Patient Information Leaflet: Important Information for the User

Ocusynt 50 micrograms/ml eye drops, solution, 50 micrograms/ml eye drops, solution in single-dose container

Latanoprost
Generic medicine
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, consult your doctor, the doctor treating your child, or your pharmacist.
This medicine has been prescribed for you only. Never give it to others: this medicine could be harmful to other people, even if their symptoms are the same as yours.
If you experience any side effect, including those not listed in this leaflet, consult your doctor, the doctor treating your child, or your pharmacist. See section 4.

Contents of this leaflet:

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

1. What Ocusynt is and what it is used for

Ocusynt contains the active substance Latanoprost, which belongs to a class of medicines known as prostaglandin analogues. Latanoprost works by increasing the natural outflow of fluid from inside the eye into the bloodstream.
Ocusynt is used in the treatment of conditions known as open-angle glaucoma and ocular hypertension in adults. Both of these conditions are associated with increased intraocular pressure, which may eventually impair vision.
Ocusynt is also used in the treatment of elevated intraocular pressure and glaucoma in children of all ages and in newborns.

2. What you need to know before using Ocusynt

Ocusynt can be used in adult women and men (including the elderly) and in children from birth up to 18 years of age. The use of Ocusynt in premature newborns (with a gestational age of less than 36 weeks) has not been investigated.
Do not use Ocusynt

if you are allergic (hypersensitive) to latanoprost or to any of the other ingredients of this medicine listed in section 6.

Warnings and precautions
Talk to your doctor or your child’s doctor or pharmacist before using Ocusynt or before giving this medicine to your child if you think that any of the following conditions apply to you or your child:

if you or your child are about to undergo or have recently undergone eye surgery (including cataract surgery)
if you or your child have eye problems (such as eye pain, irritation or inflammation, blurred vision)
if you or your child suffer from dry eyes;
if you or your child have severe asthma or if asthma is not well controlled;
if you or your child wear contact lenses. You may still use Ocusynt, following the instructions for contact lens wearers provided in section 3;
if you or your child have had or currently have a viral eye infection caused by the herpes simplex virus (HSV);
if you or your child have risk factors for eye inflammation such as iritis and uveitis, or for a condition called cystoid macular edema.

Other medicines and Ocusynt
Ocusynt may interact with other medicines. Inform your doctor, your child’s doctor or pharmacist if you or your child are using or have recently used any other medicines, including medicines (or eye drops) without a prescription. In particular, inform your doctor or pharmacist if you are taking prostaglandins, prostaglandin analogues, or prostaglandin derivatives.
If you use Ocusynt together with eye drops containing the active ingredient thiomersal, the two eye drops must be administered at least 5 minutes apart.
Pregnancy and breastfeeding
Do not use Ocusynt during pregnancy or while breastfeeding.
Inform your doctor immediately if you are pregnant, think you may be pregnant, or are planning a pregnancy.
Driving and using machines
When using Ocusynt, you may experience transient blurred vision. If this occurs, do not drive or operate machinery until your vision clears.
Ocusynt contains phosphate buffers
This medicine contains 9.34 mg/mL of phosphates, equivalent to 0.28 mg per dose.
If you have severe damage to the outermost transparent layer of the eye (the cornea), phosphates may very rarely cause cloudy spots on the cornea due to calcium accumulation during treatment.
Ocusynt 50 micrograms/mL eye drops, solution contains 0.2 mg/mL of benzalkonium chloride.
Benzalkonium chloride may be absorbed by soft contact lenses and may cause a change in their colour. Remove contact lenses before using this medicine and wait 15 minutes before reinserting them.
Benzalkonium chloride may also cause eye irritation, especially if you have dry eyes or corneal disorders (the outermost transparent layer of the eye). If you experience an abnormal sensation in the eye, burning, or pain after using this medicine, speak with your doctor.

3. How to use Ocusynt

Use Ocusynt exactly as your doctor or your child’s treating doctor has instructed you. If you have any doubts,
you should consult your doctor, your child’s treating doctor, or pharmacist.
The recommended dose for adults (including elderly patients) and children is one drop once daily in the eye(s) to be treated.
The optimal time for administration is in the evening.
Do not use Ocusynt more than once a day, as treatment efficacy may be reduced if the medicine is administered more frequently.
Use Ocusynt as directed by your doctor or your child’s treating doctor until the doctor tells you to stop treatment.
Contact lens wearers
If you or your child wears contact lenses, they must be removed before applying Ocusynt. After applying Ocusynt, wait 15 minutes before reinserting contact lenses.

Instructions for use

Instil one drop into the eye and press with a finger on the inner corner of the affected eye. Wait
one minute with eyes closed, continuing to apply pressure with the finger. This should be performed immediately
after instilling each single drop.
Repeat the procedure in the other eye, if your doctor has instructed you to do so.
The single-dose container must be used immediately after opening; any remaining medicinal product must
be discarded.
If you use Ocusynt with another eye drop
Wait at least 5 minutes between administration of Ocusynt and administration of another eye drop.
If you use more Ocusynt than you should
Putting too many drops into the eyes may cause mild irritation, tearing, and eye redness.
These effects should be temporary, but if you are concerned, contact your doctor or the doctor treating your
child for advice.
Contact your doctor as soon as possible if you or your child has accidentally ingested Ocusynt.
If you forget to use Ocusynt
Continue with your usual dose at the usual time. Do not use a double dose to make up for the missed dose. If you have any doubts, consult your doctor or pharmacist.
If you stop using Ocusynt
You should inform your doctor or the doctor treating your child if you intend to stop treatment with
Ocusynt.
If you have further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The following are known adverse events associated with the use of Ocusynt:

Very common (may affect more than 1 in 10 people):

Gradual change in eye colour due to increased brown pigment in the coloured part of the eye called the iris. This change is more likely if your eyes are of mixed colour (blue-brown, grey-brown, yellow-brown or green-brown) rather than uniform colour (blue, grey, green or brown). Any change in eye colour may occur after several years, although it generally appears within the first 8 months of treatment. The change in eye colour may be permanent and may be more noticeable if you use Ocusynt in only one eye. There appear to be no associated problems related to the change in eye colour. After stopping treatment with Ocusynt, no further change in eye colour has been observed.
Red eyes.
Eye irritation [burning sensation, sensation of sand in the eyes, itching, stinging (pinprick sensation), or foreign body sensation in the eyes]. If you experience irritation severe enough to cause excessive tearing or that leads you to discontinue the medicine, contact your doctor, pharmacist, or nurse immediately (within one week). Your therapy may need to be reviewed to ensure adequate treatment for your condition.
Gradual changes in the eyelashes of the treated eye and changes in the fine hair around the treated eye, observed mostly in people of Japanese origin. These changes include:

increased darkening, lengthening, thickening, and increased number of eyelashes or fine hairs, and growth of eyelashes in an abnormal direction.

Common (may affect less than 1 in 10 people):

Eye irritation or abrasion of the eye surface, inflammation of the eyelid margin (blepharitis), eye pain, light sensitivity (photophobia), conjunctivitis.

Uncommon (may affect up to 1 in 100 people):

Eyelid swelling, dry eyes, inflammation or irritation of the eye surface (keratitis), blurred vision, inflammation of the coloured part of the eye (uveitis), swelling of the retina (macular edema).
Skin rash.
Chest pain (angina), awareness of heartbeat (palpitations).
Asthma, shortness of breath (dyspnea).
Chest pain.
Headache, dizziness.
Muscle pain, joint pain.
Nausea, vomiting.

Rare (may affect up to 1 in 1,000 people):

Inflammation of the iris (iritis), symptoms related to swelling or abrasion/damage to the eye surface, swelling around the eyes (periorbital edema), altered eyelash direction or abnormal eyelash growth, scarring of the eye surface, fluid-filled area in the coloured part of the eye (iris cyst).
Skin reactions on the eyelids, darkening of the eyelid skin.
Worsening of asthma.
Intense skin itching.
Development of a viral eye infection caused by the herpes simplex virus (HSV).

Very rare (may affect up to 1 in 10,000 people):

Worsening of angina in patients already affected by heart disease, sunken appearance of the eye (hollowing of the eye socket).

Side effects observed more frequently in children than in adults include: runny and itchy nose, fever.

In very rare cases, some patients with severe damage to the transparent layer at the front of the eye (the cornea) have developed cloudy-shaped spots on the cornea 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 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 Ocusynt

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "Exp.".
The expiry date refers to the last day of that month.
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.

OCUSYNT 50 micrograms/ml eye drops, solution
Store in a refrigerator (2-8°C), in the original packaging to protect the medicine from light.
After first opening the bottle, store at a temperature not exceeding 25°C and the medicine must be used within 28 days; after this period, any remaining medicine must be discarded.
Record the date of first opening in the space provided on the carton.

Ocusynt 50 micrograms/ml eye drops, solution in single-dose container
Store in a refrigerator (2-8°C), in the original packaging to protect the medicine from light.
After first opening the aluminium pouch, store at a temperature not exceeding 25°C and for a maximum period of 7 days; after this period, any unused containers must be discarded.
The single-dose container must be used immediately after opening; any remaining medicine must be discarded.

6. Package contents and other information

What Ocusynt contains
The active substance is latanoprost. 1 ml of solution contains 50 micrograms of latanoprost.
The other components are:
Ocusynt in single-dose container
Sodium chloride, Monohydrate monosodium dihydrogen phosphate, Anhydrous disodium hydrogen phosphate, Water for injections.
Ocusynt in multidose bottle
Benzalkonium chloride, Sodium chloride, Monohydrate monosodium dihydrogen phosphate, Anhydrous disodium hydrogen phosphate, Water for injections.

Description of the appearance of Ocusynt and contents of the pack
Ocusynt in single-dose containers is available in packs of 30 containers of 0.2 ml each.
Ocusynt in multidose bottle is available in packs of 1 bottle of 2.5 ml.

Marketing Authorization Holder
Genetic S.p.A., Via Della Monica n. 26, 84083 Castel San Giorgio (SA)

Manufacturer
Genetic S.p.A. – Contrada Canfora – 84084 Fisciano (SA)

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