Reluviz - eye drops 25 vials of 0.5 ml

Product Description

Symptomatic treatment of seasonal allergic conjunctivitis.

Indications

Reluviz eye drops is an ocular product that treats the symptoms of eye allergy, or seasonal allergic conjunctivitis.

Composition

Active ingredients

One ml contains 0.345 mg of ketotifen hydrogen fumarate corresponding to 0.25 mg of ketotifen.

Excipients

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

Directions for use and Dosage

Dosage.
Adults, elderly and children (over 3 years): One drop of Reluviz in the conjunctival sac twice a day.

Children: The use of Reluviz is not recommended in children aged 3 years and under due to the lack of clinical data. Method of administration: Ophthalmic use.
Single-dose container. The patient should be instructed to:

1. Wash hands thoroughly before using the product.
2. Open the aluminum sachet containing a strip of 5 single-dose containers and separate one for use.
3. Open the container by completely rotating the cap 360°.
4. Tilt your head back and gently pull down the lower eyelid with one finger to form a pocket between the eyelid 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 perform 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 if only partially used.
If a drop misses the eye, repeat the operation.

Warnings

No special precautions.
Talk to your doctor or pharmacist before taking this medicine.
Children and adolescents: This medicine should not be administered to infants and children under 3 years of age due to the lack of clinical data.

Contraindications

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

Undesirable effects

Adverse reactions are classified according to frequency using the following convention: very common: (>1/10), common: (>1/100 to <1/10), uncommon: (>1/1,000 to <1/100), rare: (>1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).

Immune system disorders. 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 eyelid oedema), systemic allergic reactions, including facial swelling/oedema (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 suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

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, equal to 60% of a recommended daily oral dose for a 3-year-old child.
Clinical results have not indicated serious signs or symptoms after ingestion of a dose of up to 20 mg of ketotifen.

Pregnancy and breastfeeding

Pregnancy: There are no or limited data on the use of ketotifen eye drops during pregnancy.
Animal studies with oral toxic doses have shown an increase in pre- and post-natal 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.
Breastfeeding: Although data from animal studies after oral administration demonstrate excretion in breast milk, topical administration of ketotifen to 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.

Storage

This medicinal product does not require any special storage conditions.

Format

25 single-dose vials of 0.5 ml