DEXAMONO 1 мг/мл Глазные капли, раствор
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Инструкция по применению DEXAMONO
Содержание инструкции
DEXAMONO
1 mg/ml, eye drops, solution in single-dose containers
Desametasone phosphate
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 theirsymptoms are the same as yours, as it may be harmful.
- If any side effects occur, including those not listed in thisleaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet:
- 1. What DEXAMONO is and what it is used for
- 2. What you need to know before using DEXAMONO
- 3. How to use DEXAMONO
- 4. Possible side effects
- 5. How to store DEXAMONO
- 6. Contents of the pack and other information
1. WHAT DEXAMONO IS AND WHAT IT IS USED FOR
DEXAMONO is an ophthalmic solution in single-dose containers that contains a substance
called dexamethasone. This substance is a corticosteroid that inhibits inflammatory
symptoms.
DEXAMONO is indicated for:
- The treatment of eye inflammation.The eye must not be infected (red eye, discharge, tearing); otherwise, specific treatment of the infection must be associated (see paragraph 2).
2. WHAT YOU NEED TO KNOW BEFORE USING DEXAMONO
Do not use DEXAMONO:
- If you have an eye infectionsuch as bacterial infections (including acute purulent infections), fungal infections, viral infections (e.g. Herpes simplex, vaccinia virus, varicella-zoster) or amoebic infections,
- in the presence of corneal damage(perforation, ulceration and corneal injury with incomplete epithelialization),
- in the presence of recognized ocular hypertensioninduced by glucocorticoids (a family of corticosteroids),
- if you are allergic(hypersensitive) to desamethasone sodium phosphateor to any of the excipients of DEXAMONO.
Warnings and precautions
Consult your doctor or pharmacist before using DEXMONO.
DO NOT INJECT, DO NOT INGEST.
Avoid contact between the container tip and the eye or eyelids.
- If you use DEXAMONO you must undergo an ophthalmological check-upin any case and in particular:
- In children and the elderly, you should have more frequent ophthalmological check-ups,
- If you have an eye infection. You can only use DEXAMONO if the infection is controlled by an anti-infective treatment,
- If you have a corneal ulcer. You should not use topical desamethasone treatment, or use DEXAMONO unless inflammation is the main cause of delayed healing,
- If you have pre-existing increased intraocular pressure. If you have previously reacted to topical steroid treatment with increased intraocular pressure, if treated with DEXAMONO you are at risk of developing increased intraocular pressure,
- If you have glaucoma.
- Children: Long-term and uninterrupted therapy should be avoided.
- Severe allergic conjunctivitis: if you have severe allergic conjunctivitis that does not respond to standard therapy, you can only use DEXAMONO for a short period.
- Diabetic: if you are diabetic, inform your ophthalmologist.
- Red eye: If you have a red eye without diagnosis, you should not use DEXAMONO.
- Contact lenses: you should not use contact lenses during treatment with DEXAMONO.
Other medicines and DEXAMONO
If undergoing concomitant treatment with another eye drop, space the instillations by 15 minutes.
Calcium phosphate precipitation on the corneal surface has been reported during
concomitant topical therapy with steroids and beta-blockers.
Inform your doctor or pharmacist if you are taking or have recently taken or might
take any other medicine.
Pregnancy and breastfeeding
- There are insufficient data on the use of DEXAMONO during pregnancy to assess possible harmful effects. For this reason, it is recommended not to use DEXAMONO during pregnancy.
- It is not known whether this medicine is excreted in breast milk. However, the total dose of desamethasone is low. Therefore DEXAMONO can be used during breastfeeding. If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Driving and operating machinery
As with other eye drops, temporary blurred vision or other visual disturbances may
affect the ability to drive vehicles or operate machinery. Do not drive vehicles or
operate machinery until vision is clear.
3. HOW TO USE DEXAMONO
Dosage
Use this medicine following exactly the instructions of your doctor.
If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 1 drop 4 to 6 times a day in the affected eye. In severe cases, treatment should begin with one drop every hour, and should be reduced to one drop every 4 hours when a favorable response is observed. It is recommended to carry out a gradual reduction of the dosage in order to avoid a relapse.
- No dosage correction is required in the elderly.
- In children, long-term and uninterrupted therapy should be avoided.
Method of administration
Ophthalmic use: this medicine must be administered into the eyes.
- 1. Wash your handsthoroughly before using the product.
- 2. Instill one drop into the affected eye, while looking upwards and lowering the lower eyelid with your finger.
- 3. Immediately after instillation, apply brief pressure with your finger on the inner corner of the treated eye for a few minutes (to reduce the possibility of systemic reactions and allow optimal penetration of the medicine into the eye).
- 4. Dispose of the single-dose container after use. Do not keep the container for further use.
Frequency of administration
4 to 6 times a day.
Duration of treatment
The duration of treatment generally varies from a few days up to a maximum of 14 days.
If you use more DEXAMONO than you should
If you have instilled an excessive amount of product into the eye and complain of persistent irritation, rinse the eye with sterile water.
Contact your doctor or pharmacist immediately.
If you forget to use DEXAMONO
Do not use a double dose to make up for a missed dose.
If you stop using DEXAMONO
Do not suddenly stop treatment. Always ask your doctor if you decide to stop.
If you have any doubts 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:
Eye disorders:
Very common (may affect more than 1 in 10 people):
- increased intraocular pressure after 2 weeks of treatment.
Common (may affect up to 1 in 10 people):
- discomfort, irritation, burning, stinging pain, itching and blurred vision after instillation. These are usually short- and medium-term symptoms.
Uncommon (may affect up to 1 in 100 people):
- allergic and hypersensitivity reactions to one of the components of the eye drops,
- delayed wound healing,
- clouding of the lens (cataract),
- infections,
- glaucoma.
Very rare (may affect up to 1 in 10,000 people):
- inflammation of the membranes of the eye (conjunctivitis),
- pupil dilation (mydriasis),
- facial swelling (facial edema),
- eyelid drooping (ptosis),
- inflammation of the pigmented membrane of the iris (uveitis),
- corneal calcification,
- inflammation of the cornea (corneal keratopathy),
- changes in corneal thickness,
- corneal edema,
- corneal ulcer,
- corneal perforation.
General disorders:
Uncommon (may affect up to 1 in 100 people):
Suppression of adrenal function after frequent applications.
In very rare cases, patients with severe damage to the clear layer of the front of the eye
(cornea) have developed areas of opacity on the cornea due to calcium accumulation
during treatment.
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 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 DEXAMONO
Keep this medicine out of sight and reach of children.
Do not use DEXAMONO after the expiry date which is stated on the single-dose container
after the wording “EXP.” The expiry date refers to the last day of that month.
After first opening the sachet: use the single-dose containers within 5 days.
After first opening the sachet: use the single-dose containers within 10 days.
After first opening the single-dose container: use immediately and discard the
single-dose container with the remaining solution immediately after use.
Store the single-dose containers inside the bag to protect them from light.
Do not dispose of any medicine in wastewater or household waste.
Ask your pharmacist how to dispose of medicines you no longer use. This will help to
protect the environment.
6. PACKAGE CONTENTS AND OTHER INFORMATION
What DEXAMONO contains
- The active ingredient is desamethasone sodium phosphate. Each millilitre of solution contains 1 mg of desamethasone phosphate (as desamethasone sodium phosphate).
- The excipients are disodium edetate, disodium phosphate dodecahydrate, sodium chloride, water for injections.
Description of the appearance of DEXAMONO and package contents
DEXAMONO is a transparent solution from colorless to brownish which is presented in
single-dose containers.
Each single-dose container contains 0.4 ml of solution. The package contains 10, 20, 30,
50 or 100 single-dose containers packaged in bags.
Marketing Authorisation Holder
Laboratoires THEA,
12, rue Louis Blériot,
63017 Clermont-Ferrand, Cedex 2
FRANCE
Distributor
THEA FARMA S.p.A. Via Giotto, 36 – 20145 MILANO
Manufacturer
EXCELVISION,
Rue de la Lombardière,
07100 Annonay,
FRANCE
Laboratoire UNITHER
ZI de la Guérie
50211 COUTANCES CEDEX
FRANCE
This medicinal product is authorised in the Member States of the EEA with the following
names:
France, Poland, Portugal and Spain DEXAFREE
Belgium, Luxembourg and Netherlands MONOFREE DEXAMETHASON
Austria and Germany MONODEX
Italy DEXAMONO
This leaflet was last updated in: December 2014
Detailed information on this medicine is available on the website of the Italian Medicines Agency.
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- Страна регистрации
- Форма выпускаEye drops, solution, 1MG/ML
- Код АТХS01BA01
- 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 DEXAMONOФорма выпуска: Eye drops, solution, 1,5 MG/MLДействующее вещество: ДексаметазонПроизводитель: DOC GENERICI SRLОтпускается по рецептуФорма выпуска: Eye drops, solution in single-dose container, 1 MG/MLДействующее вещество: ДексаметазонПроизводитель: I.B.N. SAVIO S.R.LОтпускается по рецептуФорма выпуска: Eye drops, solution, 1,5 MG/MLДействующее вещество: ДексаметазонПроизводитель: SIFI S.P.A.Отпускается по рецепту
Аналоги DEXAMONO в других странах
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Аналог DEXAMONO в Испания
Аналог DEXAMONO в Польша
Аналог DEXAMONO в Украина
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Часто задаваемые вопросы
DEXAMONO требует рецепта в Италия. Вы можете уточнить у врача онлайн, подходит ли это лекарство для вашей ситуации.
Действующее вещество DEXAMONO — Дексаметазон. Эта информация помогает определить лекарства с тем же составом под другими торговыми названиями.
DEXAMONO производится компанией LABORATOIRES THEA. 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 DEXAMONO 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 DEXAMONO 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 (Дексаметазон) включают DESADOK, DEXAVISONE, ETAKORTILEN. Они могут отличаться торговым названием или формой выпуска, но содержат одинаковый терапевтический компонент. Перед изменением лечения рекомендуется проконсультироваться с врачом.
