Levoreact Ofta Eye Drops 4 ml 0.5 mg/ml

Levoreact Ofta Eye Drops is an antihistamine eye drop specifically formulated to treat the ocular symptoms of seasonal and chronic allergies, such as redness, itching and excessive tearing. Its active ingredient, 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 provides fast and long-lasting relief from allergic eye disorders.

Levoreact Ofta Eye Drops are indicated for:

• Symptomatic treatment of seasonal and perennial allergic conjunctivitis.

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

ACTIVE INGREDIENTS

Active ingredients contained in Levoreact Ofta Eye Drops 4 ml 0.5 mg/ml - What is the active ingredient in Levoreact Ofta Eye Drops 4 ml 0.5 mg/ml?

One ml of eye drops, suspension contains: levocabastine hydrochloride 0.54 mg (equivalent to 0.5 mg of levocabastine).

EXCIPIENTS

Composition of Levoreact Ofta Eye Drops 4 ml 0.5 mg/ml - What does Levoreact Ofta Eye Drops 4 ml 0.5 mg/ml contain?

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

DIRECTIONS

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

Allergic conjunctivitis.

CONTRAINDICATIONS SIDE EFFECTS

Contraindications Levoreact Ofta Eye Drops 4 ml 0.5 mg/ml - When should Levoreact Ofta Eye Drops 4 ml 0.5 mg/ml not be used?

Hypersensitivity to the active substance or to any of the excipients.

DOSAGE

Quantity and method of taking Levoreact Ofta Eye Drops 4 ml 0.5 mg/ml - How to take Levoreact Ofta Eye Drops 4 ml 0.5 mg/ml?

Adults and children: The usual dose is 1 drop in each eye, 2 times a day. The dose may be increased to 1 drop up to 3 or 4 times a day. Treatment should be continued for as long as symptoms resolve. Method of administration: Ophthalmic use.

CONSERVATION

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

Do not store above 25 degrees C.

WARNINGS

Warnings Levoreact Ofta Eye Drops 4 ml 0.5 mg/ml - It is important to know that Levoreact Ofta Eye Drops 4 ml 0.5 mg/ml:

As with all ophthalmic preparations containing benzalkonium chloride, propylene glycol and esters, patients should be advised not to wear soft (hydrophilic) contact lenses whilst taking the suspension eye drops as they may cause eye irritation. Contact lenses should be removed prior to application of the medicinal product and should wait at least 15 minutes before putting them back in. The medicinal product discolours soft contact lenses.

INTERACTIONS

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

No interaction studies have been performed.

SIDE EFFECTS

Like all medicines, Levoreact Ofta Eye Drops 4 ml 0.5 mg/ml can cause side effects - What are the side effects of Levoreact Ofta Eye Drops 4 ml 0.5 mg/ml?

Frequency of adverse reactions: very common >=1/10, common >=1/100 and <1/10, uncommon >=1/1,000 and <1/100, rare >=1/10,000 and <1/1,000, very rare <1/10,000, not known. Cardiac disorders. Not known: palpitations. Eye disorders. Common: eye pain, blurred vision; uncommon: eyelid oedema; not known: conjunctivitis, eye swelling, blepharitis, ocular hyperaemia. General disorders and administration site conditions. Common: application site reaction, including burning sensation/irritation in the eyes, eye irritation; very rare: application site reaction, such as eye redness, eye itching; not known: application site reaction, such as tearing. Immune system disorders. Not known: angioedema, hypersensitivity, anaphylactic reaction. Skin and subcutaneous tissue disorders. Not known: contact dermatitis, urticaria. Nervous system disorders. Common: headache. Report any suspected adverse reactions via the national reporting system.

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 for advice before taking Levoreact Ofta Eye Drops 4 ml 0.5 mg/ml

Studies in animals have not shown any embryotoxic or teratogenic effects. Postmarketing data on the use of levocabastine eye drops, suspension in pregnant women are limited; the risk for humans is unknown, therefore it should not be used during pregnancy unless the potential benefit for the woman justifies the potential risk to the fetus. Based on determinations of levocabastine concentrations in saliva and breast milk, of a nursing woman administered a single oral dose of 0.5 mg levocabastine, it is expected that approximately 0.3% of the total ophthalmologically administered levocabastine dose may be transmitted to the infant. However, due to the limited availability of clinical and experimental data, caution is recommended when administering the drug to nursing women. Animal data have shown no effect on male or female fertility.