EYECON

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

HYALURONIC ACID AS SODIUM

Available from:

GEM PHARMA LTD

ATC code:

S01KA01

Pharmaceutical form:

EYE DROPS, SOLUTION

Composition:

HYALURONIC ACID AS SODIUM 0.15 MG/ML

Administration route:

OCULAR

Prescription type:

Not required

Manufactured by:

PHARMA STULLN GMBH, GERMANY

Therapeutic group:

HYALURONIC ACID

Therapeutic area:

HYALURONIC ACID

Therapeutic indications:

Symptomatic treatment of dry eye syndrome.

Authorization date:

2021-12-09

Patient Information leaflet

PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACIST’S REGULATIONS
(PREPARATIONS) 1986
The medicine is dispensed without a doctor's prescription
EYECON
Eye drops
Sterile solution without a preservative
COMPOSITION: the active ingredient and its quantity:
Sodium Hyaluronate 0.15 mg/ml
INACTIVE INGREDIENTS: see section 6: "Additional Information".
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. This
leaflet contains concise information about the medicine.
If you have further questions, refer to the doctor or the pharmacist.
This medicine is intended for adults (over 18 years old). You should
use
the medicine according to the instructions given in the dosage section
of
this leaflet. Consult with the pharmacist if you need further
information.
Consult with the doctor if your dry eye symptoms get worse.
1.
WHAT IS THIS MEDICINE INTENDED FOR ?
Eyecon is intended for treating symptoms of eye dryness (dry eye
syndrome).
THERAPEUTIC GROUP: eye lubricants.
2. BEFORE USING THIS MEDICINE
SPECIAL WARNINGS REGARDING THE USE OF THE MEDICINE
BEFORE USING EYECON, TELL THE DOCTOR:
-
If you have or have ever had impaired eye function (such as glaucoma).
There are no studies of the effect of Eyecon on intraocular pressure
or
effects on its measurement.
DO NOT USE EYECON:
-
If you are sensitive (allergic) to the active ingredient or to any of
the other
ingredients of this medicine.
-
In cases where there is an increased risk of internal or external
inflammation of
the eye (for instance after eye surgery or when a patient has a
tendency to get
inflammations).
CHILDREN AND ADOLESCENTS:
Eyecon is not recommended for use in children and adolescents under 18
years of age due to lack of clinical experience in this age group.
DRUG INTERACTIONS:
IF YOU ARE TAKING OR HAVE RECENTLY TAKEN, OTHER MEDICINES INCLUDING
NONPRESCRIPTION MEDICINES AND NUTRITIONAL SUPPLEMENTS, TELL THE DOCTOR
OR PHARMACIST. If you are being treated with other eye medicines, wait
at least
5 minutes before applying Eyecon eye drops. Eyecon must be the last
m

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
(SMPC)
1.
NAME OF THE MEDICINAL PRODUCT
Eyecon
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance: sodium hyaluronate (biotechnologically produced with
the help of a
natural strain of Streptococcus)
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Eye drop, solution in unit-dose containers
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Symptomatic treatment of dry eye syndrome
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Unless otherwise directed by the doctor, place 4 times a day, 1 drop
in the conjunctival
sac. The maximum dosage is up to 8 times daily 1 drop. However,
various studies
showed that more than 4 times daily applications do not lead to
further improvement.
Eyecon should not be used if there is an increased risk of infection
of the inner and outer
eye (e.g. after eye operations or in patients susceptible to
infections).
Eyecon is not recommended for use in children under 18 years of age
due to lack of
clinical experience.
Method of administration
Ocular use.
If different medication is additionally applied to the eye, then there
should be an interval
of at least 5 minutes between applications. Always administer Eyecon
last. Clinical
experience is only available with patients over 18 years of age.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active ingredient or to any of the excipients
listed in section 6.1.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
No studies regarding the influence of Eyecon on intraocular pressure
or its impact
on measurement results are available.
The contact lenses do not have to be removed during the application if
the
ophthalmologist approves of contact lens wear for the underlying
primary disease.
4.5
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
None known so far.
4.6
FERTILITY, PREGNANCY AND LACTATION
No risks were demonstrated by reproduction studies, although
controlled studies on
pregnant women are not available.
4.7
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
Vi