Allergodil eye drops 0.05% 6ml №1

Name:
Allergodil. Release form Eye drops. Dosage 0.05% 6 ml. Qty per package: 1 pc. ProducerMeda pharma. MNNAzelastine. FTSH1-histamine receptor blocker.
Description:
A transparent, colorless solution that does not contain visible mechanical impurities. Composition 1 vial (6 ml) contains: Active ingredient: azelastine hydrochloride 3 mg. Excipients: hypromellose, disodium edetate, benzalkonium chloride, sorbitol, sodium hydroxide, water for injection. Pharmacotherapeutic groupMeans used in ophthalmology. Means used to eliminate inflammatory edema (decongestants) and other antiallergic drugs. Other antiallergic drugs. ATX code: S01GX07 Pharmacological properties Azelastine, a derivative of phthalazinon, is a strong long-acting antiallergic drug that selectively blocks Hi receptors. When applied to the mucous membrane of the eye, additional anti-inflammatory and membrane-stabilizing effects of azelastine appear. In vivo (preclinical data) and in vitro data show that azelastine inhibits the synthesis or release of chemical mediators of the early and late phase of allergic reactions, for example, leukotriene, histamine, platelet activating factor and serotonin. To date, ECG evaluation during long-term therapy in patients taking high doses of oral azelastine has shown that there is no clinically significant effect of azelastine on the QT (QTc) interval in multiple dose studies. Azelastine was not associated with the occurrence of ventricular arrhythmia or bidirectional ventricular tachycardia in 3700 patients treated with oral azelastine. Relief of the symptoms of allergic conjunctivitis should be noted after 15-30 minutes. Indications for use Prevention and treatment of symptoms of seasonal allergic conjunctivitis in adults and children 4 years of age and older; treatment of symptoms of non-seasonal (year-round) allergic conjunctivitis in adults and children 12 years of age and older. Contraindications Hypersensitivity to the active substance or other components of the drug. Dosage and administration Seasonal allergic conjunctivitis: in the absence of other doctor’s recommendations, adults and children over 4 years of age, instill 2 drops a day (morning and evening) into each eye. If necessary, the dose is increased up to 4 times a day, one drop in each eye. In case of expected exposure to an allergen, the drug is used for prophylactic purposes. Non-seasonal (year-round) allergic conjunctivitis: in the absence of other doctor’s recommendations, adults and children over 12 years of age, instill 2 times a day (morning and evening), 1 drop in each eye. If necessary, the dose is increased up to 4 times a day, one drop in each eye. Based on the safety and efficacy that have been demonstrated in clinical trials up to 6 weeks, the duration of any course of treatment should not exceed 6 weeks. Relief of the symptoms of allergic conjunctivitis should be observed after 15-30 minutes. If symptoms worsen or continue for more than 48 hours without improvement, a doctor should be consulted. If one or more doses of eye drops are missed, they should be used as soon as the patient remembers this. The next dose should be taken at the usual time. Patients should not take a double dose to make up for a missed one. Interruption or discontinuation of treatment with Allergodil eye drops is likely to cause a return of the symptoms of the disease. Side effects Information on adverse reactions is presented in accordance with the system-organ classification and frequency of occurrence. Frequency categories were defined according to the following classification: very often (>1/10), often (>1/100, but <1/10), infrequently (>1/1000, but <1/100), rare (>1 /10,000 but <1/1,000), very rare (<1/10,000), frequency unknown (cannot be estimated from available data). Immune system disorders: Very rare: allergic reactions (such as rash and itching). Nervous system disorders: Uncommon: bitter taste. On the part of the organ of vision: Often: slight transient eye irritation. Reporting adverse reactions If you experience any adverse reactions, please consult your physician. This recommendation applies to any possible adverse reactions, including those not listed in the package insert. You can also report adverse reactions to the adverse drug reactions (actions) information database, including reports of drug failures. By reporting adverse reactions, you help to get more information about the safety of the drug. Overdose Characteristic reactions after overdose are unknown, overdose reactions are unlikely. There is no experience with toxic doses of azelastine hydrochloride in humans. Based on animal studies, in case of overdose or intoxication, central nervous system disturbances are to be expected. Treatment of such disorders should be symptomatic. There is no known antidote. Interaction with other medicinal products and other types of interaction No relevant studies have been conducted with Allergodil eye drops. Studies have been conducted regarding the study of interactions of high oral doses of azelastine, but they are not applicable to Allergodil eye drops, since systemic levels after the use of eye drops are in the picogram range. Precautions This drug is not intended for the treatment of eye infections. Allergodil eye drops contain 0.00375 mg of benzalkonium chloride in each drop, which is equivalent to 0.00375 mg / 0.03 ml. Benzalkonium chloride may be absorbed by soft contact lenses and may discolor contact lenses. Before use, contact lenses must be removed and put on again at least 15 minutes after use. Benzalkonium chloride can also cause eye irritation, especially in dry eye syndrome or in diseases of the cornea (the clear layer at the front of the eye). If you have an abnormal feeling in the eye, burning or pain after using this drug, you should contact your doctor. Influence on the ability to drive vehicles and work with mechanisms After the use of Allergodil eye drops, slight short-term irritation may occur, a more significant effect on vision is unlikely. However, if any transient effects on vision are observed, the patient is advised to wait until these phenomena have disappeared before operating machines and mechanisms. Fertility, pregnancy and lactation Fertility The effect on human fertility has not been studied. Pregnancy There is insufficient information regarding the safety of the use of azelastine during pregnancy in women. The use of high doses of azelastine orally has shown that in animals used in experimental studies, undesirable effects (fetal death, growth retardation and skeletal malformation) occur. Application as an eye drop (topically) will result in minimal systemic exposure. However, caution should be exercised when using Allergodil eye drops during pregnancy. Lactation Azelastine passes into breast milk in small amounts. Therefore, it is not recommended to use Allergodil eye drops during lactation. Packaging Eye drops, 0.05% solution. 6 ml solution in a translucent high-density polyethylene vial with a low-density polyethylene dropper with a white high-density polyethylene cap. 1 bottle together with instructions for use is placed in a cardboard box. Storage conditions At temperatures not higher than . Keep out of the reach of children. Shelf life 3 years. After opening the vial, the drug should be used within 4 weeks. Do not use after the expiry date stated on the package. Holiday conditions Without a prescription. Buy Allergodil eye drops 0.05% 6ml №1 Price for Allergodil eye drops 0.05% 6ml №1 Instructions for use for Allergodil eye drops 0.05% 6ml №1