Xiop 50 micrograms/ml eye drops solution in single-dose container

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Xiop 50 micrograms/ml eye drops solution in single-dose container

Latanoprost

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you

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

Leaflet contents

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

1. What Xiop is and what it is used for

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

Xiop is used to treat conditions known as open-angle glaucoma and ocular hypertension. Both conditions are associated with increased pressure inside the eye, which may eventually affect vision.

Xiop is also used to treat elevated intraocular pressure and glaucoma in children and infants of all ages.

2. What you need to know before using Xiop

Xiop 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 premature infants (less than 36 weeks gestation).

Do not use Xiop

• 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, pharmacist, or nurse before using Xiop:

• If you or your child are scheduled for or have undergone eye surgery (including cataract surgery).
• If you or your child have eye problems (such as eye pain, irritation or inflammation, blurred vision).
• If you or your child have dry eyes.
• If you or your child have severe asthma or asthma that is not well controlled.
• If you or your child wear contact lenses. You may continue using Xiop, but you must follow the instructions provided in section 3 for contact lens wearers.
• If you or your child have had or currently have a viral eye infection caused by herpes simplex virus (HSV).

Other medicines and Xiop

Tell your doctor, your child’s doctor, or pharmacist if you or your child are taking, have recently taken, or might need to take any other medicines.

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

Pregnancy and breastfeeding

If you are pregnant, breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Xiop must not be used during pregnancy or breastfeeding.

Driving and use of machines

Blurred vision may occur for a short period of time after using Xiop. If this happens to you, do not drive and do not operate tools or machinery until your vision has cleared again.

3. How to use Xiop

Follow exactly the administration instructions provided by your doctor, your child's doctor, or your pharmacist. Consult your doctor or pharmacist if you have any doubts.

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

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

Do not use Xiop more than once a day, as treatment efficacy may decrease if administered more frequently.

Use Xiop exactly as directed by your doctor or your child's doctor until they tell you to stop.

Contact lens wearers

If you or your child wears contact lenses, they must be removed before using Xiop. After applying Xiop, wait 15 minutes before reinserting the contact lenses.

Instructions for use:

1. Wash your hands and sit or stand comfortably.
2. Twist off the cap of the single-dose container.
3. Using your finger, gently pull down the lower eyelid of the affected eye.
4. Place the tip of the single-dose container close to the eye, without touching it.
5. Gently squeeze the single-dose container so that only one drop falls into the eye, then release the lower eyelid.
6. Press with your finger on the inner corner of the affected eye, near the nose. Maintain pressure for 1 minute, keeping the eye closed.
7. Repeat the procedure in the other eye, if instructed by your doctor.
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 more drops than intended have been applied to the eye, you may experience mild eye irritation, redness, and tearing. This should resolve on its own, but if you are concerned, contact your doctor or your child's doctor for advice.

In case of accidental ingestion of Xiop 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 Toxicology Information Service at telephone number: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to use Xiop

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

If you stop using Xiop

Talk to your doctor or your child's doctor if you wish to discontinue using Xiop.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

The following adverse 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 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 of a single color (blue, gray, green or brown). The change in eye color develops gradually over years, although it is usually noticeable after 8 months of treatment. The color change may be permanent and may be more pronounced if Xiop is used in only one eye. The change in eye color does not appear to be associated with any eye problems. The change in eye color does not continue once treatment with Xiop is stopped.
• Redness of the eye.
• Eye irritation (burning sensation, gritty feeling in the eye, itching, stinging or foreign body sensation in the eye). If you experience severe eye irritation causing excessive tearing or that makes you consider stopping treatment, consult your doctor, pharmacist or nurse as soon as possible (within one week). You may need your treatment reviewed to ensure you are receiving the appropriate treatment for your condition.
• Gradual changes in the eyelashes of the treated eye and in the fine hair around the treated eye, commonly observed in patients of Japanese origin. These changes include darkening (increased pigmentation), lengthening, thickening, and increased number of eyelashes.

***Common:***may affect up to 1 in 10 patients

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

***Uncommon:***may affect up to 1 in 100 patients

• Eyelid swelling, 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 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 an extra row of eyelashes, scarring on the eye surface, fluid-filled area within the colored part of the eye (iris cyst).
• Skin reactions on the eyelids, darkening of the eyelid skin.
• Worsening of asthma.
• Severe skin itching.
• Development of a viral eye infection caused by the herpes simplex virus (HSV).

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

• Worsening of angina in patients with existing heart problems, chest pain, appearance of sunken eyes (increased depth of the eyelid crease).

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

Adverse effects observed in children at a higher frequency than in adults are runny nose, nasal itching, and fever.

Reporting of adverse effects

If you experience any kind of adverse effect, consult your doctor, pharmacist or nurse, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Conservation of Xiop

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

6. Contents of the pack and other information

Composition of Xiop

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

Appearance of the product and contents of the pack

Xiop is a sterile, clear, colorless 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.

One pouch contains 5 single-dose containers. The pouch is placed inside the cardboard box.

Only certain 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

For more information about this medicine, please contact the Marketing Authorization Holder's local representative:

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 the most recent review of this leaflet: 11/2022.

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