Label: Informationfor the patient

Xiop50 micrograms/ml eye drops in a single-dose solution

Latanoprost

Read this label carefully before starting to use this medication, as it contains important information for you

• Keep this label, as you may need to refer to it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only for you, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this label. See section 4.

1.What is Xiop and how is it used

2.What you need to know before starting to use Xiop

3.How to use Xiop

4.Possible adverse effects

5.Storage of Xiop

6.Contents of the package and additional information

Xiop contains latanoprost and belongs to a group of medicines known as prostaglandin analogs. It works by increasing the natural flow of fluid from the inside of the eye to the bloodstream.

Xiop is used to treat certain diseases known asopen-angle glaucoma and ocular hypertension. Both diseases are related to an increase in pressure within the eye, which can affect vision.

Xiop is also used to treat increased pressure within the eye and glaucoma in children and babies of all ages.

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 children (less than 36 weeks of gestation).

Do not use Xiop

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

Warnings and precautions

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

• If you or your child is about to undergo or has 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 has dry eyes.
• If you or your child has severe asthma or asthma that is not well controlled.
• If you or your child uses contact lenses. You may continue to use Xiop , but you must follow the instructions included in section 3 for contact lens users.
• If you have suffered or are suffering from a viral eye infection caused by the herpes simplex virus (HSV).

Other medications and Xiop

Inform your doctor, the doctor treating your child, or pharmacist if you or your child is using or has used recently or may need to use any other medication.

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Xiop should not be used during pregnancy or breastfeeding.

Driving and operating machinery

When using Xiop, blurred vision may appear for a short period of time. If this happens, do not drive or use tools or machines until your vision returns to normal again.

Follow exactly the administration instructions indicated by your doctor, by the doctor treating your child or by your pharmacist. Consult your doctor or pharmacist if you have doubts.

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

The single-dose container should be used immediately after opening; discard any remaining product that may be left.

Do not use Xiopmore than once a day, because the effectiveness of the treatment may decrease if administered more frequently.

Use Xiopas directed by your doctor or the doctor treating your child until they tell you to stop.

Users of contact lenses

If you or your child uses contact lenses, you must remove them before usingXiop. After applyingXiop, wait 15 minutes before putting the contact lenses back on.

Usage instructions:

1. Wash your hands and sit or stand comfortably.
2. Turn the cap of the single-dose container.
3. Using your finger, gently separate the lower eyelid of the affected eye.
4. Place the tip of the single-dose container near the eye, but not touching it.
5. Press the single-dose container gently so that only one drop falls into the eye and then release the lower eyelid.
6. Press the affected eye with your finger, near the nose. Apply pressure for 1 minute, keeping your eye closed.
7. Repeat the procedure in the other eye, if your doctor has instructed you to do so.
8. After using it, discard the single-dose container.

Using Xiop with other eye drops

Wait at least 5 minutes between applying Xiop and administering other eye drops.

Using more Xiopthan you should

If more drops have been applied to the eye than you should have, you may feel a slight irritation in the eye and also the eyes may become red and tearful. This situation should resolve, but if you are concerned, contact your doctor or the doctor treating your child for advice.

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

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

Missing a dose of Xiop

Continue with the administration of the next dose in the usual manner. Do not apply a double dose to compensate for the missed dose. If you have doubts, consult your doctor or pharmacist.

Stopping treatment with Xiop

You should talk to your doctor or the doctor treating your child if you want to stop using Xiop.

If you have any other doubts about the use of thismedication, ask your doctor, pharmacistor nurse.

Like all medications, this medication may cause side effects, although not everyone will experience 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-colored 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 may be noticeable within 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 appear to be associated with any problems. The change in eye color does not continue once treatment with Xiop has been discontinued.
• Eye redness.
• Ocular irritation (sensation of burning, sensation of sand in the eye, itching, stinging, or sensation of a foreign body in the eye). If you experience severe ocular irritation that causes excessive tearing or makes you consider interrupting treatment, consult your doctor, pharmacist, or nurse as soon as possible (within a week). You may require a review of your treatment 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, commonly observed in patients of Japanese origin. These changes include an increase in color (darkening), lengthening, thickening, and an increase in the number of eyelashes.

Common:may affect up to 1 in 10 patients

• Ocular irritation or alteration of the eye surface, inflammation of the eyelids (blepharitis), eye pain, and light sensitivity (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).
• Skin rash.
• Chest pain (angina), awareness of heart rhythm (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 damage to the eye surface, swelling around the eye (periorbital edema), eyelashes deviated or additional row of eyelashes, scars on the eye surface, area filled with fluid 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 with underlying heart problems, chest pain, appearance of sunken eyes (greater depth of the eyelid crease).

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

The side effects observedin children at a higher frequencythan in adults are runny nose, itching of the nose, and fever.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

• Keepthis medicationout of the sight and reach of children.
• Do not use this medication after the expiration date that appears on the label after CAD. The expiration date is the last day of the month indicated.
• Store in 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 through drains or in the trash. Dispose of containers and medications you no longer need at the Pharmacy Take-Back Pointof your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medications you no longer need. This way, you will help protect the environment.

Composition of Xiop

-The active ingredient is 50 micrograms/ml of latanoprost.

-The other components are: sodium dihydrogen phosphate monohydrate, anhydrous disodium phosphate, sodium chloride, water for injection preparations.

Appearance of the product and contents of the packaging

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

Xiop is available in boxes 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 introduced into the cardboard box.

Only some sizes of containers may be commercially marketed.

Holder of the marketing authorization

HORUS PHARMA

22, Allée Camille MUFFAT

Inedi 5,

06200 Nice

France

Responsible for manufacturing

Genetic S.p.A

Contrada Canfora

84084 Fisciano (SA) - ITALIA

You can requestmore information about this medication by contactingthe local representativeof the marketing authorization holder:

Horus Pharma Ibérica, S.L.U.

Gran Vía Carlos III, 98, 6th floor

08028 Barcelona - Spain

This medication is authorized in the member states of the European Economic Area with the following names:

Belgium: Xalof 50 microgram/ml eye drops, solution in a single-use packaging.

Luxembourg: Xalof 50 micrograms/ml eye drops, solution in a single-use container.

Netherlands: Xalof 0.05 mg/ml eye drops, solution in a single-use packaging.

Poland: Latanoprost Horus Pharma.

France: XIOP 50 micrograms/ml eye drops, solution in a single-use container.

Spain: Xiop 50 micrograms/ml eye drops, solution in a single-use container.

Date of the last review of this leaflet:11/2022.

Detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/