CORTIVIS

Package leaflet: Information for the patient

CORTIVIS 0.3 ML EYE DROPS, SOLUTION

Hydrocortisone sodium phosphate
(Equivalent medicine)
Read this entire leaflet carefully before using this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• 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, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Cortivis is and what it is used for

Cortivis 0.3 ml eye drops, solution contains the active substance sodium phosphate hydrocortisone.
Sodium phosphate hydrocortisone is an anti-inflammatory medicine belonging to the group of corticosteroid drugs.
Cortivis is used to treat inflammatory and allergic diseases of the anterior segment of the eyeball.

2. What you need to know before using Cortivis

Do not use Cortivis:

• If you are allergic to hydrocortisone or to any of the other ingredients of this medicine (listed in section 6).
• If you have elevated intraocular pressure.
• If you have a viral eye infection.
• If you have a fungal (mycotic) eye infection or a known bacterial infection such as tuberculosis.
• If you have a pus-producing eye infection or a stye.

Warnings and precautions
Talk to your doctor or pharmacist before using Cortivis.
The use of steroids in viral-induced corneal inflammation (keratitis) requires great caution and may only be allowed under close supervision by an ophthalmologist.
In diseases causing thinning of the cornea or sclera, the use of topical steroids may lead to perforation.
Corticosteroid use should not be repeated or prolonged without appropriate monitoring by an ophthalmologist to rule out the occurrence of serious adverse effects.
Caution should be exercised when administering this eye drop to elderly patients.

Other medicines and Cortivis
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using Cortivis.

Driving and using machines
Cortivis 0.3 ml eye drops, solution has no effect on the ability to drive vehicles or operate machinery.

3. How to use Cortivis

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 eye, 2 or more times a day, depending on the severity of the
condition.
Exercise caution when treating elderly patients.
If you use more Cortivis than you should
Contact your doctor immediately.
If you forget to use Cortivis
Do not use a double dose to make up for the missed dose.
If you stop using Cortivis
If you need to stop treatment, contact your doctor immediately.

4. Possible side effects

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

• increased intraocular pressure which may lead to glaucoma;
• cataract formation following prolonged treatment;
• development or worsening of bacterial infections caused by Herpes simplex or fungal infections;
• delayed wound healing;
• headache;
• low blood pressure;
• rhinitis and pharyngitis.
  Serious side effects (thickening of the sclera, pupil dilation, eyelid laxity) may occur after prolonged administration.

Following the instructions contained in this leaflet reduces the risk of side effects.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist.
You may also report side effects directly via the national reporting system at: www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Cortivis

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after "Expiry".
The expiry date refers to the last day of that month.
The expiry date applies to the product in its original, undamaged packaging that has been properly stored.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Cortivis contains
The active substance is hydrocortisone sodium phosphate.
Each single-dose container contains 1.005 mg of hydrocortisone sodium phosphate.
The other components are:
Sodium hyaluronate, sodium chloride, potassium chloride, dibasic sodium phosphate dodecahydrate,
monobasic sodium phosphate dihydrate, water for injections.

Description of the appearance of Cortivis and contents of the pack
Eye drops, solution: 4 or 6 sachets containing 5 single-dose containers of 0.33 ml each.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
DOC Generici S.r.l. - Via Turati 40, 20121 Milan, Italy
Manufacturer
C.O.C. Farmaceutici S.r.l.
S. Agata Bolognese (BO)