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نشرة الممارس الصحي نشرة معلومات المريض بالعربية نشرة معلومات المريض بالانجليزية صور الدواء بيانات الدواء
 لم يتم إدخال بيانات نشرة معلومات المريض لهذا الدواء حتى الآن
 لم يتم إدخال بيانات نشرة معلومات المريض لهذا الدواء حتى الآن
 Read this leaflet carefully before you start using this product as it contains important information for you

OCULAC® Eye Drops

Sodium chloride 0.3% and Hypromellose 0.5% For a full list of excipients, see section 6.1.

Eye Drops Clear colourless solution free of suspended particles.

Used topically to provide tear-like lubrication for the symptomatic relief of dry eyes and eye irritation associated
with
deficient tear production. (Usually in cases of rheumatoid arthritis, keratoconjunctivitis sicca and xerophthalmia).
Also used as an ocular lubricant for artificial eyes.


Adults, children and the elderly. The dose depends on the need for lubrication. Usually one to two drops to each
eye three times daily or as prescribed.


Hypersensitivity to any component of the product.

If irritation persists or worsens, or headache, eye pain, vision changes or continued redness occur, discontinue
use and
consult a physician.
To preserve sterility do not allow the dropper to touch the eye or any other surface.
The product contains benzalkonium chloride and should not be used when soft contact lenses are worn


None.


Fertility
Studies have not been performed to evaluate the effect of topical ocular administration of hypromellose on fertility.
Hypromellose is a pharmacologically inert compound and it would not be expected to have any effect on fertility.
Pregnancy
There are no or limited amount of data from the use of ophthalmic hypromellose in pregnant women. Systemic
exposure to hypromellose following topical ocular administration is negligible and the product has no
pharmacological properties.
Lactation
It is unknown whether topical hypromellose/metabolites are excreted in human milk. No effects on the breastfed
newborn/infant are anticipated since the systemic exposure of the breast-feeding woman to hypromellose is
negligible. In addition to this, hypromellose is pharmacologically inert.


OCULAC Eye Drops May cause transient blurring of vision on instillation.
Do not drive or operate hazardous machinery unless vision is clear.



Due to the characteristics of this preparation, no toxic effects are to be expected with an ocular overdose of this
product, nor in the event of accidental ingestion of the contents of one bottle.


Ophthalmologicals: Other ophthalmologicals
ATC code: SO1X A20
Hypromellose is an inert substance. It has no pharmacological activity.


Hypromellose is an inert substance. It has no pharmacological activity and, hence, the pharmacokinetic properties
have not been studied.


Hypromellose is an inert substance and is not expected to be absorbed systemically. Hence, although no systemic
toxicity studies have been conducted it is not expected to demonstrate any systemic toxicity or to have any effect
on reproductive processes.
Similarly, no specific local ocular toxicity or irritation studies have been conducted, however, no adverse effects
are anticipated. Indeed, hypromellose ophthalmic solution is used as a control in some ophthalmic drug studies
because of the acknowledged low level of toxicity.


Boric acid
Borax
Disodium Edetate
Benzalkonium chloride solution
Water for injection


Not applicable


36 months (unopened). 1 month once opened

Store below 25°C
Protect from light
Do not freeze


10 ml polyethylene bottle with white polyethylene cap and white pilfer proof.


None stated.


Medical and Cosmetic Products Company Ltd. (Riyadh Pharma) P.O.Box 442, Riyadh 11411 Fax: +966 11 265 0505 Email: contact@riyadhpharma.com For any information about this medicinal product, please contact the local representative of marketing authorisation holder: Saudi Arabia Marketing department Riyadh Tel: +966 11 265 0111 Email: marketing@riyadhpharma.com

03/2023
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