DORZOCLAR 20 mg /Ml Krople Do Oczu, Roztwór
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Treść ulotki
Dorzoclar 20 mg/ml eye drops, solution
Dorzolamide
Read this leaflet carefully before you start to use 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 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 Dorzoclar is and what it is used for
- 2. What you need to know before you use Dorzoclar
- 3. How to use Dorzoclar
- 4. Possible side effects
- 5. How to store Dorzoclar
- 6. Contents of the pack and other information.
1. What is Dorzoclar and what is it used for
Dorzoclar contains dorzolamide which belongs to a group of medicines called “carbonic anhydrase inhibitors”.
This medicine is prescribed to lower high intraocular pressure and for the treatment of
glaucoma. This medicine can be used alone or in combination with other medicines that
lower intraocular pressure (called beta-blockers).
2. What you need to know before you use Dorzoclar
Do not use Dorzoclar
- 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 previous history of kidney stones.
Warnings and precautions
Talk to your doctor or pharmacist before using Dorzoclar.
Inform your doctor or pharmacist about any medical problems you have or have had in the past,
including eye problems or eye surgery, and any allergy to any medicine.
If you develop eye irritation or any new eye problem, such as eye redness or
swelling of the eyelids, contact your doctor immediately.
If you think that Dorzoclar is causing you an allergic reaction (for example skin rash, severe skin reactions or itching), stop using this medicine and contact your doctor immediately.
Children
Dorzoclar 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. Ask your doctor for more information.
Use in the elderly
In studies with Dorzoclar the effects of this medicine were similar in elderly patients and younger
patients.
Use in patients with hepatic impairment
Tell your doctor if you have any liver problems or have suffered from them in the past.
Other medicines and Dorzoclar
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 other carbonic anhydrase
inhibitors such as acetazolamide or sulfonamides.
Pregnancy and breastfeeding
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 using this medicine.
Pregnancy
You should not use this medicine during pregnancy. Tell your treating doctor if you are pregnant or are planning
to become pregnant.
Breastfeeding
If treatment with this medicine is required, breastfeeding is not recommended.
Tell your doctor if you are breastfeeding or intend to breastfeed.
Driving and using machines
The effects of this medicine on the ability to drive and operate machines have not been studied.
However, there are side effects associated with this medicine, such as dizziness and blurred vision, which
may impair your ability to drive and/or operate machines. If this happens, do not drive or operate
machines until you feel well or your vision is not blurred.
Dorzoclar contains benzalkonium chloride
This medicine contains 2.32 micrograms of benzalkonium chloride per drop equivalent to 0.075 mg/ml.
Benzalkonium chloride can be absorbed by soft contact lenses and can lead to a change in
their colour. Remove contact lenses before using this medicine and wait 15 minutes before
reapplying them.
Benzalkonium chloride can also cause eye irritation, especially if you have dry eyes or corneal disorders (the outermost transparent layer of the eye). If you experience any abnormal eye sensation, burning or pain after using this medicine, talk to your doctor.
3. How to use Dorzoclar
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 in the affected eye(s) in the
morning, afternoon, and evening. If your doctor has recommended using this medicine with
a beta-blocker eye drop to lower eye pressure, then the recommended dose is one drop of
Dorzoclar in the affected eye(s) in the morning and evening.
If you are using Dorzoclar with other eye drops, the drops must be instilled at least 10 minutes apart.
Avoid having the tip of the dropper touch your eye or the areas around your eye. It could become contaminated with
bacteria that can cause eye infections, leading to serious eye damage, including loss of
vision.
To avoid possible contamination, wash your hands before using this medicine and keep the tip
of the dropper always away from contact with any surface. If you think your medicine may
be contaminated, or if you develop an eye infection, contact your doctor immediately before
continuing to use this bottle.
Instructions for use:
Always wash your hands before instilling the eye drops.
Apply the eye drops as follows:
- 1. Unscrew the protective cap.
- 2. Tilt your head back and look at the ceiling.
- 3. Gently pull down your lower eyelid to form a small pocket.
- 4. Press the inverted bottle to release one drop into the eye.
- 5. While keeping the treated eye closed, hold your finger against the inner corner of the closed eye (the part where the eye meets the nose) and wait for about 2 minutes. This helps prevent the medicine from passing into the rest of your body. Avoid touching the tip of the dropper with your eye or anything else. Replace and tighten the cap immediately after use.
If you use more Dorzoclar than you should
If you instill too many drops into your eye or if you swallow the contents of the bottle, contact your
doctor immediately.
If you forget to use Dorzoclar
It is important to use this medicine as prescribed by your doctor. If you miss a dose, apply it
as soon as possible. However, if the next dose is due soon, skip the missed dose and
return to your regular dosing schedule.
Do not use a double dose to make up for a missed dose.
If you stop using Dorzoclar
If you want to stop using this medicine, 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 breathing or swallowing, you should stop using this medicine and contact your
doctor immediately.
The following side effects have been reported with Dorzoclar both during clinical studies and during
post-marketing experience:
Very common side effects:(in more than 1 in 10 people)
Burning and stinging eye pain.
Common side effects:(between 1 and 10 people in 100)
Corneal alteration with painful eye and blurred vision (superficial punctate keratitis), itchy eye discharge
(conjunctivitis), eyelid irritation/inflammation, blurred vision, headache, nausea, bitter taste and fatigue.
Uncommon side effects:(between 1 and 10 people in 1000)
Inflammation of the iris.
Rare side effects:(between 1 and 10 people in 10,000)
Tingling or numbness of the hands and feet, temporary myopia that can resolve with
discontinuation of treatment, development of fluid under the retina (choroidal detachment following filtering
surgery), eye pain, crusting of the eyelids, lowering of eye pressure, corneal edema (with symptoms of visual
disturbances), eye irritation including redness, kidney stones, dizziness, nosebleeds, sore throat, dry mouth,
localized skin rash (contact dermatitis), severe skin reactions, allergic-type reactions such as rash, hives, itching, in
rare cases possible swelling of the lips, eyes and mouth, shortness of breath, and more rarely wheezing.
Not known(frequency cannot be estimated from available data):
Wheezing, foreign body sensation in the eye (feeling that something is in the eye),
strong heartbeat that may be fast or irregular (palpitations), increased heart rate,
increased blood pressure.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed
in this leaflet. You can also report side effects directly through the national reporting system at
http://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 Dorzoclar
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 bottle and the packaging after “Exp.”.
The expiry date refers to the last day of that month.
Dorzoclar must be used within 28 days of first opening the bottle.
Do not store above 25°C. Keep the bottle in the original packaging to protect it 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 Dorzoclar contains
- The active ingredient is dorzolamide
- 1 ml contains 20 mg of dorzolamide (equivalent to 22.3 mg of dorzolamide hydrochloride)
- The other excipients are: hydroxyethylcellulose, mannitol, disodium citrate dihydrate and purified water. Benzalkonium chloride is added as a preservative.
Description of the appearance of Dorzoclar and contents of the pack
Dorzoclar is a slightly viscous, clear, colourless or almost colourless solution.
Packs:
1 x 5.0 ml
3 x 5.0 ml
6 x 5.0 ml
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
OmniVision Italia S.r.l.
Via Montefeltro, 6
20156 Milano
Manufacturer
Tubilux Pharma S.p.A
Via Costarica 20/22
00071 Pomezia (RM), Italy
This medicinal product is authorised in the Member States of the European Economic Area with the following
names:
UK
Dorzolamide 20 mg/ml eye drops solution
ITALIA
Dorzoclar 20 mg/ml eye drops, 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 DORTSOKLARPostać farmaceutyczna: Eye drops, solution, 20 mg/mlSubstancja czynna: dorzolamideWymaga receptyPostać farmaceutyczna: Eye drops, solution, 20 MG/MLSubstancja czynna: dorzolamideProducent: AUROBINDO PHARMA (ITALIA) S.R.L.Wymaga receptyPostać farmaceutyczna: Mouthwash, 20 MG/MLSubstancja czynna: dorzolamideProducent: MYLAN S.P.A.Wymaga recepty
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DORTSOKLAR wymaga recepty w Włochy. Możesz skonsultować się z lekarzem online, aby sprawdzić, czy ten lek może być odpowiedni w Twojej sytuacji.
Substancją czynną w DORTSOKLAR jest dorzolamide. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
DORTSOKLAR jest produkowany przez OMNIVISION ITALIA 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 DORTSOKLAR 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 DORTSOKLAR 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, DORTSOLAMIDE AUROBINDO, 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.
