Description

Azel-Drop Free is a medicinal product in the form of eye drops. It contains the active ingredient azelastine hydrochloride, which belongs to the group of antiallergic (antihistamine) medications. The product does not contain preservatives.

Composition

The active substance is azelastine.

One ml of eye drops contains 0.5 mg of azelastine hydrochloride.

One drop contains 0.015 mg of azelastine hydrochloride.

Excipients: Sorbitol; Hypromellose (2663 – 4970 mPa*s); Disodium edetate; Sodium hydroxide (to adjust pH); Purified water.

Dosage

Always use this medicine exactly as described in the package leaflet or as directed by your doctor or pharmacist. If you have any further questions, ask your doctor or pharmacist.

Seasonal allergic conjunctivitis

For adults and children aged 4 years and over, the most common dose is one drop in each eye twice daily. If necessary, this dose can be increased to one drop four times daily. Azel-Drop Free can be administered prophylactically before anticipated exposure to an allergen.

Non-seasonal (perennial) allergic conjunctivitis

Adults and adolescents aged 12 years and over usually receive one drop in each eye twice daily. If necessary, the dose can be increased to one drop four times daily. Clinical trials have shown the efficacy and safety of this product for a maximum of 6 weeks of treatment, therefore a single treatment cycle should be limited to 6 weeks.

Note on self-medication:

Treatment of seasonal conjunctivitis for periods longer than 6 weeks should only be performed under medical supervision. It is recommended to consult a doctor if symptoms worsen or if the patient's condition does not improve within 48 hours.

Action

Azelastine, which is the active substance of Azel-Drop Free, has anti-allergic and local anti-inflammatory properties.

Indications

Azel-Drop Free eye drops are indicated for the treatment and prevention of symptoms of allergic, seasonal conjunctivitis in adults and children under 4 years of age and for the treatment of symptoms of non-seasonal (perennial) allergic conjunctivitis in adults and adolescents over 12 years of age.

Contraindications

The medicine should not be used Azel-Drop Free in case of hypersensitivity to the active substance or any of the product's ingredients.

Side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Common (affects 1 to 10 users in 100): mild, transient irritation (e.g. burning, itching, tearing)

Uncommon (affects 1 to 10 users in 1,000): bitter taste in the mouth.

Very rare (affects less than 1 in 10,000 people): allergic reactions (such as rash and itching).

Warnings and precautions

Azel-Drop Free is not intended to treat eye infections.

Patients on long-term treatment should be monitored. This product contains 0.0035 mg of benzalkonium chloride in each drop, which corresponds to a concentration of 0.125 mg/ml.

This medicine contains benzalkonium chloride, which may cause eye irritation, dry eye symptoms, and may affect the tear film and corneal surface. It should be used with caution in patients with dry eye syndrome and in patients whose cornea may be at risk.

Benzalkonium chloride may be absorbed by soft contact lenses and discolor them. Remove contact lenses before applying the drops and wait at least 15 minutes before reinserting them.

Keep out of the sight and reach of children, at a temperature below 25°C, in the outer packaging to protect from light.

Do not use the medicine after 4 weeks after first opening the bottle.

Use of other medications

Please tell your doctor or pharmacist about all the medicines you are taking, have recently taken or are planning to take, including medicines obtained without a prescription.

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Special caution should be exercised when using Azel-Drop Free during pregnancy.

The drug passes into breast milk in small amounts - its use during lactation is not recommended.

Use of the drug in children and adolescents

For seasonal symptoms, the drug can be used in children aged 4 and over. It can also be used to treat year-round symptoms in adolescents aged 12 and over.

Driving and operating machinery

Caution should be exercised if temporary visual disturbances occur.