Xaloptic free

Package leaflet: Information for the patient

Xaloptic Free, 50 micrograms/ml, eye drops, solution in single-dose container
Latanoprost
Please read all of 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 further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific person, adult or child. Do not pass it on to others. It may harm them even if their symptoms are the same as yours.
• If you get any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

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

1. What Xaloptic Free is and what it is used for

Xaloptic Free contains latanoprost and belongs to a group of medicines called prostaglandin analogues. It works by increasing the natural outflow of fluid from inside the eye into the bloodstream.
Xaloptic Free is indicated in adults for the treatment of one type of glaucoma called open-angle glaucoma and for the treatment of elevated intraocular pressure. These conditions are associated with increased intraocular pressure and may consequently affect vision.
Xaloptic Free may also be used in children of any age for the treatment of elevated intraocular pressure and glaucoma.

2. Important information before using Xaloptic Free

Xaloptic Free can be used in adult men and women (including elderly patients) and in children from birth up to 18 years of age. It has not been studied in preterm newborns (born before completing 36 weeks of gestation).

When not to use Xaloptic Free

• if the patient is allergic to latanoprost or any of the other ingredients of this medicine (listed in section 6),
• if the patient is pregnant or planning to become pregnant,
• if the patient is breastfeeding.

Warnings and precautions

Before starting treatment with Xaloptic Free, discuss with the doctor treating the adult or child, pharmacist, or nurse:

• if the adult or child has undergone eye surgery (including cataract surgery), or if such surgery is planned,
• if the adult or child has an eye disease (such as eye pain, ocular surface irritation or inflammation, blurred vision),
• if the adult or child has dry eye,
• if the adult or child has severe or uncontrolled asthma,
• if the adult or child wears contact lenses. To continue using Xaloptic Free, follow the instructions regarding contact lens use (see section 3).
• if the patient has had or currently has a viral eye infection caused by herpes simplex virus (HSV).

Xaloptic Free and other medicines

Tell the doctor or pharmacist of the adult or child about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use. Xaloptic Free may interact with other medicines; therefore, concomitant use of two or more prostaglandins, prostaglandin analogues, or prostaglandin derivatives is not recommended.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine. Xaloptic Free must not be used in pregnant women or in women who are breastfeeding.

Driving and operating machinery

During treatment with Xaloptic Free, blurred vision may occur, which is a transient symptom. In such cases, patients should not drive or use any tools or machinery until normal visual acuity returns.

Xaloptic Free contains phosphates

The medicine contains 6.3 mg of phosphates per millilitre. In patients with severe damage to the transparent front part of the eye (cornea), phosphates may very rarely cause corneal calcification and clouding during treatment due to calcium deposition.

3. How to use Xaloptic Free

This medicine should always be used exactly as prescribed by the doctor treating the adult or
child, or as recommended by a pharmacist. If in doubt, consult the treating doctor or
pharmacist.
The recommended dose for adults (including elderly patients) and children is one drop once daily
in the affected eye(s). Xaloptic Free is best administered in the evening.
The contents of a single-dose container should be used immediately after opening; any remaining
medicine must be discarded.
Do not use Xaloptic Free more than once daily, as more frequent administration may reduce the
effectiveness of treatment.
Continue using Xaloptic Free as directed by the treating doctor until instructed otherwise.

Contact lenses:
Before administering Xaloptic Free to the eye of an adult or child, remove contact lenses. Contact
lenses may be reinserted 15 minutes after using Xaloptic Free.

Instructions for use:
Follow these steps carefully to ensure proper administration of Xaloptic Free:

1. Wash your hands, then sit or stand comfortably.
2. Twist and remove the closure tip from the single-dose container.
3. Gently pull down the lower eyelid of the affected eye with a finger.
4. Bring the tip of the single-dose container as close to the eye as possible without touching it.
5. Gently squeeze the single-dose container so that only one drop enters the eye, then release the lower eyelid.
6. Press with a finger on the inner corner of the eye (near the nose). Maintain this pressure for one minute without opening the eye.
7. Repeat these steps for the other eye if treatment has been prescribed by the doctor.
8. Discard the single-dose container immediately after use.

Using Xaloptic Free with other eye drops
Wait at least 5 minutes between using Xaloptic Free and applying any other eye drops.

Accidental overdose of Xaloptic Free
If more drops than recommended are administered, mild eye irritation with redness and tearing may
occur. In case of doubt, consult the treating doctor.
If Xaloptic Free is accidentally swallowed by an adult or child, contact a doctor as soon as possible.

Missed dose of Xaloptic Free
Continue with the usual dosing schedule at the prescribed times. Do not use a double dose to make
up for a missed dose. If in doubt, consult the doctor or pharmacist.

Stopping Xaloptic Free treatment
If you intend to discontinue using Xaloptic Free, consult the treating doctor.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The following adverse effects are known after the use of latanoprost:
Very common (may affect more than 1 in 10 patients):

• Gradual change in eye colour due to increased amount of brown pigment in the coloured part of the eye called the iris. If a patient has mixed-colour eyes (i.e. blue-brown, grey-brown, yellow-brown, green-brown), these changes are more likely to occur than if the patient has eyes of a single colour (blue, grey, green or brown). Changes in eye colour may occur after several years of treatment,
  but most commonly occur within the first 8 months of treatment. The colour change may be
  long-lasting and more noticeable when Xaloptic Free is used in only one eye. Changes in eye colour
  are not associated with any pathological changes. Changes in eye colour do not progress after discontinuation of Xaloptic Free.

• Eye redness.

• Eye irritation (including burning sensation, feeling of sand in the eyes, itching, stinging or sensation of a foreign body in the eye). If eye irritation occurs to such a degree that it causes excessive tearing or desire to discontinue the medicine, medical advice should be sought immediately (within one week) from a doctor, pharmacist or nurse. Re-evaluation of treatment may be necessary to ensure appropriate management for the patient.

• Gradual changes in the appearance of eyelashes of the treated eye and mild eyelid hair growth around it, observed predominantly in individuals of Japanese origin. These changes include darkening, lengthening, thickening and increased number of eyelashes.

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

• Eye surface irritation or defects, eyelid inflammation, eye pain, light sensitivity (photophobia), conjunctivitis.

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

• Eyelid swelling, dry eyes, inflammation or irritation of the eye surface (keratitis), blurred vision, inflammation of the coloured part of the eye (uveitis), retinal swelling (macular oedema).
• Skin rash.
• Chest pain (angina), sensation of rapid or irregular heartbeat (palpitations).
• Asthma, shortness of breath (dyspnoea).
• Chest pain.
• Headache, dizziness.
• Muscle pain, joint pain.
• Nausea, vomiting.

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

• Iritis, symptoms of swelling or abrasion/damage to the eye surface, periorbital oedema; change in the direction of eyelash growth or development of a double row of eyelashes, scarring on the eye surface, formation of fluid-filled cysts (iris cysts) in the coloured part of the eye.
• Local skin reactions on the eyelids, darkening of eyelid skin.
• Worsening of asthma.
• Acute skin itching.
• Viral eye infections caused by herpes simplex virus (HSV).

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

• Worsening of angina symptoms in patients with heart disease, appearance of sunken eyes (deepening of the eyelid groove).

In very rare cases, in some patients with severe damage to the external, transparent layer of the eyeball (cornea), corneal opacities caused by calcium deposits have appeared during treatment.
Adverse effects occurring more frequently in children and adolescents than in adults include colds and fever.
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Xaloptic Free

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
The marking on the packaging following the abbreviation EXP indicates the expiry date, and following the abbreviation LOT/L indicates the batch number.
Store in a refrigerator (2°C - 8°C).
After first opening the sachet: Store at a temperature not exceeding 25°C for up to 7 days.
The contents of the single-dose container must be used immediately after opening. The single-dose container should be discarded after use.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such measures help protect the environment.

6. Contents of the pack and other information

What Xaloptic Free contains

• The active substance is 50 micrograms/ml of latanoprost.
• The other ingredients are: monohydrate sodium dihydrogen phosphate, anhydrous disodium phosphate, sodium chloride, water for injections.

What Xaloptic Free looks like and contents of the pack
Xaloptic Free is a clear, colourless, sterile eye drop solution in single-dose containers. Each single-dose container contains 0.2 ml of eye drops.
Xaloptic Free is available in packs containing 15, 30, 45, 60, 90 or 120 single-dose containers of 0.2 ml.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. +48 22 364 61 01
Manufacturer
Genetic S.p.A.
Contrada Canfora
84084 Fisciano (SA)
Italy