RELESTAT SOLUTION

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Abbvie (Pty) Ltd

Dosage:

See ingredients

Pharmaceutical form:

SOLUTION

Composition:

EACH 1,0 ml SOLUTION CONTAINS EPINASTINE HYDROCHLORIDE 0,5 mg

Authorization status:

Registered

Authorization date:

2006-11-08

Patient Information leaflet

AbbVie (Pty) Ltd
Relestat
Epinastine hydrochloride 0,5 mg/ml
Eye Drops
1.3.2 Patient Information Leaflet
Page 1 of 6
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS
Schedule 2
PROPRIETARY NAME, STRENGTH AND PHARMACEUTICAL FORM
RELESTAT, EPINASTINE HYDROCHLORIDE 0,5 mg/ml, eye drops
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
RELESTAT
is available
without a
doctor’s
prescription, for
you
to
treat
a
mild
illness.
Nevertheless you still need to use RELESTAT carefully to get the best
results from it.

Keep this leaflet. You may need to read it again.

Do not share RELESTAT with any other person.

Ask your pharmacist if you need more information or advice.

You must see a doctor if you symptoms worsen or do not improve after
10 days.
1.
WHAT RELESTAT CONTAINS
The active substance is epinastine hydrochloride. One ml of eye drop
solution contains 0,5 mg
of epinastine hydrochloride.
The other ingredients are benzalkonium chloride 0,01 % _m/v_ (a
preservative), disodium edetate,
sodium chloride, sodium dihydrogen phosphate dehydrate and purified
water.
2.
WHAT RELESTAT IS USED FOR
RELESTAT is an anti-allergic eye drop solution used to treat the
symptoms of seasonal allergic
conjunctivitis, 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.
3.
BEFORE YOU USE RELESTAT
DO NOT USE RELESTAT:

If you are allergic (hypersensitive) to epinastine hydrochloride,
benzakonium chloride, or any
of the other ingredients of RELESTAT listed in section “WHAT
RELESTAT CONTAINS”.
AbbVie (Pty) Ltd
Relestat - 0.5 mg/ml (Eye drops)
Date of Submission: 24 February 2023
Module: 1.5.5.4
AbbVie (Pty) Ltd
Relestat
Epinastine hydrochloride 0,5 mg/ml
Eye Drops
1.3.2 Patient Information Leaflet
Page 2 of 6
TAKE SPECIAL CARE WITH RELESTAT:

RELESTAT is a topical eye drop and should not be injected or taken
orally;

IF YOU WEAR SOFT CONTACT LENSES: you must remove them before using
R

Summary of Product characteristics

AbbVie (Pty) Ltd
Relestat
Epinastine hydrochloride 0,5 mg/ml
Eye Drops
1.3.1.1 Professional Information
Page 1 of 6
SCHEDULING STATUS
Schedule 2
PROPRIETARY NAME AND DOSAGE FORM
RELESTAT Eye drops
COMPOSITION
Epinastine hydrochloride 0,5 mg per ml.
Excipients: Benzalkonium chloride 0,01 % m/v as preservative, disodium
edetate, sodium
chloride, sodium dihydrogen phosphate dihydrate, purified water.
PHARMACOLOGICAL CLASSIFICATION
A.15.4 Ophthalmic preparations. Other
PHARMACOLOGICAL ACTION
PHARMACODYNAMIC PROPERTIES
Epinastine is a topically active, direct H
1
-receptor antagonist, with a high binding affinity for the
histamine H
1
-receptor and a 400 times lower affinity for the histamine H
2
-receptor. Epinastine
also possesses affinity for the α
1
-, α
2
-, and the 5-HT
2
-receptor. It has low affinity for cholinergic,
dopaminergic and a variety of other receptor sites. Epinastine does
not readily penetrate the
blood/brain barrier.
Following topical eye application in animals, epinastine showed
evidence for antihistaminic
activity, a modulating effect on the accumulation of inflammatory
cells and mast cell stabilising
activity.
In provocation studies with allergens in humans, epinastine was able
to ameliorate ocular
symptoms following ocular antigen challenge. The duration of the
effect was at least 8 hours.
PHARMACOKINETIC PROPERTIES
Following administration of one drop of RELESTAT in each eye twice
daily, an average
maximum plasma concentration of 0,042 ng/ml is reached after about two
hours.
Epinastine has a volume of distribution of 417 litres and is 64 %
bound to plasma proteins.
The clearance is 928 ml/min and the terminal plasma elimination
half-life is about 8 hours. Less
AbbVie (Pty) Ltd
Relestat - 0.5 mg/ml (Eye drops)
Date of Submission: 24 February 2023
Module: 1.5.5.3
AbbVie (Pty) Ltd
Relestat
Epinastine hydrochloride 0,5 mg/ml
Eye Drops
1.3.1.1 Professional Information
Page 2 of 6
than 10 % is metabolised.
Epinastine is mainly excreted unchanged. The renal elimination is
mainly via active tubular