TRUSOPT 20 mg /Ml Krople Do Oczu, Roztwór
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Treść ulotki
TRUSOPT 20 mg/ml eye drops, solution
dorzolamide
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 their symptoms are the same as yours, as it may be harmful.
- If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet:
- 1. What TRUSOPT is and what it is used for
- 2. What you need to know before you use TRUSOPT
- 3. How to use TRUSOPT
- 4. Possible side effects
- 5. How to store TRUSOPT
- 6. Contents of the pack and other information
1. What is TRUSOPT and what is it used for
TRUSOPT contains dorzolamide which belongs to a group of medicines called "carbonic anhydrase inhibitors".
This medicine is prescribed to lower elevated intraocular pressure and for the therapy of
glaucoma. This medicine can be used alone or as combination therapy with other
medicines that lower intraocular pressure (called beta-blockers).
2. What you need to know before you use TRUSOPT
Do not use TRUSOPT
- if you are allergic to dorzolamide hydrochloride or to any of the other ingredients of this medicine (listed in section 6).
- if you have severe kidney impairment or kidney problems, or a history of kidney stones.
Warnings and precautions
Talk to your doctor or pharmacist before using TRUSOPT.
Tell your doctor or pharmacist about any medical problems you currently have or have had in
the past, including eye problems and eye surgery, and about any allergies to other
medicines.
If you develop eye irritation or any other new eye problem, such as
eye redness or eyelid swelling, contact your doctor immediately.
If you suspect that TRUSOPT is causing an allergic reaction (e.g., skin rash,
severe skin reaction or itching), stop using this medicine and contact your
doctor immediately.
Use in Children
TRUSOPT has been studied in infants and children under 6 years of age with increased pressure
in the eye(s) or who have been diagnosed with glaucoma. For more information, consult
your doctor.
Use in the elderly
In clinical studies with TRUSOPT, the effects of this medicine observed in elderly patients and in
younger patients were similar.
Use in patients with hepatic impairment
Tell your doctor about any current or past liver problems.
Other medicines and TRUSOPT
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines (including eye drops). This is particularly important if you are taking another
carbonic anhydrase inhibitor such as acetazolamide or a sulfonamide.
Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are
breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
This medicine should not be used during pregnancy. Tell your doctor if you are pregnant or
planning to become pregnant.
Breastfeeding
If treatment with this medicine is necessary, breastfeeding is not recommended.
Tell your doctor if you are breastfeeding or intend to breastfeed.
Driving and using machines
The effects on the ability to drive and operate machines have not been studied. There are
side effects associated with the use of TRUSOPT, such as dizziness and blurred vision, which
may interfere with the ability to drive and operate machines. You should avoid driving or
using machines until you feel well or your vision is not blurred.
TRUSOPTcontains benzalkonium chloride
TRUSOPT contains the preservative benzalkonium chloride. This preservative can deposit in
soft contact lenses and can alter the coloring of the lenses. If you use contact lenses, you should
consult your doctor before using this medicine.
3. How to use TRUSOPT
Use this medicine following the instructions of your doctor exactly. If you have any doubts, consult your
doctor or pharmacist. The appropriate dose and duration of treatment will be established by your
doctor.
When this medicine is used alone, the recommended dose is one drop to be instilled
into the affected eye(s) in the morning, one in the afternoon, and one in the evening.
If the doctor has recommended the use of this medicine
together with a beta-blocker-based eye drop to lower eye pressure, the recommended dose is one drop of TRUSOPT to
be instilled into the affected eye(s) in the morning and one in the evening.
If TRUSOPT is used together with other eye drops, the drops must be instilled at intervals of
at least 10 minutes.
The tip of the dropper must not come into contact with the eye or the surrounding areas. It may
become contaminated with bacteria, which can cause eye infections that can
cause serious eye damage, including loss of vision.
To avoid possible contamination, wash your hands before using this medicine and
do not rest the tip of the dropper on any surface. If you think the medicine
may be contaminated or if you develop an eye infection, contact
your doctor immediately before continuing to use the medicine.
Instructions for use:
Do not use the container if the plastic safety seal around the neck of the container is
missing or broken. When you open the container for the first time, tear off the plastic safety seal.
Each time you use TRUSOPT:
- 1. Wash your hands.
- 2. Open the container. Pay particular attention that the tip of the dropper containerdoes not touch the eye, the skin around the eye, or your fingers.
- 3. Tilt your head back and hold the container upside down over your eye.
- 4. Pull down your lower eyelid and look up. Hold the container and gently press on the flattened sides and let one drop fall into the space between your lower eyelid and your eye.
- 5. Press with your finger on the corner of your eye, near your nose, or close your eyelids for 2 minutes. This helps prevent the medicine from passing into the rest of your body.
- 6. Repeat the instructions from 3 to 5 with the other eye if it has been prescribed by your doctor.
- 7. Replace the cap and close the container tightly.
[Only OCUMETER PLUS containers]
- 1. Before using the medicine for the first time, make sure the safety seal located on the front of the container is intact. A space between the container and the cap is normal for a container that has not yet been opened.
►
- 2. First wash your hands then tear off the safety seal to break the seal.
- 3. To open the container, unscrew the cap by rotating it in the direction indicated by the arrows that are on top of the cap. Do not pull the cap directly off the container. Pulling the cap directly off will prevent the dropper from working properly.
- 4. Tilt your head back and gently pull down your lower eyelid, so as to form a pocket between the eyelid and the eye.
- 5. Turn the container upside down and press gently with your thumb or index finger at the compressible area (as shown) until a single drop has been introduced into the eye, as prescribed by your doctor.
DO NOT LET THE TIP OF THE DROPPER COME INTO CONTACT WITH THE EYE OR WITH THE
EYELID.
- 6. If administering the drops is difficult after opening the container for the first time, replace the cap on the container and tighten (not excessively) and then remove by turning the cap in the opposite direction as indicated by the arrows on top of the cap.
- 7. Repeat steps 4 and 5 for the other eye, if your doctor has prescribed treatment for both eyes.
- 8. Screw the cap back on tightly. The arrow on the left side of the cap must be aligned with the arrow on the left side of the container label for proper closure. Do not overtighten to avoid damaging the container and cap.
- 9. The dropper is calibrated for dispensing a single drop; DO NOT widen the hole in the dropper.
- 10. Once the doses are exhausted, the container will still contain some residual medicine. The container actually contains an excess of medicine to ensure the availability of the complete dose of medicine prescribed by your doctor. Do not remove the excess medicine from the container.
If you use more TRUSOPT than you should
If you instill too many drops into your eye or if you ingest any of the contents of the container, contact
your doctor immediately.
If you forget to use TRUSOPT
It is important that this medicine is administered as prescribed by your doctor. If you forget to instill a dose, take that dose as soon as possible. However, if
it is almost time for the next dose, skip the missed dose and resume
your usual dosing schedule.
Do not take a double dose to make up for a missed dose.
If you stop using TRUSOPT
If you want to stop treatment, talk to your doctor first. 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.
If you experience allergic reactions including hives, swelling of the face, lips, tongue, and/or
throat which can cause difficulty in breathing or swallowing, you should stop taking this
medicine and immediately contact your doctor.
The following side effects have been reported with TRUSOPT in clinical studies or after
marketing:
Very common side effects:(affect more than 1 in 10 users)
Burning and stinging pain in the eyes.
Common side effects:(affect 1 to 10 users in 100)
Corneal disease with eye pain and blurred vision (superficial punctate keratitis), itchy eye discharge
(conjunctivitis), eyelid irritation/inflammation, blurred vision, headache, nausea, bitter taste
sensation, and fatigue.
Uncommon side effects:(affect 1 to 10 users in 1,000)
Inflammation of the iris.
Rare side effects:(affect 1 to 10 users in 10,000)
Tingling or numbness of the hands or feet, temporary myopia that may resolve with
discontinuation of treatment, formation of fluid under the retina (choroidal detachment after
filtering surgery), eye pain, crusting on the eyelids, ocular hypotension, corneal edema
(with symptoms of visual disturbances), eye irritations including redness, kidney stones,
dizziness, nosebleeds, throat irritation, dry mouth, localized skin rashes
(contact dermatitis), severe skin reactions, allergic-type reactions including skin rashes, hives, itching, in
rare cases possible swelling of lips, eyes and mouth, shortness of breath, and more
rarely wheezing.
Not known:(frequency cannot be estimated based on available data)
Wheezing, foreign body sensation in the eye (feeling that something is
in the eye).
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly
through the national reporting system at: www.agenziafarmaco.gov.it/content/come-segnalare-
una-sospetta-reazione-avversa. By reporting side effects you can help provide
more information on the safety of this medicine.
5. How to store TRUSOPT
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 container and on the
pack after “Exp.:” The expiry date refers to the last day of that month.
Once the container TRUSOPT has been opened, it must be used within 28 days.
This medicine does not require any particular storage temperature.
Keep the container in the outer packaging to protect the medicine 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 protect the environment.
6. Contents of the pack and other information
What TRUSOPT contains
- The active substance is dorzolamide.
- Each ml contains 22.26 mg of dorzolamide hydrochloride equivalent to 20 mg of dorzolamide.
- The other ingredients are: hydroxyethylcellulose, mannitol, sodium citrate, sodium hydroxide and water for injections. Benzalkonium chloride is added as a preservative.
Description of the appearance of TRUSOPT and contents of the pack
TRUSOPT is a clear, colourless or almost colourless, slightly viscous solution.
TRUSOPT is supplied in a white translucent plastic container with 5 ml of solution. The
plastic container is closed with a white screw cap.
The Ocumeter Plus ophthalmic dropper is made of a translucent high-density polyethylene container
containing 5 ml of solution.
The tamper-evident seal consists of a safety band located on the container label.
Pack sizes:
1 x 5 ml (single container of 5 ml)
3 x 5 ml (three containers of 5 ml)
6 x 5 ml (six containers of 5 ml)
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Santen Italy S.r.l.
Via Roberto Lepetit
8/10 - 20124 Milano
Production, Packaging and Quality Control
Laboratoires Merck Sharp & Dohme - Chibret
Mirabel Plant, Route de Marsat, Riom, 63963 Clermont-Ferrand Cedex 9 (France)
Santen Oy, Niittyhaankatu 20, 33720 Tampere, Finland
This medicinal product is authorised in the Member States of the European Economic Area with
the following denominations:
Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg,
Netherlands, Portugal, Spain, Sweden, United Kingdom:
TRUSOPT
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- Kraj rejestracji
- Postać farmaceutycznaEye drops, solution, 20 MG/ML
- Kod ATCS01EC03
- Substancja czynna
- Wymaga receptyNie
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki TRUSOPTPostać farmaceutyczna: Eye drops, solution, 20 mg/mlSubstancja czynna: dorzolamideWymaga receptyPostać farmaceutyczna: Eye drops, solution, 20 MG/MLSubstancja czynna: dorzolamideProducent: OMNIVISION ITALIA SRLWymaga receptyPostać farmaceutyczna: Eye drops, solution, 20 MG/MLSubstancja czynna: dorzolamideProducent: AUROBINDO PHARMA (ITALIA) S.R.L.Wymaga recepty
Odpowiedniki TRUSOPT w innych krajach
Leki z tą samą substancją czynną dostępne w innych krajach.
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TRUSOPT nie wymaga recepty w Włochy. Możesz skonsultować się z lekarzem online, aby sprawdzić, czy ten lek może być odpowiedni w Twojej sytuacji.
Substancją czynną w TRUSOPT jest dorzolamide. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
TRUSOPT jest produkowany przez SANTEN ITALY SRL. 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 TRUSOPT 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 TRUSOPT 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 AUROBINDO. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
