RELESTAT 5 ML Глазные капли, раствор
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Инструкция по применению RELESTAT
Содержание инструкции
- What is Relestat and what is it used for
- What you need to know before you use Relestat
- How to use Relestat
- Possible side effects
- How to store Relestat
- Package Contents and Other Information
Relestat, 0.5 mg/ml, eye drops, solution
Epinastine hydrochloride
Read this leaflet carefully before you start using this medicine because it contains
important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or
pharmacist has told you.
- Keep this leaflet. You may need to read it again.
- If you want more information or advice, ask your pharmacist.
- If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
- See a doctor if you do not feel better or if your symptoms get worse. Contents of this leaflet:
- 1. What Relestat is and what it is used for
- 2. What you need to know before you use Relestat
- 3. How to use Relestat
- 4. Possible side effects
- 5. How to store Relestat
- 6. Contents of the pack and other information
1. What is Relestat and what is it used for
Relestat is an antiallergic medicine.
It is an eye drop solution used for the treatment of symptomsof allergic conjunctivitis
seasonal, a seasonal allergic condition that affects the eye. The main symptoms treated by
Relestat include watery eyes and itching, redness and swelling of the eyes or eyelids.
2. What you need to know before you use Relestat
Do not use Relestat:
- If you are allergicto epinastine hydrochloride or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before using Relestat.
- If you wear soft contact lenses: you must remove them before using Relestat eye drops. After using Relestat ,wait at least 15 minutes before wearing the lenses. See also section 2 “Relestat contains benzalkonium chloride”.
- If you have used any other eye drops during treatment withRelestat: wait at least 10 minutes between administering Relestat and other eye drops.
Other medicines and Relestat
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
If you have used any other eye drops during treatment with Relestat ,see the section
“Warnings and precautions ”above.
Pregnancy and breastfeeding
Pregnancy
If you are pregnant, suspect you may be 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.
Breastfeeding
It is not known whether Relestat passes into breast milk. Ask your doctor or pharmacist for advice before using
this medicine while breastfeeding.
Driving and using machines
Immediately after administering Relestat, blurred vision may occur for a
short period of time. In this case, do not drive or use machines until your vision is
clear.
Relestat contains benzalkonium chloride and phosphates
This medicine contains 0.5 mg of benzalkonium chloride per 5 ml of solution, equivalent to 0.1
mg/ml.
Relestat contains a preservative, called benzalkonium chloride, which can be absorbed by soft contact
lenses and may lead to a change in their color.
If you wear soft contact lenses (also called hydrophilic lenses), you must remove them before using
Relestat eye drops. After using Relestat, wait at least 15 minutes before wearing the lenses.
Benzalkonium chloride can also cause eye irritation, especially if you have dry eyes or
corneal disorders (the outermost transparent layer of the eye). If you experience an
abnormal sensation in your eye, burning or pain after using this medicine, talk to your doctor.
This medicine contains 23.75 mg of phosphates per 5 ml, equivalent to 4.75 mg/ml.
If you have severe damage to the outermost transparent layer of the eye (the cornea), phosphates may
cause, in very rare cases, opaque spots on the cornea due to calcium accumulation during the
treatment (see section 4).
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3. How to use Relestat
Use this medicine following exactly as described in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Use in children
Relestat should not be used in children under 12 years of age.
Use in adults and adolescents (12 years of age and over)
The recommended dose is 1 dropin each eyeneeding treatment, twice a day, for example in the morning and in the evening.
Relestat should be used daily while ocular symptoms are present during the allergy season but for no more than 8 weeks.
Instructions for use
Do not use the bottle if the tamper-evident seal on the bottle neck is broken before use. Apply the eye drops as follows:
- 1. Wash your hands. Tilt your head back and look up.
- 2. Gently pull down your lower eyelid to form a small “pocket”.
- 3. Turn the bottle upside down and press to instill one drop of eye drops into each eye to be treated.
- 4. Release your lower eyelid and close your eye for 30 seconds.
If the drop does not enter the eye, repeat the operation.
To avoid contamination of the solution in the bottle, the tip of the bottle must not touch the eye or come into contact with anything else.
Replace the cap and tighten well after use.
Wipe away any excess liquid from your cheek with a clean tissue.
Correct application of the eye drops is very important. If you have any doubts, ask your doctor or pharmacist.
If you use more Relestat than you should
If you have used more drops of Relestat than you should, it is unlikely to cause any harm. Administer the drop(s) at the usual time. If this causes you concern, consult your doctor or pharmacist.
If you forget to use Relestat
If you forget a dose, apply the eye drops as soon as you remember, unless it is almost time for your next dose, in which case you should skip the missed dose. Then, apply the next dose as usual and continue with the normal dosing schedule.
Do not use a double dose to make up for a forgotten dose.
If you stop using Relestat
Relestat should be used as prescribed by your doctor.
If you have any doubts about using 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.
It is unlikely that any of these side effects will be serious; most of them will probably be mild and
limited to the eye.
If you experience any of the following side effects, stop using Relestat and contact
your doctor immediately or go to the nearest hospital:
- asthma (an allergic condition involving the lungs that causes difficulty breathing)
- symptoms of angioedema (swelling of the face, tongue or throat; difficulty swallowing; itching and difficulty breathing)
The following side effects may occur:
Common(may affect up to 1 in 10people)
- burning or irritation of the eye (usually mild)
Uncommon(may affect up to 1 in 100people)
General side effects:
- headache
- swelling and irritation inside the nose, which can cause runny or blocked nose, sneezing
- unusual taste in the mouth
Side effects involving the eye
- redness of the eyes
- dry eyes
- itchy eyes
- difficulty seeing clearly
- discharge from the eyes
Not known (frequency cannot be estimated from available data)
- increased tearing
- eye pain
- allergic reaction to the eyes
- eye swelling
- eyelid swelling
- skin rashes and redness
Other side effects reported with the use of eye drops containing phosphates
This medicine contains 23.75 mg of phosphates per 5ml, equivalent to 4.75 mg/ml.
If you have severe damage to the outermost transparent layer of the eye (the cornea), phosphates may
cause, in very rare cases, opaque spots on the cornea due to calcium build-up during
treatment (see section 4).
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 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.
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5. How to store Relestat
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 label of the bottle and on the
carton after SCAD.
Do not use this medicine if you notice that the eye drops show any sign of deterioration, for
example a change in colour, and return it to the pharmacist.
Store at a temperature not exceeding 25°C.
Keep the bottle inside the carton in order to protect the product from light.
Dispose of the bottle 28 days after first opening, even if it still contains some eye drops.
This will avoid infections. To help you remember, write the date of first opening of the bottle
in the designated space on the carton.
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. Package Contents and Other Information
What Relestat contains
The active ingredient is epinastine hydrochloride. One ml of eye drops, solution, contains 0.5 mg of
epinastine hydrochloride.
The other ingredients are benzalkonium chloride (a preservative), disodium edetate, sodium
chloride, sodium phosphate monobasic dihydrate, sodium hydroxide/hydrochloric acid (to adjust the
pH) and purified water.
Description of the appearance of RELESTAT and contents of the pack
RELESTAT is an eye drop in solution, colorless and clear, in a plastic bottle with a screw cap.
When unopened, each bottle is filled to approximately halfway and contains 5 ml of solution.
Each pack contains 1 bottle.
Marketing Authorisation Holder
AbbVie S.r.l.
S.R. 148 Pontina km 52 snc
04011 Campoverde di Aprilia (LT)
Italy
Manufacturer
Allergan Pharmaceuticals Ireland
Castlebar Road
Westport
County Mayo
Ireland
This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
| I Member State | Medicinal Product Name |
| Austria, Germany | RELESTAT 0.5 mg/ml eye drops |
| Belgium | RELESTAT, 0.5 mg/ml, eye drops, solution |
| a Czech Republic | PURIVIST 0.5 mg/ml eye drops, solution |
| i Denmark, Greece, Luxembourg, Poland, Sweden | RELESTAT |
| z France | PURIVIST (0.5 mg/ml, eye drops solution) |
| n Hungary | RELESTAT 0.5 mg/ml solution eye drops |
| Ireland, United Kingdom | RELESTAT, 0.5 mg/ml, eye drops solution |
| e Italy | RELESTAT, 0.5 mg/ml, eye drops, solution |
| Netherlands | RELESTAT eye drops, solution, 0.5 mg/ml |
| g Portugal | RELESTAT, 0.5 mg/ml, eye drops, solution |
| Slovak Republic | PURIVIST |
| Spain | RELESTAT 0.5 mg/ml eye drops solution |
- Страна регистрации
- Форма выпускаEye drops, solution, 5 ML
- Код АТХS01GX10
- Действующее вещество
- Отпускается по рецептуНет
- Производитель
- Информация на этой странице носит справочный характер и не является медицинской консультацией. Перед началом приема лекарства обязательно проконсультируйтесь с врачом.
- Аналоги RELESTATФорма выпуска: Eye drops, solution, 2%Действующее вещество: cromoglicic acidПроизводитель: BRUSCHETTINI S.R.L.Отпускается без рецептаФорма выпуска: Eye drops, solution, 250 MICROGRAMMI/MLДействующее вещество: ketotifenПроизводитель: BRUSCHETTINI S.R.L.Отпускается без рецептаФорма выпуска: Eye drops, solution, 1 MG/MLДействующее вещество: олопатадинПроизводитель: DOC GENERICI SRLОтпускается без рецепта
Аналоги RELESTAT в других странах
Лекарства с тем же действующим веществом, доступные в других странах.
Аналог RELESTAT в Польша
Аналог RELESTAT в Испания
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Электронный рецепт отправляется на вашу почту — действителен по всей Польше.
Часто задаваемые вопросы
RELESTAT не требует рецепта в Италия. Вы можете уточнить у врача онлайн, подходит ли это лекарство для вашей ситуации.
Действующее вещество RELESTAT — epinastine. Эта информация помогает определить лекарства с тем же составом под другими торговыми названиями.
RELESTAT производится компанией ABBVIE 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 RELESTAT 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 RELESTAT 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 (epinastine) включают BRUNIKROM, BRUNISTILL, KALMIRA. Они могут отличаться торговым названием или формой выпуска, но содержат одинаковый терапевтический компонент. Перед изменением лечения рекомендуется проконсультироваться с врачом.
