CEQUA 0.9 MG/ML Krople do oczu, roztwór w jednorazowym pojemniku
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Treść ulotki
Cequa 0.9 mg/ml eye drops, solution in single-dose container
cyclosporine
Read this leaflet carefully before taking this medicine.
- 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. Never give it to other people, even if their symptoms are the same as yours, because it could be dangerous.
- If you experience any side effects, speak to your doctor or pharmacist. This includes any
Contents of this leaflet:
- 1. What Cequa is and what it is used for
- 2. Before taking Cequa
- 3. How to take Cequa
- 4. Possible side effects
- 5. How to store Cequa
- 6. Contents of the pack and other information
1. What is Cequa and what is it used for
Cequa contains the active substance cyclosporine. Cyclosporine belongs to a group of medicines known as immunosuppressant agents used to reduce inflammation.
Cequa is used to treat moderate to severe dry eye disease (dry keratoconjunctivitis) in adult patients who have not responded adequately to artificial tears.
See a doctor if you do not feel better or if you feel worse.
Visit your doctor at least every 3 months to evaluate the effect of Cequa.
2. Before taking Cequa
Do not take Cequa
- if you are allergic to cyclosporine or any of the other ingredients of this medicine (listed in section 6);
- if you have had or have cancer inside or around the eye;
- if you have an eye infection.
Warnings and precautions
Use Cequa only in the eyes.
Consult your doctor or pharmacist before using Cequa
- if you have had an eye infection caused by the herpes virus that may have damaged the clear part of the eye (cornea),
- if you are taking medicines containing steroids,
- if you are taking medicines for the treatment of glaucoma.
Remove contact lenses before using Cequa; you can reinsert them 15 minutes after administering
Cequa.
Children and adolescents
Cequa should not be used in children and adolescents under 18 years of age.
Other medicines and Cequa
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Consult your doctor if you are using eye drops containing steroids, as these may increase the risk of
side effects.
Cequa eye drops must be used at least 15 minutes after the use of any other eye drops.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, if you are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.
Cequa should not be used during pregnancy.
If there is a possibility of becoming pregnant, you should use a method of contraception during the use of this medicine.
Cequa is likely to be present in breast milk in very small amounts. If you are breastfeeding, consult your
doctor before using this medicine.
Driving and operating machinery
Vision may be blurred immediately after using Cequa eye drops, single-dose container.
If this happens, wait until your vision returns to normal before driving or operating
machinery.
Cequa contains phosphates
This medicine contains 0.0159 mg of phosphates in each drop. If you suffer from severe damage to the
clear layer in the front of the eye (the cornea), phosphates may, in very rare cases, cause opaque
spots on the cornea due to calcium build-up during treatment.
3. How to use Cequa
Always use this medicine exactly as your doctor or pharmacist has told you. If you are not
sure, ask your doctor or pharmacist.
The recommended dose is one drop in each affected eye, twice a day, approximately 12 hours apart.
Instructions for use
Follow these instructions carefully and ask your doctor or pharmacist if anything is unclear.
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- wash your hands.
- if you wear contact lenses, remove them before using the drops; you can reinsert them 15 minutes after administering the eye drops.
- open the aluminum pouch, remove one single-dose container and put the remaining single-dose containers back into the pouch
- unscrew the cap (image 1).
- lower the lower eyelid (image 2).
- tilt your head back and look at the ceiling.
- gently allow one drop of the medicine to flow onto the eye, making sure not to touch your eyes with the tip of the single-dose container.
- blink several times to distribute the eye drops on the eye.
- after applying the drop, press a finger into the corner of the eye near the nose and gently close your eyelids for about 2 minutes (image 3) (this helps the local effect).
- if you are using the drops in both eyes, repeat the steps for the other eye.
- dispose of the single-dose container immediately after use, even if there is still some liquid inside.
- the remaining single-dose containers must be stored in the aluminum pouch.
If a drop misses the eye, try again.
If you use more Cequa than you should, rinse your eyes with water. Do not insert any more drops until the time of
your next regular dose.
If you forget to use Cequa,continue with the next dose as scheduled .
Do not take a double dose to make up for a missed dose. Do not use more than one drop at a time
in the affected eye(s).
If you stop using Cequa, talk to your doctor.
If you have any further questions 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:
The most common side effects occur within and around the eyes.
Very common (may affect up to 1 in 10 people): pain or discomfort when inserting a drop for
the first time.
Common (may affect up to 1 in 100 people): redness of the eyes, eye irritation,
watering eyes, eye irritation.
Uncommon (may affect up to 1 in 100 people): increased watering of the eyes, increased
sensitivity to light, eye pain, swelling of the conjunctiva (membrane covering the white
part of the eye), inflammation of the eyelid margins, ocular and periocular infections, headache and irritation
of the throat.
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/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help provide more information on the safety of this
medicine
5. How to store Cequa
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 outer packaging, on the aluminium
blister and on the single-dose containers after “Exp.”. The expiry date refers to the last day of that
month.
Do not store at a temperature above 25°C. Do not freeze. After opening the aluminium blisters, the
single-dose containers must be kept in the blisters to prevent evaporation. Period of validity
after first opening the aluminium blister: 5 days. Discard any individual open single-dose
container with the remaining solution immediately after use.
Do not use this medicine if you notice visible particles.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Cequa contains
The active ingredient is cyclosporine. One ml of Cequa contains 0.9 mg of cyclosporine.
The other ingredients are:
Macrogolglycerol hydroxystearate, octoxinol-40, disodium hydrogen phosphate dihydrate (E339), disodium phosphate
(E339), sodium chloride, povidone (E1201), hydrochloric acid (for pH adjustment) (E507),
sodium hydroxide (for pH adjustment) (E524) and water for injections
Description of Cequa and contents of the pack
Cequa is a clear and colourless solution in a single-dose container.
It is supplied in single-dose containers made of low-density polyethylene (LDPE).
Each single-dose container contains 0.25 ml of eye drops, solution.
The single-dose containers are wrapped in a sealed aluminium polyfoil pouch.
Pack sizes: 60 single-dose containers.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Sun Pharmaceutical Industries Europe B.V.
Polaris avenue 87
2132 JH Hoofddorp
Netherlands
Local representative
SUN Pharma Italia S.r.l.
Viale Giulio Richard, 3
20143 Milano
Manufacturer responsible for batch release
Laboratoire Unither
1 Rue De L Arquerie
Coutances 50200
France
This medicinal product is authorised in the Member States of the EEA with the following denominations:
Netherlands: Cequa 0.9 mg/mL eye drops, solution in single dose container
Austria: Cequa 0.9 mg/mL eye drops, solution in single dose container
Germany: Cequa 0.9 mg/ml eye drops, solution in single dose container
Denmark: Sekua 0.9 mg/mL eye drops, solution in single dose container
Spain: Cequa 0.9 mg/mL eye drops, solution in single dose container
Finland: Cequa 0.9 mg/mL eye drops, solution in single dose container
France: Cequa 0.9 mg/mL, eye drops, solution in single dose container
Italy: Cequa
Norway: Cequa 0.9 mg/mL eye drops, solution in single dose container
Sweden: Cequa 0.9 mg/mL eye drops, solution in single dose container
This leaflet was last revised on
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- Kraj rejestracji
- Postać farmaceutycznaEye drops, solution in single-dose container, 0.9 MG/ML
- Kod ATCS01XA18
- Substancja czynna
- Wymaga receptyNie
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki KEQUAPostać farmaceutyczna: Emulsion eye drops, 1 MG/MLSubstancja czynna: ciclosporinProducent: SANTEN OYBez receptyPostać farmaceutyczna: Emulsion eye drop, 1MG/MLSubstancja czynna: ciclosporinProducent: SANTEN OYBez receptyPostać farmaceutyczna: Eye drops, solution, 1 mg/mLSubstancja czynna: ciclosporinProducent: LABORATOIRES THEABez recepty
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Substancją czynną w KEQUA jest ciclosporin. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
KEQUA jest produkowany przez SUN PHARMACEUTICAL INDUSTRIES (EUROPE) B.V.. 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 KEQUA 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 KEQUA w Warszawie, Krakowie, Wrocławiu lub Gdańsku w każdej aptece, posiadając ważną receptę.
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