IOPIZE 50 MICROGRAMMI/ML Глазные капли, раствор
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Инструкция по применению IOPITSE
Содержание инструкции
IOPIZE 50 mcg/ml eye drops, solution
Latanoprost
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 the doctor treating your child, or your pharmacist.
- This medicine has been prescribed for you or your child only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
- If any side effects occur, including any not listed in this leaflet, tell your doctor or the doctor treating your child, or your pharmacist. See section 4. Contents of this leaflet:
- 1. What IOPIZE is and what it is used for
- 2. What you need to know before you use IOPIZE
- 3. How to use IOPIZE
- 4. Possible side effects
- 5. How to store IOPIZE
- 6. Contents of the pack and other information
1. WHAT IOPIZE IS AND WHAT IT IS USED FOR
IOPIZE is a solution for ophthalmic use only. It contains the active substance
latanoprost which belongs to a group of medicines called prostaglandins.
IOPIZE is used in the treatment of conditions known as open-angle glaucoma and ocular hypertension.
Both of these conditions are linked to increased intraocular pressure, ultimately altering vision.
IOPIZE is also used in the treatment of elevated intraocular pressure and glaucoma in
children of all ages and infants.
2. WHAT YOU NEED TO KNOW BEFORE USING IOPIZE
IOPIZE can be used in adult women and men (including the elderly) and in children from birth to 18 years. The use of IOPIZE in premature infants (with a gestational age of less than 36 weeks) has not been investigated.
Do not use IOPIZE:
- If you are allergic (hypersensitive) to latanoprost or any of the other ingredients of this medicine (listed in section 6).
- If you are pregnant or planning to become pregnant.
- If you are breastfeeding.
Warnings and precautions
Consult your doctor or the doctor caring for your child, or your pharmacist before using IOPIZE or before giving this medicine to your child if you think that any of the following conditions apply to you or your child:
- If you or your child have recently had, or are about to have, eye surgery (including cataract surgery).
- If you or your child have eye problems (such as eye pain, irritation or inflammation, blurred vision).
- If you or your child suffer from dry eyes.
- If you or your child have severe asthma or if asthma is not well controlled.
- If you or your child wear contact lenses. You can still use IOPIZE but follow the instructions for contact lens wearers in section 3.
- If you have suffered from or are currently suffering from a viral eye infection caused by the Herpes Simplex(HSV) virus.
Other medicines and IOPIZE
IOPIZE can interact with other medicines. Tell your doctor or the doctor caring for your child, or your pharmacist if you or your child are taking or have recently taken any other medicines, including medicines (or eye drops) without a prescription.
Pregnancy and breastfeeding
Pregnancy
Do not use IOPIZE during pregnancy. Inform your doctor immediately if you are pregnant, suspect you may be pregnant or are planning to become pregnant.
Breastfeeding
Do not use IOPIZE during breastfeeding.
Driving and using machines
When using IOPIZE you may experience transient blurred vision. If this happens, do not drive or use tools or machines until your vision is clear again.
Important information about some of the ingredients of IOPIZE
IOPIZE contains a preservative called benzalkonium chloride. This preservative can cause eye irritation or damage to the surface of the eye. Benzalkonium chloride can be absorbed by contact lenses and is known to cause a change in the colour of soft contact lenses. You should therefore avoid contact of the medicine with soft contact lenses.
If you or your child wear contact lenses, you should remove them before applying IOPIZE. After applying IOPIZE, you should wait 15 minutes before putting your contact lenses back in. For instructions for contact lens wearers, see section 3.
3. HOW TO USE IOPIZE
Use IOPIZE always exactly as your doctor or your child’s doctor has instructed. If you have
any doubts, ask your doctor or your child’s doctor or your pharmacist.
The usual dose in adults (including the elderly) and children is 1 drop once a day in the eye(s)
to be treated. The best time to administer is in the evening.
Do not use IOPIZE more than once a day, as the effectiveness of the treatment may be reduced if the
medicine is administered more frequently.
Use IOPIZE as your doctor, or your child’s doctor, has told you, until the
doctor tells you to stop the treatment.
Contact Lens Wearers
If you or your child wear contact lenses, you must remove them before applying IOPIZE. After
applying IOPIZE, you must wait 15 minutes before re-applying the contact lenses.
Instructions for Use
- 1. Wash your hands before using the eye drops.
- 2. Rotate the outer protective cap with the “wings”.
- 3. Rotate the inner protective cap.
- 4. Tilt your head back. Gently lower the lower eyelid of the eye to be treated with your index finger.
- 5. Bring the tip of the bottle close to the eye but without touching it and exert slight pressure so that one drop of eye drops falls into the eye to be treated.
- 6. Release the lower eyelid and exert slight pressure on the inner corner of the affected eye for one minute, after applying the eye drops.
- 7. Replace the protective cap after use.
If you are using IOPIZE with another eye drop
Wait at least 5 minutes between administering IOPIZE and administering another eye drop.
If you use more IOPIZE than you should
Putting too many drops in your eyes may lead to mild irritation, tearing and redness of the
eyes. These effects should be transient, but if you are concerned, contact your doctor or your child’s doctor for
advice.
Contact your doctor as soon as possible if you or your child accidentally ingest IOPIZE.
If you forget to use IOPIZE
If a dose is missed, treatment should continue normally with the
next administration. In any case, do not take a double dose to make up for the
missed dose. If you have any doubts, ask your doctor or pharmacist.
If you stop using IOPIZE
Ask your doctor or your child’s doctor if you intend to stop treatment with
IOPIZE.
If you have any further questions about the use of this product, ask your doctor or your child’s
doctor or your pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, IOPIZE can cause side effects, although not everybody gets them.
The following side effects have been reported:
Very common side effects (may affect more than 1 in 10 people):
- Gradual alteration of the eye color due to an increase in the amount of brown pigment in the colored part of the eye, called the iris. This change is more likely to occur in people with heterochromia (blue-brown, gray-brown, yellow-brown or green-brown eyes) rather than eyes of a single color (blue, gray, green or brown eyes). Any change in eye color may occur after years, although it generally appears within the first 8 months of treatment. The color change may be permanent and may be more noticeable if you use IOPIZE in only one eye. There do not appear to be any problems associated with the alteration of eye color. After stopping treatment with IOPIZE, no further alteration of eye color has been observed.
- Red eyes.
- Eye irritation (burning sensation, gritty sensation, itching, stinging pain or foreign body sensation in the eyes).
- Gradual changes in the eyelashes of the treated eye (darkening, thickening, lengthening, densification) and changes in the vellus hair around the treated eye (observed mainly in the Japanese population).
Common side effects (may affect more than 1 in 100 and less than 1 in 10 people):
- Irritation of the ocular surface.
- Inflammation of the eyelid (blepharitis).
- Eye pain and sensitivity to light (photophobia).
Uncommon side effects (may affect more than 1 in 1,000 and less than 1 in 100 people):
- Swelling of the eyelid (palpebral edema).
- Dry eye.
- Inflammation or irritation of the eye surface (keratitis).
- Blurred vision.
- Conjunctivitis.
- Skin rash.
Rare side effects (may affect more than 1 in 10,000 and less than 1 in 1,000 people):
- Inflammation of the iris, the colored part of the eye (iritis/uveitis).
- Swelling of the retina (macular edema).
- Swelling and damage to the eye surface (corneal edema or erosion).
- Swelling of the area around the eyes (periorbital edema).
- Altered eyelash orientation.
- Asthma, worsening of asthma symptoms and shortness of breath (dyspnea).
- Skin reactions on the eyelids, darkening of the skin of the eyelids.
- Abnormal growth of an additional row of eyelashes (distichiasis).
Very rare side effects (may affect less than 1 in 10,000 people):
- Chest pain.
- Worsening of angina in patients with heart disease.
- Sunken appearance of the eye (hollowing of the eye socket).
Side effects with unknown frequency (frequency cannot be estimated based on available data):
- Palpitations (irregular or accelerated heartbeats).
- Headache.
- Dizziness.
- Iris cyst
- Muscle and joint pain.
- Viral eye infection caused by the Herpes Simplexvirus (HSV).
The side effects observed more frequently in children compared to adults were: runny and itchy nose, fever.
In very rare cases, some patients with severe damage to the transparent layer in the front of the eye (the cornea) have developed cloud-like spots on the cornea due to calcium accumulation during treatment.
If any of these side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. 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 IOPIZE
Keep this medicine out of the sight and reach of children.
Store in a refrigerator (2°C - 8°C). Do not freeze.
After first opening: store at a temperature below 25°C and use within 4 weeks.
Keep the vial in the outer carton to protect it from light.
Do not use this medicine after the expiry date which is stated on the pack and the vial after EXP.
The expiry date refers to the last day of that month.
Do not use this medicine if you notice that the solution is not clear and colourless.
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 IOPIZE contains
The active ingredient is latanoprost.
1 ml of eye drops contains 50 mcg of latanoprost.
A 2.5 ml bottle of eye drops contains 125 mcg of latanoprost.
The other components are benzalkonium chloride, sodium chloride, sodium phosphate monobasic dihydrate, sodium
phosphate dibasic dodecahydrate, purified water.
Description of the appearance of IOPIZE and contents of the pack
IOPIZE 50 mcg/ml eye drops, solution is a colorless transparent liquid.
IOPIZE is available in packs of 1, 3 and 6 boxes.
Not all pack sizes may be marketed.
Each box contains a bottle of IOPIZE. Each bottle contains 2.5 ml of eye drops.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
S.I.F.I. S.p.A. – Via Ercole Patti, 36 – 95025 Aci S. Antonio (CT)
Manufacturers:
S.I.F.I. S.p.A.
Via Ercole Patti, 36 – 95025 Aci S. Antonio (CT)
Italy
Catalent Pharma Solutions (formerly Cardinal Health Inc)
2200 Lake Shore Drive - Woodstock, IL 60098
USA
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- Страна регистрации
- Форма выпускаEye drops, solution, 50 MICROGRAMMI/ML
- Код АТХS01EE01
- 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 IOPITSEФорма выпуска: Emulsion eye drops, 50 ?g / mlДействующее вещество: ЛатанопростПроизводитель: SANTEN OYОтпускается по рецептуФорма выпуска: Eye drops, solution, 50 MICROGRAMMI/MLДействующее вещество: ЛатанопростПроизводитель: OMNIVISION ITALIA SRLОтпускается по рецептуФорма выпуска: Eye drops, solution, 0.005 %Действующее вещество: ЛатанопростПроизводитель: ALFA INTES INDUSTRIA TERAPEUTICA SPLENDORE S.R.L.Отпускается по рецепту
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Аналог IOPITSE в Испания
Аналог IOPITSE в Польша
Аналог IOPITSE в Украина
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Часто задаваемые вопросы
IOPITSE требует рецепта в Италия. Вы можете уточнить у врача онлайн, подходит ли это лекарство для вашей ситуации.
Действующее вещество IOPITSE — Латанопрост. Эта информация помогает определить лекарства с тем же составом под другими торговыми названиями.
IOPITSE производится компанией SIFI S.P.A.. 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 IOPITSE с учетом вашей ситуации и местных правил. Вы можете записаться на онлайн-консультацию, чтобы обсудить возможные варианты.
Польша имеет хорошо развитую систему здравоохранения в крупных городах, таких как Варшава, Краков, Вроцлав и Гданьск. Аптеки широко доступны и работают в соответствии с действующим законодательством, обеспечивая доступ к рецептурным препаратам.
Вы можете купить IOPITSE 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 (Латанопрост) включают KATIOLANTSE, DROPLATAN, GALAXIA. Они могут отличаться торговым названием или формой выпуска, но содержат одинаковый терапевтический компонент. Перед изменением лечения рекомендуется проконсультироваться с врачом.
