Sofacor

Patient Information Leaflet: Information for the user

Sofacor 3.35 mg/ml eye drops, solution in single-dose container

Hydrocortisone sodium phosphate
Read this entire 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 give it to others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effects, including those 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 Sofacor is and what it is used for

This medicine is an ophthalmic solution in a single-dose container, containing 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 eye surface (conjunctivitis).
The eye must not be infected (see Do not use Sofacor).

2. What you need to know before using Sofacor

Do not use SOFACOR

• If you are allergic to the active substance (hydrocortisone), or to any of the other ingredients of this medicine (listed in section 6).
• If you have high pressure inside the eye (ocular hypertension) caused by glucocorticoids (a class of corticosteroids) or other causes.
• If you have an acute viral infection caused by herpes simplex virus, or most other viral infections in the ulcerative stage (except when the infection is being treated with an antiviral agent for herpes virus).
• If you have conjunctivitis with ulcerative inflammation of the cornea (keratitis), even in the early stages.
• If you have a bacterial eye infection (acute purulent infection, conjunctivitis, blepharitis, or stye).
• If you have a fungal infection of the eye (ocular mycosis).
• If you have 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 and you do not have a prior diagnosis, do not use this medicine.
• If you have a viral eye infection (herpes), use this medicine only if the infection is being treated with an antiviral agent and close monitoring of your eyes is ensured.
• If you have 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 topical corticosteroids applied to the eye.
• If you are currently using or have previously used a corticosteroid medicine for a long time and have an eye wound (corneal ulcer), a fungal infection may be suspected.
• Regular and frequent monitoring of your eye condition is required during treatment. Prolonged use of corticosteroids may increase intraocular pressure and lead to glaucoma, especially in patients who already have elevated intraocular pressure or who are at risk of developing this condition with local steroid treatment (see Possible side effects), and may cause clouding of the eye's lens (cataract), particularly in children and elderly patients.
• The use of corticosteroids may lead to opportunistic eye infections. In addition, topical ocular corticosteroids may promote, worsen, or mask the signs and symptoms of opportunistic eye infections.
• Avoid wearing contact lenses during treatment with this medicine.
• Contact your doctor if blurred vision or other visual disturbances occur.

Children
There are no data on safety and efficacy in children.
In children, prolonged and continuous corticosteroid therapy may cause adrenal suppression.
Increased intraocular pressure in children occurs more frequently, is more severe, and develops more rapidly than in adults.

Other medicines and Sofacor
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines without a prescription.
Some medicines may increase the effects of Sofacor, and your doctor may need to monitor carefully if you are taking these medicines (including certain HIV medications: ritonavir, cobicistat).

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, if you suspect you may be pregnant, or if you are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine.

• Use of this medicine during pregnancy is not recommended, except when 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 while breastfeeding.

Driving and using machines
Temporary blurred vision or other visual disturbances may affect your ability to drive or operate machinery. Do not drive or use machinery 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 exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 2 drops into the affected eye(s), 2 to 4 times daily, as prescribed.
A gradual reduction of the dose is recommended to avoid a relapse. The duration of treatment usually ranges from a few days up 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.

How to use the drops
This medicine must be administered into the eye.
Follow the instructions below when using the drops:

1. Wash your hands and sit or position yourself comfortably.
2. Open the sachet containing the 10 single-dose containers. Write the date of first opening on the sachet.
3. Detach one single-dose container from the strip.

4. Open by twisting off the top part of the single-dose container as shown. After opening, do not touch the tip of 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 the eye, but do not let it touch the eye.
7. Gently squeeze the single-dose container so that two drops go into the eye, then release the lower eyelid.

8. Press a finger against the corner of the affected eye near the nose. Keep the eye closed for one minute.

9. Repeat for the other eye if instructed by your doctor. Each single-dose container contains enough solution for both eyes.
10. Dispose of the single-dose container after use. Do not keep it for later use.
11. Store unused single-dose containers in the sachet. Place the opened sachet back into the cardboard carton. Unopened containers should be used within one month of first opening the sachet.

If you are using any other eye medicine, wait 5 minutes between each application.

If you use more Sofacor than you should
Rinse the eyes with sterile water if an excessive amount has been applied and if prolonged irritation occurs.
Contact your doctor or pharmacist immediately.

If you forget to use Sofacor
Do not use a double dose to make up for the forgotten dose.

If you stop using Sofacor
Do not stop treatment abruptly. Always consult your doctor before stopping treatment.

If you have any doubts about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Not known: frequency cannot be estimated from the 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 to treat eye conditions.
Not known: frequency cannot be estimated from the available data

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

If you have severe damage to the outermost transparent layer of the eye (the cornea), phosphates may very rarely cause opaque corneal spots due to calcium accumulation during treatment.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly via 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 stated on the box, 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: use the single-dose containers within 1 month.
Keep the single-dose containers inside the sachet to protect them from light.
Record 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 content must be immediately discarded after administration.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package Contents and Other Information

What Sofacor contains
The active substance is hydrocortisone sodium phosphate.
1 ml of eye drops solution contains 3.35 mg of hydrocortisone sodium phosphate.
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 package contents
This medicine is presented as eye drops solution in single-dose containers.
The solution is practically clear, colourless to slightly yellow, practically free from visible particles, packaged in a pouch containing 10 single-dose containers of 0.4 ml of product.
A package contains 10 (1x10), 20 (2x10), 30 (3x10) or 60 (6x10) single-dose containers.
It is possible that not all pack sizes are marketed.

Marketing Authorization 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 medicine is authorized in the European Economic Area Member States under the following names:
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 (Agenzia Italiana del Farmaco)