INDOM 5 mg /Ml Krople Do Oczu, Zawiesina
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Treść ulotki
Indom 5 mg/ml eye drops, suspension
Indometacin
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 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 Indom is and what it is used for
- 2. What you need to know before you use Indom
- 3. How to use Indom
- 4. Possible side effects
- 5. How to store Indom
- 6. Contents of the pack and other information
1. What Indom is and what it is used for
This medicine contains the active ingredient indometacin, which belongs to the group of medicines called
non-steroidal anti-inflammatory drugs (NSAIDs) that work by relieving the symptoms of inflammation.
Indom is an eye drop used for the treatment of inflammatory conditions, even painful ones, not due to
an infection, affecting the outermost part of the eye (anterior segment). In particular, it is
used for cataract surgery.
2. What you need to know before using Indom
Do not use Indom
- if you are allergic to indometacin or any of the other ingredients of this medicine (listed in section 6);
- if, when taking aspirin or other non-steroidal anti-inflammatory drugs, you have suffered from breathing difficulties due to narrowing of the airways (bronchospasm). Avoid using this medicine if you wear contact lenses.
Warnings and precautions
Consult your doctor or pharmacist before using Indom.
The use, especially if prolonged, of medicines for topical use can cause allergic reactions (sensitization reactions). In this case, stop treatment and consult your doctor.
The use of topical non-steroidal anti-inflammatory drugs (NSAIDs) can cause inflammation of the cornea (keratitis).
In patients at risk, continued use of topical NSAIDs can cause defects in the tissue lining the surface of the cornea, thinning of the cornea, corneal damage, ulcers or perforation of the cornea. These effects can pose a danger to sight.
If you suffer from a peptic ulcer, a condition in which there are lesions in the stomach and intestines, use this medicine with particular caution.
If you have a predisposition to bleeding or are taking other medicines that may promote a tendency to bleed (see also section “Other medicines and Indom”), you should be careful and inform your doctor before using this eye drop.
Once the multi-dose bottle is opened, avoid contact of the dropper tip with your fingers, with the surface of the eye and with other surfaces.
The single-dose container does not contain preservatives, therefore after use discard the vial even if it contains residual medicine.
Children
The safety of this medicine in children has not been established.
Other medicines and Indom
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicine.
This medicine can alter the ocular effect of epinephrine, a substance that contributes to lowering intraocular pressure. Therefore, if you are also using epinephrine-based eye drops, it is necessary to check the intraocular pressure to ensure that the desired values are maintained.
Although only a small amount of indometacin can pass into the bloodstream after instillation into the eyes, it is advisable to consider the possible interactions observed with NSAIDs taken systemically (orally, sublingually, rectally or by injection).
The following are some medicines for which it is advisable to consult your doctor before using Indom:
- oral anticoagulants, for increased risk of bleeding;
- other NSAIDs, including salicylates taken at doses greater than 3 g/day, for increased risk of developing ulcers and bleeding of the stomach and intestines.
Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
If you are pregnant or breastfeeding, use this medicine only if absolutely necessary and under the direct supervision of your doctor.
Driving and operating machinery
The use of this medicine can cause a feeling of dizziness, vertigo and headache which can alter the ability to drive vehicles and operate machinery.
Indom in 7 ml bottle contains benzalkonium chloride
This medicine, in the “7 ml bottle” package, contains 0.1 mg of benzalkonium chloride per 1 ml.
Benzalkonium chloride can be absorbed by soft contact lenses and can lead to a change in their color. Remove your contact lenses before using this medicine and wait 15 minutes before reinserting them. Benzalkonium chloride can also cause irritation to the eyes, especially if you have dry eye or corneal disorders (the most superficial transparent layer of the eye). If you experience an abnormal sensation in the eye, burning or pain after using this medicine, talk to your doctor.
Indom contains phosphates
This medicine contains 5.7 mg of phosphate buffer per 1 ml. If you have severe damage to the outermost transparent layer of the eye (the cornea), phosphates may, in very rare cases, cause opaque spots on the cornea due to calcium accumulation during treatment.
3. How to use Indom
Use this medicine following the instructions of your doctor or pharmacist exactly. If you have any doubts
consult your doctor or pharmacist.
The doctor will determine the dose to be used and the duration of treatment with this medicine.
Shake the bottle well before using this medicine.
If you wear contact lenses, remove them before applying the 7 ml bottle eye drops, you can put them back on
after 15 minutes.
If you use more Indom than you should
The amount of active ingredient in each bottle is not toxic, however, in case of
ingestion/accidental intake of an excessive dose of Indom, immediately inform your doctor or
go to the nearest hospital.
If you forget to use Indom
Do not use a double dose to make up for a missed dose.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The use of this medicine may cause the following side effects:
Frequency not known(the frequency of which cannot be estimated on the basis of the available data):
- redness and burning of the tissue covering the front of the eye and the inside of the eyelids (conjunctiva);
- alteration of the corneal tissue (corneal epithelium);
- increased internal pressure of the eyes;
- swelling of the eyelid or cornea due to fluid accumulation (palpebral or corneal edema);
- inflammation of the cornea (keratitis striata);
- itching.
In rare cases, this eye drop may induce further inflammation and perforation of the membranes of the
ocular surface, especially in patients at risk.
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
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects you can
contribute to providing more information on the safety of this medicine.
5. How to store Indom
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 packaging after “Exp.”.
The expiry date refers to the last day of that month.
Store at a temperature not exceeding 25°C.
Keep the container tightly closed to protect the medicine from light.
7 ml bottle: once the multi-dose bottle is opened, use the medicine within 28 days of its
opening.
0.5 ml single-dose container: discard the single-dose container after use even if it contains residual
medicine.
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 Indom
Indom5 mg/ml eye drops, suspension - 7 ml bottlecontains
- The active ingredient is indometacin. 100 ml of eye drops contain 500 mg of indometacin.
- The other ingredients are: hydroxyethylcellulose; disodium phosphate monobasic dihydrate; disodium phosphate dodecahydrate; sodium chloride; disodium edetate; tyloxapol; benzalkonium chloride; purified water.
Indom5 mg/ml eye drops, suspension - single-dose containers of 0.5 ml
- The active ingredient is indometacin. 100 ml of eye drops contain 500 mg of indometacin.
- The other ingredients are: hypromellose; disodium phosphate monobasic dihydrate; disodium phosphate dodecahydrate; sodium chloride; disodium edetate; purified water.
Description of the appearance of Indom and contents of the pack
Pack containing 30 single-dose containers made of polyethylene of 0.5 ml.
Pack containing 1 multi-dose bottle of 7 ml of polyethylene with dropper and cap equipped with a
tamper-evident seal.
Marketing Authorisation Holder and Manufacturer
ALFA INTES Industria Terapeutica Splendore S.r.l.
Via Fratelli Bandiera, 26
80026 Casoria (NA)
Italy
MM/AAAA
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- Kraj rejestracji
- Postać farmaceutycznaEye drops, suspension, 5 MG/ML
- Kod ATCS01BC01
- Substancja czynna
- Wymaga receptyNie
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki INDOMPostać farmaceutyczna: Eye drops, solution, 0.1%Substancja czynna: indometacinProducent: BAUSCH & LOMB-IOM S.P.A.Wymaga receptyPostać farmaceutyczna: Eye drops, solution, 0.5%Substancja czynna: ketorolacProducent: ABBVIE S.R.L.Bez receptyPostać farmaceutyczna: Eye drops, solution, 0.5%Substancja czynna: bendazacProducent: OMNIVISION ITALIA SRLWymaga recepty
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INDOM 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 INDOM jest indometacin. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
INDOM jest produkowany przez ALFA INTES INDUSTRIA TERAPEUTICA SPLENDORE 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 INDOM 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 INDOM 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 (indometacin) to m.in. INDOKOLLIRIO, AKULAR, BENDALINA. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
