CLOBET 0.1% Krople do oczu, roztwór
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Treść ulotki
CLOBET 0,1% eye drops, suspension
clobetasone-17-butyrate
Generic medicine
Read this leaflet carefully before 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 CLOBET is and what it is used for
- 2. What you need to know before you use CLOBET
- 3. How to use CLOBET
- 4. Possible side effects
- 5. How to store CLOBET
- 6. Contents of the pack and other information
1. What is CLOBET and what is it used for
This medicine is an eye drop that contains clobetasone-17-butyrate, an active ingredient belonging to the
group of corticosteroids, which reduces swelling and inflammation.
CLOBET is indicated in case of irritation, redness and itching of the eyes due to allergy or
inflammation (such as for example conjunctivitis, uveitis, keratitis) also caused by surgery or
physical or chemical factors (for example trauma, fumes, dust, intense lights or foreign bodies).
Consult your doctor if you do not notice any improvement or if you notice a worsening of symptoms after the days of
prescribed therapy.
2. What you need to know before using CLOBET
Do not use CLOBET if:
- you are allergic to the active ingredient or to any of the other ingredients of this medicine (listed in section 6) or to other medicines containing cortisone;
- you have eye infections due to herpes simplex, unless CLOBET has been prescribed to you in combination with other medicines to treat herpes;
- you have corneal infections due to viruses and associated with ulcers or if you have chickenpox in the acute phase;
- you have tested positive for the fluorescein test;
- you have eye infections or skin infections near the eyes, due to fungi (mycosis);
- you have eye infections that manifest with pus (purulent infections);
- you have tuberculosis of the eye;
- you have eye problems such as: increased eye pressure (intraocular hypertension), reduced vision (narrow-angle glaucoma), hordeolum or diseases that cause thinning of the cornea or the white part of the eye (sclera);
- you are pregnant or breastfeeding.
Do not use CLOBET withan airtight bandage (occlusive therapy), if you have a skin condition called atopic dermatitis.
Warnings and precautions
Consult your doctor or pharmacist before using CLOBET.
Do not use eye products based on steroid anti-inflammatory drugs (corticosteroids, to which clobetasone belongs) after removing a superficial foreign body from the front part of the eye (cornea).
Be careful with CLOBET, as with other eye medications based on cortisone:
- prolonged use may cause cataracts or increased eye pressure. In case of prolonged therapy, your doctor will assess the need to perform control tests;
- the use of contact lenses increases the risk of eye infection. For this reason, it is preferable not to use them during and immediately after the end of treatment. With some anti-inflammatory drugs for topical use of the class to which CLOBET belongs (corticosteroids) the following have been reported:
- cases of cataracts and corneal perforation
- viral, bacterial and fungal infections that can 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, you should consider these infections. If you observe signs of hypersensitivity, you should stop using CLOBET. 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 CLOBET 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 a 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 children (Cushing's syndrome). Hereditary and degenerative eye diseases do not respond to treatment with steroid-type anti-inflammatory drugs, such as clobetasone. Contact your doctor if you experience blurred vision or other visual disturbances.
Children and adolescents
In early infancy, the product should only be administered in case of actual need and under the direct control of the doctor.
Other medicines and CLOBET
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicine. This is particularly important if you are taking:
- medicines against increased eye pressure (antiglaucoma);
- medicines that act on the muscles of the eye, such as cycloplegics and mydriatics, for example atropine.
If you are using other eye drops or ointments other than CLOBET, allow at least 15 minutes to pass between the application of each medicine. The ophthalmic ointment should always be applied last.
Pregnancy, breastfeeding and fertility
Do not use CLOBET if you suspect you are pregnant, if you are pregnant or if you are breastfeeding.
Driving and operating machinery
Avoid taking CLOBET while driving vehicles or operating machinery.
CLOBET contains benzalkonium chloride.
This medicine contains 2.73 micrograms of benzalkonium chloride per drop equivalent to 0.1 mg/ml.
Benzalkonium chloride 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 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 CLOBET
Use this medicine following exactly as stated in this leaflet or as instructed by your doctor, who will indicate the correct dose and duration of treatment, based on the severity of your condition. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 1 drop, 2-4 times a day every 6-12 hours, unless otherwise indicated by your doctor.
In particularly severe cases, instill 1 drop every 1 - 2 hours until a significant
improvement is obtained; then decrease the frequency of instillations.
Do not use CLOBET for more than 30 consecutive days and do not exceed the recommended doses.
Contact your doctor if you do not notice any improvement, if the disorder recurs, or if you notice any change in its characteristics.
Children and adolescents
In early infancy, the product should be administered only when actually necessary and under the direct
supervision of a doctor.
Method of administration
CLOBET is an eye drop medication (ophthalmic use). For use, carefully read the following
instructions:
- 1. always wash your hands thoroughly and shake the bottle carefully;
- 2. administer the drops inside the eye after gently lifting the eyelids, avoiding touching the eye, or other parts, with the tip of the dropper;
- 3. immediately close the bottle after each single application.
If you use more CLOBET than you shouldthe risk of experiencing undesirable effects increases. In case of
ingestion/accidental intake, immediately notify your doctor or go to the nearest hospital.
If you forget to use CLOBET
Do not use a double dose to make up for a missed dose.
If you stop the treatment with CLOBET
If you have any doubts about the use of 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.
Tell your doctor if, during therapy with CLOBET, you notice:
- burning, itching, redness (hyperemia) of the eye;
- difficulty in healing eye wounds, which occurs especially in case of frequent and prolonged use of the eye drops.
Increases in pressure inside the eye have been reported in sensitive patients, but are generally milder and less
frequent with clobetasone compared to other anti-inflammatory drugs of the same class
(corticosteroids) for ocular use.
Long-term treatments can cause:
- ocular hypertension and/or glaucoma (serious eye disease);
- optic nerve damage, visual field alterations, cataracts;
- delays in 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. In diseases that cause thinning of the front part of the eye (cornea and sclera), perforation has been described after the use of local anti-inflammatory (steroid) drugs.
Although not reported in patients treated with CLOBET, 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.
If you use CLOBET in high doses and/or for prolonged periods of time, or in children under 2 years of age,
you may experience systemic disorders caused by corticosteroids (suppression of the pituitary-adrenal axis) which may
manifest with symptoms such as loss of appetite, hypotension, abdominal pain, weight loss,
fatigue, headache, nausea, vomiting.
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/content/segnalazioni-reazioni-avverse. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store CLOBET
Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions. CLOBET must be
used within 1 month of the first opening of the bottle.
Do not use this medicine after the expiry date which is stated on the package and the bottle 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 eliminate
medicines that you no longer use. This will help protect the environment.
6. Contents of the pack and other information
What CLOBET contains
- The active ingredient is: clobetasone-17-butyrate. 1 ml of suspension contains 1 mg of clobetasone-17-butyrate.
- The other ingredients are: benzalkonium chloride, polyethylene glycol 300, citric acid, sodium citrate, polysorbate 80, water for injections.
Description of the appearance of CLOBET and contents of the pack
CLOBET is an eye drop available in a 5 ml bottle equipped with a dropper and screw cap.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
OmniVision Italia S.r.l.
Via Montefeltro, 6
20156 Milano
Manufacturer
TUBILUX PHARMA S.p.A. – Via Costarica, 20/22 – 00071 Pomezia (ROMA)
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- Kraj rejestracji
- Postać farmaceutycznaEye drops, solution, 0.1%
- Kod ATCS01BA09
- Substancja czynna
- Wymaga receptyNie
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki KLOBETPostać farmaceutyczna: Eye drops, suspension, 1 MG/MLSubstancja czynna: clobetasoneProducent: VISUFARMA S.P.A.Bez 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
Odpowiedniki KLOBET w innych krajach
Leki z tą samą substancją czynną dostępne w innych krajach.
Odpowiednik KLOBET w Hiszpania
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KLOBET 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 KLOBET jest clobetasone. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
KLOBET jest produkowany przez OMNIVISION ITALIA SRL. 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 KLOBET 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 KLOBET 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. VISUKLOBEN, 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.
