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Package leaflet
Information for use, please, read carefully!
UNIDEXA® 0,1% UNIMED PHARMA®
(Dexamethasoni natrii phosphas)
Eye drops, solution
Manufacturer: UNIMED PHARMA Ltd., Bratislava, Slovak Republic
Composition:
Active substance:
Dexamethasoni natrii phosphas (dexametasone phosphate disodium salt) 1mg in 1
mL of solution
Excipients:
Benzalkonii chloridum (benzalconium chloride), Dexpanthenolum (dexpanthenol),
Natrii chloridum (sodium chloride), Dinatrii phosphas dodecahydricus (sodium
hydrogen phosphate), Natrii dihydrogenophosphas dihydricus (sodium dihydrogen
phosphate), Dinatrii edetas dihydricus (disodium edetane), Polysorbatum 80
(polysorbate 80), Hypromellosum (hypromellose), Aqua purificata (purified water).
Pharmacotherapeutic group: Ophthalmologics.
Charakteristics: Dexametasone is a synthetic glucocorticosteroid (the adrenal
cortex derivative) showing significant anti-inflammatory and anti-allergic effects.
Those effects it achieves by blocking the A2 phospholipase enzyme by retardation of
leokocytes transfer to a fokus of inflammation, by phagocytosis obstruction and by
retardation of kinins freeing.
Indications: the UNIDEXA® 0.1 % UNIMED PHARMA® product is used in cases of
the non-specific allergic conjunctiva inflammation, the non-infectious inflammations of
eye-lashes, conjunctiva, cornea and the eye front segment (parts) tissue structures,
as keratoconjunctivitis, iritis, iridocyclitis, episcleritis and scleritis are. Moreover, it is
utilized after injuries (a foreign particle penetration, chemical, light and thermal
damage of cornea) and after eye surgeries, to reduce inflammatory reactions and to
suppress immunologic reactions during healing after cornea transplantation.
Contraindications: The product must no be used in case of over-sensitiveness on
the active substance or on any component of the product. It must not be also used in
case of the suppurative eye inflammations and in case of inflammations induced by
viruses (for instance the infections caused by the Herpes simplex virus, smallpox), at
the tuberculous eye infection or in case of the eye infection induced by the diseasecausing fungi or moulds. The product must not be used by the patients suffering from
glaucoma and from cornea damage and ulcer. Extra serious reasons and increased
caution is required in case of the patients suffering from diabetes mellitus.
The product must not be applied to new-borns. There must be extra serious reasons
for the eye drops application to pregnant and nursing mothers and to children.
Unwanted effects: The product is very well tolerated. The risk of unwanted effect at
short-term application is little. However, log-term usage may lead to the intraocular
pressure increase and to glaucoma origination. Also the cornea and the albuginea
oculi weakening and thinning (danger of a hole generation) and the sub-capsular
cataract (cloudiness under the corneal capsule) origination may occur. Sometime,
subsequent eye infections may occur, wounds healing may be retarded, rarely ptosis
(the eye lid drop) and the cornea expansion occur. Immediately after application a
blurred vision may occur.
Risk of overall unwanted effects is necessary to be taken in account mainly in case of
a long-term treatment by high doses, especially in children case. If such unwanted
effects or other unusual reactions occur, it is necessary to call your doctor
immediately.
Interactions: The UNIDEXA® 0.1 % UNIMED PHARMA® product and other
simultaneously used products effects may mutually affect. Therefore, your doctor
should be informed about all medicines you actually use, or you plan to use, as those
on prescription, so as those freely distributed. If another doctor would plan to
prescribe to you a new medicine, inform him you already use the UNIDEXA ® 0.1 %
UNIMED PHARMA® eye drops, solution.
Simultaneous usage of the UNIDEXA® 0.1 % UNIMED PHARMA® product and
mydriatics (the drug products expanding the cornea) increases the risk of the
intraocular pressure raising. The UNIDEXA® 0.1 % UNIMED PHARMA® product may
reduce effect of the medicines used for the intraocular pressure reduction.
Dosage and drug application method: Individually, according to illness
seriousness. The exact dosage and treatment duration is always set up by a doctor.
In case of severe or acute inflammations, 1 drop every 60 minutes into the
conjunctival sac, after symptoms improvement 1 drop every 4 hours, eventually later
1 drop 3-4 times daily.
The product may be combined with local antibiotics.
Attention: Besides of special cases, therapy duration should not exceed two weeks.
In case of long-term treatment it is recommended to attend regular controls of the
intraocular pressure in intervals set up by a doctor.
The product may affect ability of driving motor vehicles and operating machines.
Wearing the contact lenses simultaneously with the product application is not
allowed.
In case of dosing according to prescription, overdose is practically excepted. In case
of the UNIDEXA® 0.1 % UNIMED PHARMA® eye drops, solution incidental one-shot
usage, in adults no inadequate reaction is expected. In case of the product usage by
a child, call a doctor.
Warning: The product must not be used after the shelf life, stated on a package,
expiration. The open container content should be used up to 1 month. After the
medicine application, close a container immediately. The product must be stored out
of the children hand.
Packaging: 1  10 mL, 1 x 5 mL
Storage: Do not store above 25oC. Do not refrigerate. Protect to light.
Date of the last revision:
Oriešková 11, 821 05 Bratislava,
Slovak Republic