Patient information leaflet

Solprene eye drops, solution

Prednisolone, Neomycin
Please read this 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, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, consult your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

What Solprene is and what it is used for
What you need to know before using Solprene
How to use Solprene
Possible side effects
How to store Solprene
Contents of the pack and other information

1. What Solprene is and what it is used for

Solprene is an ophthalmic medicine containing a combination of two active substances. Prednisolone is a substance that acts against inflammation, while neomycin has antimicrobial activity.
This medicine is indicated for inflammatory and allergic disorders of the anterior segment of the eye, when there is a microbial component.

2. What you need to know before using Solprene

Do not use Solprene

if you are allergic to prednisolone or neomycin, or to any of the other ingredients of this medicine (listed in section 6);
if you have elevated pressure inside the eye (ocular hypertension);
if you have a viral eye infection such as acute Herpes simplex (another virus-induced eye disease), unless you are being treated with specific antiviral medications;
if you have inflammation of the conjunctiva (the transparent membrane covering the eye and inner eyelid surface) and cornea (a part of the eye) with lesions (conjunctivitis with ulcerative keratitis), even in the early stage (positive fluorescein test);
if you have tuberculosis of the eye (a severe eye inflammation);
if you have a fungal infection of the eye (fungal keratitis);
if you have an eye inflammation with pus formation (acute purulent ophthalmia);
if you have inflammation of the transparent membrane covering the inner eyelid surface with pus formation (purulent conjunctivitis);
if you have purulent or herpetic blepharitis (inflammation of the eyelids with pus formation caused by the Herpes simplex virus);
if you have a stye (inflammation of the sebaceous glands of the eyelashes, resembling a boil).

Warnings and precautions
Talk to your doctor or pharmacist before using Solprene.
Exercise particular caution with Solprene:

if you need to use this medicine for a prolonged period. Prolonged use of Solprene may lead to undesirable effects. Continuous use for more than one month is not recommended. If prolonged use cannot be avoided, frequent monitoring of intraocular pressure is advisable. Additionally, prolonged use of the medicine may promote the growth of drug-resistant bacteria, including fungi, potentially leading to further infections.
if you develop a new infection during treatment (e.g., fungal infection), or signs of irritation or hypersensitivity to the medicine; in such cases, discontinue use of Solprene and consult your doctor for appropriate therapy.
if you suffer from a condition causing thinning of the cornea or sclera (the membranes covering the eye), as the use of medicines such as Solprene administered via the ocular route may lead to perforation of these membranes.
if you have viral infections of the cornea (viral herpetic keratitis), since the use of this medicine is not recommended in such cases (see “Do not use Solprene”). If your doctor considers treatment with Solprene strictly necessary, it may be permitted only under close supervision by an ophthalmologist.
Contact your doctor if you experience blurred vision or other visual disturbances.

Other medicines and Solprene
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines.
No interactions with other medicines are known.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.
During pregnancy, use Solprene only when strictly necessary and under direct medical supervision.

Driving and using machines
No effects on the ability to drive or operate machinery have been observed.

Solprene eye drops contain phosphate buffer
This medicine contains: 0.3684 mg of phosphate buffer per drop, equivalent to 7.37 mg/ml, with a theoretical drop volume of approximately 50 µL.
If you have severe damage to the outermost transparent layer of the eye (the cornea), phosphates may very rarely cause cloudy corneal deposits due to calcium accumulation during treatment.

3. How to use Solprene

Use this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is: one drop in the conjunctival sac 4 to 6 times a day, or more frequently, as prescribed by the doctor.
If you use more Solprene than you should
If you accidentally ingest or take an excessive dose of Solprene, inform your doctor immediately or go to the nearest hospital.
If you forget to use Solprene
Do not apply a double dose to make up for the missed application.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
The following side effects may occur with Solprene:

local irritation (transient)
stinging and burning sensation (occasionally)
blurred vision (frequency not known)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Solprene

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after “Exp.”
The expiry date refers to the last day of that month.
Do not use the medicine more than 30 days after first opening the container.
Store below 25°C.
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 Solprene contains

The active substances are sodium prednisolone phosphate and neomycin sulfate. 1 ml contains 5.5 mg of sodium prednisolone phosphate and neomycin sulfate (equivalent to 3.5 mg of neomycin).
The other components are: disodium hydrogen phosphate, sodium dihydrogen phosphate, sodium hyaluronate, sodium citrate, sodium metabisulfite, 2-phenylethanol, polyethylene glycol 4000, water for injections.

Description of the appearance of Solprene and contents of the pack
Solprene is an eye drop solution.
5 ml dropper bottle.
Marketing Authorization Holder
Farmigea S.p.A., Via G. B. Oliva 6/8, 56121 - Pisa
Manufacturer
Farmigea S.p.A., Via G. B. Oliva 8, 56121 - Pisa