Softacort

Package Leaflet: Information for the Patient

Softacort, 3.35 mg/ml, eye drops, solution in a single-dose container
Hydrocortisone sodium phosphate

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

• 1. What is Softacort and what is it 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 is Softacort and what is it used for

This medicine is eye drops in single-dose containers, which contain a substance called hydrocortisone. This substance is a corticosteroid, which reduces inflammation symptoms. The medicine is used to treat mild allergic or inflammatory conditions of the eye surface (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 you are allergic to the active substance (hydrocortisone) or any of the other ingredients of this medicine (listed in section 6).
• If you have high pressure in the eye (intraocular pressure) caused by glucocorticoids (a group of corticosteroids) or caused by other factors.
• If you have acute viral infections (such as herpes) and any other viral diseases in the stage of ulceration (unless the infection is being treated with antiviral drugs).
• If you have conjunctivitis with ulcerative keratitis (corneal inflammation), even at an early stage.
• If you have a bacterial eye infection (acute purulent infection, conjunctivitis, blepharitis, and hordeolum).
• If you have a fungal eye infection (ocular mycosis).
• If you have a bacterial infection called tuberculosis that affects the eyes (ocular tuberculosis).

Warnings and precautions

• Before starting to use this medicine, discuss it with your doctor, pharmacist, or nurse.
• If you have eye redness that has not been diagnosed, do not use this medicine.
• If you have a viral eye infection (herpes), this medicine can only be used if antiviral treatment is being administered, and the patient's eye condition should be closely monitored.
• If you have a disease that causes thinning of the outer part of the eye (cornea and sclera), there may be a higher risk of perforation due to the use of topical corticosteroids in the eye.
• If you have been using or have used corticosteroids for a long time and have eye wounds (corneal ulcers), a fungal infection may be suspected.
• During treatment, it is necessary to regularly monitor the eye condition closely. It has been shown that long-term use of corticosteroids causes increased intraocular pressure and the development of glaucoma, especially in patients who have high intraocular pressure or are at risk of developing such a condition during local steroid treatment (see Possible side effects), and causes cataract (lens opacity), especially in children and the elderly.
• The use of corticosteroids may cause opportunistic eye infections. Additionally, corticosteroids used topically in the eye may stimulate, exacerbate, or mask the symptoms of opportunistic eye infections.
• Do not wear contact lenses during treatment with this medicine.
• If you experience blurred vision or other vision disturbances, contact your doctor.

Children

There is no data on the safety and efficacy of using this medicine in children. Continuous, long-term treatment with corticosteroids in children may cause adrenal suppression. Increased intraocular pressure in children occurs more frequently, has a more severe course, and occurs faster than in adult patients.

Softacort and other medicines

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and about medicines you plan to take, including those available without a prescription. Some medicines may enhance the effect of Softacort, so your doctor may need to monitor you closely if you are taking such medicines (including some HIV medicines: ritonavir, cobicistat).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before using this medicine.

• The use of this medicine is not recommended during pregnancy, except in situations where the doctor considers it necessary and the treatment will be carried out under close supervision.
• It is not known whether the medicine is excreted in breast milk. The doctor will decide whether to use this medicine during breastfeeding or not.

Driving and using machines

Temporary blurred vision or other vision disturbances may affect driving and operating machinery. Do not drive or operate machinery until your vision returns to normal.

Softacort contains phosphates

The medicine contains 0.227 mg of phosphates in each drop.

3. How to use Softacort

Dose

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 2 drops into the affected eye (eyes), 2 to 4 times a day, depending on the prescribed dosing regimen. To avoid relapse of the disease, it is recommended to gradually reduce the dose. The duration of treatment usually ranges from a few days to a maximum of 14 days. In adults and elderly patients, the same dose of the medicine is used.

Use in children

The efficacy and safety of using this medicine in children have not been established.

Instructions for use

This medicine is intended for use in the eyes. To administer the drops, follow the instructions:

• 1. Wash your hands, stand or sit comfortably.
• 2. Open the sachet containing 10 single-dose containers. Record the date of first opening of the sachet.
• 3. Tear off one single-dose container from the strip.

• 4. To open the single-dose container, twist the top 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.
• 6. Place the tip of the single-dose container close to the eye, without touching the eye surface.
• 7. Gently squeeze the single-dose container to release two drops into the eye, then release the lower eyelid.

• 8. Press the inner corner of the affected eye at the base of the nose. Hold for 1 minute, with your eyes closed.

• 9. Repeat the steps for the second eye, if your doctor has told you to. Each single-dose container contains enough solution to administer to both eyes.
• 10. Discard the single-dose container after use. Do not store for reuse.
• 11. Unopened single-dose containers should be placed back in the sachet, and the opened sachet in the box. Unopened single-dose containers should be used within 1 month of opening the sachet.

If you are using other eye drops, wait at least 5 minutes between administering this medicine and the other eye drops.

Using more Softacort than you should

If you accidentally put too many drops in your eye and experience prolonged irritation, flush your eye with sterile water. Contact your doctor or pharmacist immediately.

Forgetting to use Softacort

Do not use a double dose to make up for a forgotten dose.

Stopping using Softacort

Do not stop treatment suddenly. Always consult your doctor if you are considering stopping treatment. If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Frequency not known: frequency cannot be estimated from the available data

• transient discomfort (burning, stinging) after instillation.

The following side effects have been reported with this group of medicines (corticosteroids) used to treat eye disorders.

Frequency not known: frequency cannot be estimated from the available data

• allergic reactions,
• delayed wound healing,
• cataract (posterior subcapsular),
• opportunistic infections (viral, such as herpes, fungal),
• increased intraocular pressure (glaucoma),
• pupil dilation (mydriasis),
• ptosis (drooping eyelid),
• inflammation of the uvea (uveitis),
• changes in corneal thickness,
• corneal disease (crystalline keratopathy),
• blurred vision.

In patients with severe damage to the transparent, anterior part of the eye (cornea), phosphates may, in very rare cases, cause corneal opacities due to calcium deposits during treatment.

Reporting of side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, e-mail: [email protected]. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this 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 which is stated on the carton, sachet, and single-dose container after EXP. The expiry date refers to the last day of that month. Do not store above 25°C. After first opening of the sachet:shelf life of the single-dose containers – 1 month. Store the single-dose containers in the sachet to protect from light. Record the date of first opening of the sachet on the sachet. After opening the single-dose container:use immediately and discard the single-dose container after use. Since it is not possible to maintain sterility after opening a single-dose container, any remaining solution should be discarded immediately after use. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. 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.
• The other ingredients are: disodium phosphate dodecahydrate, sodium dihydrogen phosphate monohydrate, sodium chloride, disodium edetate, hydrochloric acid, water for injections.

What Softacort looks like and contents of the pack

The medicine is a clear, colorless to slightly yellowish solution in a single-dose container. The solution is practically free from particles. The medicine is packaged in sachets of 10. One single-dose container contains 0.4 ml of the product. The pack sizes are 10 (1x10), 20 (2x10), 30 (3x10), or 60 (6x10) single-dose containers. Not all pack sizes may be marketed.

Marketing authorization holder

Laboratoires THEA, 12, rue Louis Blériot, 63017 Clermont-Ferrand Cedex 2, France

Manufacturer

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

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Austria, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom - Softacort, Belgium, Luxembourg, Netherlands - Softacor, Italy - Sofacor, Ireland - Zoftacot

Date of last revision of the leaflet: 15-09-2023

Detailed information on this medicine is available on the website www.urpl.gov.pl