Latanoprost Zentiva

Package leaflet: Information for the patient

Latanoprost Zentiva 0.005% eye drops, solution

Please read all of this leaflet carefully before using this medicine (or administering it to the child you are caring for), 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 or for your child only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

The following sections apply to you or to the child you are caring for.
Contents of this leaflet:

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

1. What Latanoprost Zentiva eye drops is and what it is used for

Latanoprost belongs to a group of medicines called prostaglandin analogues.
Latanoprost Zentiva reduces intraocular pressure by increasing the natural outflow of fluid from inside the eye into the bloodstream.
Latanoprost Zentiva is used in the treatment of conditions known as open-angle glaucoma and ocular hypertension in adults. Both of these conditions are associated with elevated intraocular pressure, which may eventually impair vision.
Latanoprost Zentiva is also used to treat elevated intraocular pressure and glaucoma in children of all ages and in infants.

2. What you need to know before using Latanoprost Zentiva

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

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

Warnings and precautions
Talk to your doctor or pharmacist before using Latanoprost Zentiva if you or your child have or have previously had:

• eye surgery, such as cataract surgery, or are about to undergo eye surgery;
• eye problems (such as eye pain, irritation or inflammation, blurred vision);
• dry eye;
• severe asthma, or asthma that is not well controlled;
• a viral eye infection caused by the herpes simplex virus (HSV).
• if you or your child wears contact lenses, you may still use Latanoprost Zentiva by following the instructions for contact lens wearers provided in section 3.

Other medicines and Latanoprost Zentiva
Latanoprost Zentiva may interact with other medicines. Inform your doctor, the doctor treating your child, or your pharmacist if you or your child are using or have recently used any other medicines, including over-the-counter medicines (or eye drops).
In particular, inform your doctor or pharmacist if you know you are using prostaglandins, prostaglandin analogues, or prostaglandin derivatives.
Pregnancy and breastfeeding
Do not use Latanoprost Zentiva if you are pregnant or breastfeeding unless your doctor considers it necessary. If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Driving and using machines
When using Latanoprost Zentiva, you may experience blurred vision for a short period. If this occurs, do not drive or operate machinery until your vision is clear again.
Latanoprost Zentiva contains benzalkonium chloride and phosphate buffers.
This medicine contains 0.2 mg of benzalkonium chloride per millilitre.
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 (see section 3).
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 to your doctor.
This medicine contains 9.34 mg of phosphates per millilitre. If you have severe damage to the transparent outer layer of the eye (the cornea), phosphates may very rarely cause cloudy deposits on the cornea due to calcium accumulation during treatment.

3. How to use Latanoprost Zentiva

Use Latanoprost Zentiva exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist.
The recommended dose for adults (including elderly patients) and children is one drop of Latanoprost Zentiva instilled into the affected eye(s) once daily. The best time to use it is in the evening.

Instructions for use
Follow the steps described below to ensure correct use of Latanoprost Zentiva.

1. Wash your hands and sit or stand in a comfortable position.
2. Unscrew the outer protective cap.

3. Gently pull down the lower eyelid of the eye to be treated with your fingers.
4. Hold the dropper tip close to the eye, without touching it.
5. Gently squeeze the bottle so that one single drop enters the eye, then release the lower eyelid.

6. Press with one finger on the corner of the treated eye near the nose. Wait for 1 minute, keeping the eyes closed.
7. If your doctor has instructed you to do so, repeat the procedure in the other eye.
8. Replace the cap on the bottle to close it.

If you are using Latanoprost Zentiva with another eye drop
Wait at least 5 minutes between using Latanoprost Zentiva and applying any other eye drops.

Contact lens wearers
If you or your child wears contact lenses, remove them before applying Latanoprost Zentiva. Wait 15 minutes after applying Latanoprost Zentiva before reinserting contact lenses.

If you use more Latanoprost Zentiva than you should
If you have instilled too many drops into the eye, you may experience mild eye irritation, tearing, and redness. If this condition persists, or if you accidentally swallow Latanoprost Zentiva, consult your doctor as soon as possible.
Do not use Latanoprost Zentiva more than once a day, as the effectiveness of treatment may be reduced if administered more frequently.

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

If you stop using Latanoprost Zentiva
You should continue using Latanoprost Zentiva eye drops until your doctor tells you to stop. If you stop using this medicine, intraocular pressure may rise again.

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 have been observed with Latanoprost Zentiva.

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

• A gradual change in eye colour due to an increase in brown pigment in the coloured part of the eye known as the iris. If you have eyes with mixed colours (blue-brown, grey-brown, yellow-brown or green-brown), you are more likely to experience this colour change than if you have eyes of a single colour (blue, grey, green or brown). Any change in eye colour may take years to develop, although it is usually noticeable within 8 months of treatment. The colour change may be permanent and may be more noticeable if you use Latanoprost Zentiva in only one eye. There appear to be no problems associated with the change in eye colour. The change in eye colour does not continue after treatment with Latanoprost Zentiva has been stopped.
• Redness of the eye.
• Eye irritation (a burning sensation, feeling of grittiness, itching, stinging or sensation of a foreign body in the eye). If you experience eye irritation severe enough to cause excessive tearing or make you consider stopping treatment, contact your doctor, pharmacist or nurse promptly (within one week). Your treatment may need to be re-evaluated to ensure you continue to receive appropriate treatment for your condition.
• Gradual changes in the eyelashes of the treated eye and fine hairs around the treated eye, particularly noticeable in people of Japanese origin. These changes include increased pigmentation (darkening), length, thickness and number of eyelashes.

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

• Irritation or damage to the surface of the eye, inflammation of the eyelids (blepharitis), eye pain, sensitivity to light (photophobia), conjunctivitis.

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

• Swelling of the eyelid, dry eye, inflammation or irritation of the surface of the eye (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 of swelling or scratch/lesion on the surface of the eye, swelling around the eye (periorbital edema), misdirected eyelashes or an extra row of eyelashes, damaging the surface of the eye, fluid-filled area within the coloured part of the eye (iris cyst). Skin reactions on the eyelids, darkening of the skin of the eyelids.
• Worsening of asthma.
• Severe itching of the skin.
• 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 with underlying heart disease, sunken appearance of the eye (deepening of the eye socket).

Side effects observed more frequently in children than in adults are runny and itchy nose and fever.
In very rare cases, some patients with severe damage to the transparent layer at the front of the eye (the cornea) may develop cloudy spots on the cornea due to calcium deposits during treatment.

Reporting of side effects
If you experience any side effects, 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 Latanoprost Zentiva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton (EXP). The expiry date refers to the
last day of that month.
Store in a refrigerator (2°C - 8°C).
Keep the bottle in the original packaging to protect it from light.
After first opening of the bottle: do not store above 25°C and use within four weeks.
Do not use Latanoprost Zentiva if you notice that the bottle is damaged or if the eye drops appear different for any other reason.
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 Latanoprost Zentiva contains

• The active substance is latanoprost. 1 ml of eye drops solution contains 50 micrograms of latanoprost.
• The other components are: sodium chloride, benzalkonium chloride, monosodium phosphate monohydrate, disodium phosphate anhydrous, water for injections.

Description of the appearance of Latanoprost Zentiva and contents of the pack
5 ml low-density polyethylene dropper bottle with a tamper-evident 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 Authorisation Holder
Zentiva Italia S.r.l. Via P. Paleocapa 7, 20121 Milano, Italy

Manufacturer responsible for batch release
Zentiva k.s
U kabelovny 130,
102 37 Prague 10
Czech Republic

This medicinal product is authorised in the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
United Kingdom (Northern Ireland): Latanoprost 0.005% w/v eye drops solution
Italy: Latanoprost Zentiva 0.005% eye drops, solution