Summary of Product Characteristics
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SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT <Product name> 1.5 mg/ml, oromucosal spray, solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One ml of the spray contains 1.5 mg of benzydamine hydrochloride (Benzydamini hydrochloridum), corresponding to 1.34 mg benzydamine. One puff (0.17 ml) of the spray delivers 255 micrograms of benzydamine hydrochloride, corresponding to 228 micrograms benzydamine. Excipient(s) with known effect: methyl parahydroxybenzoate (E 218), 1 mg/ml and ethanol 96%, 81 mg/ml. Each puff (0.17 ml) of the spray delivers 0.17 milligrams of methyl parahydroxybenzoate (E 218) and 13.84 milligrams of ethanol 96%. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Oromucosal spray, solution. A clear, colourless solution with characteristic peppermint scent, with pH 5.3-6.7. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Treatment of symptoms associated with inflammatory conditions of the oral cavity and throat (pain, reddening, swelling). 4.2 Posology and method of administration Posology Adults and children more than 12 years old: 4 to 8 puffs of the spray (deliver 1,02 to 2,04 mg of benzydamine hydrochloride, corresponding to 0,91 to 1,82 mg of benzydamine) from 2 to 6 times a day; not more often, than every 1.5 – 3 hours. Children 6 to 12 years old: 4 puffs of the spray (deliver 1,02 mg of benzydamine hydrochloride, corresponding to 0,91 mg of benzydamine) from 2 to 6 times a day; not more often, than every 1.5 – 3 hours. Children less than 6 years old: 1 puff of the spray per 4 kg of body weight (delivers 0,26 mg of benzydamine hydrochloride, corresponding to 0,23 mg of benzydamine per 4 kg of body weight) from 2 to 6 times a day; not more often than every 1.5 – 3 hours. Maximum single dose 4 puffs (deliver 1,02 mg of benzydamine hydrochloride, corresponding to 0,91 mg of benzydamine) should not be exceeded. Elderly: No special dosage recommendations are made for elderly patients. There is no need to modify the dosage. Treatment must not exceed 7 days. Method of administration 1 Oropharyngeal use. Set the ending of the measuring device in a horizontal position. If the product is used for the first time, press the measuring device firmly with the thumb or the forefinger while holding the bottle in an upright position. To obtain proper spraying repeat this procedure 5 times. If the product is used for the next time, press the measuring device 2 times. Then direct the ending of the measuring device into the oral cavity and press the measuring device. 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 The contact with eyes should be avoided. 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 day, or who appear feverish or have other symptoms, must therefore seek the advice of their doctor or dentist as appropriate. Long-lasting use can cause allergic reactions. If it occurs, the product should be discontinued and doctor consulted to set up a suitable therapy. The use of benzydamine is not recommended in cases of hypersensitivity to salicylic acid or other NSAIDs. Caution is required in patients with a history of bronchial asthma or allergic diseases, as bronchospasm events may develop in these subjects. This medicinal product contains small amounts of ethanol (alcohol), less than 100 mg per one puff (see section 2). This medicinal product contains methyl parahydroxybenzoate (E 218) (see section 2). May cause allergic reactions (possibly delayed), and exceptionally, bronchospasm. 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 is no information as regards use of benzydamine in pregnancy. Animal studies of effect in pregnancy are insufficient and thus the potential risk in man cannot be assessed (see section 5.3). <Product name> should not be used during pregnancy. Breastfeeding There is no information as regards use of benzydamine in lactation. The product excretion in mother’s milk has not been studied. Animal studies of effect in lactation are insufficient and thus the potential risk in man cannot be assessed (see section 5.3). <Product name> should not be used during breastfeeding. Fertility There is no human data on the effect of benzydamine on fertility. 2 4.7 Effects on ability to drive and use machines <Product name> has no or negligible influence on the ability to drive and use machines. 4.8 Undesirable effects The adverse reactions reported are tabulated below, classified by system organ class and ordered by descending order of severity. The frequency of possible side effects listed below is defined using the following convention: Very common (≥ 1/10) Common (≥ 1/100 to < 1/10) Uncommon (≥ 1/1000 to < 1/100) Rare (≥ 1/10000 to < 1/1000) Very rare (< 1/10000) Not known (frequency cannot be estimated from the available data). Immune system disorders Rare – hypersensivity reactions Not known – anaphylactic reactions Respiratory, thoracic and mediastinal disorders Very rare – laryngospasm Gastrointestinal disorders Rare – burning and dryness of the mouth Skin and subcutaneous tissue disorders Uncommon – photosensivity Very rare – angioedema. Right after the medicine is used numbness or “stinging” sensation in the oral cavity or throat may occur. This reaction is associated with normal action of the medicine and disappears after a short time. In individual cases, nausea or vomiting may occur what are triggered by irritation reflex of the throat related to administration of the medicine. Those symptoms cease spontaneously after the medicine is discontinued. 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 <to be completed nationally>. 4.9 Overdose Very rarely symptoms of overdosing such as excitation, convulsions, sweating, ataxia, tremor and vomiting have been reported after the oral administration of benzydamine dosages much larger than recommended. In the event of acute overdose 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 3 Pharmacotherapeutic group: stomatological preparations - other agents for local oral treatments, ATC code: A01AD02. Benzydamine belongs to the group of nonsteroidal anti-inflammatory drugs. It stabilises the cellular membrane and inhibits prostaglandin synthesis. It shows local anti-inflammatory and analgesic activity, and exerts local anesthetic action on the oral mucosa. Clinical studies demonstrate that benzydamine is effective for treatment of local mouth and pharynx irritative processes. 5.2 Pharmacokinetic properties Absorption and distribution The absorption through the mucosa and pharynx was demonstrated by the presence of measurable quantities of benzydamine in the human plasma, which are however insufficient to produce systemic effect. Biotransformation and elimination The excretion occurs mainly in the urine, and mostly in the form of inactive metabolites and conjugation products. 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. 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 Methyl parahydroxybenzoate (E 218) Sodium cyclamate (E 952) Glycerol (E 422) Sodium hydrogen carbonate Polysorbate 80 Ethanol 96% Peppermint flavour [containing peppermint oil, ethanol] Phosphoric acid, concentrated (for pH-adjustment) Purified water 6.2 Incompatibilities Not applicable. 6.3 Shelf life Shelf life is 36 months. In-use shelf life is 160 days. 6.4 Special precautions for storage 4 Store below 25oC. For storage conditions after first opening of the medicinal product, see section 6.3. 6.5 Nature and contents of container The product is packed into white polyethylene (HDPE) bottles crimp/snap a 30 ml with a snap 0.17 ml, polyethylene (HDPE) metering pump VP6/33 snap, 0.17 ml and polypropylene adapter for 0.17 ml metering pump. The bottle with a snap 0.17 ml metering pump and adapter for 0.17 ml metering pump and package leaflet is placed in cardboard box. The number of doses is 150. 6.6 Special precautions for disposal and other handling No special requirements. 7. MARKETING AUTHORISATION HOLDER <To be completed nationally> 8. MARKETING AUTHORISATION NUMBER(S) <To be completed nationally> 9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: <To be completed nationally> 10. DATE OF REVISION OF THE TEXT <To be completed nationally> 5 .