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DIRECTION FOR USE
(Information laeflet in English)
Information for use, read carefully!
HYPROMELOZA-P®
(Hypromellosum 5 mg/ml)
Form: Eye drops, solution
Manufacturer: UNIMED PHARMA Ltd., Bratislava, Slovak Republic
Composition of medical device:
Hypromellosum (Hypromellose )5 mg in 1 ml of solution
Excipients:
Dexpanthenolum (Dexpanthenol), Benzalkonii chloridum (benzalkonium chloride),
Natrii chloridum (sodium chloride), Dinatrii edetas (disodium edetate), Aqua ad
iniectabilia (water for injections).
Characteristics:
The HYPROMELOZA-P® is the product with protective epithelization and wetting
effect.
On
the
cornea
and
the
conjunctiva
surface
hypromellose
(hydroxypropylmethylcellulose) creates a temporary protective film, which way it
makes the eye external surface wet and it serves as a replacement in case of the tears
insufficient creation. It gives quick relax in case of smaller eye irritations of not
infection origin. It removes the "dry eyes" feeling. Present dexpanthenol (the B group
vitamine) contributes to quicker regeneration of cells on the cornea surface
(epithelization).
Usage:
The HYPROMELOZA-P® product is used for treatment of insufficient tear creation
and dry eyes syndrome (keratoconjunctivitis sicca) e.g. in the Sjögren syndrome upon
doctor´s recommendation.
The product can be used in cases of small cornea erosions by dropping tiny particles
into the conjunctival sac or after eye surgeries.
It helps also to relieve itching and uncomfortable feelings accompanying the eye simple
irritations due to wind, dust, smoking, contaminated atmosphere, contact lenses, etc., as
well as the eye fatigue due to long-term reading, driving motor vehicles, watching TV
or computer minitor screen.
The product can be used by adults, juveniles and children.
Do not use in case:
The product must not be used in case of oversensitiveness on its components and
simultaneously with wearing soft contact lenses. Also in the acute phase of the eye etch,
until the etching substance and the perished tissue from the conjunctival sac total
removal.
Undesirable effects:
Less common these side effects may occur: eye irritation, hyperaemia, itching and
stickiness of eyelashes.
In case of unusual reactions eventual occurrence consult the product using continuation
with an ophthalmologist.
Interactions:
The HYPROMELOZA-P® product must not be used simultaneously with the eye
products containing metal salts. If you take also other eye products, consult suitability
of simultaneous utilization with an ophthalmologist. However, in general it is
recommended to keep at least 5 minutes between other eye products and the
HYPROMELOZA-P® product application.
Dosage and administration.
It is individual; 1-2 drops 2-3 times daily are applied to the eye conjunctival sac. It is
also possible to apply 1-2 drops every hour if necessary.
Special warning:
If the problems, which the product was applied, will not retrieve during two days or
they get even worse, call your ophthalmologist, who will examinate you and eventually
recommend another form of treatment.
Immediately after the product application unclear vision can occur, that could make
motor vehicles driving and machines operation more difficult. Therefore, it is
recommended to perform these activities soonest after twenty minutes after the product
application.
It is not allowed to wear the soft lenses simultaneously with the product application.
Before application of the product it is necessary take them out and to wear them again
soonest 30 minutes after the application.
If the product is accidentally digested, no side effects even in case of children are
expected. Drinking large amount of liquid is recommended and in case of child eventual
examination by a paediatrician, if some problems occur.
Instructions for use:
The preparation is intended for ocular use after opening.
A protective cap should be screwed off; a patient bends his/her head back slightly,
turns the bottle up down and instills a prescribed number of drops into the lower
conjunctival sac by squeezing a plastic bottle. A dropper tip should avoid contact with
the eye or eyelids. At last, a cap should be screwed tightly in order to avoid
contamination. Bottle is stored in vertical position.
Packaging: 1  10 ml
Storage:
Store the product at the temperature up to 25C. Do not refrigerate/freeze. The product
must not be used after expiration of the shelf life marked on the cover. The open
packaging is to be utilized up to 28 days. Keep the product out of reach and sight of
children
Date of the text last revision: March 2009
Oriešková 11, 821 05 Bratislava,
Slovak Republic
„CE1299“