Description
Dosage form
Spray for topical use dosed
Indications
Symptomatic pain therapy for inflammatory diseases of the oral cavity and ENT organs (of various etiologies):
gingivitis, glossitis, periodontal disease, stomatitis (incl. after radiation and chemotherapy)
pharyngitis, laryngitis, tonsillitis
candidiasis of the oral mucosa (as part of combination therapy)
calculous inflammation of the salivary glands
after surgery and trauma (tonsillectomy, fractures of the jaw after tooth extraction and srdlp.
In infectious and inflammatory diseases requiring systemic treatment, the use of the drug as part of combination therapy is necessary.
Contraindications
hypersensitivity to benzidamine or other components of the
drug children under 3 years of age.
Precautions
Hypersensitivity to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs, bronchial asthma (including a history of).
Special instructions
Hypersensitivity reactions may occur with the use of the drug. In this case, it is recommended to discontinue treatment and consult a doctor to prescribe appropriate therapy.
In a limited number of patients, the presence of ulcers in the throat and oral cavity may indicate a more serious pathology. If symptoms persist for more than 3 days, consult a doctor.
The use of the drug is not recommended in patients with hypersensitivity to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs. The drug should be used with caution in patients with a history of bronchial asthma due to the possibility of developing bronchospasm in patients with the drug. The drug contains parahydroxybenzoates, which can cause allergic reactions. The drug contains 13.2 mg of ethanol in a single dose (single injection). Ethanol content in a single dose:
– for adults (including elderly patients) and children over 12 years old – 52.8 – 105.6 mg
– for children from 6 to 12 years old – 52.8 mg
– for children from 3 to 6 years old – 13.2 mg of ethanol for every 4 kg of body weight, but not more than 52.8 mg (maximum single dose).
Influence on the ability to drive vehicles and mechanisms
Does not affect the ability to drive vehicles and work with mechanisms.
Composition
1 dose
benzydamine hydrochloride 0.255 mg
Excipients:
ethanol 95% – 13.89 mg,
glycerol (glycerin) – 8.52 mg,
methyl parahydroxybenzoate mg 0.1,
sodium sulfate 0.1 mg, 0.05 mg mg,
sodium bicarbonate – 0.019 mg,
polysorbate 20 – 0.009 mg,
sodium hydroxide solution 1 M or a solution of hydrochloric acid 0.5 M – up to pH 5.0-7.0,
water d / i – up to 170 μl.
Dosage and Administration
Locally, after meals. One dose (one injection) corresponds to 0.255 mg of benzidamine.
Adults (including elderly patients) and children over 12 years of age – 4-8 injections 2-6 times a day.
Children from 6 to 12 years old – 4 injections 2-6 times a day.
For children from 3 to 6 years old – 1 injection for every 4 kg of body weight, but no more than 4 injections (maximum single dose) 2-6 times a day.
Course of treatment
Duration of treatment is 7 days if after 7 days of treatment there is no improvement, it is necessary to consult a doctor.
Side effects
Classification of the incidence of side effects according to the World Health Organization (WHO):
Very often -> 1/10.
Often, from> 1/100 to <1/10. Infrequently – from> 1/1000 to <1/100. Rarely – from> 1/10000 to <1/1000. Very rare – <1/10000. Frequency unknown – cannot be estimated based on available data. In each group, unwanted effects are presented in decreasing order of severity. Local reactions: rarely – dry mouth, burning sensation in the oral cavity frequency is unknown – numbness in the oral cavity. Allergic reactions: infrequently – photosensitivity rarely – hypersensitivity reactions, skin rash, skin itching very rarely – angioedema, laryngospasm frequency unknown – anaphylactic reactions. If any of the side effects indicated in the instructions are aggravated, or any other side effects not listed in the instructions are noted, you should immediately inform your doctor. Drug Interactions No other drug interaction studies have been conducted. Overdose of Currently, no cases of overdose of the drug have been reported. Symptoms: when using the drug in accordance with the instructions for use, an overdose is unlikely. If the drug is accidentally swallowed, the following symptoms are possible: vomiting, abdominal cramps, anxiety, fear, hallucinations, cramps, ataxia, fever, tachycardia, respiratory depression. Treatment: symptomatic cleanse the stomach by inducing vomiting, or rinse the stomach using a gastric tube (under the supervision of a physician) to provide medical supervision, supportive therapy and necessary hydration. The antidote is not known. Storage conditions At a temperature not exceeding 25 ° C. Keep out of the reach of children. Term hodnosty 4 years Deystvuyuschee substances benzydamine Pharmacy terms OTC Possible product names Angidak spray for local use dosed 0.255 mg dose 15 ml
