Possible adverse reactions are grouped according to systems and organs and frequency of occurrence: very often (≥1 / 10), often (≥1 / 100 to <1/10), infrequently (≥1 / 1000 to <1/100), rarely ( ≥1 / 10000 to <1/1000).
Within each group, serious reactions are listed first.
Like any drug, ORALAYR® can cause side reactions in some patients.
During treatment, both local and general adverse reactions may occur.
Reactions at the site of application (eg, itching in the mouth and irritation in the throat) usually occur at the beginning of therapy, are temporary and decrease over time. If the patient develops reactions at the site of application, then symptomatic therapy (for example, antihistamines) is possible.
Immediately stop taking the drug and consult a doctor if the following symptoms occur: severe symptoms in the throat region or systemic allergic reactions (i.e., rapid development of reactions on the skin and / or mucous membranes, shortness of breath, persistent abdominal pain, falling blood pressure and / or associated symptoms).
Treatment can be resumed only after a doctor's consultation.
Infectious diseases: often - nasopharyngitis, rhinitis; infrequently - oral herpes, otitis.
On the part of the blood and lymphatic system: infrequent - enlarged lymph nodes.
From the immune system: infrequently - hypersensitivity, oral allergic syndrome.
Disorders of the psyche: infrequently - depression.
From the nervous system: very often - headache; infrequently - a change in taste sensations, drowsiness, dizziness; rarely - anxiety.
From the side of the organ of vision: often - itching in the eyes, conjunctivitis, lacrimation; infrequent - redness of the eyes, swelling of the eyes, dry eye syndrome.
From the side of the hearing organ and labyrinthine disorders: often - itching of the ears; infrequently - discomfort in the ear.
From the side of the vessels: rarely - redness.
From the respiratory system, chest and mediastinum: very often irritation in the throat; often asthma, allergic rhinitis (nasal congestion, sneezing, runny nose, nose discomfort), cough, pain in the oropharynx, pharyngeal edema, sinus congestion, dyspnoea, dysphonia, dry throat, blisters in the oropharynx, discomfort in the oropharynx; infrequent - numbness in the throat, a feeling of tightness in the throat, wheezing, swelling of the larynx.
Disorders from the gastrointestinal tract: very often - itching in the mouth; often - abdominal pain, diarrhea, vomiting, edema of the mouth, tongue itching, swelling of the lips, oral paresthesia, dyspepsia, tongue edema, oral hypoesthesia, stomatitis, itching of lips, discomfort in the mouth, nausea, burning mouth syndrome, dry mucous oral cavity shell, swallowing disorder; infrequently - pain in the oral cavity. Gingivitis, cheilitis, gastritis, glossitis, salivary gland enlargement, gastroesophageal reflux, disorders in the area of the tongue (clinical signs of an allergic reaction in the area of the tongue associated with local release of histamine), increased salivation, ulcerative stomatitis, pain in the esophagus, swelling of the soft palate, disorders in the mouth (clinical signs of an allergic reaction in the mouth,associated with the local release of histamine), pain when swallowing, belching.
From the skin and subcutaneous tissues: often - hives, itching, atopic dermatitis; infrequently - Quincke's edema, rash, acne; rarely - swelling of the face.
General disorders and disorders at the site of administration: often - discomfort in the chest; infrequently - a feeling of restraint in the throat, asthenia, flu-like syndrome.
Laboratory and instrumental data: rarely - an increase in the number of eosinophils.
Trauma, intoxication and complications of manipulation: rarely - a tendency to mechanical damage to the skin.
In clinical trials with adult patients, a reduction in the number of side effects in treatment in the second and third flowering season was found compared with the first season.
Side effects when used in children and adolescents
The following side effects occur in children and adolescents more often than in adults: very often - cough, nasopharyngitis, edema of the oral cavity; often - oral allergic syndrome, cheilitis, glossitis, a feeling of tightness in the throat, discomfort in the ear.
In addition, children and adolescents had the following adverse reactions: often tonsillitis, bronchitis; infrequently - a pain in the chest.
Additional side effects found during use in children, adolescents and adults (post-registration experience, frequency of occurrence unknown): exacerbation of asthma, systemic allergic reaction, eosinophilic esophagitis.