ZICLOR 1 мг/г/2,5 мг/г Офтальмологический гель
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Инструкция по применению TSIKLOR
Содержание инструкции
ZICLOR 1 mg/g / 2,5 mg/g ophthalmic gel
betametasone/cloramfenicolo
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 only for you. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
- If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4. Contents of this leaflet:
- 1. What ZICLOR is and what it is used for
- 2. What you need to know before using ZICLOR
- 3. How to use ZICLOR
- 4. Possible side effects
- 5. How to store ZICLOR
- 6. Contents of the pack and other information
1. What is ZICLOR and what is it used for
ZICLOR is a gel containing betamethasone, a corticosteroid with anti-inflammatory action, and
chloramphenicol, an antibiotic.
ZICLOR is indicated for the treatment of ophthalmic infections when it is useful to combine the anti-
inflammatory action of betamethasone.
See your doctor if you do not feel better or if you feel worse.
2. What you need to know before you use ZICLOR
Do not use ZICLOR
- if you are allergic to betamethasone or chloramphenicol or any of the other ingredients of this medicine (listed in section 6). Tell your doctor before using ZICLOR if you have or have had any of the following conditions:
a) Increased eye pressure (Ocular hypertension);
b) Acute eye infections caused by the Herpes simplex virus and most other viral diseases of the
cornea in an acute ulcerative phase, conjunctivitis with ulcerative keratitis even in the initial phase. Use is not recommended in viral corneal infections, but may possibly be allowed only under the strict supervision of an ophthalmologist;
c) Eye infection caused by the tuberculosis bacterium;
d) Eye infection caused by fungi (eye mycosis);
e) Ocular infections with evident pus production such as purulent conjunctivitis and purulent blepharitis
which may be masked or aggravated by corticosteroids.
Warnings and precautions
Long-term use of ZICLOR may:
- increase the pressure in the eye with the risk of progressive damage to the optic nerve (glaucoma). However, the amount of betamethasone contained in ZICLOR gel reduces the risk of glaucoma,
- cause vision problems,
- promote cataracts,
- promote new eye infections. During prolonged treatments, frequent checks of the internal eye pressure are advisable. Continuous application of ZICLOR for more than one month is not recommended without specialist supervision. If your eye condition is associated with thinning of the cornea and sclera, frequent checks by your doctor are advisable, as cases of corneal perforation caused by corticosteroids have been described. Contact your doctor if you experience blurred vision or other visual disturbances. In association with prolonged topical applications of steroids and antibiotics, the development of microorganisms that are not sensitive (development of bacterial resistance) and a fungal infection of the cornea is more likely; if this should occur or no clinical improvement is noticed within a reasonable period of time, inform your doctor. Do not use contact lenses if you have an eye infection. Rare cases of reduction in the number of bone marrow cells (myelodysplasia), including aplastic anemia, have been described following prolonged use of chloramphenicol for topical use in patients with pre-existing hematological diseases. For this reason, the product should be used for short periods, unless explicitly indicated by your doctor.
Children
Do not administer ZICLOR to a child unless it has been prescribed by a doctor and the child must
be regularly monitored by a doctor.
Other medicines and ZICLOR
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
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 using this medicine.
Pregnancy
Data relating to the use of betamethasone in pregnant women are limited.
Do not use ZICLOR during pregnancy unless under the direct control of your doctor.
Breastfeeding
Chloramphenicol has been identified in newborns/infants breastfed by treated women.
The doctor must decide whether to interrupt breastfeeding or avoid using ZICLOR, taking into
consideration the benefit of breastfeeding for the child and the benefit of therapy for the woman.
Driving and using machines
ZICLOR slightly alters the ability to drive vehicles or use machines, as it may
blur your vision for a few minutes after application.
ZICLOR in the multidose container of 5 g contains methyl parahydroxybenzoateand propyl
parahydroxybenzoate, these components can cause allergic reactions (even delayed).
3. How to use ZICLOR
Use this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, ask your doctor or pharmacist.
The recommended dose for adolescents and adults, including the elderly, is 1 application in the conjunctival sac, from 2 to 3 times a day, as prescribed by your doctor.
In case of concomitant therapy with other eye drops, wait 10 to 15 minutes before subsequent
applications.
Multidose bottle
Do not use the bottle if the seal around the cap is broken before first opening.
Wash your hands thoroughly before opening the bottle. Tilt your head back and look at the ceiling.
- 1. Gently pull down the lower eyelid of the eye that needs treatment until a small "pocket" is formed (fig.1).
- 2. Turn the bottle upside down and squeeze it to release one drop into the “pocket” (fig.2).
- 3. Release the lower eyelid and blink a few times (fig.3).
- 4. Repeat steps 1 to 3 for the other eye, if it needs treatment.
To help prevent infection, do not let the tip of the bottle touch the eye, the surrounding tissue
or anything else. Close the bottle tightly with the screw cap immediately after use.
Between instillations, the bottle must be kept vertically with the tip pointing downwards.
Single-dose containers
Before use, make sure the single-dose container is intact.
Wash your hands thoroughly before opening the container.
- 1. Detach the single-dose container from the strip (fig. 1).
- 2. Hold the single-dose container by the base and shake downwards (fig. 2).
- 3. Open by twisting the top and pulling (fig. 3).
- 4. Gently pull down the lower eyelid of the eye that needs treatment until a small "pocket" is formed.
- 5. Turn the container upside down and squeeze it to let one drop fall into the “pocket” (fig. 4).
To help prevent infection, do not let the tip of the container touch the eye, the surrounding tissue
or anything else.
Use in children
The safety and efficacy of ZICLOR in children under one year of age have not yet been
established.
Do not administer ZICLOR to children over one year of age unless prescribed by a doctor
and used under the direct supervision of the doctor.
If you use more ZICLOR than you should
No cases of overdose have been reported.
If you forget to use ZICLOR
Do not use a double dose to make up for a missed dose.
If you stop using ZICLOR
If you have any doubts about using this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, ZICLOR can cause side effects, although not everybody gets them.
Side effects have been listed below according to their frequency:
Very rare (may affect less than 1 in 10,000 people)
Eye disorders:
Prolonged topical use of chloramphenicol may lead to the onset of local irritation (burning or stinging sensation) and allergic reactions; treatment should be discontinued if these symptoms occur.
After prolonged use of corticosteroids, the risk of ocular hypertension should be considered.
Immune system disorders:
Transient allergic reactions are possible, including burning, rapid swelling of the skin and mucous membranes, urticaria, dermatitis; if these symptoms occur, discontinue treatment.
Not known (frequency cannot be estimated from available data)
Eye disorders:
After prolonged use of corticosteroids, a thinning of the cornea should be considered, which may lead to perforation.
Blurred vision has been reported.
Blood and lymphatic system disorders:
The development of adverse reactions due to systemic absorption is unlikely. However, in case of prolonged use or previous (anamnestic) quantitative or qualitative alteration of blood composition, the risk of reduction in the number of bone marrow cells (aplastic anemia) induced by chloramphenicol should be considered.
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please 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 ZICLOR
Store in a refrigerator (2-8°C).
Multi-dose vial
Cstore at a temperature below 25°C for a period of 28 days after the first opening of the
vial.
Single-dose containers
After the first opening of the aluminum pouch: store at a temperature below 25°C and use
within 10 days; after this period the containers must be discarded.
The medicine in the single-dose container must be used immediately after opening the
vial; any remaining medicine must be discarded.
Keep this medicine out of the sight and reach of children.
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 use this medicine if you notice an intense yellow color.
Do not dispose of any medicine in the 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 ZICLOR contains
Multidose bottle
The active ingredients are betamethasone sodium phosphate and chloramphenicol.
The other ingredients are: macrogol 300, polyvinyl alcohol (E1203), carbomer, disodium edetate
(E385), methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), 2M sodium hydroxide
(E524), purified water.
Single-dose containers
The active ingredients are betamethasone sodium phosphate and chloramphenicol.
The other ingredients are: macrogol 300, polyvinyl alcohol (E1203), carbomer, disodium edetate
(E385), 2M sodium hydroxide (E524), purified water.
Description of the appearance of ZICLOR and contents of the pack
ZICLOR is presented as a gel. It is available in multidose and single-dose presentations.
The multidose bottle is made of polyethylene. The pack contains a 5 g bottle.
The single-dose containers are made of polyethylene. The pack contains 30 single-dose containers of 0.25 g,
divided into 3 strips of 10 single-dose containers, each strip of 10 single doses is packaged in a
sachet.
Marketing authorisation holder and manufacturer
ALFA INTES Industria Terapeutica Splendore S.r.l.
Via F.lli Bandiera 26 - 80026 Casoria (NA)
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- Страна регистрации
- Форма выпускаOphthalmic gel, 1 MG/G/2,5 MG/G
- Код АТХS01CA05
- Действующее вещество
- Отпускается по рецептуДа
- Производитель
- Информация на этой странице носит справочный характер и не является медицинской консультацией. Перед началом приема лекарства обязательно проконсультируйтесь с врачом.
- Аналоги TSIKLORФорма выпуска: Eye drops, powder and solvent for solution, 3 GДействующее вещество: betamethasone and antiinfectivesПроизводитель: ALFA INTES INDUSTRIA TERAPEUTICA SPLENDORE S.R.L.Отпускается по рецептуФорма выпуска: Ophthalmic ointment, 0,2% + 0,5%Действующее вещество: betamethasone and antiinfectivesПроизводитель: THEA FARMA S.P.A.Отпускается по рецептуФорма выпуска: Eye drops, solution, 0.1% + 10%Действующее вещество: betamethasone and antiinfectivesПроизводитель: BRUSCHETTINI S.R.L.Отпускается по рецепту
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TSIKLOR требует рецепта в Италия. Вы можете уточнить у врача онлайн, подходит ли это лекарство для вашей ситуации.
Действующее вещество TSIKLOR — betamethasone and antiinfectives. Эта информация помогает определить лекарства с тем же составом под другими торговыми названиями.
TSIKLOR производится компанией ALFA INTES INDUSTRIA TERAPEUTICA SPLENDORE S.R.L.. Упаковка и торговое название могут отличаться в зависимости от дистрибьютора.
Врачи, включая Семейные врачи, Психиатры, Дерматологи, Кардиологи, Эндокринологи, Гастроэнтерологи, Пульмонологи, Нефрологи, Ревматологи, Гематологи, Инфекционисты, Аллергологи, Гериатры, Педиатры, Онкологи, могут оценить целесообразность применения TSIKLOR с учетом вашей ситуации и местных правил. Вы можете записаться на онлайн-консультацию, чтобы обсудить возможные варианты.
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Вы можете купить TSIKLOR в Варшаве, Кракове, Вроцлаве или Гданьске в любой аптеке при наличии действующего рецепта.
Чтобы получить рецепт, вы можете воспользоваться Oladoctor:
Другие лекарства с тем же действующим веществом (betamethasone and antiinfectives) включают ALFATEX, BETABIOPTAL, BRUMETON KOLLOIDALE. Они могут отличаться торговым названием или формой выпуска, но содержат одинаковый терапевтический компонент. Перед изменением лечения рекомендуется проконсультироваться с врачом.
