VISUCORTEX 1.5 MG/ML Krople do oczu, roztwór
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Treść ulotki
VISUCORTEX 1,5 mg/ml eye drops, solution
Desametasone sodium phosphate
Read this leaflet carefully before you start using this medicine as it contains
important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
- If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet:
- 1. What VISUCORTEX is and what it is used for
- 2. What you need to know before you use VISUCORTEX
- 3. How to use VISUCORTEX
- 4. Possible side effects
- 5. How to store VISUCORTEX
- 6. Contents of the pack and other information
1. What VISUCORTEX is and what it is used for
VISUCORTEX contains a substance called desamethasone. This substance is a
corticosteroid, a hormone that performs numerous activities, with an important function in controlling
inflammation.
VISUCORTEX belongs to a group of medicines called “Anti-inflammatory agents, Corticosteroids
not associated”.
VISUCORTEX is used for the treatment of inflammation of some parts of the eye
(conjunctiva, eyelid, cornea, sclera, uvea), also due to allergies, such as: allergic spring
conjunctivitis, blepharitis and blepharoconjunctivitis, allergic keratoconjunctivitis, scleritis and
episcleritis, uveitis.
2. What you need to know before using VISUCORTEX
Do not use VISUCORTEX:
- if you are allergic to dexamethasone or any of the other ingredients of this medicine (listed in section 6);
- if you have high pressure inside your eye (ocular hypertension);
- if you have eye infections caused by viruses (Herpes simplexinfections, viral corneal infections in the acute ulcerative stage);
- if you have inflammation of the conjunctiva (conjunctivitis) with corneal ulceration even in the early stages (positive fluorescein test);
- if you suffer from tuberculosis;
- if you have fungal eye infections (eye mycosis);
- if you have pus-filled eye infections (acute purulent ophthalmia, purulent conjunctivitis, purulent blepharitis and herpetic blepharitis);
- if you have an eyelid infection characterized by a swelling similar to a pimple or abscess (hordeolum);
- if you have injuries or abrasions to the cornea;
- if you are pregnant or breastfeeding (see “Pregnancy and breastfeeding”).
VISUCORTEX should not be used in children under three years of age.
Warnings and precautions
Talk to your doctor or pharmacist before taking VISUCORTEX.
The use, especially if prolonged, of corticosteroids, such as dexamethasone, can cause an
increase in pressure inside the eye.
If you use VISUCORTEX for more than two weeks, your doctor will check your
eye pressure.
Do not use VISUCORTEX for long periods, as the use of corticosteroids promotes the onset
of cataracts (a condition in which the lens becomes cloudy), which can also become irreversible
in the presence of viral infections (see "Do not use VISUCORTEX").
Your doctor will prescribe VISUCORTEX with great caution if you suffer from diseases accompanied by
thinning of the cornea.
If you suffer from corneal inflammation caused by Herpesviruses (herpetic keratitis),
VISUCORTEX will be prescribed to you only under strict control of the ophthalmologist.
The use of VISUCORTEX in the presence of conjunctivitis (caused by bacteria, viruses or fungi) can
hide the signs of worsening infection.
The use of VISUCORTEX in the presence of injuries delays healing, favoring the onset and
spread of any infections.
If you suffer from dry eyes and use VISUCORTEX frequently or for prolonged
periods, or have a compromised cornea, your doctor will perform careful checks.
Contact your doctor if you experience blurred vision or other visual disturbances.
Talk to your doctor if you experience swelling and weight gain around the trunk and face as
these are usually the first manifestations of a syndrome called Cushing's syndrome.
Suppression of the function of the adrenal glands can develop after discontinuation of a
prolonged or intensive treatment with VISUCORTEX. Talk to your doctor before
stopping treatment on your own. These risks are particularly important in children and in
patients treated with a medicine called ritonavir or cobicistat .
Children
In children from 3 to 12 years of age, the medicine should be administered only when actually necessary and under
direct medical supervision.
Other medicines and VISUCORTEX
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
Talk to your doctor if you are taking ritonavir or cobicistat, as they can increase the level of
dexamethasone in the blood.
Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, or are planning a pregnancy, or if you are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.
If you are pregnant, your doctor will prescribe VISUCORTEX only when absolutely necessary and
under his/her direct supervision.
Driving and using machines
VISUCORTEX does not impair the ability to drive vehicles or operate machinery. As with any
eye medicine, if you experience transient blurred vision during use, you should wait
until your vision returns to normal before driving or operating machinery.
VISUCORTEX eye drops in a multi-dose bottle contains benzalkonium chloride
VISUCORTEX eye drops, solution in a multi-dose bottle contains benzalkonium chloride 0.2 mg per 1
ml equivalent to 1 mg/ml which can be absorbed by soft contact lenses and can
lead to a change in their color. Remove contact lenses before using this medicine
and wait 15 minutes before re-applying them
Benzalkonium chloride can also cause irritation to the eyes, especially if you have dry eyes or
corneal disorders (the transparent superficial layer of the eye). If you experience an
abnormal sensation in the eye, burning or pain after using this medicine, talk to your doctor.
Benzalkonium chloride has been reported to cause some eye diseases (punctate keratopathy and/or toxic ulcerative keratopathy).
VISUCORTEX eye drops in a multi-dose bottle contains phosphate buffer.
VISUCORTEX eye drops, solution in a multi-dose bottle contains sodium phosphate monobasic dihydrate
1.656 mg per 1 ml equivalent to 8.283 mg in 5 ml and disodium phosphate dihydrate 4.97 mg per 1 ml
equivalent to 24.850 mg per 5 ml.
VISUCORTEX single-dose eye drops contains phosphate buffer.
VISUCORTEX eye drops, single-dose solution contains sodium phosphate monobasic dihydrate 1.656 mg
per 1 ml equivalent to 0.497 mg in 0.3 ml and disodium phosphate dihydrate 4.97 mg per 1 ml equivalent to
1.491 mg per 0.3 ml.
2. How to use VISUCORTEX
Use this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose is: one eye drop, three - four times a day, or as prescribed
by your doctor.
Apply the drop into the fold of the conjunctiva (conjunctival fornix).
Instructions for use
Eye drops, solution in a multi-dose bottle:
- 1) Remove the cap
- 2) Remove the cap from the bottle
- 3) If you wear contact lenses, remove them before applying the eye drops and reapply them after 15 minutes
- 4) Turn the bottle upside down and apply by pressing; avoid contact between the container's tip and your eye or other surfaces.
Eye drops, solution in single-dose containers:
- 1) Make sure the single-dose container is intact
- 2) Detach the single-dose container from the strip
- 3) Open by rotating the tab until the container is open
- 4) Turn the container upside down and apply by pressing.
If you use more VISUCORTEX than you should
No cases of overdose have been reported.
If you accidentally ingest VISUCORTEX or use it for a prolonged period at excessive doses,
toxic effects may occur. In case of accidental ingestion/intake of an excessive dose of VISUCORTEX, immediately inform your doctor or go to the nearest hospital.
Any overdose requires temporary discontinuation of administration in order to
avoid irritant, ulcerative phenomena or acute glaucoma. However, this interruption must be
carried out gradually. If accidentally ingested, drink fluids to dilute.
If you forget to use VISUCORTEX
Do not use a double dose to make up for a missed dose.
If you stop using VISUCORTEX
If you have any doubts about using this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Possible side effects due to desamethasone are:
- Increased pressure inside the eye after 15-20 days of application, in people predisposed to or affected by glaucoma.
- Opacification of the lens (cataract) following prolonged treatments.
- Eye irritation and eye perforation (scleral or corneal perforation), glaucoma and blurred vision;
- Hypersensitivity reactions and development or worsening of Herpes simplex or fungal or bacterial infections.
- Delayed wound healing.
In all these cases, the doctor will stop the treatment and prescribe adequate therapy.
Occasionally, the product may cause mild itching or burning.
Blurred vision has been reported with an unknown frequency.
Hormonal problems: increased hair growth on the body (especially in women), weakness and
muscle atrophy, purple stretch marks on the skin of the body, increased blood pressure,
irregular or absent menstrual cycle, changes in protein and calcium levels in the body, delayed growth
in children and adolescents and swelling and weight gain of the body and face (called
“Cushing's syndrome”) (see paragraph 2, “Warnings and precautions”).
Adverse reactions reported with eye drops containing phosphates
If you have severe damage to the outermost transparent layer of the eye (the cornea), phosphates may
cause, in very rare cases, opaque spots on the cornea due to calcium accumulation during
treatment.
Reporting of side effects
If you get any side effects, even if not listed in this leaflet, tell your doctor or pharmacist. You can also
report side effects directly through the national reporting system
at https://www.aifa.gov.it/web/guest/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the
safety of this medicine.
5. How to store VISUCORTEX
Keep this medicine out of the sight and reach of children.
Store at a temperature below 25°C.
The multi-dose bottle eye dropsmust be used within 28 days of first opening the
bottle; after this period, any remaining medicine must be discarded.
The single-dose container eye dropsmust be used immediately after opening the
container; any remaining medicine must be discarded.
After opening the aluminum sachet, the containers must be used within 28 days;
after this period, any remaining containers must be discarded.
Do not use this medicine after the expiry date which is stated on the pack after “Exp.:”. The
expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.
6. Contents of the pack and other information
What VISUCORTEX contains
VISUCORTEX 1.5 mg/ml eye drops, solution in a multi-dose bottle
- The active ingredient is: dexamethasone sodium phosphate. 1 ml of solution contains 1.5 mg of dexamethasone sodium phosphate.
- The other ingredients are: Trisodium citrate dihydrate, Disodium phosphate monobasic dihydrate, Disodium phosphate dihydrate, Benzalkonium chloride, Water for injections.
VISUCORTEX 1.5 mg/ml eye drops, solution in single-dose containers
- The active ingredient is: dexamethasone sodium phosphate. 1 ml of solution contains 1.5 mg of dexamethasone sodium phosphate.
- The other ingredients are: Trisodium citrate dihydrate, Disodium phosphate monobasic dihydrate, Disodium phosphate dihydrate, Water for injections.
Description of the appearance of VISUCORTEX and contents of the pack
VISUCORTEX is presented as eye drops, solution.
The contents of the pack are:
- Pack of one bottle containing 5 ml;
- Pack of 20 single-dose containers of 0.3 ml; each strip of 5 containers is packaged in an aluminum pouch.
Marketing Authorisation Holder
Visufarma S.p.A.
Via Alberto Cadlolo, 21
00136 Rome
Manufacturer
Genetic S.p.A., Contrada Canfora, 84084 Fisciano (SA)
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- Kraj rejestracji
- Postać farmaceutycznaEye drops, solution, 1,5 MG/ML
- Kod ATCS01BA01
- Substancja czynna
- Wymaga receptyTak
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki VISUKORTEXPostać farmaceutyczna: Eye drops, solution, 1,5 MG/MLSubstancja czynna: dexamethasoneProducent: DOC GENERICI SRLWymaga receptyPostać farmaceutyczna: Eye drops, solution, 1MG/MLSubstancja czynna: dexamethasoneProducent: LABORATOIRES THEAWymaga receptyPostać farmaceutyczna: Eye drops, solution in single-dose container, 1 MG/MLSubstancja czynna: dexamethasoneProducent: I.B.N. SAVIO S.R.LWymaga recepty
Odpowiedniki VISUKORTEX w innych krajach
Leki z tą samą substancją czynną dostępne w innych krajach.
Odpowiednik VISUKORTEX w Hiszpania
Odpowiednik VISUKORTEX w Polska
Odpowiednik VISUKORTEX w Ukraina
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Często zadawane pytania
VISUKORTEX wymaga recepty w Włochy. Możesz skonsultować się z lekarzem online, aby sprawdzić, czy ten lek może być odpowiedni w Twojej sytuacji.
Substancją czynną w VISUKORTEX jest dexamethasone. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
VISUKORTEX jest produkowany przez VISUFARMA S.P.A.. Nazwy handlowe i opakowania mogą się różnić w zależności od dystrybutora.
Lekarze, tacy jak Lekarze rodzinni, Psychiatrzy, Dermatolodzy, Kardiolodzy, Endokrynolodzy, Gastroenterolodzy, Pulmonolodzy, Nefrolodzy, Reumatolodzy, Hematolodzy, Zakaźnicy, Alergolodzy, Geriatrzy, Pediatrzy, Onkolodzy, mogą ocenić, czy stosowanie VISUKORTEX jest odpowiednie w Twoim przypadku, w zależności od sytuacji klinicznej i lokalnych przepisów. Możesz umówić konsultację online, aby omówić objawy i możliwe dalsze kroki.
Polska posiada dobrze rozwiniętą infrastrukturę ochrony zdrowia w dużych miastach, takich jak Warszawa, Kraków, Wrocław i Gdańsk. Apteki są łatwo dostępne i działają zgodnie z obowiązującymi przepisami, zapewniając dostęp do leków na receptę.
Możesz kupić VISUKORTEX w Warszawie, Krakowie, Wrocławiu lub Gdańsku w każdej aptece, posiadając ważną receptę.
Aby uzyskać receptę, możesz skorzystać z Oladoctor:
Inne leki zawierające tę samą substancję czynną (dexamethasone) to m.in. DESADOK, DEXAMONO, DEXAVISONE. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
