ZOLIOP 20 mg /Ml Глазные Капли, Раствор
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Инструкция по применению TSOLIOP
Содержание инструкции
ZOLIOP 20 mg/ml COLLIRIO, SOLUZIONE
Dorzolamide
information for you
- If you have any doubts, ask your doctor or pharmacist.
- This medicine has been prescribed solely for you. Never give it to other people, as it could be dangerous, even if their symptoms are the same as yours.
- If you experience any side effects, talk to your doctor or pharmacist. This
- 4.
- 1. What Zoliop is and what it is used for
- 2. What you need to know before you use Zoliop
- 3. How to use Zoliop
- 4. Possible side effects
- 5. How to store Zoliop
- 6. Contents of the pack and other information
1. What is Zoliop and what is it used for
It is an eye drop and each bottle contains 5 ml of medicine.
The active ingredient contained in Zoliop is dorzolamide hydrochloride, which belongs to a group of drugs
called ‘carbonic anhydrase inhibitors’. This medicine is used to reduce
intraocular pressure in cases of glaucoma or ocular hypertension (an increase in eye pressure) and can
be used alone or in addition to other drugs called ‘beta-blockers’.
2. What you need to know before using Zoliop:
Do not use Zoliop:
- If you are allergic (hypersensitive) to dorzolamide hydrochloride or to any of the excipients contained in this medicine (listed in section 6)
- If you have severe kidney impairment or kidney problems, or a history of kidney stones
Warnings and precautions
Inform your doctor or pharmacist before using this medicine:
- If you have any current medical conditions or have had them in the past, including eye problems and eye surgery, and in case of any allergies to other medicines.
- If you develop eye irritation or any other new eye problem, such as eye redness or eyelid swelling, contact your doctor immediately.
- If you suspect that this medicine is causing an allergic reaction (e.g., skin rash, severe skin reaction, or itching) stop using the medicine and contact your doctor immediately.
- If you have, or have had, liver problems in the past.
- If you wear contact lenses (see the subheading that follows “This medicine contains the preservative benzalkonium chloride”)
Children
This medicine has been studied in newborns and children under 6 years of age with increased
pressure in the eye(s) or who have been diagnosed with glaucoma. For more information, consult your
doctor.
Other medicines and Zoliop
Inform your doctor or pharmacist if you are taking, have recently taken or are planning to take other
medicines, especially another carbonic anhydrase inhibitor such as acetazolamide, or a sulfonamide.
Pregnancy, breastfeeding and fertility
If you are pregnant or may become pregnant, if you are breastfeeding or if you are planning a pregnancy, inform
your doctor or pharmacist before taking this medicine. This medicine should not be
used during pregnancy or while breastfeeding.
Driving and operating machinery
In some patients this medicine may cause dizziness and blurred vision. You should avoid driving
or using machinery until you feel well or no longer have blurred vision.
Zoliop contains the preservative benzalkonium chloride,which can cause eye irritation and is known
to have an effect on altering the colour of soft contact lenses. If you wear contact lenses, remove them before
instilling the eye drops. Wait at least 15 minutes before re-applying the contact lenses.
3. How to use Zoliop
Always use this medicine exactly as your doctor or pharmacist has prescribed. If you have any doubts, ask your doctor or pharmacist for clarification.
If you wear contact lenses, remove them before applying the eye drops. Wait at least 15 minutes before
wearing them again.
Dosage
The appropriate dosage and duration of treatment will be established by your doctor.
- If this medicine is used alone, the dose is one drop in the affected eye, or in the affected eyes, in the morning, afternoon and evening.
- If this medicine is used together with a beta-blocker eye drop, the dose is one drop in the affected eye, or in the affected eyes, in the morning and evening.
- If this medicine is used together with another eye drop, the drops must be instilled at least 10 minutes apart.
Instructions for use:
This medicine must be used solely as an eye drop; do not ingest.
Before applying the eye drops, always wash your hands. Apply one drop of the medicine to each
affected eye in the following way:
- 1. Tilt your head back looking towards the ceiling.
- 2. Gently lower the lower eyelid to form a small pocket.
- 3. Press the inverted dropper bottle to release one drop inside the eye.
- 4. Keeping the affected eye closed, press your finger against the corner of the closed eye (the corner between the eye and the nose) and hold it for one minute.
- 5. Close the cap tightly immediately after use. THE TIP OF THE DROPPER MUST NOT COME INTO CONTACT WITH THE EYE, THE SURROUNDING AREAS OR ANY SURFACE. It could become contaminated
bacterial which can cause eye infections that can lead to serious eye damage, including loss of
vision.
The dropper tip has been designed to dispense a single drop. DO NOT widen the
hole in the tip.
Children
This medicine has been studied in infants and children under 6 years of age who have shown
increased eye pressure or have been diagnosed with glaucoma. For more information, talk to your
doctor.
If you use more Zoliop than you should
If you instill too many drops in the eye or if the contents of the bottle are ingested, contact your
doctor immediately as it may cause drowsiness, nausea, dizziness, headache, fatigue, abnormal dreams
and difficulty swallowing, with the consequence of possible hospitalization.
If you forget to use Zoliop
If you forget to instill a dose, take that dose as soon as possible. However, if it is almost
time for the next dose, skip the missed dose and continue with the next dose as
scheduled. Do not use a double dose to make up for a missed dose.
If you stop taking Zoliop
Do not stop using this medicine without first talking to your doctor.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects
Stop using the medicine and contact your doctor immediatelyif you experience any of the following symptoms (general allergic reaction): skin rash; swelling of the face, lips, tongue or throat; difficulty breathing or swallowing.
The following side effects have been reported with this medicine in clinical studies or after marketing:
Very common side effects (may affect more than 1 in 10 people):
- Burning and stinging eye pain.
Common (may affect up to 1 in 10 people):
- Corneal disease with eye pain and blurred vision (superficial punctate keratitis), inflammation or irritation of the eyelid, itchy eye discharge (conjunctivitis), glassy eye, blurred vision
- Fatigue, weakness, headache, nausea, bitter taste sensation.
Uncommon(may affect up to 1 in 100 people):
- Inflammation of the iris.
Rare(may affect up to 1 in 1,000 people):
- Tingling or numbness of the hands or feet
- Corneal edema (with symptoms of visual disturbances), ocular hypotension, fluid formation under the retina (choroidal detachment, following filtering surgery), temporary myopia that resolves with discontinuation of treatment, eye irritation including redness, eye pain, crusting of the eyelids
- Kidney stones, dizziness, nosebleeds, sore throat, dry mouth
- Serious skin reactions including blisters, localized skin rashes (contact dermatitis) and general allergic reactions including skin rashes, swelling of lips, eyes and mouth, shortness of breath and, more rarely, wheezing. Side effects with unknown frequency (frequency cannot be estimated from available data):
- Wheezing
- Foreign body sensation in the eye (feeling that something is in the eye)
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Zoliop
Keep this medicine out of the sight and reach of children.
Do not use this medicine if you notice that the seal is broken or damaged before first use.
Do not use this medicine after the expiry date which is stated on the label of the bottle and on the packaging
after EXP or EXD. The expiry date refers to the last day of that month.
The medicine must be used within 28 days of first opening even if the bottle is not empty; any
remaining product must be discarded.
Do not store the bottle at a temperature above 25 ˚ C.
Medicines should not be disposed of via 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 Zoliop contains
- The active substance is dorzolamide. Each ml of solution contains 20 mg of dorzolamide (equivalent to 22.26 mg of dorzolamide hydrochloride).
- The other components are benzalkonium chloride (preservative), hydroxyethylcellulose, mannitol, sodium citrate, water for injections and sodium hydroxide or hydrochloric acid (to adjust the pH).
Description of the appearance of Zoliop and contents of the pack
This medicine is a clear, from colorless to almost colorless, slightly viscous solution, contained in
a 5 ml bottle.
The medicine is available in packs of 1, 2 or 3 bottles.
Not all pack sizes may be marketed.
Marketing authorisation holder and manufacturer
Marketing authorisation holder
Farmigea S.p.A, Via G.B. Oliva 6/8, 56121 Pisa, Italy
Manufacturer
Farmigea S.p.A, Via G.B. Oliva 8, 56121 Pisa, Italy
Exclusive distributor for sales
Elleva Pharma S.r.l. - Via S. Francesco 5/7 - 80034 Marigliano, Napoli
This medicinal product is authorised in the Member States of the European Economic Area with the following
names:
| United Kingdom | r Dorzolamide, 20 mg/ml eye drops, solution |
| Ireland | a Dorzolamide, 20 mg/ml eye drops, solution |
| Italy | Zoliop, 20 mg/ml eye drops, solution |
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- Страна регистрации
- Форма выпускаEye drops, solution, 20 MG/ML
- Код АТХS01EC03
- 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 TSOLIOPФорма выпуска: Eye drops, solution, 20 mg/mlДействующее вещество: дорзоламидаПроизводитель: ALFA INTES INDUSTRIA TERAPEUTICA SPLENDORE S.R.L.Отпускается по рецептуФорма выпуска: Eye drops, solution, 20 MG/MLДействующее вещество: дорзоламидаПроизводитель: OMNIVISION ITALIA SRLОтпускается по рецептуФорма выпуска: Eye drops, solution, 20 MG/MLДействующее вещество: дорзоламидаПроизводитель: AUROBINDO PHARMA (ITALIA) S.R.L.Отпускается по рецепту
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Часто задаваемые вопросы
TSOLIOP требует рецепта в Италия. Вы можете уточнить у врача онлайн, подходит ли это лекарство для вашей ситуации.
Действующее вещество TSOLIOP — дорзоламида. Эта информация помогает определить лекарства с тем же составом под другими торговыми названиями.
TSOLIOP производится компанией FARMIGEA S.P.A.. Упаковка и торговое название могут отличаться в зависимости от дистрибьютора.
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Вы можете купить TSOLIOP в Варшаве, Кракове, Вроцлаве или Гданьске в любой аптеке при наличии действующего рецепта.
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Другие лекарства с тем же действующим веществом (дорзоламида) включают DIMATS, DORTSOKLAR, DORTSOLAMIDE AUROBINDO. Они могут отличаться торговым названием или формой выпуска, но содержат одинаковый терапевтический компонент. Перед изменением лечения рекомендуется проконсультироваться с врачом.
