RELUVIZ * COLL 25FL 0.5ML

RELUVIZ * COLL 25FL 0.5ML

Therapeutic indications

Symptomatic treatment of seasonal allergic conjunctivitis.

Dosage and method of use

Dosage.Adults, seniors and children (over 3 years):One drop of Reluviz in the conjunctival sac twice a day.Children:Reluviz is not recommended for use in children 3 years of age and younger due to a lack of clinical data.Method of administration:Ophthalmic use.Multidose bottle. The patient should be instructed to: 1. Wash hands thoroughly before using the product. 2. Bring the tip of the dropper closer to the eye, possibly with the help of the mirror, avoiding touching the eye or eyelid or any surface with the dropper tip to avoid contaminating the solution. 3. Instill a drop in the eye, looking up and slightly lowering the lower lid, until a “pocket” forms between the lid and the eye. 4. Close the eyelids and operate the nasolacrimal occlusion for 1-2 minutes. This will help reduce systemic absorption. 5. Wash your hands before repeating the procedure for the second eye if the eye drops are to be used in both eyes. 6. Close the cap tightly after use.Single-dose container.The patient should be instructed to: 1. Wash hands thoroughly before using the product. 2. Open the foil pouch containing a strip of 5 single-dose containers and separate one for use. 3. Open the container by turning the cap fully in a 360 ° turn. 4 Tilt your head back and gently pull the lower lid down with your finger to form a pocket between the lid and the eye. 5. Place the tip of the single-dose container close to the eye, without touching it to apply a drop of solution. 6. Close the eyelids and operate the nasolacrimal occlusion for 1-2 minutes. This will help reduce systemic absorption. 7. Wash your hands before repeating the procedure for the second eye if the eye drops are to be used in both eyes. Reluviz single-dose does not contain preservatives, once opened, it must be thrown away after use even in case of partial use. If a drop does not enter the eye, repeat the operation.

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Side effects

Adverse reactions are ranked under headings of frequency using the following convention: very common: (≥1 / 10), common: (≥1 / 100 toDisorders of the immune system.Uncommon: Hypersensitivity.Nervous system disorders.Uncommon: Headache.Eye disorders.Common: Eye irritation, eye pain, punctate keratitis, punctate erosion of the corneal epithelium; uncommon: Blurred vision (during instillation), dry eye, eyelid disorder, conjunctivitis, photophobia, conjunctival haemorrhage.Gastrointestinal disorders.Uncommon: dry mouth.Skin and subcutaneous tissue disorders.Uncommon: rash, eczema, urticaria.General disorders and administration site conditions.Uncommon: Somnolence.Adverse reactions from post-marketing experience (frequency not known).The following post-marketing events have been observed: - hypersensitivity reactions including local allergic reactions (mostly contact dermatitis, eye swelling, itching and edema of the eyelids), systemic allergic reactions including swelling / edema of the face (in some cases associated with contact dermatitis) and exacerbation of pre-existing allergic conditions, such as asthma and eczema; - dizziness.Reporting of suspected adverse reactions:Reporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Special warnings

No particular precautions. Talk to your doctor or pharmacist before taking this medicine.Children and adolescents:This medicinal product should not be given to infants and children under 3 years of age due to lack of clinical data.Reluviz eye drops in multidose bottle contains benzalkonium chloride:Reluviz eye drops in multidose bottle contains the preservative benzalkonium chloride which can be absorbed by soft contact lenses and can lead to a change in their color. Therefore Reluviz eye drops in multidose bottle should not be used if the patient wears this type of lens. Lenses need to be removed before fitting and you need to wait 15 minutes before putting them back on. Benzalkonium chloride can cause eye irritation, dry eye, alteration of the film and of the corneal surface. To be used with caution in patients with dry eye and corneal compromise. Patients should be monitored for prolonged use.

Pregnancy and breastfeeding

Pregnancy:There are no or limited data on the use of ketotifen eye drops in pregnancy. Animal studies with toxic oral doses have shown an increase in pre- and postnatal mortality, but have not shown teratogenic effects. Systemic levels after ocular administration are much lower than those after oral use. As a precautionary measure, it is preferable to avoid the use of Reluviz during pregnancy.Feeding time:Although data from animal studies following oral administration demonstrate excretion into breast milk, topical administration of ketotifen in women is unlikely to produce detectable quantities in breast milk. Reluviz eye drops can be used during breastfeeding.Fertility:There are no data available on the effect of ketotifen hydrogen fumarate on fertility.

Expiration and retention

This medicinal product does not require any special storage conditions. For storage conditions after first opening of the medicinal product, see section 6.3.

Interactions with other drugs

If Reluviz is used concomitantly with other eye medications, at least 5 minutes should elapse between the application of the two medications. Oral administration of ketotifen may potentiate the effects of CNS depressants, antihistamines and alcohol. Although these phenomena have not been observed with ketotifen-containing eye drops, the possibility of such effects cannot be excluded.

Overdose

No cases of overdose have been reported. Oral intake of the contents of a 5 ml bottle is equivalent to 1.25 mg of ketotifen, which is 60% of a recommended daily oral dose for a 3-year-old child. Clinical results indicated no serious signs or symptoms after ingestion of a dose of up to 20 mg of ketotifen.

Active principles

One ml contains 0.345 mg of ketotifen hydrogen fumarate corresponding to 0.25 mg of ketotifen.Excipient with known effects:This medicine in the multidose container contains 0.05 mg / ml of benzalkonium chloride. For the full list of excipients, see section 6.1.

Excipients

Multi-dose eye drops:Glycerol; Sodium hydroxide (for pH adjustment); Water for injections; Benzalkonium chloride.Single-dose eye drops:Glycerol; Sodium hydroxide (for pH adjustment); Water for injections.