Levoreact Ofta Eye Drops 4 ml 0.5 mg/ml

Levoreact Ofta Eye Drops is an antihistamine eye drop specifically formulated for the treatment of ocular symptoms of seasonal and chronic allergies, such as redness, itching and excessive tearing. Its active ingredient, la levocabastine, works by blocking the action of histamine, a substance that the body produces during allergic reactions, thus helping to reduce the associated symptoms. Levoreact Ofta offers fast and long-lasting relief from allergic eye disorders.

Levoreact Ofta Eye Drops it is indicated for:

• Symptomatic treatment of seasonal and perennial allergic conjunctivitis.

• Relieve eye symptoms such as redness, itching and tearing associated with allergies.

INDICATIONS

Why is Levoreact Ofta Eye Drops 4 ml 0.5 mg/ml used? What is it for?

Allergic conjunctivitis.

ACTIVE INGREDIENTS AND EXCIPIENTS

What is the composition of Levoreact Ofta Eye Drops 4 ml 0.5 mg/ml?

Composition

One ml of eye drops, suspension contains: levocabastine hydrochloride 0.54 mg (equal to 0.5 mg of levocabastine). Excipients with known effects: propylene glycol, benzalkonium chloride.

Excipients

Propylene glycol, sodium dihydrogen phosphate monohydrate, disodium hydrogen phosphate anhydrous, hydroxypropyl methylcellulose 2910, polysorbate 80, benzalkonium chloride, disodium edetate, water for injections.

DOSAGE

How is Levoreact Ofta Eye Drops 4 ml 0.5 mg/ml taken?

Dosage Adults and children: the usual dose is 1 drop of Levoreact Ophthalmic per eye, 2 times a day. The dose can be increased to 1 drop up to 3 or 4 times a day. Treatment must be continued for the period necessary for the symptoms to disappear. Method of administration Ophthalmic use. For instructions on the use and handling of the medicine before administration.

CONTRAINDICATIONS AND SIDE EFFECTS

When should Levoreact Ofta Eye Drops 4 ml 0.5 mg/ml not be used and what side effects can it cause?

Contraindications

Hypersensitivity to the active substance or to any of the excipients (see the section "What is the composition of Levoreact Ofta Eye Drops 4 ml 0.5 mg/ml?").

Side effects

Adverse drug reactions identified during clinical and epidemiological studies and with postmarketing experience following the use of Levoreact Oftalmico are reported in the Table 1; frequencies are reported according to the following conventional classification: Very common ≥1/10 Common ≥1/100 and less than 1/10 Uncommon ≥1/1000 and less than 1/100 Rare ≥1/10,000 and less than 1/1000 Very rare less than 1/10,000 Not known The frequency cannot be estimated from the available data Table 1: Adverse drug reactions identified during clinical trials and postmarketing experience with Levoreact Ophthalmic. Cardiac diseases Does not notice palpitations Eye pathologies Common Eye pain, blurred vision; Uncommon Edema of the eyelids; Not known Conjunctivitis, eye swelling, blepharitis, ocular hyperemia. Systemic pathologies and conditions relating to the administration site Common Application site reaction, including burning/eye irritation, eye irritation. Very rare Reaction at the application site, such as redness of the eyes, ocular itching. Not known Application site reaction, such as tearing. Immune system disorders Not known Angioedema, hypersensitivity, anaphylactic reaction. Pathologies of the skin and subcutaneous tissue Not known Contact dermatitis, urticaria. Nervous system disorders Common Headache. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.

INTERACTIONS

Which medicines or foods can modify the effect of Levoreact Ofta Eye Drops 4 ml 0.5 mg/ml?

No interaction studies have been carried out.

PREGNANCY AND BREASTFEEDING

Can Levoreact Ofta Eye Drops 4 ml 0.5 mg/ml be used during pregnancy and breastfeeding?

Pregnancy Studies conducted in animals have not shown embryotoxic or teratogenic effects. Postmarketing data regarding the use of levocabastine eye drops, suspension in pregnant women are limited; the risk for humans is not known, therefore Levoreact Ophthalmic should not be used during pregnancy, unless the potential benefit for the woman justifies the potential fetal risk. Breastfeeding Based on determinations of the concentration of levocabastine in saliva and breast milk of a breastfeeding woman who has been administered a single 0.5 mg oral dose of levocabastine, approximately 0.3% of the total dose of levocabastine administered ophthalmologically is expected to be transmitted to the nursing infant. However, due to the limited availability of clinical and experimental data, caution is recommended when administering Levoreact Ophthalmic to breastfeeding women. Fertility Animal data showed no effects on male or female fertility.

WARNINGS

What are the warnings of Levoreact Ofta Eye Drops 4 ml 0.5 mg/ml?

Warnings and precautions

As with all ophthalmic preparations containing benzalkonium chloride, propylene glycol and esters, patients should be advised not to use soft (hydrophilic) contact lenses during treatment with Levoreact Ophthalmic eye drops suspension because they may cause eye irritation. Remove contact lenses before applying the medicine and wait at least 15 minutes before putting them back. The medicine discolors soft contact lenses.

Overdose

Symptoms No cases of overdose have been reported with Levoreact Ophthalmic. However, the occurrence of sedation after accidental ingestion of the contents of the bottle cannot be excluded. Treatment In case of accidental ingestion, advise the patient to drink plenty of non-alcoholic liquids in order to accelerate the renal elimination of levocabastine.

Driving vehicles and using machinery

Levoreact Ophthalmic does not induce sedation or interfere with psychomotor activity. Adverse reactions such as irritation, pain, swelling, itching, redness of the eyes, burning sensation in the eyes, tearing and blurred vision have been reported. Therefore, caution is advised when driving vehicles and using machinery after applying Levoreact Oftalmico.

CONSERVATION

How is Levoreact Ofta Eye Drops 4 ml 0.5 mg/ml stored?

Do not store above 25°C.

FORMAT

What is the format of Levoreact Ofta Eye Drops 4 ml 0.5 mg/ml?

4 ml

DRUG LEGAL TEXT

Content responsibility

This sheet contains information that is not intended to replace a doctor's diagnosis or advice, as only the doctor can draw up any prescription and give therapeutic indications. All contents must be understood and are of an exclusively informative nature and aimed exclusively at bringing to the attention of customers or potential customers in the pre-purchase phase of the products sold through this site. In case of pathologies, disorders or allergies it is always best to consult your doctor first.

Please note

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