The package insert of the drug Relestat

the package insert of the medicine Relestat. Therapeutic class of Allergy. Active principles hydrochloride.

what For?

Relestat is an eye drop indicated for the treatment and prevention of the symptoms of
irritation and itching in the eyes that characterize allergic conjunctivitis seasonal.

Contraindications

When should I not use?

Relestat may not be used in people with an allergy to any of components
of formula.

Dosage

How to use?

Relestat is a clear colourless solution.

• You should use this medicine only in the eyes.
• Before you use the medicine, check out the name on the label, for there is no deception. Do not use Relestat if there are signs of tampering
and/or damage of the bottle.

• The solution already comes ready to use. Do not touch the tip of the bottle in the eyes, fingers or other surface any, to avoid the
contamination of the vial of eye drops.
• You must apply the number of drops of the dose recommended by your doctor in one or both eyes. The usual dose is 1 drop applied
in(s) eye(s) affected(s), two times a day.

• Pour the recommended dose into the eye, in the bag conjunctival, avoiding to touch the tip of the bottle in the tissues of the eye.
• The duration of treatment should be established by your doctor.
• If you use soft contact lenses or hydrophilic, remove the lenses before you apply Relestat
Wait at least 10-15 minutes to replace the lenses after the application of eye drops.

• If you are using Relestat concomitantly with other eye drops, wait an interval of 5 minutes between the application of each
medicine.

• Close the bottle well after use. Follow the guidance of your doctor, always respecting the schedules, doses and the duration of the
treatment. Do not stop treatment without the knowledge of your doctor. Do not use the medicine with the term of validity
loser. Before use note the appearance of the medicine.

Side Effects

What are the evils that can cause me?

as with any medicine, there can occur undesirable reactions. In clinical trials with Relestat the majority of the reactions
undesirable was transient and not presented severity requiring discontinuation of treatment. The reactions of the eye the most frequent were:
manifestations of local irritation after the application, such as burning eyes and blurred vision mild and transient. Other possible reactions are: eyes
red, swelling, dry eyes, increased sensitivity, intolerance to light and itching, among others. Were reported also, rarely, reactions in general such as: headache, asthma, nasal irritation, rhinitis, dry mouth, change of taste and itchy skin, among others. Tell your doctor if you experience reactions unpleasant.

ATTENTION: This product is a new drug, and while surveys have shown efficacy and acceptable safety for the marketing,
may occur as undesirable effects not known. If this occurs, the physician responsible should be reported.

Warnings and Precautions

what should I know before using?

You should pay attention to when you apply the drops of eyedrops in the eyes and not to touch the tip of the bottle in the eyes or around the eyes, or any other external surface. Handling wrong may contaminate the eye drops and cause infections in the eyes. Immediately look for the
your doctor to receive proper guidance, if you have some trauma or infection. Users of contact lenses Take the lenses before you apply Relestat and wait at least 10-15 minutes to replace them.
Interference in the ability to drive vehicles and operate machinery
The application of the eye drops generally does not cause vision changes. In case of mild blurring of vision soon after the application, it is recommended
wait until the vision returns to normal before driving a motor vehicle or operate machinery.
Elderly patients
No differences were observed in efficacy and safety between elderly patients and other age groups, so that there are no special recommendations regarding use in the elderly.

Use in children
The safety and efficacy of Relestat has been studied in pediatric patients older than 3 years.

This medicine is against-indicated in the age group of 0 to 3 years. Women who are pregnant or breastfeeding No studies have been conducted on the use of Relestat in patients who are pregnant or breastfeeding. Should not be used during pregnancy, and the
breastfeeding, except under medical guidance. Tell your doctor or dentist if pregnancy occurs or if you start to breastfeeding
during the use of this medicine.

Overdose

what to do if someone use a larger amount than is recommended?

there have been reported cases of superdose with Relestat (hydrochloride of epinastine) ophthalmic solution in humans. It is unlikely the occurrence of overdose as a vial of 5 ml of Relestat contains 2.2 mg, which is a quantity
of epinastine much lower than the dose contained in the tablets epinastine administered orally. Therefore it is not likely the occurrence of poisoning after oral intake, even if the entire content of the bottle is swallowed.