SOKETOL 0.5 MG/ML Krople do oczu, roztwór
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Treść ulotki
SOKETOL 0.5 mg/ml eye drops, solution
Ketotifene
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 to do.
- 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 a short period of treatment.
Contents of this leaflet:
- 1. What SOKETOL is and what it is used for
- 2. What you need to know before using SOKETOL
- 3. How to use SOKETOL
- 4. Possible side effects
- 5. How to store SOKETOL
- 6. Contents of the pack and other information
1. What is SOKETOL and what is it used for
SOKETOL contains the active ingredient ketotifen and belongs to a group of medicines called
antihistamine-antiallergic for ocular use.
SOKETOL 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.
Consult your doctor if you do not feel better or if you feel worse after a short period of treatment.
2. What you need to know before using SOKETOL
Do not use SOKETOL
- if you are allergic to ketotifen or any of the other ingredients of this medicine (listed in section 6);
- if you are pregnant (see “Pregnancy, breastfeeding and fertility”).
Warnings and precautions
Talk to your doctor or pharmacist before using SOKETOL.
This medicine may cause, upon application, a slight and temporary burning sensation.
Other medicines and SOKETOL
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines. If you are using SOKETOL together with other medicines for the eyes, allow at least 5
minutes between each application. Oral administration of ketotifen can enhance the effects of medicines with a depressant action on the central nervous system (such as tranquillizers, hypnotics), antihistamines (anti-allergy medicines) and alcohol. Although these effects have not been observed with the use of ketotifen-based eye drops, the possibility that they may still occur cannot be excluded.
SOKETOL with food, beverages and alcohol
SOKETOL may increase the effects of alcohol.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
No data are available on the use of ketotifen in pregnancy. The use of SOKETOL during pregnancy should
be limited to cases of actual necessity.
Do not use SOKETOL if you are pregnant, unless your doctor considers it strictly necessary.
Breastfeeding
SOKETOL can be used during breastfeeding.
Fertility
No data are available regarding the effects of ketotifen on fertility in men.
Driving and operating machinery
SOKETOL, at the beginning of treatment, may cause blurred vision or drowsiness and reduce your
reaction ability (especially in sensitive individuals). Therefore, if this happens, do not drive vehicles
and do not operate machinery.
SOKETOL in the multi-dose bottle pack of 10 ml contains benzalkonium chloride
This medicine 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
colour. Remove your 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 transparent superficial layer of the eye). If you experience an abnormal eye sensation, burning or pain after using this medicine, talk to your doctor.
3. How to use SOKETOL
Use this medicine following exactly as described in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended doseis 1 drop into the conjunctival sac 2 times a day.
Instructions for use of the multi-dose bottle:
- 1) To open the bottle, unscrew the closing cap.
- 2) To avoid any contamination, do not allow the dropper to come into contact with any surface, or direct contact with the eye.
- 3) After use, close the bottle by screwing the closing cap back on.
Instructions for use of the single-dose container:
- 1) Separate the single-dose container from the strip.
- 2) Open the container by rotating the cap.
- 3) Hold the container upside down above the eye and press with your thumb and index finger until the drops come out.
- 4) Dispose of the container, even if some medicine remains after use.
If you use more SOKETOL than you should
Cases of overdose have not been reported.
Oral intake of the contents of the 10 ml multi-dose bottle is equivalent to 5 mg of
ketotifen.
Oral intake of the contents of the 0.5 ml single-dose container is equivalent to 0.25
mg of ketotifen.
No serious signs or symptoms have been reported after ingestion of a dose up to 20 mg of ketotifen.
If you forget to use SOKETOL
Do not use a double dose to make up for a missed dose.
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 everybody gets them.
The following side effects have been reported:
Common(may affect up to 1 in 10 people)
- eye pain and/or irritation;
- corneal inflammation (punctate keratitis);
- damage to the corneal epithelium (punctate erosion of the corneal epithelium).
Uncommon(may affect up to 1 in 100 people)
- allergy (hypersensitivity);
- headache;
- blurred vision (particularly during the application of the eye drops); dry eye; eyelid disorders; inflammation of the conjunctiva, i.e. the semi-transparent membrane that lines the inner surface of the eyelids and the front of the eye (conjunctivitis); uncomfortable feeling in the eyes caused by light (photophobia); bleeding of the conjunctiva (conjunctival hemorrhage);
- dry mouth;
- skin redness (rash);
- skin inflammation characterized by itching, redness, scaling and raised skin (eczema);
- sudden appearance of rash and itching (urticaria);
- drowsiness.
Frequency not known(frequency cannot be estimated from 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; swelling of the area around the eyes; itching of the eyelids and swelling);
- allergic reactions affecting the whole body (systemic) such as swelling and fluid accumulation in the face, sometimes 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).
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell 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 help provide more information on the safety of
this medicine.
5. How to store SOKETOL
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.
The expiry date indicated refers to the product in intact packaging, correctly stored.
Multidose bottle of 10 ml
The medicine must be used within 28 days after the first opening of the bottle.
Single-dose containers
After the first opening of the aluminum sachet: use within 10 days.
Once the single-dose container is opened, the medicine must be used immediately. Any
residue must be discarded.
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 SOKETOL contains
Multidose bottle of 10 ml
- The active ingredient is ketotifen. 1 ml of solution contains 0.69 mg of ketotifen fumarate (equivalent to 0.5 mg of ketotifen). The other ingredients are: sorbitol (E420), benzalkonium chloride, hypromellose (E464), sodium hydroxide, purified water. Single-dose containers
- The active ingredient is ketotifen. 1 ml of solution contains 0.69 mg of ketotifen fumarate (equivalent to 0.5 mg of ketotifen).
- The other ingredients are: sorbitol (E420), hypromellose (E464), sodium hydroxide, purified water.
Description of the appearance of SOKETOL and contents of the pack
SOKETOL is presented as eye drops, solution. It is available in multidose and
single-dose presentations.
Multidose bottle of 10 ml
The pack contains a 10 ml dropper bottle.
Single-dose containers
The pack contains 30 single-dose containers of 0.5 ml divided into 3 strips of 10 single-dose containers.
Each strip of 10 single-dose containers is packaged in a sachet.
Marketing authorisation holder and manufacturer
Alfa Intes Industria Terapeutica Splendore S.r.l.
Via F.lli Bandiera 26 - 80026 Casoria (NA)
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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 SOKETOLPostać farmaceutyczna: Eye drops, solution, 250 MICROGRAMMI/MLSubstancja czynna: ketotifenProducent: BRUSCHETTINI S.R.L.Bez receptyPostać farmaceutyczna: Eye drops, solution, 0.5 MG/MLSubstancja czynna: ketotifenProducent: VISUFARMA S.P.A.Bez receptyPostać farmaceutyczna: Eye drops, solution, 0.25 MG/MLSubstancja czynna: ketotifenProducent: GENETIC S.P.A.Bez recepty
Odpowiedniki SOKETOL w innych krajach
Leki z tą samą substancją czynną dostępne w innych krajach.
Odpowiednik SOKETOL w Hiszpania
Odpowiednik SOKETOL w Polska
Odpowiednik SOKETOL w Ukraina
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Często zadawane pytania
SOKETOL 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 SOKETOL jest ketotifen. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
SOKETOL 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 SOKETOL 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 SOKETOL 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, EUSTAMYL, KETIRIX. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
