SAFLUROUND 15 MICROGRAMMI/ML Krople do oczu, roztwór
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Treść ulotki
Safluround 15 micrograms/ml
Eye drops, solution
Tafluprost
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, pharmacist or nurse.
- This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
- If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.
Contents of this leaflet:
- 1. What Safluround is and what it is used for
- 2. What you need to know before you use Safluround
- 3. How to use Safluround
- 4. Possible side effects
- 5. How to store Safluround
- 6. Contents of the pack and other information
1. What is Safluround and what is it used for
What type of medicine is it and how does it work?
Safluround eye drops contain tafluprost, which belongs to a group of medicines called prostaglandin analogues. Safluround reduces the pressure inside the eye and is used when the pressure
inside the eye is too high.
What is this medicine used for?
Safluround is used to treat a type of glaucoma called open-angle glaucoma, and also a
condition known as ocular hypertension in adults. Both conditions are related to an increase
in pressure inside the eye and can eventually impair vision.
2. What you need to know before using Safluround
Do not use Safluround:
- if you are allergic to tafluprost or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Safluround
Keep in mindthat Safluround may have the following effects, some of which may be permanent:
- Safluround may increase the length, thickness, colour and/or number of eyelashes and may cause unusual hair growth on the eyelids.
- Safluround may cause darkening of the skin around the eyes. Remove any residual solution present on the skin. This will reduce the risk of skin darkening.
- Safluround may change the colour of the iris (the coloured part of the eye). If you use Safluround in only one eye, the colour of the treated eye may become permanently different from the colour of the other eye.
- Safluround may cause hair growth in areas where the solution repeatedly comes into contact with the skin surface.
Tell your doctor
- if you have kidney problems
- if you have liver problems
- if you suffer from asthma
- if you suffer from other diseases of the eye.
Children and adolescents
The use of Safluround is not recommended in children and adolescents under 18 years of age due to the
lack of safety and efficacy data.
Other medicines and Safluround
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.
If you apply other medicines to the eye, wait at least 5 minutes between applying Safluround and
applying the other medicine.
Pregnancy, breastfeeding and fertility
If you may become pregnant, you should use effective contraception during treatment with Safluround. Do not use Safluround during pregnancy. Do not use Safluround during breastfeeding. Ask
your doctor for advice.
Driving and using machines
Safluround slightly impairs the ability to drive vehicles or use machines. After applying
Safluround, transient blurred vision may occur. Do not drive and do not use tools or
machinery until your vision has returned to normal.
- 3.How to useand SafluroundUse this medicine exactly as your doctor or pharmacist has told you. If you have doubts, ask your doctor or pharmacist.
The recommended dose is1 drop of Safluround in each eye to be treated, once a day, in the
evening. Do not apply a greater number of drops and do not use the medicine more often than prescribed by
your doctor. This could make Safluround less effective.
Use Safluround in both eyes only if your doctor has prescribed it.
For use as an eye drop only. Do not ingest.
Instructions for use:
When used for the first time, before instilling a drop into the eye, you must first practice using the bottle by pressing it slowly to release a drop away from the eye.
When you feel confident that you can release one drop at a time, choose the position you find most comfortable
for instilling the eye drop (you can sit, lie on your back or stand in front of a
mirror).
When starting a new bottle:
Do not use the bottle if the sachet is torn or if the plastic ring around the neck of the bottle is missing or broken.
Open the sachet along the dotted line. Note the date you opened the bottle in the appropriate space on the
outer box.
Each time you use Safluround:
- 1. Wash your hands.
- 2. When using the bottle for the first time, remove the tamper-evident ring from the cap by pulling on the tab.
- 3. Open the bottle by pulling the cap.
- 4. When using the bottle for the first time, let a waste drop fall.
- 5. Hold the bottle between your thumb and middle finger.
- 6. Tilt your head back or lie down. Place your hand on your forehead. Your index finger should be aligned with your eyebrow or resting on the bridge of your nose. Be particularly careful that the tip of the dropper bottle does not touch your eye, the skin around your eye or your fingers to prevent potential contamination of the solution.
- 7. Pull down your lower eyelid with your other hand and look up. Gently press the bottle and let a drop fall into the space between your lower eyelid and your eye. Be aware that there may be a slight delay between pressing and the drop coming out. Do not press too hard.
- 8. Close your eye and press on the inner corner of your eye with your finger for about a minute. This may help prevent the eye drop from draining through the tear duct
- 9. Remove any excess solution from the skin around your eye to reduce the risk of darkening of the eyelid skin.
- 10. Shake the bottle downwards once to remove any residue of solution from the tip. Do not touch or clean the tip.
- 11. Replace the cap and close the bottle tightly.
There will be a residual volume of approximately 1 ml after using the amount required for 28 days. Do not try to
empty the bottle.
If the drop does not enter the eye,repeat the operation.
If your doctor has prescribed you to apply the eye drops to both eyes,repeat steps 6 to 9 for
the other eye.
If you apply other medicines to your eyes,wait at least 5 minutes between applying Safluround and
applying the other medicine.
If you use more Safluround than you should,it is unlikely to cause serious consequences. Apply the
next dose at the usual time.
If the medicine is accidentally ingested, ask your doctor for advice.
If you forget to use Safluround,apply a single drop as soon as you remember, then return to
your normal dosing schedule. Do not use a double dose to make up for a missed dose.
Do not stop using Safluroundwithout consulting your doctor. If you stop treatment with
Safluround, the pressure inside your eye will increase again. This can cause permanent damage
to your eye.
If you have any questions about using this medicine, ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Most side effects are not serious.
Common side effects
The following effects may occur in up to 1 in 10 people:
Effects on the nervous system:
- headache
Effects on the eye:
- eye itching
- eye irritation
- eye pain
- eye redness
- changes in length, thickness and number of eyelashes
- eye dryness
- feeling of a foreign body in the eye
- alteration of eyelash color
- redness of the eyelids
- small pinpoint inflamed areas on the surface of the eye
- sensitivity to light
- increased tearing
- blurred vision
- reduced ability of the eyes to distinguish details
- alteration of the color of the iris (may be permanent).
Uncommon side effects
The following effects may occur in up to 1 in 100 people:
Effects on the eye:
- alteration of the color of the skin around the eyes
- swollen eyelids
- tired eyes
- swelling of the superficial membranes of the eye
- eye discharge
- inflammation of the eyelids
- signs of inflammation inside the eye
- eye discomfort
- pigmentation of the superficial membranes of the eye
- follicles on the superficial membranes of the eye
- allergic inflammation
- abnormal eye sensitivity
Effects on the skin and subcutaneous tissue:
- unusual growth of fluff on the eyelids.
Not known: frequency cannot be estimated from available data
Effects on the eye:
- inflammation of the iris/uvea (middle layer of the eye).
- eyes that appear sunken.
- macular edema/cystoid macular edema (swelling of the retina inside the eye leading to worsening of vision).
Effects on the respiratory system:
- worsening of asthma, shortness of breath.
In very rare cases, some patients with severe damage to the clear layer in the front of the eye
(cornea) have developed cloudy spots on the cornea due to calcium accumulation during treatment.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse.
You can also report side effects directly through the national reporting system
at http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa .
By reporting side effects you can help provide more information on the safety of
this medicine.
5. How to store Safluround
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 label of the bottle and on the packaging
after 'Exp.'. The expiry date refers to the last day of that month.
Store in a refrigerator (2°C – 8°C). Do not freeze.
Store in the original packaging to protect the medicine from light.
You must discard the bottle 28 days after first opening, to prevent infections, and use a new bottle.
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. Package contents and other information
What Safluround contains
- The active substanceis tafluprost. 1 ml of solution contains 15 micrograms of tafluprost. One drop contains approximately 0.45 micrograms of tafluprost.
- The other ingredients areglycerol, disodium hydrogen phosphate dihydrate, disodium edetate, polysorbate 80 and water for injections. Hydrochloric acid and/or sodium hydroxide are added to adjust the pH. Description of the appearance of Safluround and package contentsSafluround is a clear and colorless liquid (solution), practically free from visible particles. It is supplied in a pack containing 1 or 3 transparent plastic bottles with 3 ml of solution each. The transparent plastic bottles are closed with a cap. Each bottle is packaged in a sachet. Not all pack sizes may be marketed.
Marketing authorisation holder and manufacturer
Santen Oy
Niittyhaankatu 20
33720 Tampere
Finland
Manufacturer
Santen Oy
Niittyhaankatu 20
33720 Tampere
Finland
Tubilux Pharma SpA
Via Costarica 20/22
00071 Pomezia (Roma)
Italy
This medicinal product is authorised in the Member States of the European Economic Area under the following
names:
| i Germany | TAFLOTAN sine |
| z n Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, Greece, Hungary, Iceland, e Latvia, Lithuania, Norway, Slovakia, Sweden, Spain | Taflotan |
| g Poland | Taflotan multi |
| A Austria, Belgium, Croatia, Ireland, Luxembourg, Netherlands, Portugal, Romania, Slovenia | Saflutan |
| Italy | Safluround |
More detailed information on this medicine is available on the website of the Italian Medicines Agency.
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- Kraj rejestracji
- Postać farmaceutycznaEye drops, solution, 15 MICROGRAMMI/ML
- Kod ATCS01EE05
- Substancja czynna
- Wymaga receptyTak
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki SAFLUROUNDPostać farmaceutyczna: Eye drops, solution, 15 MICROGRAMMI/MLSubstancja czynna: tafluprostProducent: SANTEN ITALY SRLWymaga receptyPostać farmaceutyczna: Eye drops, solution, 40 MCG/MLSubstancja czynna: travoprostProducent: FIDIA FARMACEUTICI S.P.A.Wymaga receptyPostać farmaceutyczna: Eye drops, solution, 0.3 MG/MLSubstancja czynna: bimatoprostProducent: SIFI S.P.A.Wymaga recepty
Odpowiedniki SAFLUROUND w innych krajach
Leki z tą samą substancją czynną dostępne w innych krajach.
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SAFLUROUND wymaga recepty w Włochy. Możesz skonsultować się z lekarzem online, aby sprawdzić, czy ten lek może być odpowiedni w Twojej sytuacji.
Substancją czynną w SAFLUROUND jest tafluprost. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
SAFLUROUND jest produkowany przez SANTEN OY. 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 SAFLUROUND 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 SAFLUROUND 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 (tafluprost) to m.in. SAFLUTAN, AKAMBA, AMIRIOX. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
