PATIENT INFORMATION LEAFLET

Droplatan 50 micrograms/ml eye drops, solution

Latanoprost
Generic medicine
Please read all of this leaflet carefully before you start 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, the doctor treating your child, or your pharmacist.
This medicine has been prescribed for you or your child only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you or your child experience any side effects, including those not listed in this leaflet, inform your doctor, the doctor treating your child, or your pharmacist. See section 4.

Contents of this leaflet:

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

1. What Droplatan is and what it is used for

Droplatan reduces intraocular pressure by increasing the natural outflow of fluid from inside the eye into the bloodstream. It belongs to a group of medicines called prostaglandin analogues.
Droplatan is used in the treatment of open-angle glaucoma and ocular hypertension in adults.
These conditions are caused by elevated intraocular pressure. If not adequately treated, they may affect vision.
Droplatan is also used in the treatment of elevated intraocular pressure and glaucoma in children of all ages and in infants.

2. What you should know before using Droplatan

Droplatan 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 Droplatan in premature neonates (with gestational age less than 36 weeks) has not been investigated.
Do not use Droplatan

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

Warnings and precautions
Talk to your doctor or the doctor treating your child before using Droplatan or before giving this medicine to your child if you think any of the following conditions apply to you or your child:
If you or your child have severe asthma, or poorly controlled asthma.
If you or your child have had eye surgery, such as cataract surgery, or are about to undergo eye surgery.
If you or your child have injuries in the area surrounding the eye lens.
If you or your child have any medical condition that may affect vision (such as diabetes).
If you or your child have swelling in the back part of the eye (a condition known as macular edema) or any other eye inflammation.
If you or your child suffer from dry eye.
If you or your child wear contact lenses. You may still use Droplatan, following the instructions for contact lens wearers provided in section 3.
If you have had or currently have a viral eye infection caused by herpes simplex virus (HSV).
Droplatan is used in open-angle glaucoma and ocular hypertension. Inform your doctor if you have another type of glaucoma. Droplatan may permanently change the colour of the eye. This may also affect the eyelashes and the skin around the eyes (see section 4).
Talk to your doctor or pharmacist before using Droplatan.
Other medicines and Droplatan
Inform your doctor, the doctor treating your child, or your pharmacist if you or your child are taking, have recently taken, or might take any other medicines.
Droplatan may interact with other medicines taken at the same time.
Do not use Droplatan with any other medicine containing prostaglandins, as intraocular pressure may increase.
Pregnancy, breastfeeding and fertility
Droplatan must not be used during pregnancy.
Droplatan may pass into breast milk and must not be used during breastfeeding.
If you are pregnant, think you might be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Driving and using machines
Like other eye drops, if blurred vision occurs after the first instillation, wait until symptoms resolve before driving or operating machinery.
Droplatan contains benzalkonium chloride
This medicine contains 5.26 micrograms of benzalkonium chloride per drop, equivalent to 0.2 mg/ml.
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 eye or corneal disorders (the transparent outer layer of the eye). If you experience an unusual sensation, burning, or pain in the eye after using this medicine, speak with your doctor.
Droplatan contains phosphate
This medicine contains 0.167 mg of phosphate per drop, equivalent to 6.34 mg/ml.
If you have severe damage to the outer transparent layer of the eye (the cornea), phosphates may very rarely cause cloudy spots on the cornea due to calcium accumulation during treatment.

3. How to use Droplatan

Use this medicine exactly as directed by your doctor or the doctor treating your child. If you have any doubts, consult your doctor, the doctor treating your child, or pharmacist.
The recommended dose for adults, including elderly patients, is one drop of Droplatan in the affected eye(s) once daily. The best time to use it is in the evening.
Do not use Droplatan more than once a day, as the effectiveness of treatment may be reduced if the medicine is administered more frequently.
Use Droplatan as instructed by your doctor or the doctor treating your child until your doctor tells you to stop treatment.

Contact lens wearers
If you or your child wears contact lenses, remove them before applying Droplatan. After applying Droplatan, wait 15 minutes before reinserting the contact lenses.

Use with other eye drops:
If you need to use other eye drops, wait at least five minutes before using them.

How to use Droplatan
Follow the steps below to ensure correct use of Droplatan:

Wash your hands and sit or stand comfortably.
Unscrew the outer protective cap.
Gently pull down the lower eyelid of the affected eye with your fingers.
Hold the dropper tip near the eye, without touching it.
Gently squeeze the bottle so that one single drop enters the eye, then release the lower eyelid.
Press gently with one finger on the inner corner of the affected eye, near the nose. Wait for 1 minute, keeping the eyes closed.
If your doctor has instructed you to do so, repeat the same procedure for the other eye.
Close the bottle tightly.

If you use more Droplatan than you should
If you have instilled too many drops into the eye, you may experience mild eye irritation or redness of the eye area. If this condition persists, or if Droplatan is accidentally swallowed, consult your doctor or the doctor treating your child as soon as possible.

If you forget to use Droplatan
If you forget to apply the drops at the usual time, do not instill a double dose to make up for the missed dose. Instead, wait until the next scheduled dose and then use the normal dose.

If you stop using Droplatan
You must continue using Droplatan eye drops until your doctor or the doctor treating your child tells you to stop. If you stop using this medicine, intraocular pressure may rise again.

If you have any 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 everybody will experience them.
The following are known adverse events associated with the use of Droplatan:

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

Gradual change in eye colour due to increased amount of brown pigment in the coloured part of the eye called the iris. This change is more likely if your eyes have a mixed colour (blue-brown, grey-brown, yellow-brown or green-brown) rather than a 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 colour change may be permanent and may be more noticeable if you use Droplatan in only one eye. There appear to be no associated problems with the change in eye colour. After stopping treatment with Droplatan, no further change in eye colour has been observed.
Red eyes.
Eye irritation [burning sensation, gritty feeling, 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 of your condition.
Gradual change in the eyelashes of the treated eye and changes in the fine hair around the treated eye, mostly observed in people of Japanese origin. These changes include darkening, lengthening, thickening and increased number of eyelashes.

Common: (may affect up to 1 in 10 people)

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

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

Swelling of the eyelids, 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).
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 of the ocular surface, swelling around the eyes (periorbital edema), altered eyelash orientation or abnormal eyelash growth, corneal scarring, fluid-filled area in the coloured part of the eye (iris cysts).
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 (chest pain), sunken appearance of the eye (enophthalmos).

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

If you have severe damage to the outermost transparent layer of the eye (the cornea), phosphates may very rarely cause opaque 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.

Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Droplatan

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the vial after "Exp.".
The expiry date refers to the last day of that month.
Store in a refrigerator (2°C - 8°C).
Keep in the original packaging to protect the medicine from light.
After first opening the vial: do not store above 25°C and use within four weeks.
Do not dispose of medicines 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 Droplatan contains
The active substance is latanoprost 50 micrograms per ml.
The other components are: sodium chloride, benzalkonium chloride, monobasic monohydrate sodium phosphate, anhydrous disodium phosphate, water for injections.

Description of the appearance of Droplatan and contents of the pack
Dropper bottle made of polyethylene, 5 ml capacity, with transparent polyethylene screw cap.
Each bottle contains 2.5 ml of eye drops solution, corresponding to approximately 80 drops of solution.
Pack sizes: 1 x 2.5 ml
3 x 2.5 ml
6 x 2.5 ml
It is possible that not all pack sizes are marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
OmniVision Italia S.r.l.
Via Montefeltro, 6
20156 Milan, Italy

Manufacturer
Tubilux Pharma Spa
Via Costarica 20/22
00071 Pomezia (Rome), Italy