VOLTAREN 1 мг/мл Глазные капли, раствор
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Инструкция по применению VOLTAREN OFTABAK
Содержание инструкции
- VOLTAREN OFTABAK 1 mg/ml, eye drops, solution
- VOLTAREN OFTABAK contains ricinoleic acid macrogolglycerol which may cause contact dermatitis
VOLTAREN OFTABAK 1 mg/ml, eye drops, solution
Diclofenac sodium
Generic medicine
Read this leaflet carefully before you start to use this medicineas it contains important
information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor, pharmacist or nurse.
- 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 you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.
Contents of this leaflet
- 1. What VOLTAREN OFTABAK is and what it is used for
- 2. What you need to know before you use VOLTAREN OFTABAK
- 3. How to use VOLTAREN OFTABAK
- 4. Possible side effects
- 5. How to store VOLTAREN OFTABAK
- 6. Contents of the pack and other information
1. What is VOLTAREN OFTABAK and what is it used for
This medicine contains a non-steroidal anti-inflammatory drug (NSAID) for ophthalmic use.
It is used during some eye surgeries and for post-operative follow-up:
- inhibition of miosis (narrowing of the pupillary diameter) in cataract surgery,
- prevention of inflammation in cataract and anterior segment eye surgeries,
- treatment of eye pain in photorefractive keratectomy (corrective surgery for myopia) within the first 24 hours after surgery.
2. What you need to know before using VOLTAREN OFTABAK
Do not use VOLTAREN OFTABAK
- if you are allergic (hypersensitive) to diclofenac sodium or any of the excipients of this medicine (listed in section 6),
- if you have had previous episodes of allergy, urticaria (itchy skin rash), acute rhinitis (swelling and irritation inside the nose) or asthma started by taking this eye drop or a similar medicine, such as other NSAIDs or aspirin,
- if you are pregnant, from the beginning of the 6th month of pregnancy (after 24 weeks).,
Warnings and precautions
Consult your doctor, pharmacist or nurse before using VOLTAREN OFTABAK.
- You must use this medicine with caution:
- VOLTAREN OFTABAK can, like other NSAIDs, in rare cases induce allergic reactions including anaphylactic reactions (serious allergic reactions that cause difficulty breathing or dizziness), even without previous exposure to the drug.
- If you experience hypersensitivity reactions or signs of allergy to this medicine, especially asthma attacks or sudden swelling of the face and neck, stop therapy and contact your doctor or emergency services immediately.
- Before using this medicine, tell your doctor if you have asthma associated with chronic rhinitis, chronic sinusitis and/or nasal polyps.
- An acute eye infection can be masked by the topical use of anti-inflammatory drugs. NSAIDs do not have antibacterial properties. In case of eye infection, their use with one/some anti-infective drugs must be done with caution.
- The concomitant use of topical NSAIDs and topical steroids (such as desamethasone) may increase potential healing problems.
- NSAIDs can delay corneal repair.
- If you have a predisposition to bleeding or if you are taking anticoagulant therapy (medicines that thin the blood).
- In case of high doses and prolonged use, the use of topical NSAIDs can cause keratitis.
- Patients who have undergone repeated eye surgeries in a short period of time, who have diabetes, ocular surface disease (e.g. Dry Eye Syndrome), rheumatoid arthritis may be at higher risk of corneal adverse events.
- The use of contact lenses is not recommended after cataract surgery. Your doctor will advise you when you can use contact lenses again.
- If your symptoms worsen or do not improve, you should see a doctor.
Other medicines and VOLTAREN OFTABAK
If you are using another eye drop at the same time as VOLTAREN OFTABAK, wait 15 minutesbetween one
treatment and the other.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines, including those available without a prescription.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, if you suspect or are planning a
pregnancy, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
You should not take this medicine during the first 5 months of pregnancy (up to 24 weeks), unless
your doctor considers it absolutely necessary. If you need it, your doctor will prescribe the lowest
dose for the shortest possible time.
From the beginning of the 6th month until the end of pregnancy (after 24 weeks), this medicine is
contraindicated and should NEVER be taken due to the serious effects on the baby.
If you have taken this medicine during pregnancy, inform your obstetrician immediately so that you can
be monitored if necessary.
Breastfeeding
VOLTAREN OFTABAK can be used during breastfeeding.
Fertility
Like all non-steroidal anti-inflammatory drugs (NSAIDs), this medicine can affect fertility
in women and make it difficult to conceive. This effect ceases when treatment is stopped.
Tell your doctor if you are planning a pregnancy or if you have problems conceiving.
Driving and operating machinery
You may experience transient visual disturbance after administration of VOLTAREN OFTABAK. Wait until
normal vision returns before driving or operating dangerous machinery.
VOLTAREN OFTABAK contains castor oil ricinoleate macrogol
VOLTAREN OFTABAK contains ricinoleic acid macrogolglycerol which may cause contact dermatitis
(skin reaction).
3. How to use VOLTAREN OFTABAK
Use VOLTAREN OFTABAK following exactly the instructions of your doctor. If you have any doubts, consult your
doctor or pharmacist.
Dosage
The recommended dose in adults and the elderly is as follows:
Inhibition of miosis during cataract surgery:
Pre-operative: apply one drop up to five times during the three hours before surgery.
Cataract and anterior segment surgery of the eye:
- Pre-operative: instill 1 drop up to 5 times during the 3 hours before surgery;
- Post-operative: instill 1 drop 3 times immediately after surgery and then 1 drop from 3 to 5 times a day, for no more than 4 weeks. Eye pain in photorefractive keratectomy (refractive surgery for myopia):
- Pre-operative: instill 2 drops within the hour preceding surgery;
- Post-operative: instill 2 drops within the hour following surgery and then 4 drops within the 24 hours post-operative.
Do not exceed the recommended dose.
Use in children:
Specific studies have not been conducted.
Route of administration
This medicine is intended to be administered into the eye (ophthalmic use).
Do not inject, do not swallow.
The eye drops must not be used for peri- or intraocular injection.
Wash your hands thoroughly before using the product.
Avoid contact of the container tip with the eye or eyelids.
Instill one drop into the affected eye, looking upwards and slightly lowering the
lower eyelid.
Close the bottle after use.
After instillation, press with a finger in the corner between the eye and the nose and gently close
the eyelids for 2 minutes. This helps to prevent VOLTAREN
OFTABAK from entering the rest of the body.
If you forget to use VOLTAREN OFTABAK
Do not take a double dose to make up for a missed dose.
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.
The following side effects have been reported:
Uncommon: may affect up to 1 in 100 people
- Burning sensation following instillation
- Vision disturbances following instillation Rare: may affect up to 1 in 1000
- Hypersensitivity reactions, itching and redness
- Photosensitivity reactions (allergic reaction after exposure to the sun)
- Punctate keratitis (lesions on the cornea), corneal ulcerations, corneal thinning
- Dyspnea (difficulty breathing)
- Worsening of asthma Not known: the frequency cannot be estimated based on the available data
- Rhinitis (swelling and irritation inside the nose)
- Conjunctival hyperemia (redness of the eyes), allergic conjunctivitis (inflammation of the surface of the eye), eyelid edema (swelling of the eyelids)
- Cough
- Urticaria (itching), skin rash, contact eczema.
- Due to the presence of castor oil ethoxylate, risk of contact eczema.
If any of these side effects gets serious, or if you notice any side effects not listed in this leaflet
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your
doctor or pharmacist. 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.
5. HOW TO STORE VOLTAREN OFTABAK
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 package and the bottle. The expiry date refers to the last day of the month.
Do not store at a temperature above 25°C.
The bottle must not be stored for more than eight weeks after first opening.
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 protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What VOLTAREN OFTABAK contains
- The active ingredient is diclofenac sodium at a concentration of 1 mg/ml.
- The excipients are macrogolglycerol ricinoleate, trometamol, boric acid and water (water for injections).
Description of the appearance of VOLTAREN OFTABAK and contents of the pack
VOLTAREN OFTABAK is a clear yellow liquid presented in a bottle containing 10 ml of eye drops,
solution.
Marketing Authorisation Holder
LABORATOIRES THEA
12, rue Louis Blériot
63017 CLERMONT-FERRAND CEDEX 2
FRANCE
Distributor for sale:
THEA FARMA S.p.A. – Via Tiziano, 32 – 20145 MILANO
Manufacturer
EXCELVISION
Rue de la Lombardière
07100 ANNONAY
FRANCE
This medicinal product is authorised in the Member States of the European Economic Area with the following
names:
Austria, Norway………………………………………………………… VOLTAREN OPHTHA ABAK
Belgium, Bulgaria, Czech Republic, Finland, Greece, Luxembourg, Netherlands, Poland, Portugal, Spain,
Sweden ......................................................................................................... DICLOABAK
Denmark ........................................................................................... VOLTABAK
France ................................................................................................ VOLTARENOPHTABAK
Italy .................................................................................................... VOLTAREN OFTABAK
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- Страна регистрации
- Форма выпускаEye drops, solution, 1 MG/ML
- Код АТХS01BC03
- 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 VOLTAREN OFTABAKФорма выпуска: Eye drops, solution, 0.1%Действующее вещество: ДиклофенакПроизводитель: OMNIVISION ITALIA SRLОтпускается по рецептуФорма выпуска: Eye drops, solution, 0.1%Действующее вещество: ДиклофенакПроизводитель: FARMIGEA S.P.A.Отпускается по рецептуФорма выпуска: Eye drops, solution, 1 MG/MLДействующее вещество: ДиклофенакПроизводитель: VISUFARMA S.P.A.Отпускается по рецепту
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Действующее вещество VOLTAREN OFTABAK — Диклофенак. Эта информация помогает определить лекарства с тем же составом под другими торговыми названиями.
VOLTAREN OFTABAK 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 VOLTAREN OFTABAK с учетом вашей ситуации и местных правил. Вы можете записаться на онлайн-консультацию, чтобы обсудить возможные варианты.
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Другие лекарства с тем же действующим веществом (Диклофенак) включают DIKLOKULAR, DIKLOFTIL, VISUNAK. Они могут отличаться торговым названием или формой выпуска, но содержат одинаковый терапевтический компонент. Перед изменением лечения рекомендуется проконсультироваться с врачом.
