treatment as short as possible.
Breast-feeding
There is insufficient information on the excretion of benzydamine in human milk. Difflam should not be used during breast-feeding.
4.7 Effects on ability to drive and use machines
Difflam has no or negligible 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).
| System-Organ Class | Frequency | Undesirable effect |
| Immune system disorders | Not Known | Anaphylactic reaction, Hypersensitivity reaction |
| Respiratory, thoracic, and mediastinal disorders | Very rare | Laryngospasm |
| Gastrointestinal Disorders | Rare Not known | Burning mouth, Dry mouth Hypoaesthesia oral |
| Skin and subcutaneous tissue disorders | Uncommon Very rare | Photosensitivity 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.
4.9 Overdose
Symptoms
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.
Management
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 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.
A 7 days non inferiority, phase IV, multicenter, randomized, open label, active-controlled study has compared the efficacy and safety of Benzydamine hydrochloride 0,3% oromucosal spray and Benzydamine hydrochloride 3 mg lozenges in 363 patients with acute sore throat.
The primary objective of the study was to assess the efficacy of benzydamine hydrochloride (spray or lozenges), in sore throat pain relief at 2 minutes (T2 min) after a single dose (one 3 mg benzydamine lozenge vs 4 nebulizations) administration, using a 7 point STRRS (Sore Throat Relief Rating Scale). The secondary objective of the study was to assess the efficacy of benzydamine hydrochloride (spray or lozenges), in sore throat pain relief at 1 minute (T1) after a single dose administration using STRRS. A pain relief at least slight (STRRS score >1), was observed 1 minute after complete dissolution of the lozenge (mean dissolution time 9.12 minutes) in 87% of patients and in 91% of patients after 2 minutes. A pain relief at least moderate (STRRS score >3,) was observed after 15 minutes in approximately 83% of patients.
The improvement in difficulty in swallowing and swollen sensation were also observed. Improvement in swallowing difficulty and throat swelling was observed 5 minutes after complete dissolution of the lozenge (mean dissolution time 9.12 minutes), reaching a 22% and 25% reduction, respectively, that increased to 42% for both parameters after 2 hours.
Safety profile of benzydamine was confirmed.
5.2 Pharmacokinetic properties
Absorption
The absorption through the mucosa of the mouth and pharynx was demonstrated by the presence of measurable quantities of benzydamine in the human plasma.
Distribution
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.
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)
Fragrance containing allergens - Citral, Citronellol, d-Limonene, Geraniol, Linalool (present in Orange and Honey Flavours)
6.2 Incompatibilities
Not applicable.
6.3 Shelf-life
4 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
Lozenge is wrapped in paraffin paper.
Ten lozenges form one stick, packaged in printed polyethylene-paper-aluminium trilaminated material.
Lozenges can be packaged also in PVC/PE/PVDC – ALU blister.
Pack sizes of 20 lozenges.
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
Cooper Consumer Health B.V.,
Verrijn Stuartweg 60, 1112 AX Diemen,
The Netherlands
8. MARKETING AUTHORISATION NUMBERS
PL 60682/0013
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
09/09/2010
10 DATE OF REVISION OF THE TEXT
20/01/2026