Xalatan

PACKAGE LEAFLET: INFORMATION FOR THE USER

XALATAN 50 micrograms/mL Eye Drops, Solution

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

Contents of this leaflet:

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

1. WHAT XALATAN IS AND WHAT IT IS USED FOR

Xalatan belongs to a class of medicines known as prostaglandin analogues. Xalatan works by increasing the natural outflow of fluid from inside the eye into the bloodstream.
Xalatan 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.
Xalatan 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 XALATAN

Xalatan 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 Xalatan in premature newborns (with a gestational age of less than 36 weeks) has not been investigated.
Do not use Xalatan

• 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, your child’s doctor, or pharmacist before using Xalatan 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 is about to undergo or has recently undergone eye surgery (including cataract surgery)
• If you or your child has eye problems (such as eye pain, irritation or inflammation, blurred vision)
• If you or your child suffers from dry eyes
• If you or your child has severe asthma or asthma that is not well controlled
• If you or your child wears contact lenses. You may still use Xalatan, following the instructions for contact lens wearers provided in section 3
• If you or your child has had or currently has a viral eye infection caused by herpes simplex virus (HSV). Other medicines and Xalatan Xalatan 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) obtained without a prescription. In particular, inform your doctor or pharmacist if you are taking prostaglandins, prostaglandin analogues, or prostaglandin derivatives.

Pregnancy and breastfeeding
You must not use Xalatan if you are pregnant or breastfeeding, unless your doctor considers it necessary. If you are pregnant or breastfeeding, if you think you may be pregnant, or if you are planning to have a baby, consult your doctor before using this medicine.
Driving and using machines
When using Xalatan, you may experience transient blurred vision. If this occurs, you must not drive or operate machinery until your vision is clear again.
Xalatan contains benzalkonium chloride and phosphate buffers
This medicine contains 0.2 mg/mL of benzalkonium chloride.
Benzalkonium chloride may be absorbed by soft contact lenses and may change the colour of contact lenses. You must remove your contact lenses before using this medicine and reinsert them 15 minutes after administration.
Benzalkonium chloride may also cause eye irritation, particularly if you have dry eyes or corneal disorders (the clear layer at the front of the eye). If you experience abnormal eye sensitivity, burning, or eye pain after using this medicine, contact your doctor.
This medicine contains 6.3 mg/mL of phosphates, equivalent to 0.2 mg/drop.
If you have severe damage to the transparent layer at the front of the eye (the cornea), phosphates may, in very rare cases, cause cloudy spots on the cornea due to calcium accumulation during treatment.

3. HOW TO USE XALATAN

Use XALATAN exactly as prescribed by your doctor or the doctor treating your child. If you have any doubts, consult your doctor, the doctor treating your child, or your pharmacist.
The recommended dose in adults (including elderly patients) and children is one drop once daily in the affected eye(s). The optimal time for administration is in the evening.
Do not use XALATAN more than once a day, as the effectiveness of treatment may be reduced if the medicine is administered more frequently.
Continue using XALATAN as directed 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 XALATAN. After applying XALATAN, wait 15 minutes before reinserting the contact lenses.

Instructions for use

1. Wash your hands and sit or stand in a comfortable position.
2. Remove the outer cap by gently twisting it off (the outer cap may be discarded).

3. Unscrew the inner protective cap. Keep the protective cap for later use.

4. Gently pull down the lower eyelid of the eye to be treated with one finger.
5. Hold the dropper tip close to the eye without touching it.
6. Gently squeeze the bottle so that a single drop goes into the eye, then release the lower eyelid.
7. Press with one finger on the inner corner of the treated eye. Keep eyes closed for one minute.
8. Repeat the procedure in the other eye, if your doctor has instructed you to do so.
9. Close the bottle with the inner protective cap.

If you use XALATAN with another eye drop
Wait at least 5 minutes between administering XALATAN and any other eye drop.

If you use more XALATAN than you should
Applying too many drops into the eyes may cause mild eye irritation, tearing, and eye redness. These effects should be temporary. However, 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 swallowed XALATAN.

If you forget to use XALATAN
Continue using the usual dose at the regular time. Do not use a double dose to make up for a forgotten dose. If you have any doubts, consult your doctor or pharmacist.

If you stop using XALATAN
Inform your doctor or the doctor treating your child if you intend to discontinue treatment with XALATAN.

If you have further questions about the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE EFFECTS

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

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 colour change may be permanent and may be more noticeable if you use Xalatan in only one eye. There appear to be no associated problems related to the change in eye colour. After stopping treatment with Xalatan, no further change in eye colour has been observed.
• Red eyes.
• Eye irritation [burning sensation, gritty sensation, 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). You may require an adjustment of your therapy to ensure adequate treatment of your condition.
• Gradual changes in the eyelashes of the treated eye and changes in the surrounding periocular hair, mostly observed in people of Japanese origin. These changes include increased darkening, lengthening, thickening, and increased number of eyelashes.

Common (may affect less than 1 in 10 people):
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 of the eye surface, swelling around the eyes (periorbital edema), misdirected eyelashes 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 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 (enophthalmos).

The adverse effects observed more frequently in children than in adults have been: 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) developed cloudy spots on the cornea due to calcium deposits during treatment.

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

5. HOW TO STORE XALATAN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the outer carton and on the bottle. The expiry date refers to the last day of the month.
Before opening, store the bottle at room temperature (do not store above 25°C), protected from light.
After first opening, store the bottle at room temperature (do not store above 25°C) and use within 4 weeks of opening. When not using Xalatan, keep the bottle in the outer carton to protect it from light.
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. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What Xalatan contains
The active substance is latanoprost 50 micrograms/mL.
The excipients are: benzalkonium chloride, sodium chloride, monobasic monohydrate sodium phosphate (E339i)
and anhydrous dibasic sodium phosphate (E339ii), dissolved in water for injections.

Description of the appearance of Xalatan and contents of the package
Xalatan Eye Drops, Solution is a clear, colourless liquid.
Xalatan is available in pack sizes of 1, 3 and 6 bottles. Not all pack sizes may be marketed.
Each bottle contains 2.5 mL of Xalatan Eye Drops, Solution.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Viatris Pharma S.r.l.
Via Vittor Pisani 20
20124 Milano
Italy

Manufacturer
Pfizer Manufacturing Belgium NV
Rijksweg 12, 2870 Puurs
Belgium

This leaflet was last updated on:
This medicinal product is authorised in the European Economic Area Member States under
the following names:
Xalatan: Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Ireland, Italy,
Luxembourg, Netherlands, Portugal, United Kingdom, Spain.