RELESTAT

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

EPINASTINE HYDROCHLORIDE

Available from:

ABBVIE BIOPHARMACEUTICALS LTD, ISRAEL

ATC code:

S01GX10

Pharmaceutical form:

OPHTHALMIC SOLUTION

Composition:

EPINASTINE HYDROCHLORIDE 0.05 %W/V

Administration route:

OCULAR

Prescription type:

Required

Manufactured by:

ALLERGAN PHARMACEUTICALS IRELAND

Therapeutic group:

EPINASTINE

Therapeutic area:

EPINASTINE

Therapeutic indications:

Treatment of the symptoms of seasonal allergic conjunctivitis.

Authorization date:

2020-10-31

Patient Information leaflet

REL APL MAR 23 CL
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS
(PREPARATIONS)
– 1986
The medicine is dispensed with a doctor's prescription only
RELESTAT
®
OPHTHALMIC SOLUTION
ACTIVE INGREDIENT AND ITS CONCENTRATION:
epinastine hydrochloride 0.05% w/v
Inactive ingredients and allergens in this medicine: see section 2
under "Important
information about some of
this medicine’s
ingredients", and section 6 "Additional
information".
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. This
leaflet contains
concise information about the medicine. If you have any further
questions, refer to the
doctor or pharmacist.
This medicine has been prescribed to treat your illness/for you. Do
not pass it on to
others. It may harm them, even if it seems to you that their
illness/medical condition is
similar to yours.
1. WHAT IS THIS MEDICINE INTENDED FOR?
For treatment of the symptoms of seasonal allergic conjunctivitis.
THERAPEUTIC GROUP: Decongestants and anti-allergy drugs
(antihistamines).
Seasonal allergic conjunctivitis is a seasonal allergic disease
affecting the eye. The main
symptoms treated by Relestat include watery eyes and eyes or eyelids
which are itchy,
red or swollen.
2. BEFORE USING THE MEDICINE
DO NOT USE THIS MEDICINE IF:
you are sensitive (allergic) to the active ingredient epinastine
hydrochloride or to any of
the other ingredients in this medicine (listed in section 6
–
“Additional information”).
SPECIAL WARNINGS ABOUT USING THIS MEDICINE
BEFORE USING RELESTAT, TELL YOUR DOCTOR IF:
•
YOU WEAR SOFT CONTACT LENSES: you must remove them before using the
Relestat
solution. After using Relestat, wait at least 15 minutes before
putting your lenses back
in. See also Section 2 - "Important information about some of
this medicine’s
ingredients".
•
YOU HAVE TO USE ANY OTHER EYE DROPS DURING TREATMENT WITH RELESTAT:
leave at least
10 minutes between putting in Relestat and the other drops.
CHILDREN AND ADOLESCENTS
REL APL MAR 23 CL
Do not use Relestat in children und

Summary of Product characteristics

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CL
Page 1 of 7
1.
NAME OF THE MEDICINAL PRODUCT
Relestat
®
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
0.05% w/v epinastine hydrochloride.
Excipient(s) with known effect: benzalkonium chloride 0.1 mg/ml and
phosphate 4.75 mg/ml.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Ophthalmic solution.
A clear colourless sterile solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of the symptoms of seasonal allergic conjunctivitis
.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose for adults is one drop instilled in each affected
eye
twice daily, during the symptomatic period.
There is no experience in clinical studies with the use of Relestat
for more
than 8 weeks.
_Older people _
Relestat has not been studied in older people. Post-marketing safety
data
from the tablet formulation of epinastine hydrochloride (up to 20 mg
once
daily) indicates that there are no particular safety issues for older
people
compared with adult patients. As such, no dosage adjustment is
considered to
be necessary.
_Paediatric population _
The safety and efficacy in children ≥12 years has been established
in clinical
trials. Relestat may be used in adolescents (12 years of age and
older) at the
same dosage as in adults.
The safety and efficacy of Relestat in children aged less than 3 years
have not
been established. No data are available. There are limited data on the
safety
in children aged 3-12 years described in section 5.1
.
_Patients with _hepatic impairment
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Page 2 of 7
Relestat has not been studied in patients with hepatic impairment.
Post-marketing safety data from the tablet formulation of epinastine
hydrochloride (up to 20 mg once daily) indicates that the incidence of
adverse
reactions was higher in this group compared with adult patients
without
hepatic impairment. The daily dose of a 10 mg epinastine hydrochloride
tablet
is more than 100-fold higher than the daily dose following Relestat.
In
addition, the metabolism of epinastin