DORZOLAMIDE 20 mg /Ml Krople Do Oczu, Roztwór
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Dorzolamide Aurobindo 20mg/ml eye drops, solution
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 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 those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
- .
Contents of this leaflet:
- 1. What Dorzolamide Aurobindo is and what it is used for
- 2. What you need to know before you use Dorzolamide Aurobindo
- 3. How to use Dorzolamide Aurobindo
- 4. Possible side effects
- 5. How to store Dorzolamide Aurobindo
- 6. Contents of the pack and other information
1. What is Dorzolamide Aurobindo and what is it used for
Dorzolamide Aurobindo is a sterile eye drop. Dorzolamide Aurobindo contains dorzolamide, a sulfonamide substance, as the active ingredient.
Dorzolamide Aurobindo is a carbonic anhydrase inhibitor for ophthalmic use that reduces intraocular hypertension.
It is indicated for the treatment of elevated intraocular pressure in conditions such as ocular hypertension and glaucoma (open-angle glaucoma, pseudoexfoliative glaucoma). Dorzolamide Aurobindo may
be used as monotherapy or in association with other drugs that reduce eye pressure (called
beta-blockers).
2. What you need to know before using Dorzolamide Aurobindo
Do not use Dorzolamide Aurobindo
- if you are allergic to dorzolamide or any of the other ingredients of this medicine .
- if you have severe kidney problems.
Warnings and precautions
Talk to your doctor before using Dorzolamide Aurobindo
- if you have or have had liver problems in the past
- if you have been found to have a corneal defect
- if you have allergies to any medicine
- if you have undergone, or are about to undergo, eye surgery
- if you have suffered eye injuries or have an eye infection
- if you have suffered from kidney stones in the past
- if you are taking another carbonic anhydrase inhibitor orally
- if you wear contact lenses (see paragraph ‘Dorzolamide Aurobindo contains the preservative benzalkonium chloride’).
Contact your doctor immediately if you experience irritation or any new eye problems, such as redness or swelling on the surface of the eye or on the eyelid.
Stop using Dorzolamide Aurobindo and contact your doctor immediately if you think
Dorzolamide Aurobindo is causing you an allergic reaction (e.g. skin rash, severe adverse reactions with blisters on the skin that may affect the mouth, eyes and genitals, itching,
eye inflammation).
Children
Dorzolamide Aurobindo has been studied in infants and children under 6 years of age who have high eye pressure or have been diagnosed with glaucoma. For more
information, please consult your doctor.
Dorzolamide Aurobindo and other medicines
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines..
In particular, tell your doctor if you are taking another carbonic anhydrase inhibitor such as
acetazolamide. You can take this medicine by mouth, as eye drops, or with any other
method.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before taking this medicine.
Dorzolamide Aurobindo should not be used during pregnancy unless clearly indicated by your doctor.
Dorzolamide Aurobindo should not be used during breastfeeding.
Driving and operating machinery
Dorzolamide Aurobindo can cause dizziness and vision disturbances in some patients. Do not drive vehicles or do not
use tools or machinery until the symptoms have disappeared.
Dorzolamide Aurobindo contains the preservative benzalkonium chloride
Benzalkonium chloride can cause eye irritation.
Benzalkonium chloride is known to alter the coloring of soft contact lenses.
Avoid contact with soft contact lenses.
Remove contact lenses before instillation and wait at least 15 minutes before re-applying them.
3. How to use Dorzolamide Aurobindo
Use this medicine following the doctor's instructions exactly. If you have any doubts, consult your doctor
or pharmacist.
The doctor will establish the appropriate dosage and duration of treatment.
When Dorzolamide Aurobindo is administered alone, the usual dose is one drop in the affected eye(s) three times a day, for example in the morning, afternoon and evening.
If the doctor has prescribed the use of Dorzolamide Aurobindo in association with a beta-blocker eye drop
(medicines that reduce eye pressure), then the usual dose is one drop of Dorzolamide
Aurobindo in the affected eye(s) twice a day, for example in the morning and evening.
If Dorzolamide Aurobindo is used together with another eye drop, you must allow at least 10 minutes between
the instillation of Dorzolamide Aurobindo and the other medicine. Alternatively, if you need to use Dorzolamide
Aurobindo instead of another eye drop used to lower eye pressure, stop the other
medicine after having taken the appropriate dosage for that day and start treatment with Dorzolamide
Aurobindo the next day.
Do not change the dosage of the medicine without first consulting your doctor. If you need to stop the
treatment, contact your doctor immediately.
Avoid contact of the dropper tip with the eye or surrounding areas. It could
become contaminated with bacteria that can cause infections responsible for serious eye damage, including loss of
vision. To avoid possible bacterial contamination, avoid contact of the dropper tip with
any surface.
Instructions for correct use:
It is recommended to wash your hands before using the eye drops.
It may be easier to apply the eye drops in front of a mirror.
- 1. Before using the medicine for the first time, make sure that the safety seal located on the front
of the bottle is intact. A space between the bottle and cap is normal for a bottle that has not yet been
opened.
- 2. Remove the cap from the bottle.
- 3. Tilt your head back and gently pull down the lower eyelid, so as to form a small pocket between the eyelid and the eye.
- 4. Turn the bottle upside down and press gently until a single drop is introduced into the eye, as prescribed by the doctor. DO NOT BRING THE DROPPER TIP INTO CONTACT WITH THE EYE OR EYELID.
- 5. Repeat steps 3 and 4 for the other eye, if the doctor has prescribed treatment for both eyes
- 6. Replace the cap and close the bottle immediately after use. If you use more Dorzolamide Aurobindo than you shouldIf you put too much eye drops in your eye or swallow some, contact your doctor immediately.
If you forget to use Dorzolamide Aurobindo
It is important to use Dorzolamide Aurobindo as prescribed by your doctor.
If you forget a dose, instill it as soon as possible. However, if the time to instill the next dose is near, skip the forgotten dose and resume your usual dosing schedule.
Do not use a double dose to make up for a forgotten dose.
If you stop the treatment with Dorzolamide Aurobindo
Dorzolamide Aurobindo must be used every day to work correctly. If you need to stop the
treatment, contact your doctor immediately.
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 everyone will experience them.
Stop using this medicine and seek immediate medical advice if you develop allergic reactions. Symptoms of allergic reactions include:
- swelling of the face, lips, tongue and/or throat which may cause difficulty in breathing or swallowing
- severe skin reactions with blisters that may affect the mouth, eyes and genitals
- urticaria With Dorzolamide Aurobindo the following side effects may occur:
Very common side effects(may affect more than 1 in 10 people)
- burning and stinging sensation in the eye
Common side effects(may affect up to 1 in 10 people)
- corneal disease with redness of the eye and blurred vision (superficial punctate keratitis), inflammation or swelling of the outer surface of the eye/eyes and possible inflammation of the eyelid(s) and/or skin around the eye/eyes, tearing or itching of the eye/eyes, blurred vision, effects on the outer surface of the eye
- nausea, bitter taste sensation
- asthenia/fatigue
- headache Uncommon side effects(may affect up to 1 in 100 people)
- inflammation of the middle layer of the eye
Rare side effects(may affect up to 1 in 1000 people)
- swelling of the superficial ocular layer, detachment of the choroid which may be accompanied by visual disturbances/alterations (following eye surgery), ocular hypotony, redness of the eye/eyes, eye pain, crusting of the eyelid(s), transient myopia (which resolves upon discontinuation of the medicine)
- throat irritation, dry mouth
- Hypersensitivity: signs and symptoms of localized reactions (reactions on the eyelids) and systemic allergic reactions, including swelling of the face, lips, tongue and/or throat, which may cause difficulty breathing or swallowing, urticaria and itching, shortness of breath and more rarely bronchospasm (contraction of the smooth muscle of the bronchi).
- dizziness, numbness/tingling sensation
- formation of calculi at the level of the urinary tract
- nose bleeding
- severe skin reaction, skin inflammation
Not known(frequency cannot be estimated based on available data)
- Shortness of breath
- Foreign body sensation in the eye (feeling that something is in the eye)
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your
doctor or pharmacist. You can also report side effects directly through the national reporting system at
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 Dorzolamide Aurobindo
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 the packaging
after “Exp”. The expiry date refers to the last day of that month.
Store the bottle in the outer packaging to protect the medicine from light. Store at a temperature
below 30°C.
Dorzolamide Aurobindo must be used within 28 days of first opening the bottle. Therefore,
you must discard the bottle 4 weeks after first opening, even if some of the solution remains. To
remind yourself, write the date of opening in the designated space on the packaging.
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. Package contents and other information
What Dorzolamide Aurobindo contains
- The active ingredient is dorzolamide. Each ml contains 20 mg of dorzolamide (as dorzolamide hydrochloride).
- The other ingredients are mannitol, hydroxyethylcellulose, benzalkonium chloride (as a preservative), sodium citrate, sodium hydroxide for pH adjustment and water for injectable preparations.
Description of the appearance ofDorzolamide Aurobindo and package contents
Dorzolamide Aurobindo is a sterile, isotonic, colorless, clear, slightly viscous buffer solution
contained in an opaque, medium-density polyethylene bottle, with a sealed dropper and a cap
consisting of two assembled parts. Each bottle contains 5 ml of eye drops.
Dorzolamide Aurobindo is available in packs of 1, 3 or 6 bottles.
Not all pack sizes may be marketed.
Marketing authorisation holder
Aurobindo Pharma (Italia) s.r.l. – Via San Giuseppe, 102 – 21047 Saronno (VA)
Manufacturer responsible for batch release
Pharmathen S.A. – 6 Dervenakion str. – 15351 Pallini, Attiki (Greece)
Famar S.A., Plant A – 63 Agiou Dimitriou Street – 17456 Alimos (Greece)
This medicinal product is authorised in the Member States of the European Economic Area with the following
names:
Austria Dorzolamid Actavis 20 mg/ml Eye Drops
Cyprus Domide
Denmark Arzolamid
Estonia Dorzolamide Actavis
Finland Dorzolamid Actavis 20mg/ml eye drops, solution
Germany Dorzolamid-Actavis 20mg/ml Eye Drops
Ireland Dorzolamide 20mg/ml Eyedrops
Italy Dorzolamide Aurobindo
Lithuania Dorzolamide Actavis 20 mg/ml eye drops, solution
Latvia Dorzolamide Actavis
Malta Domide
Netherlands Dorzolamide Actavis 20 mg/ml, eye drops, solution
Portugal Dorzolamida Aurovitas
United Kingdom Dorzolamide 20mg/ml Eye Drops Solution
Spain Dorzolamida Actavis 20 mg/ml eye drops in solution
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- Kraj rejestracji
- Postać farmaceutycznaEye drops, solution, 20 MG/ML
- Kod ATCS01EC03
- Substancja czynna
- Wymaga receptyTak
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki DORTSOLAMIDE AUROBINDOPostać farmaceutyczna: Eye drops, solution, 20 mg/mlSubstancja czynna: dorzolamideWymaga receptyPostać farmaceutyczna: Eye drops, solution, 20 MG/MLSubstancja czynna: dorzolamideProducent: OMNIVISION ITALIA SRLWymaga receptyPostać farmaceutyczna: Mouthwash, 20 MG/MLSubstancja czynna: dorzolamideProducent: MYLAN S.P.A.Wymaga recepty
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DORTSOLAMIDE AUROBINDO wymaga recepty w Włochy. Możesz skonsultować się z lekarzem online, aby sprawdzić, czy ten lek może być odpowiedni w Twojej sytuacji.
Substancją czynną w DORTSOLAMIDE AUROBINDO jest dorzolamide. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
DORTSOLAMIDE AUROBINDO jest produkowany przez AUROBINDO PHARMA (ITALIA) S.R.L.. Nazwy handlowe i opakowania mogą się różnić w zależności od dystrybutora.
Lekarze, tacy jak Lekarze rodzinni, Psychiatrzy, Dermatolodzy, Kardiolodzy, Endokrynolodzy, Gastroenterolodzy, Pulmonolodzy, Nefrolodzy, Reumatolodzy, Hematolodzy, Zakaźnicy, Alergolodzy, Geriatrzy, Pediatrzy, Onkolodzy, mogą ocenić, czy stosowanie DORTSOLAMIDE AUROBINDO jest odpowiednie w Twoim przypadku, w zależności od sytuacji klinicznej i lokalnych przepisów. Możesz umówić konsultację online, aby omówić objawy i możliwe dalsze kroki.
Polska posiada dobrze rozwiniętą infrastrukturę ochrony zdrowia w dużych miastach, takich jak Warszawa, Kraków, Wrocław i Gdańsk. Apteki są łatwo dostępne i działają zgodnie z obowiązującymi przepisami, zapewniając dostęp do leków na receptę.
Możesz kupić DORTSOLAMIDE AUROBINDO w Warszawie, Krakowie, Wrocławiu lub Gdańsku w każdej aptece, posiadając ważną receptę.
Aby uzyskać receptę, możesz skorzystać z Oladoctor:
Inne leki zawierające tę samą substancję czynną (dorzolamide) to m.in. DIMATS, DORTSOKLAR, DORTSOLAMIDE MYLAN JENERIKS. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
