SOFACOR 3.35 MG/ML Krople do oczu, roztwór
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Treść ulotki
Sofacor 3.35 mg/ml eye drops, solution in single-dose container
Sodium phosphate hydrocortisone
Read this leaflet carefully before 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 they have the same symptoms as you, as it could be harmful.
- If any side effects occur, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.
Contents of this leaflet:
- 1. What Sofacor is and what it is used for
- 2. What you need to know before using Sofacor
- 3. How to use Sofacor
- 4. Possible side effects
- 5. How to store Sofacor
- 6. Contents of the pack and other information
1. What is Sofacor and what is it used for
This medicine is an eye drop solution in a single-dose container, which contains a substance called
hydrocortisone. This substance is a corticosteroid that inhibits the symptoms of inflammation.
It is used to treat mild allergic and inflammatory conditions of the surface of the eye(s)
(conjunctivitis).
The eye must not be infected (see Do not use Sofacor).
2. What you need to know before you use Sofacor
Do not use SOFACOR
- If you are allergic to the active ingredient (hydrocortisone), or to any of the other ingredients of this medicine (listed in section 6).
- If you suffer from high pressure inside the eye (ocular hypertension) induced by glucocorticoids (a family of corticosteroids) or from other causes.
- If you suffer from an acute herpes simplex virus infection and most other viral infections at the ulceration stage (except when the infection is being treated with an anti-infective for the herpes virus).
- If you suffer from conjunctivitis with ulcerative inflammation of the cornea (keratitis), even at an early stage.
- If you suffer from a bacterial infection of the eye (acute purulent infection, conjunctivitis, blepharitis and hordeolum).
- If you suffer from fungal infections of the eye (ocular mycosis).
- If you suffer from a bacterial infection affecting the eye called tuberculosis (ocular tuberculosis).
Warnings and precautions
- Talk to your doctor, pharmacist or nurse before using this medicine.
- If your eye is red, without a previous diagnosis, do not use this medicine.
- If you suffer from a viral infection of the eye (herpes), use this medicine only if the infection is being treated with an anti-infective and close monitoring of your eyes is required.
- If you suffer from a disease that causes thinning of the outer part of the eye (cornea and sclera), there may be a higher risk of perforation caused by the use of topical corticosteroids applied to the eye.
- If you are using or have used a corticosteroid medicine for a long time and have a wound in your eye (corneal ulcer), a fungal infection may be suspected.
- Regular and frequent monitoring of the condition of your eyes is required during treatment. Prolonged use of corticosteroids can cause an increase in eye pressure and the onset of glaucoma, especially in patients who already suffer from elevated intraocular pressure or are at risk of developing this condition with local steroid treatment (see Possible side effects) and can cause clouding of the lens of the eye (cataract), especially in children and the elderly.
- The use of corticosteroids can cause opportunistic eye infections. In addition, topical ocular corticosteroids can promote, worsen or mask the signs and symptoms of opportunistic infections in the eyes.
- Avoid using contact lenses during treatment with this medicine.
- Contact your doctor if you experience blurred vision or other visual disturbances.
Children
There is no data on safety and efficacy in children.
In children, continued and prolonged therapy with corticosteroids can induce adrenal suppression.
An increase in eye pressure in children is much more frequent, more severe, and more rapid than
in adults.
Other medicines and Sofacor
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines, including over-the-counter medicines.
Some medicines can increase the effects of Sofacor and your doctor may want to carefully check
if you are using these medicines (including some medicines for HIV: ritonavir, cobicistat).
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, if you suspect you are pregnant or are planning a
pregnancy, ask your doctor or pharmacist for advice before using this medicine.
- The use of this medicine during pregnancy is not recommended unless considered necessary by your doctor and under strict supervision.
- It is not known whether this medicine passes into breast milk. Your doctor will decide whether you can use this medicine during breastfeeding.
Driving and using machines
Temporary blurred vision or other visual problems can affect your ability to
drive or use machines. Do not drive or use machines until your vision has returned to normal.
Sofacor contains phosphates
This medicine contains 0.227 mg of phosphate buffer per drop.
3. How to use Sofacor
Dosage
Use this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts
consult your doctor or pharmacist.
The recommended dose is 2 drops in the affected eye(s), from 2 to 4 times a day, as prescribed.
A gradual reduction of the dose is recommended to avoid a relapse. The duration of treatment
usually ranges from a few days to a maximum of 14 days.
The same dose is used for both adults and the elderly.
Use in children
Efficacy and safety in children have not been demonstrated.
How to use the drops
This medicine must be administered into the eye.
Follow these instructions when using the drops:
- 1. Wash your hands and sit or stand in a comfortable position.
- 2. Open the sachet containing the 10 single-dose containers. Write the date of first opening on the sachet.
- 3. Detach a single-dose container from the strip.
- 4. Open by twisting the top of the single-dose container as shown. Do not touch the tip after opening the container.
- 5. Use your fingers to gently pull down the lower eyelid of the affected eye.
- 6. Position the tip of the single-dose container close to, but not touching the eye.
- 7. Gently press the single-dose container so that two drops enter the eye, then release the lower eyelid.
- 8. Press a finger into the corner of the affected eye towards the nose. Wait one minute keeping the eye closed.
- 9. Repeat for the other eye if your doctor has told you to do so. Each single-dose container contains enough solution for both eyes.
- 10. Dispose of the single-dose container after use. Do not keep it for subsequent use.
- 11. Store unused single-dose containers in the sachet. Place the open sachet in the cardboard box. Unopened containers must be used within one month of first opening the sachet.
If you are using any other medicine to apply to the eye, you should wait 5 minutes between each application.
If you use more Sofacor than you should
Wash your eyes with sterile water if too much product has been applied to the eye and if there is prolonged
irritation.
Contact your doctor or pharmacist immediately.
If you forget to use Sofacor
Do not use a double dose to make up for a missed dose.
If you stop using Sofacor
Do not stop treatment abruptly. Always consult your doctor if you are considering
stopping treatment.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Not known: the frequency cannot be estimated from available data
- transient eye discomfort (burning, stinging pain) after application.
The following side effects have been reported with medicines of the same group (corticosteroids)
when used for the treatment of eye conditions.
Not known: the frequency cannot be estimated from available data
- allergic reactions,
- delayed wound healing,
- clouding of the eye’s lens (posterior capsule opacification cataract),
- opportunistic infections (viral infections such as herpes, fungal infection),
- increased pressure in the eye (glaucoma),
- pupil dilation (mydriasis),
- drooping eyelids (ptosis),
- inflammation inside the eye (uveitis),
- changes in the thickness of the front part of the eye (cornea),
- inflammation of the cornea (corneal crystalline keratopathy),
- blurred vision.
If you have severe damage to the outermost transparent layer of the eye (the cornea), phosphates may cause in
very rare cases opaque spots on the cornea due to calcium accumulation during treatment.
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
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 Sofacor
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 box, on the sachet and on the
single-dose container after EXP. The expiry date refers to the last day of that month.
Do not store at a temperature above 25°C.
After first opening of the sachet:use the single-dose containers within 1 month.
Keep the single-dose containers inside the sachet to protect them from light.
Write the date of first opening on the sachet.
After first opening of the single-dose container:use immediately and discard the single-dose
container after use.
Since sterility cannot be maintained after opening the single-dose container, any
remaining contents must be immediately discarded after administration.
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 Sofacor contains
The active ingredient is sodium phosphate hydrocortisone.
1 ml of eye drops solution contains 3.35 mg of sodium phosphate hydrocortisone.
The other components are disodium phosphate dodecahydrate, sodium dihydrogen phosphate monohydrate, sodium chloride,
disodium edetate, hydrochloric acid (for pH adjustment), water for injections.
Description of the appearance of Sofacor and contents of the pack
This medicine is presented as eye drops solution in single-dose container.
The solution is practically clear, from colorless to slightly yellow, practically free of visible
particles, packaged in a strip of 10 single-dose containers of 0.4 ml of product.
One pack contains 10 (1x10), 20 (2x10), 30 (3x10) or 60 (6x10) single-dose containers.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
LABORATOIRES THEA
12, RUE LOUIS BLERIOT
63017 CLERMONT-FERRAND CEDEX 2
FRANCE
Manufacturers
LABORATOIRES UNITHER
ZI de la Guérie
50 211 COUTANCES CEDEX
FRANCE
LABORATOIRES THEA
12, RUE LOUIS BLERIOT
63017 CLERMONT-FERRAND CEDEX 2
FRANCE
This medicinal product is authorised in the Member States of the European Economic Area with the following
denominations:
Austria, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland,
Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden,
United Kingdom……………………………………………………………………………………………………………………………………. Softacort
Belgium, Luxembourg, Netherlands ...................................................................................................Softacor
Ireland ……………………………………………………………………………………………………………………………………..Zoftacot
Italy………………………………………………………………………………………………………………………………………………Sofacor
This leaflet was last updated on:
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, 3.35 MG/ML
- Kod ATCS01BA02
- Substancja czynna
- Wymaga receptyTak
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki SOFAKORPostać farmaceutyczna: Eye drops, solution, 0.3 MLSubstancja czynna: hydrocortisoneProducent: DOC GENERICI SRLWymaga receptyPostać farmaceutyczna: Eye drops, solution, 0.1%Substancja czynna: clobetasoneProducent: OMNIVISION ITALIA SRLBez receptyPostać farmaceutyczna: Eye drops, solution, 1,5 MG/MLSubstancja czynna: dexamethasoneProducent: DOC GENERICI SRLWymaga recepty
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SOFAKOR wymaga recepty w Włochy. Możesz skonsultować się z lekarzem online, aby sprawdzić, czy ten lek może być odpowiedni w Twojej sytuacji.
Substancją czynną w SOFAKOR jest hydrocortisone. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
SOFAKOR jest produkowany przez LABORATOIRES THEA. 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 SOFAKOR 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 SOFAKOR 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 (hydrocortisone) to m.in. KORTIVIS, KLOBET, DESADOK. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
