Allergodil eye drops,solution 0.5mg/ml 6m

Allergodil 0.5 mg/ml eye drops 6 ml

Name: Allergodil
Form: eye drops solution
Dose: 0.5 mg/ml
Packaging: 6 ml (bottle)

Allergodil Description and indications

Indications for use :

• treatment and prevention of symptoms of allergic seasonal conjunctivitis in adults and children over 4 years of age;
• treatment of symptoms of year-round allergic conjunctivitis in adults and children over 12 years of age.

Allergodil, eye drops are used in the relief of redness, itching and tearing of the eyes occurring with hay fever or as a result of allergic reactions to agents such as dust mites and animal dander.

Allergodil, eye drops are used for eye problems accompanying hay fever in adults and children aged 4 years and older.

Allergodil, eye drops are used for eye problems caused by allergies to factors such as dust mites and animal dander in adults and children 12 years of age and older.

Do not use Allergodil, eye drops to treat eye infections.

Action

Azelastine, a phthalazinone derivative, is a compound with a strong and long-lasting anti-allergic effect. It acts antagonistically, selectively on H1 receptors. When applied topically to the eyes, the drug also exhibits anti-inflammatory effects. Preclinical in vivo and in vitro studies show that azelastine reduces the synthesis or release of chemical mediators involved in the early and late phases of the allergic reaction, such as leukotrienes, histamine, PAF (platelet-activating factor) and serotonin. In previous studies in patients taking long-term high doses of azelastine orally, ECG results have confirmed that administration of multiple doses of the product does not cause clinically significant changes in the corrected QT interval (QTc). No association was observed between azelastine treatment and the occurrence of ventricular arrhythmias or torsade de pointes in more than 3,700 patients treated with the oral form of azelastine.

Composition - what ingredients the drug Allergodil contains

1 ml of Allergodil drops contains 0.5 mg of azelastine hydrochloride.

Dosage - how to use the drug Allergodil

Seasonal allergic conjunctivitis. Adults and children over 4 years: usually 1 drop of the drug is administered into each eye, 2x/day. If necessary, this dose can be increased to 1 drop, administered 4x/day. Eye drops can be administered prophylactically before anticipated exposure to the allergen. Year-round allergic conjunctivitis. Adults and children over 12 years: usually 1 drop of Allergodil is administered into each eye, 2x/day. If necessary, this dose can be increased to 1 drop, administered 4x/day. In clinical trials, the efficacy and safety of Allergodil eye drops were confirmed during treatment lasting up to 6 weeks, so 1 cycle of treatment with the product should be limited to 6 weeks.

Contraindications

Hypersensitivity to azelastine hydrochloride or to any of the excipients.

Notes and warnings about the drug Allergodil

This is a medication. For safety, use it according to the package insert. Do not exceed the maximum dose of the drug. If in doubt, consult your doctor or pharmacist.

Special warnings / Precautions

Allergodil eye drops are not indicated for the treatment of eye infections. The drug product, eye drops, contains benzalkonium chloride, a preservative commonly used in ophthalmic preparations, but which may cause punctate keratitis and/or toxic ulcerative keratitis. In addition, benzalkonium chloride can cause eye irritation and discoloration of soft contact lenses. As with other eye drops, eye drops should not be worn with contact lenses while using the product. Slight transient eye irritation caused by dropping the product can be expected. This is unlikely to cause significant visual impairment. However, patients experiencing any transient visual disturbance should not drive or operate machinery until these symptoms have resolved.

Interactions

No studies have been conducted on the interaction of the product, eye drops with other drugs. The results of studies on the interaction of large doses of azelastine hydrochloride in oral form are known, but they are insignificant in the case of the drug, eye drops, because the concentration of the active substance in the body after dropping the product is very small (on the order of picograms).

Pregnancy and lactation

There are insufficient data to confirm the safety of azelastine in women during pregnancy. In experimental animal studies, large oral doses of the substance caused adverse effects (fetal death, growth retardation and skeletal malformations). After topical application of the product, concentrations of the active substance in the body are minimal (on the order of picograms), however, caution should be exercised when using the product, eye drops during pregnancy. Small amounts of azelastine penetrate into breast milk and therefore the use of roduct, eye drops in breastfeeding women is not recommended.

Side effects

Immunological system disorders: (very rarely) allergic reactions. Nervous system disorders: (not very often) bitter taste in the mouth. Eye disorders: (frequently) eye irritation.

Overdose

Specific symptoms of overdose following ocular administration of the product are not known. When the product is used according to the recommended route of administration, overdose is unlikely. There is no experience with toxic doses of azelastine hydrochloride in humans. After overdose or in cases of intoxication, central nervous system disorders can be expected (analogous to those found in animal studies). In such cases, symptomatic treatment should be used. There is no known specific antidote for azelastine.

Responsible Entity
Mylan Healthcare Sp. z o.o.