XIOP 50 micrograms/ml eye drops in single-dose containers

2. What you need to know before you start using Xiop

Xiop can be used in adult men and women (including elderly patients) and in children from birth to 18 years of age. It has not been investigated in premature infants (less than 36 weeks of gestation).

Do not use Xiop

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

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting to use Xiop:

• If you or your child is going to have or has had 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 has dry eyes.
• If you or your child has severe asthma or uncontrolled asthma.
• If you or your child uses contact lenses. You can continue to use Xiop, but you must follow the instructions for contact lens users included in section 3.
• If you or your child has had a viral infection of the eye caused by the herpes simplex virus (HSV).

Other medicines and Xiop

Tell your doctor, your child's doctor, or pharmacist if you or your child is using or has recently used or might use any other medicines.

Xiop may interact with other medicines. Therefore, it is not recommended to use two or more prostaglandins, prostaglandin analogues, or prostaglandin derivatives.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Xiop should not be used during pregnancy or breastfeeding.

Driving and using machines

When using Xiop, you may experience blurred vision for a short period of time. If this happens, do not driveor use tools or machines until your vision is clear again.

3. How to use Xiop

Follow the instructions for administration given by your doctor, your child's doctor, or pharmacist. Ask your doctor or pharmacist if you have any questions.

The recommended dose for adults (including elderly patients) and children is one drop once a day in the affected eye(s). The best time to instill the product is at night.

The single-dose container should be used immediately after opening; any remaining product should be discarded.

Do not use Xiop more than once a day, as the effectiveness of the treatment may decrease if it is administered more frequently.

Use Xiop as your doctor or your child's doctor has told you until they tell you to stop.

Contact lens users

If you or your child uses contact lenses, you must remove them before using Xiop. After applying Xiop, you must wait 15 minutes before putting the contact lenses back in.

Instructions for use:

1. Wash your hands and sit or stand comfortably.
2. Twist the cap of the single-dose container.
3. Gently separate the lower eyelid of the affected eye with your finger.
4. Place the tip of the single-dose container close to the eye, without touching it.
5. Gently press the single-dose container so that only one drop falls into the eye, then release the lower eyelid.
6. Press the finger on the edge of the affected eye, near the nose. Apply pressure for 1 minute, keeping the eye closed.
7. Repeat the operation in the other eye, if your doctor has told you to do so.
8. After use, discard the single-dose container.

If you use Xiop with other eye drops

Wait at least 5 minutes between the application of Xiop and the administration of other eye drops.

If you use more Xiop than you should

If you have applied more drops in the eye than you should, you may feel a slight irritation in the eye and your eyes may become red and watery. This situation should disappear, but if you are concerned, contact your doctor or your child's doctor for advice.

In case of accidental ingestion by you or your child, contact your doctor as soon as possible.

In case of overdose or accidental ingestion, contact your doctor or pharmacist or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to use Xiop

Continue with the administration of the next dose as usual. Do not apply a double dose to make up for the forgotten dose. If you have any doubts, consult your doctor or pharmacist.

If you stop using Xiop

You should talk to your doctor or your child's doctor if you want to stop using Xiop.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects have been observed with the use of latanoprost:

Very common:may affect more than 1 in 10 patients

• Gradual change in eye color due to an increase in the amount of brown pigment in the colored part of the eye known as the iris. If you have mixed-color eyes (blue-brown, gray-brown, yellow-brown, or green-brown), you are more likely to experience this change than if your eyes are a single color (blue, gray, green, or brown). The change in eye color takes years to develop, although it can usually be seen after 8 months of treatment. The change in eye color may be permanent and may be more noticeable if Xiop is used in only one eye. The change in eye color does not seem to be associated with any problems. The change in eye color does not continue once treatment with Xiop has been stopped.
• Redness of the eye.
• Ocular irritation (burning sensation, feeling of grit in the eye, itching, stinging, or foreign body sensation in the eye). If you experience severe ocular irritation that makes your eyes water excessively, or makes you consider stopping treatment, consult your doctor, pharmacist, or nurse as soon as possible (within a week). You may need to have your treatment reviewed to ensure you are receiving the appropriate treatment for your condition.
• Gradual change in the eyelashes of the treated eye and the fine hair around the treated eye, usually observed in patients of Japanese origin. These changes include an increase in color (darkening), length, thickness, and number of eyelashes.

Common:may affect up to 1 in 10 patients

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

Uncommon:may affect up to 1 in 100 patients

• Swelling of the eyelids, dry eye, inflammation or irritation of the eye surface (keratitis), blurred vision, inflammation of the colored part of the eye (uveitis), swelling of the retina (macular edema).
• Rash.
• Chest pain (angina), awareness of heartbeat (palpitations).
• Asthma, difficulty breathing (dyspnea).
• Chest pain.
• Headache, dizziness.
• Muscle pain, joint pain.
• Nausea.
• Vomiting.

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

• Inflammation of the iris (iritis), symptoms of swelling or injury/damage to the eye surface, swelling around the eye (periorbital edema), misdirected eyelashes or extra row of eyelashes, scarring on the eye surface, fluid-filled area within the colored part of the eye (iris cyst).
• Reactions on the skin of the eyelids, darkening of the skin of the eyelids.
• Worsening of asthma.
• Severe itching of the skin.
• Development of a viral infection in the eye caused by the herpes simplex virus (HSV).

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

• Worsening of angina in patients who also have heart problems, chest pain, appearance of sunken eyes (greater depth of the eyelid sulcus).

In very rare cases, some patients with severe damage to the front transparent part of the eye (cornea) have developed cloudy areas in the cornea due to calcium deposits produced during treatment.

The side effects observed in children at a higher frequency than in adults are runny nose, itching of the nose, and fever.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly through the Spanish Medicines Information System: https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Xiop

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the label after EXP. The expiry date is the last day of the month shown.
• Store in a refrigerator (between 2°C and 8°C). Once the bag is opened: store below 25°C for a maximum of 7 days.
• Medicines should not be disposed of via wastewater or household waste. Place the containers and medicines you no longer need in the SIGRE collection point at the pharmacy. If you have any doubts, ask your pharmacist how to dispose of the containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and further information

Composition of Xiop

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

Appearance of the product and contents of the pack

Xiop is a clear, colorless sterile solution presented in single-dose containers. Each single-dose container contains 0.2 ml of eye drops solution.

Xiop is available in packs of 15, 30, 45, 60, 90, and 120 single-dose containers of 0.2 ml.

A bag contains 5 single-dose containers. The bag is inserted into the carton box.

Not all pack sizes may be marketed.

Marketing authorization holder

HORUS PHARMA

22, Allée Camille MUFFAT

Inedi 5,

06200 Nice

France

Manufacturer

Genetic S.p.A

Contrada Canfora

84084 Fisciano (SA) - ITALY

You can request more information about this medicine by contacting the local representativeof the marketing authorization holder:

Horus Pharma Ibérica, S.L.U.

Gran Vía Carlos III, 98, 6º

08028 Barcelona - Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Belgium: Xalof 50 microgram/ml oogdruppels, oplossing in verpakking voor eenmalig gebruik.

Luxembourg: Xalof 50 microgrammes/ml collyre en solution en récipient unidose.

Netherlands: Xalof 0,05 mg/ml oogdruppels, oplossing in verpakking voor éénmalig gebruik.

Poland: Latanoprost Horus Pharma.

France: XIOP 50 microgrammes/ml collyre en solution en récipient unidose.

Spain: Xiop 50 microgramos/ml colirio en solución en envase unidosis.

Date of last revision of this package leaflet:11/2022.

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/