OFTACORTAL 0.15% Глазные капли, раствор
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Инструкция по применению OFTAKORTAL
Содержание инструкции
OFTACORTAL 0,15% eye drops, solution
Dexamethasone sodium phosphate
Equivalent 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 for you 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 pharmacist. See section 4.
Contents of this leaflet:
- 1. What OFTACORTAL is and what it is used for
- 2. What you need to know before you use OFTACORTAL
- 3. How to use OFTACORTAL
- 4. Possible side effects
- 5. How to store OFTACORTAL
- 6. Contents of the pack and other information
1. What is OFTACORTAL and what is it used for
OFTACORTAL is a steroidal anti-inflammatory drug (also called a corticosteroid) indicated in the
treatment of ocular inflammations of various natures:
- Spring conjunctivitis, allergic conjunctivitis (inflammation of the conjunctiva of allergic origin);
- Blepharitis and allergic blepharoconjunctivitis (inflammation of the eyelid margin and conjunctiva of allergic origin);
- Allergic keratoconjunctivitis (inflammation of the cornea and conjunctiva of allergic origin);
- Inflammation of the outer wall of the eye, the sclera (scleritis, episcleritis) or the uvea (uveitis).
2. What you need to know before using OFTACORTAL
Do not use OFTACORTAL
- if you are allergic (hypersensitive) to dexamethasone or any of the other ingredients of this medicine (listed in section 6);
- if you have ocular hypertension;
- if you suffer from herpes simplex or other corneal viruses in an acute ulcerative phase, unless associated with specific chemotherapeutic drugs for herpes;
- if you have conjunctivitis with corneal ulceration even in the early stages (positive fluorescein test);
- if you suffer from tuberculosis and fungal eye infections, purulent conjunctivitis, hordeolum;
- in purulent or herpetic inflammation of the eyelid margin which may be masked or aggravated by corticosteroids;
- when you have corneal lesions or abrasions because topical corticosteroids delay healing of damaged tissues, promoting possible infections;
- in children under three years of age;
- generally during pregnancy and breastfeeding;
- if the aluminum blister or containers are visibly damaged;
Warnings and precautions
Consult your doctor before using OFTACORTAL.
Pay particular attention with OFTACORTAL:
- if you suffer from herpetic inflammation of the cornea, you can only use it under strict supervision of the ophthalmologist, as corticosteroids can promote aggravation with irreversible corneal opacification;
- if you use it for more than two weeks, because it may increase intraocular pressure. In this case, therefore, keep the ocular tone and pressure under control. Avoid prolonged use because corticosteroids promote the onset of cataracts, blurred vision or other visual disturbances. Prolonged use over time (1 to 4 years) and high doses of corticosteroids for ophthalmic use can lead to clouding of the lens (posterior subcapsular cataract) (see section 4);
- if you suffer from conditions accompanied by corneal thinning;
- if you suffer from corneal lesions or abrasions as the application of corticosteroids to damaged tissues delays healing, promoting the onset and spread of any infections; the use of corticosteroids in the presence of lesions delays the healing of damaged tissues, promoting the onset and spread of any infections;
- if you suffer from bacterial, viral or fungal conjunctivitis, because it may worsen the disease or mask the signs of infection progression (see section 2 “Do not use OFTACORTAL”). Consult your doctor if you feel swelling and weight gain around the trunk and face as these are usually the first manifestations of a syndrome called Cushing's syndrome. Suppression of adrenal gland function may develop after discontinuation of prolonged or intensive treatment with Oftacortal. Consult your doctor before stopping treatment on your own. These risks are particularly important in children and patients treated with a medicine called ritonavir or cobicistat.
Children
In children from 3 to 12 years of age, the medicine should be administered only when actually necessary and under the
direct control of the doctor.
Other medicines and OFTACORTAL
Tell your doctor if you are taking, have recently taken or might take any other
medicines.
Consult your doctor if you are using ritonavir or cobicistat, as they may increase the level of
dexamethasone in the blood.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor for advice before using this medicine. In early infancy
and during pregnancy, the product should be administered only when actually necessary and under the direct control
of the doctor.
Driving and operating machinery
No effects on driving and operating machinery are known.
As with any eye medicine, if you experience transient blurred vision during
use, wait until your vision returns to normal before driving or using machinery.
Oftacortal contains phosphate buffer
This medicine contains 0.18 mg of phosphate buffer per drop equivalent to 3.66 mg/ml (with
theoretical drop volume of approximately 50 µL).
If you have severe damage to the outermost transparent layer of the eye (the cornea), phosphates may
cause very rare opaque spots on the cornea due to calcium accumulation during
treatment.
3. How to use OFTACORTAL
Instill one drop into one or both eyes 3-4 times a day as prescribed by your
doctor.
The eye drops are in single-dose containers, do not contain preservatives and should be used immediately after opening.
Avoid contact between the tip of the container and the eye or any other surface.
Always use this medicine exactly as your doctor has instructed. If you have any doubts, consult your
doctor or pharmacist.
Instructions for use
- 1) Make sure the single-dose container is intact.
- 2) Detach the single-dose container from the strip.
- 3) Open by rotating the top without pulling.
If you use more OFTACORTAL than you should
Excessive use or accidental ingestion may cause toxic effects, inform your doctor
and follow their instructions.
If you forget to use OFTACORTAL
Continue therapy with the next dose without doubling it to compensate for the forgotten dose.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Possible side effects due to the use of Oftacortal are:
Effects on the body:
- Allergic reactions (hypersensitivity)
The following side effects have occurred with medicines belonging to the same group of medicines
as Oftacortal (corticosteroids):
Effects on the eye:
- opacity of the lens that alters vision (subcapsular cataract)
- eye infection (including bacterial, fungal and viral infections)
- eye irritation
- perforation of the eye (scleral or corneal perforation)
- increased pressure in the eye
- eye disease due to increased pressure inside the eye (glaucoma)
- feeling of itching or burning in the eye
- blurred vision (frequency not known). In very rare cases, some patients with severe damage to the clear layer in the front of the eye (cornea) have developed opaque spots on the cornea due to calcium accumulation during treatment. Unknown side effects (frequency cannot be estimated based on available data): Hormonal problems: increased hair growth on the body (especially in women), weakness and muscle atrophy, purple stretch marks on the skin of the body, increased blood pressure, irregular or absent cycle, changes in protein and calcium levels in the body, delayed growth in children and adolescents and swelling and weight gain of the body and face (called “Cushing’s syndrome”) (see section 2 “Special warnings”). In all these cases it is appropriate to stop treatment and seek appropriate therapy.
Reporting of side effects
If you get any side effects, even those not listed in this leaflet,
tell your doctor or pharmacist.
Side effects can also be reported 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 OFTACORTAL
Keep this medicine out of the reach and sight of children.
Do not store at a temperature above 25 °C.
Do not use the product after the expiry date which is reported on the package after “Exp.”
The expiry date refers to the last day of the month in intact packaging,
correctly stored.
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.
Shelf life after opening
Discard the opened vial after administration.
Keep the still-closed containers inside the opened sachet and in the cardboard box and use them
within 28 days.
6. Contents of the pack and other information
What OFTACORTAL contains
One single-dose container contains:
The active ingredient is desamethasone sodium phosphate 0.45 mg, equivalent to desamethasone 0.342 mg.
The other ingredients are: trisodium citrate dihydrate, sodium phosphate monobasic monohydrate,
disodium phosphate dodecahydrate, water for injectable preparations.
Description of the appearance of OFTACORTAL and contents of the pack
Pack containing 20 single-dose containers in low-density polyethylene of 0.3 ml, divided into 4
strips of 5 units, individually packaged in PET/Al/PE sachets.
Marketing Authorisation Holder and Manufacturer:
Farmigea SpA, Via G.B. Oliva 6/8, 56121 Pisa (PI), Italy
Distributor: Diadema Farmaceutici srl - Via Malasoma 14/16 - 56121 Pisa - Italy
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- Страна регистрации
- Форма выпускаEye drops, solution, 0.15%
- 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 OFTAKORTALФорма выпуска: Eye drops, solution, 1,5 MG/MLДействующее вещество: ДексаметазонПроизводитель: DOC GENERICI SRLОтпускается по рецептуФорма выпуска: Eye drops, solution, 1MG/MLДействующее вещество: ДексаметазонПроизводитель: LABORATOIRES THEAОтпускается по рецептуФорма выпуска: Eye drops, solution in single-dose container, 1 MG/MLДействующее вещество: ДексаметазонПроизводитель: I.B.N. SAVIO S.R.LОтпускается по рецепту
Аналоги OFTAKORTAL в других странах
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Аналог OFTAKORTAL в Испания
Аналог OFTAKORTAL в Польша
Аналог OFTAKORTAL в Украина
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Часто задаваемые вопросы
OFTAKORTAL требует рецепта в Италия. Вы можете уточнить у врача онлайн, подходит ли это лекарство для вашей ситуации.
Действующее вещество OFTAKORTAL — Дексаметазон. Эта информация помогает определить лекарства с тем же составом под другими торговыми названиями.
OFTAKORTAL производится компанией FARMIGEA 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 OFTAKORTAL 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 OFTAKORTAL 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, DEXAMONO, DEXAVISONE. Они могут отличаться торговым названием или формой выпуска, но содержат одинаковый терапевтический компонент. Перед изменением лечения рекомендуется проконсультироваться с врачом.
