VISUCLOBEN 1 mg /Ml Krople Do Oczu, Zawiesina
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Treść ulotki
VISUCLOBEN
1mg/ml eye drops, suspension
Clobetasone butyrate
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 their symptoms are the same as yours, because it could be harmful.
- If you get any side effects,including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet:
1. What VISUCLOBEN is and what it is used for
2. What you need to know before you use VISUCLOBEN
3. How to use VISUCLOBEN
4. Possible side effects
5. How to store VISUCLOBEN
6. Contents of the pack and other information
1. What VISUCLOBEN is and what it is used for
VISUCLOBEN is a medicine for ophthalmic (eye) use containing the active substance clobetasone
butyrate which belongs to a group of medicines called corticosteroids.
VISUCLOBEN is used in the treatment of:
- eye inflammationscaused by allergic diseases or eye inflammations not caused by the presence of microorganisms (allergic conjunctivitis, vernal conjunctivitis, keratoconjunctivitis phlyctenulosis, rosacea keratitis, interstitial keratitis, iritis, cyclitis, etc.)
- eye injuries(keratoconjunctival lesions from chemical-physical agents such as ultraviolet radiation, X-rays, heat, etc. or from penetration of foreign bodies). Consult your doctor if you do not notice any improvement or if you notice a worsening of symptoms after the prescribed days of therapy.
2. What you need to know before using VISUCLOBEN
Do not use VISUCLOBEN
- if you are allergicto clobetasone butyrate or to any of the other ingredients of this medicine (listed in section 6).
- in the presence of
- acute herpes simplex infections and most viral diseases of the front part of the eye (cornea), chickenpox in the acute phase, inflammation of the eye with superficial damage to the cornea even in the early stages (ulcerative keratitis); if your doctor has subjected you to fluorescein testing and this has resulted positive.
- fungal infections (tuberculosis, mycoses)
- eye inflammations (such as acute ophthalmitis and conjunctivitis) and of the eyelid margin (purulent and herpetic blepharitis)
- inflammations and infections of the eyelid (stye)
Warnings and precautions
Consult your doctor or pharmacist before using Visucloben.
Use Visucloben under medical supervision.
Do not use eye products based on steroid anti-inflammatory drugs (corticosteroids, to which
clobetasone belongs) after the removal of a superficial foreign body from the front
of the eye (cornea).
If you have been prescribed long-term or repeated treatment with these types of drugs, you must
provide for a periodic eye examination for:
- a careful evaluation of the cornea and lens (the internal lens of the eye).
- a check of the ocular pressure, although it has been shown that VISUCLOBEN has minimal undesirable effects on intraocular pressure in prolonged treatments. With some anti-inflammatory drugs for local use of the class to which VISUCLOBEN belongs (corticosteroids) have been reported:
- cases of cataract and corneal perforation
- viral, bacterial and fungal infections that may be activated, aggravated or masked by the use of these products. Fungal infections are particularly prone to develop on the occasion of prolonged local treatments with corticosteroids; if you have persistent corneal lesions (ulcerations) you should consider these infections. If you observe signs of hypersensitivity, you should stop using VISUCLOBEN. Continuous application for more than one month is not recommended. Always use the product under the personal control of the doctor. The correct use of Visucloben generally does not give rise to those undesirable effects that could occur if the medicine were taken, for example, by mouth; however, it is possible that the drops containing corticosteroids (such as clobetasone) are absorbed in sufficient quantity to cause a partial decrease in the activity of the gland above the kidney (adrenal gland) in adults and a hormonal disease in the child (Cushing's syndrome). Hereditary and degenerative eye diseases do not respond to treatment with corticosteroid-type anti-inflammatory drugs, such as clobetasone. Contact your doctor if you experience blurred vision or other visual disturbances. Children and adolescentsIn early infancy, the product should only be administered in case of actual need and under the direct control of the doctor.
Other medicines and VISUCLOBEN
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicine.
No interactions with other medicines are known.
Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
No studies have been conducted on VISUCLOBEN in pregnant women or during breastfeeding.
Driving and operating machinery
VISUCLOBEN does not alter or negligibly alters the ability to drive vehicles or operate
machinery.
VISUCLOBEN Eye drops, suspension (10 ml bottle) contains benzalkonium chloride
The medicine contains Benzalconium chloride 1 mg per 10 ml equivalent to 10 mg/100 ml which may which
can be absorbed by soft contact lenses and may 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 eye irritation, especially if you have dry eyes or
corneal disorders (the most superficial transparent layer of the eye). If you experience an
abnormal sensation in the eye, burning or pain after using this medicine, talk to your doctor.
3. How to use VISUCLOBEN
Use this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist.
The recommended dose is:
Adults
Instill 1 drop of VISUCLOBEN into the conjunctival sac 2 - 4 times a day.
In particularly severe cases, instill 1 drop every 1 - 2 hours until a significant
improvement is obtained; then decrease the frequency of instillations.
Children and adolescents
In very early infancy, the product should be administered only when actually necessary and under the
direct control of the doctor.
If you use more VISUCLOBEN than you should
In case of accidental ingestion/intake of an excessive dose of
VISUCLOBEN, contact your doctor immediately or go to the nearest hospital.
If you forget to use VISUCLOBEN
Do not use a double dose to make up for a missed dose.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, VISUCLOBEN can cause side effects, although not everybody gets them.
Locally, the following may occur:
- hypersensitivity reactionssuch as hyperemia (increased blood flow to the eye causing redness and swelling), burning and itching, which require discontinuation of therapy. Increases in pressure inside the eye have been reported in sensitive patients, but are generally milder and less frequent with Clobetasone than with other anti-inflammatory drugs of the same class (corticosteroids) for ocular use. Prolonged treatments may cause:
- ocular hypertension and/or glaucoma (serious eye disease)
- optic nerve damage, alterations in the visual field, cataract
- delayed wound healing
- infections
Rarely, patients receiving anti-inflammatory drugs (corticosteroids) by other routes of
administration or even locally in the eye, for other conditions, have reported:
- eye infections with Herpes simplex virus. Perforation has been described after the use of local anti-inflammatory drugs (steroids) in diseases that cause thinning of the front part of the eye (cornea and sclera).
Although not reported in patients treated with VISUCLOBEN, small watery blisters (serous vesicles) have been rarely
reported with anti-inflammatory (corticosteroid) therapy
after cataract surgery.
Blurred vision has been reported with an unknown frequency.
Reporting of side effects
If you get any side effects, even those 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 VISUCLOBEN
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry datewhich is stated on the packaging after Exp.
The expiry date refers to the last day of that month.
The expiry date refers to the product in intact packaging, correctly stored.
Store at a temperature not exceeding 25° C.
The eye drops must be used within 30 days of first opening the bottle.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help protect the environment.
6. Contents of the pack and other information
What VISUCLOBEN contains
VISUCLOBEN Eye drops, suspension (10 ml bottle)
The active ingredient is: clobetasone-17-butyrate
100 ml of eye drops, suspension contains: clobetasone-17-butyrate 100 mg;
The other ingredients are: macrogol 300, benzalkonium chloride, sodium citrate, citric acid
monohydrate, polyvinyl alcohol, water for injections
Description of the appearance of VISUCLOBEN and contents of the pack
VISUCLOBEN Eye drops is presented as a suspension, in packs of:
1 Bottle of 10 ml
Marketing Authorisation Holder
VISUFARMA S.p.A.
Via Alberto Cadlolo, 21
- 00136 - Rome - Italy
Manufacturer
VISUCLOBEN Eye drops, suspension 10 ml bottle
TUBILUX PHARMA S.p.A.
Via Costarica, 20-22
Pomezia (Rome)
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- Kraj rejestracji
- Postać farmaceutycznaEye drops, suspension, 1 MG/ML
- Kod ATCS01BA09
- Substancja czynna
- Wymaga receptyNie
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki VISUKLOBENPostać farmaceutyczna: Eye drops, solution, 0.1%Substancja czynna: clobetasoneProducent: OMNIVISION ITALIA SRLBez receptyPostać farmaceutyczna: Eye drops, solution, 0.3 MLSubstancja czynna: hydrocortisoneProducent: DOC GENERICI SRLWymaga receptyPostać farmaceutyczna: Eye drops, solution, 1,5 MG/MLSubstancja czynna: dexamethasoneProducent: DOC GENERICI SRLWymaga recepty
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VISUKLOBEN nie wymaga recepty w Włochy. Możesz skonsultować się z lekarzem online, aby sprawdzić, czy ten lek może być odpowiedni w Twojej sytuacji.
Substancją czynną w VISUKLOBEN jest clobetasone. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
VISUKLOBEN 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 VISUKLOBEN 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 VISUKLOBEN 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 (clobetasone) to m.in. KLOBET, KORTIVIS, DESADOK. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
