EUSTAMYL 0.5 MG/ML Krople do oczu, roztwór
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Treść ulotki
EUSTAMYL 0.5 mg/ml eye drops, solution
ketotifene fumarate
Read this leaflet carefully before using this medicine as it contains important
information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
- Keep this leaflet. You may need to read it again.
- If you want more information or advice, ask your pharmacist.
- If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
- See a doctor if you do not feel better or if your symptoms get worse after using the medicine.
Contents of this leaflet:
- 1. What EUSTAMYL is and what it is used for
- 2. What you need to know before you use EUSTAMYL
- 3. How to use EUSTAMYL
- 4. Possible side effects
- 5. How to store EUSTAMYL
- 6. Contents of the pack and other information
1. What is EUSTAMYL and what is it used for
EUSTAMYL contains the active ingredient ketotifene fumarate which belongs to a class of medicines with
antiallergic activity.
EUSTAMYL is used for the local treatment of allergic inflammation (spring,
atopic and others) of short and long duration of the eyes such as:
- conjunctivitis
- keratoconjunctivitis.
See your doctor if you do not feel better or if you feel worse after using the medicine.
2. What you need to know before using EUSTAMYL
Do not use EUSTAMYL
- if you are allergic to the active ingredient or to any of the other ingredients of this medicine (listed in section 6)
- if you are pregnant and breastfeeding (see “Pregnancy and breastfeeding”).
Warnings and precautions
Talk to your doctor or pharmacist before using EUSTAMYL.
You should only use EUSTAMYL to treat the external part of the eyes.
When applying to the eyes, EUSTAMYL may cause a slight and fleeting burning sensation.
Other medicines and EUSTAMYL
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
If you are using other eye medications, wait at least 5 minutes between each application.
The use of ketotifen in oral formulations may increase the effects of medicines with a
depressive effect on the central nervous system (such as tranquilizers, used for the treatment of anxiety and insomnia and
hypnotics, used to induce or facilitate sleep), antihistamines (medicines used against
allergies) and alcohol. Although these effects have not been observed with the use of ketotifen as eye drops, the
possibility that they may still occur cannot be ruled out.
EUSTAMYL with alcohol
Ketotifen may interact with alcohol, but this is unlikely to happen, as the amount
of ketotifen in the body is low following administration of EUSTAMYL as eye drops.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
Do not use EUSTAMYL if you are pregnant, unless your doctor considers it strictly necessary.
Breastfeeding
As it is unlikely that the medicine will pass into breast milk, you can use EUSTAMYL during
breastfeeding.
Fertility
There are no data on the effects of this medicine on fertility in men.
Driving and operating machinery
If you are a sensitive subject, EUSTAMYL, at the beginning of treatment, may reduce your ability to
react.
If you have blurred vision or feel sleepy, do not drive vehicles and do not operate machinery.
EUSTAMYL eye drops in a multi-dose bottle contains benzalkonium chloride
EUSTAMYL eye drops in a multi-dose bottle contains the preservative benzalkonium chloride 0.01 g per 100 ml
equivalent to 0.001 g per 5 ml which may be absorbed by soft contact lenses and may lead to
a change in their color. Remove contact lenses before using this medicine and wait 15 minutes
before re-applying them
Benzalkonium chloride may also cause eye irritation, especially if you have dry eyes 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.
3. How to use EUSTAMYL
Use this medicine following exactly as described in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
The recommended dose is:
1 drop in the eye 2 or more times a day.
Multidose bottle of 10 ml
- 1- Unscrew the cap and the bottle is ready for use.
- 2- Close the bottle immediately after use.
- 3- To avoid any contamination, do not allow the dropper to come into contact with any surface, or direct contact with the eye.
- 4- The eye drops should not be used for more than 30 days after the first opening of the bottle.
Single-dose container of 0.5 ml
- 1- Separate a single-dose container.
- 2- To open the container, rotate the cap in one direction.
- 3- Apply gentle pressure to the body of the container to apply one drop of solution to the affected ocular surface.
EUSTAMYL single-dose does not contain preservatives, once opened, discard it after use even if partially used.
If you use more EUSTAMYL than you should
No cases of overdose have been reported to date.
EUSTAMYL eye drops in a multidose bottle
Oral intake of 1.25 mg of ketotifen, the active ingredient of EUSTAMYL, is equivalent to 60% of the daily oral dose recommended for a 3-year-old child. With doses up to 20 mg of ketotifen, no serious signs or symptoms have been reported.
EUSTAMYL eye drops in a single-dose container
Oral intake of 0.1 mg of ketotifen, the active ingredient of EUSTAMYL, is equivalent to 5% of the daily oral dose recommended for a 3-year-old child. With doses up to 20 mg of ketotifen, no serious signs or symptoms have been reported.
If you forget to use EUSTAMYL
Do not use a double dose to make up for a missed dose.
If you stop using EUSTAMYL
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.
During clinical studies conducted with EUSTAMYL, the following side effects have been reported with the
following frequency:
Common side effects (may affect up to 1 in 10 people):
- eye irritation;
- eye pain;
- inflammation with painful lesions of the cornea, the transparent membrane covering the front of the eye (punctate keratitis);
- loss or damage to the skin of the surface of the cornea (corneal epithelium) with small point-shaped erosions (punctate epithelial erosion);
Uncommon side effects (may affect up to 1 in 100 people):
- allergic reactions (hypersensitivity);
- headache;
- blurred vision during application of the eye drops;
- dry eye;
- eyelid disorders;
- inflammation of the conjunctiva, i.e. the semi-transparent membrane lining the inner surface of the eyelids and the front of the eye (conjunctivitis);
- discomfort in the eyes caused by light (photophobia);
- severe bleeding of the conjunctiva (conjunctival hemorrhage);
- dry mouth;
- skin redness (rash);
- skin inflammation characterized by itching, redness, scaling and raised skin (eczema);
- skin condition characterized by sudden onset of rash and itching (urticaria);
- drowsiness.
Rare side effects (may affect up to 1 in 1000 people):
- mild burning,
- local irritation with redness (hyperemia) and inflammation of the eyelids (blepharitis).
Following marketing of the medicine, the following side effects have been reported and with the
following frequency:
Frequency not known(the frequency cannot be estimated from the available data):
- allergic reactions (hypersensitivity reactions) including local ones (such as contact dermatitis, characterized by redness, scaling, small blisters, bubbles, small superficial wounds and crusts that occur when coming into contact with certain substances; eye swelling; itching of the eyelids and edema, fluid accumulation with swelling) and those affecting the whole body (systemic) such as swelling and fluid accumulation in the face, often associated with contact dermatitis;
- worsening of pre-existing allergic conditions such as asthma (inflammatory disease of the airways characterized by difficulty breathing, wheezing, coughing and tightness in the chest) and eczema (skin inflammation characterized by itching, redness, scaling and raised skin).
If you follow the instructions provided, you reduce the risk of side effects.
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
https://www.aifa.gov.it/web/content/segnalazioni-reazioni-avverse
By reporting side effects you can help provide more information on the safety of
this medicine.
5. How to store EUSTAMYL
Store at a temperature not exceeding 30°C.
For EUSTAMYL multidose bottleof 10 ml, the period of validity after first opening is 30 days at a
temperature not exceeding 30°C.
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after “Expiry”.
The expiry date refers to the last day of that month.
Do not dispose of any medicine in the wastewater or household waste. Ask your pharmacist how to eliminate
medicines that you no longer use. This will help protect the environment.
6. Contents of the pack and other information
What EUSTAMYL contains
- The active ingredient is: ketotifen fumarate - 100 ml contain 0.069 g, equivalent to 0.05 g of ketotifen.
- The other ingredients are: Multi-dose bottle: Glycerol; Benzalkonium chloride; Water for injections. Single-dose container: Hydroxyethylcellulose; Sorbitol; Water for injections.
Description of the appearance of EUSTAMYL and contents of the pack
Pack with multi-dose container: 1 polyethylene dropper bottle of 10 ml, equipped with a
child-resistant and tamper-evident cap.
Pack with single-dose containers: 25 single-dose polyethylene containers of 0.5 ml. The containers, in
strips of 5 units, are enclosed in polithene-aluminium-polyester sachets.
Marketing Authorisation Holder
VISUfarma S.p.A.
Via Alberto Cadlolo, 21
00136 Rome
Manufacturer:
FARMIGEA S.p.A.
Via G.B. Oliva, 8
56121 Ospedaletto – Pisa (Italy)
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- Kraj rejestracji
- Postać farmaceutycznaEye drops, solution, 0.5 MG/ML
- Kod ATCS01GX08
- Substancja czynna
- Wymaga receptyNie
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki EUSTAMYLPostać farmaceutyczna: Eye drops, solution, 250 MICROGRAMMI/MLSubstancja czynna: ketotifenProducent: BRUSCHETTINI S.R.L.Bez receptyPostać farmaceutyczna: Eye drops, solution, 0.25 MG/MLSubstancja czynna: ketotifenProducent: GENETIC S.P.A.Bez receptyPostać farmaceutyczna: Eye drops, solution, 0.5 MG/MLSubstancja czynna: ketotifenProducent: POLIFARMA S.P.A.Bez recepty
Odpowiedniki EUSTAMYL w innych krajach
Leki z tą samą substancją czynną dostępne w innych krajach.
Odpowiednik EUSTAMYL w Hiszpania
Odpowiednik EUSTAMYL w Polska
Odpowiednik EUSTAMYL w Ukraina
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Często zadawane pytania
EUSTAMYL 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 EUSTAMYL jest ketotifen. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
EUSTAMYL jest produkowany przez VISUFARMA S.P.A.. 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 EUSTAMYL 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 EUSTAMYL 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 (ketotifen) to m.in. BRUNISTILL, KETIRIX, KETOFTIL. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
