Label:Information for the User

Softacort 3.35 mg/ml eye drops in single-dose solution

Sodium phosphate of hydrocortisone

Read this label carefully before starting to use this medication,because it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult yourdoctor, pharmacist, or nurse.
• This medication has been prescribedonlyto you, and you should not give it to others even if they havethe same symptomsas you, as it may harm them.
• If you experience any adverse effects,consult your doctor, pharmacist, or nurse,evenif they are not listed in this label.See section 4.

1.What isSoftacortand what is it used for

2.What you need to knowbeforestarting touseSoftacort

3.How to useSoftacort

4.Possible adverse effects

1. Storage ofSoftacort

6.Contents of the package and additional information

This medication is a single-dose solution eye drop that contains a substance called hydrocortisone. This substance is a corticosteroid that inhibits the symptoms of inflammation.

It is used to treat mild allergic or inflammatory conditions of the superficial part of your eye or eyes (conjunctiva).

The eye should not be infected (see Do not use Softacort).

Do not use Softacort

• If you are allergic to the active ingredient (hydrocortisone) or to any of the other components of this medication (listed in section 6).
• If you have high eye pressure (ocular hypertension), which is known to be associated with the use of glucocorticoids (corticosteroid family) or other causes.
• If you have acute viral infections caused by the herpes virus and in most other viral diseases in the ulcerative phase (unless the infection is being treated with antiviral treatment for the herpes virus).
• If you have conjunctivitis with ulcerative inflammation of the cornea (keratitis) even in the initial phase.
• If you have a bacterial infection in the eye (acute purulent infection, conjunctivitis, blepharitis, and hordeolum).
• If you have a fungal infection in the eye (ocular mycosis).
• If you have a bacterial infection called tuberculosis that affects your eye (ocular tuberculosis).

Warnings and precautions

• Consult your doctor, pharmacist, or nurse before starting to use this medication.

• If you have an undiagnosed red eye, do not use this medication.
• If you have a viral eye infection (herpes), use this medication only if the infection is being treated with antiviral treatment and requires close monitoring of your eyes.
• If you have a disease that causes thinning of the outer part of your eye (cornea and sclera), there may be an increased risk of perforation due to the use of topical corticosteroids applied to the eye.
• If you have been using a corticosteroid medication for a long time and have an eye wound (corneal ulcer), a fungal infection may be suspected.
• During treatment, close and regular monitoring of your eyes is required. The prolonged use of corticosteroids has shown to cause an increase in intraocular pressure and the onset of glaucoma, especially in patients who already suffer from high intraocular pressure or who are at risk of developing such a condition with local steroid treatment (see Possible side effects) and cause opacity of the lens in your eye (cataract), particularly in children and in the elderly population.
• The use of corticosteroids can cause opportunistic eye infections. In addition, topical ocular corticosteroids can promote, worsen, or mask signs and symptoms of opportunistic eye infections.
• Avoid using contact lenses during treatment with this medication.
• Contact your doctor if you experience blurred vision or other visual disturbances.

Children

No safety and efficacy data are available in children.

Prolonged treatment with corticosteroids can cause adrenal suppression.

In children, increased intraocular pressure occurs more frequently, with greater severity, and more rapidly than in adults.

Use of Softacort with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication, including over-the-counter medications.

Some medications may increase the effects of Softacort, and your doctor may wish to monitor you closely if you are using these medications (including some HIV medications: ritonavir, cobicistat).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

• This medication is not recommended during pregnancy except when your doctor considers it necessary and under strict supervision.

The safety of this medication during breastfeeding is unknown. Your doctor will decide if you can use or not use this medication during breastfeeding.

Driving and operating machinery

You may experience blurred vision immediately after applying Softacort. Do not drive or operate machinery until this effect has disappeared.

Softacort contains phosphates

This medication contains 0.227 mg of phosphates in each drop.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist.This medication should be used exactly as directed.In case of doubt, consult your doctor or pharmacist again.

The recommended dose is 2 drops in the (the) affected eye(s), 2 to 4 times a day, as prescribed by a doctor.A gradual reduction in dose is recommended to avoid a relapse.The treatment duration may vary from a few days to a maximum of 14 days.

The same dose is used for both adults and elderly patients.

Use in children

The efficacy and safety in children have not been established.

Instructions for use

This medication is intended to be administered in the eye.

To use the eye drops, please follow these instructions:

1. Wash your hands and sit or stand comfortably.
2. Open the package containing 10 single-use vials. Note the date of first opening on the package.
3. Separate a single-use vial from the strip.

1. Turn the tip of the single-use vial as shown. Do not touch the tip after opening the vial.

1. Use your finger to gently separate the lower eyelid from the affected eye.
2. Place the tip of the single-use vial near the eye, but do not touch it.
3. Press the single-use vial gently so that 2 drops fall into the eye and then remove your finger from the lower eyelid.

8.Press the affected eye with your finger, near the nose. Apply pressure for 1 minute, keeping your eye closed.

1. Repeat the procedure in the other eye, if your doctor has instructed you to do so.Each single-use vial contains enough for both eyes.

1. Dispose of the single-use vial after use.Do not save it for later use.

1. Place the unopened single-use vials inside the package.Place the opened package inside the box.The unopened vials can be used within a month of opening the package.

If you use any other eye drops, wait at least 5 minutes between each application.

Using more Softacort than you should

Rinse the eye with sterile water if too much product has been administered to the eye and prolonged irritation occurs.

Contact your doctor or pharmacist immediately.

Missing a dose of Softacort

You should not apply an additional drop to the eye to compensate for the missed dose.

Stopping treatment with Softacort

Do not stop treatment abruptly.Always consult your doctor if you are considering discontinuing treatment.

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Unknown frequency:cannot be estimated from the available data

• transient eye discomfort (burning, itching) after application.

The following side effects have been reported with medications in the same group (corticosteroids) when used to treat eye conditions.

Unknown frequency:cannot be estimated from the available data

• allergic reactions
• delayed wound healing
• posterior capsular opacification of the eye lens (cataract)
• opportunistic infections (herpes-type viruses, fungal infections)
• increased eye pressure (glaucoma)
• pupil dilation (mydriasis)
• drooping eyelids (ptosis)
• inflammation within the eye (uveitis)
• changes in the thickness of the front part of the eye (cornea)
• inflammation of the cornea (crystalline keratopathy)
• blurred vision

If you suffer from severe damage to the transparent layer at the front of the eye (cornea), treatment with phosphates, in rare cases, may cause cloudy patches in the cornea due to calcium.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https//: notificaram.es. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box, on the blister pack, and on the single-use container after CAD or EXP. The expiration date is the last day of the month indicated.

Store below25°C.

After the first opening of the blister pack:use the single-use container within a month.

Keep the single-use containers inside the blister pack to protect them from light.

Write the date of the first opening of the blister pack.

After the first opening of the single-use container:use immediately and discard the single-use container after use.

Sterility cannot be maintained after opening a single-use container, so you must open a new container before each use.

Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition ofSoftacort

• The active ingredient ishydrocortisone sodium phosphate.

1 ml of eye drop solution contains 3.35 mg of hydrocortisone sodium phosphate.

• The other components are disodium dodecahydrate phosphate, sodium dihydrogen phosphate monohydrate, sodium chloride, disodium edetate, hydrochloric acid (to adjust the pH), and water for injection preparations.

Appearance of the product and contents of the package

This medication is presented as an eye drop solution in single-dose containers.

The solution is practically transparent, colorless to slightly yellow, practically free of particles, presented in the interior of a package with 10 units, each single-dose container contains 0.4 ml of eye drop solution.

The boxes contain 10 (1 x 10), 20 (2 x 10), 30 (3 x 10), or 60 (6 x 10) single-dose containers.

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization

Laboratoires THEA

12 RUE LOUIS BLERIOT

63017 CLERMONT-FERRAND CEDEX 2

FRANCE

Manufacturer

Laboratoires UNITHER

1 rue de l’Arquerie

50200 Coutances

FRANCE

or

Laboratoires THEA

12, rue Louis Blériot

63017 CLERMONT-FERRAND Cedex 2

FRANCE

Local representative

Laboratorios THEA, S.A.

C/ Enric Granados nº 86-88, 2nd floor

08008 – BARCELONA

This medication is authorized in the member states of the European Economic Area with the following names:

Germany, Austria, Bulgaria, Cyprus, Croatia, Denmark, Slovenia, Spain, Finland, France, Greece, Iceland, Norway, Poland, Portugal, Czech Republic, Slovak Republic, United Kingdom, Romania, SwedenSoftacort

Belgium, Netherlands, LuxembourgSoftacor

IrelandZoftazot

ItalySofacor

Last review date of this leaflet: October 2023

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.