DIFFLAM Lozenge (2020)
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Περιεχόμενα
Name of the medicinal product
Difflam 3 mg Lozenges, mint flavour.
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 3183 mg of Isomalt (E953) and 3.5 mg of Aspartame (E951). ...
Pharmaceutical form
Lozenge. Green square-shaped lozenges, with a central cavity.
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.
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. Paediatric population Children 6-11 years of age The medicinal product should be administered ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in the section 6.1.
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 ...
Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.
Pregnancy and lactation
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 ...
Effects on ability to drive and use machines
Difflam has no or negligible influence on the ability to drive and use machines, when it is used at the recommended dose.
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 ...
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 ...
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 ...
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 ...
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 ...
List of excipients
Isomalt (E953) Aspartame (E951) Levomenthol Citric acid, monohydrate Lemon flavour Mint flavour Quinoline yellow (E104) Indigotin dye (E132)
Incompatibilities
Not applicable.
Shelf life
4 years.
Special precautions for storage
Do not store above 25°C. Store in original package in order to protect from moisture.
Nature and contents of container
Lozenge is wrapped in paraffin paper. Ten lozenges are wrapped together in printed polyethylene-paper-aluminium trilaminated material. Each pack contains 20 or 30 lozenges (two or three packets of ten ...
Special precautions for disposal and other handling
No special requirements. Any unused product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Mylan Products Ltd., Station Close, Potters Bar, Hertfordshire, EN6 1TL, UK
Marketing authorization number(s)
PL 46302/0095
Date of first authorization / renewal of the authorization
Date of first authorisation: 30/01/2001 Date of latest renewal: 06/08/2010
Date of revision of the text
March 2020
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