SOFTACORT

Patient Information Leaflet

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Softacort, 3.35 mg/ml, eye drops, solution in single-dose container
Hydrocortisoni natrii phosphas
Please read this leaflet carefully before using the medicine, as it contains important information for you.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents

1. What Softacort is and what it is used for
2. Important information before using Softacort
3. How to use Softacort
4. Possible side effects
5. How to store Softacort
6. Contents of the pack and other information

1. What Softacort is and what it is used for

This medicine is eye drops in single-dose containers, containing a substance called hydrocortisone. This substance is a corticosteroid which suppresses symptoms of inflammation.
The medicine is used in the treatment of mild allergic or inflammatory conditions of the surface of the eye(s) (conjunctiva).
The eye should not be infected (see When not to use Softacort).

2. Important information before using Softacort

When not to use Softacort:

• If the patient is allergic to the active substance (hydrocortisone) or to any of the other ingredients of this medicine (listed in section 6).
• If the patient has elevated intraocular pressure (intraocular hypertension) caused by glucocorticoids (a group of corticosteroids) or due to other factors.
• If the patient has acute herpes simplex virus infection or any other viral disease at the ulcerative stage (unless the infection is being treated with antiviral agents active against herpes simplex virus).
• If the patient has keratoconjunctivitis with ulcerative keratitis (corneal inflammation), even at an early stage.
• If the patient has a bacterial eye infection (acute purulent infection, conjunctivitis, blepharitis, or hordeolum).
• If the patient has a fungal eye infection (fungal keratitis).
• If the patient has a bacterial infection called tuberculosis affecting the eyes (ocular tuberculosis).

Warnings and precautions

• Before starting treatment with this medicine, discuss it with your doctor, pharmacist, or nurse.
• If the patient has eye redness that has not been diagnosed, this medicine should not be used.
• If the patient has a viral eye infection (herpes simplex), this medicine may be used only if antiviral treatment is also administered, and close monitoring of the eye condition is required.
• If the patient has a disease causing thinning of the outer layer of the eye (cornea and sclera), there may be an increased risk of perforation due to the use of locally administered corticosteroids.
• If the patient has been using or has used corticosteroid medicines for a long time and has eye wounds (corneal ulceration), fungal infection should be suspected.
• Close and regular monitoring of the eye condition is necessary during treatment. Prolonged use of corticosteroids has been shown to increase intraocular pressure and lead to glaucoma, especially in patients who already have elevated intraocular pressure or are at risk of developing it during local steroid therapy (see Possible side effects), and may also cause lens opacity (cataract), particularly in children and elderly patients.
• The use of corticosteroids may lead to opportunistic eye infections. Moreover, corticosteroids administered locally to the eye may activate, worsen, or mask objective and subjective symptoms of opportunistic eye infections.
• Wearing contact lenses should be avoided during treatment with this medicine.
• If the patient experiences blurred vision or other visual disturbances, they should contact their doctor.

Children
There is no data available on the safety and efficacy of using Softacort in children.
Uninterrupted, long-term corticosteroid treatment in children may suppress adrenal function.
Increased intraocular pressure in children occurs more frequently, progresses more rapidly, and has a more severe course than in adult patients.

Softacort and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently using or has recently used, as well as any medicines the patient plans to take, including those available without a prescription.
Some medicines may enhance the effect of Softacort; therefore, the doctor may perform careful monitoring if the patient is taking such medicines (including certain drugs used in HIV treatment: ritonavir, cobicistat).

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.

• Use of this medicine during pregnancy is not recommended, except when considered necessary by the doctor and treatment is conducted under strict medical supervision.
• It is not known whether the medicine is excreted in breast milk. The treating physician will decide whether this medicine can be used during breastfeeding.

Driving and operating machinery
Transient blurred vision or other visual disturbances may affect the ability to drive or operate machinery. Do not drive or operate machinery until normal vision returns.

Softacort contains phosphates
The medicine contains 0.227 mg of phosphates per drop.

3. How to use Softacort

Dosage
This medicine should always be used as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
The recommended dose is 2 drops into the affected eye(s), 2 to 4 times daily, depending
on the prescribed dosing regimen. To prevent recurrence of the disease, gradual
reduction of the dose is recommended. The duration of treatment usually lasts from several days to a maximum of 14 days.
The same dose is used in adults and elderly patients.
Use in children
The efficacy and safety of this medicine in children have not been established.
Instructions for use
This medicine is for ophthalmic use only.
To administer the drops, follow these instructions:

1. Wash your hands and stand or sit comfortably.
2. Open the sachet containing 10 single-dose containers. Record the date of first opening of the sachet (Ημερομηνία πρώτου ανοίγματος).
3. Tear off one single-dose container from the strip.

4. To open the single-dose container, twist the top part of the container as shown in the picture. Do not touch the tip of the container after opening.

5. Gently pull down the lower eyelid of the affected eye with your finger.
6. Hold the tip of the single-dose container close to the eye, but without touching the eye surface.
7. Gently squeeze the single-dose container to instill two drops into the eye, then release the lower eyelid.

8. Press with a finger on the inner corner of the affected eye near the nose. Hold for 1 minute with eyes closed.

9. Repeat the procedure for the second eye if directed by a doctor. Each single-dose container contains enough solution for instillation into both eyes.
10. Discard the single-dose container after use. Do not store for reuse.
11. Place unused, unopened single-dose containers back into the sachet, and the opened sachet back into the carton. Unopened single-dose containers should be used within one month of opening the sachet.

If other eye drops are being used, administer them at least 5 minutes after using this medicine.
Use of more than the recommended dose of Softacort
If too much medicine is instilled into the eye and prolonged irritation occurs, rinse the eye with sterile water.
Contact your doctor or pharmacist immediately.
Missed dose of Softacort
Do not use a double dose to make up for a missed dose.
Stopping Softacort treatment
Do not stop treatment abruptly. Always consult your doctor if you are considering stopping treatment.
If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
Frequency unknown: frequency cannot be estimated from the available data

• Transient discomfort (burning, stinging) after instillation. The following adverse reactions have been reported with drugs of the same class (corticosteroids) used in the treatment of eye disorders.

Frequency unknown: frequency cannot be estimated from the available data

• Allergic reactions,
• Delayed wound healing,
• Clouding of the lens in the eye (posterior subcapsular cataract),
• Opportunistic infections (viral, such as herpes, fungal infections),
• Increased intraocular pressure (glaucoma),
• Pupil dilation (mydriasis),
• Drooping of the eyelid (blepharoptosis),
• Inflammation in the eye (uveitis),
• Changes in the thickness of the front part of the eye (cornea),
• Corneal inflammation (crystalline keratopathy),
• Blurred vision.

In patients with severe damage to the transparent front part of the eye (cornea), phosphates may in very rare cases lead during treatment to corneal clouding due to calcium deposits.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can also be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 4921301, fax: +48 22 4921309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions enables better assessment of the safety of the medicine.

5. How to store Softacort

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Do not store above 25°C.
Store single-dose containers in the sachet to protect from light.
After first opening the sachet: shelf life of single-dose containers – 1 month.
The date of first opening the sachet should be written on the sachet (Ημερομηνία πρώτου ανοίγματος).
After first opening a single-dose container: use immediately and discard the single-dose container after use.
Since sterility cannot be maintained after opening a single-dose container, any remaining solution must be discarded immediately after use.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Softacort contains

• The active substance is hydrocortisone sodium phosphate. 1 ml of eye drops solution contains 3.35 mg of hydrocortisone sodium phosphate. One drop contains approximately 0.12 mg of hydrocortisone sodium phosphate.
• Other ingredients are: disodium phosphate dodecahydrate, sodium dihydrogen phosphate monohydrate, sodium chloride, disodium edetate, hydrochloric acid (for pH adjustment), water for injections.

What Softacort looks like and contents of the pack
Softacort is an eye drop solution in a single-dose container.
The solution is practically clear, colourless to slightly yellowish, and practically free from particles. The product is packed in sachets of 10 units. Each single-dose container holds 0.4 ml of the medicinal product.
Pack sizes: 10 (1x10), 20 (2x10), 30 (3x10) or 60 (6x10) single-dose containers.
For more detailed information, please contact the Marketing Authorisation Holder or the Parallel Importer.

Marketing Authorisation Holder in Greece, country of export:
Laboratoires THEA
12, rue Louis Blériot
63017 Clermont-Ferrand Cedex 2
France

Manufacturer:
Laboratoire Unither
1 rue de l’Arguerie
50200 Coutances
France
Laboratoires THEA
12, rue Louis Blériot
63017 Clermont-Ferrand Cedex 2
France

Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Poland

Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland

Marketing Authorisation Number in Greece, country of export: 64103/31.08.2017
125302/24-11-2022

Parallel Import Authorisation Number: 7/26

This medicinal product is authorised in the European Economic Area (EEA) Member States under the following names:
Austria, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland,
Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden: Softacort
Belgium, Luxembourg, Netherlands: .....................................................................................................Softacor
Italy: ..........................................................................................................................................Sofacor
Ireland: .........................................................................................................................................Zoftacot