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

Patient Information Leaflet

Introduction

Patient Information Leaflet

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

latanoprost

Read the entire leaflet carefully before you start using this medicine, as 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, the doctor treating your child, or your pharmacist.
• This medicine has been prescribed for you or your child only and must not be given to other people, even if they have the same symptoms, as it may harm them.
• If you or your child experience any side effects, consult your doctor, the doctor treating your child, or your pharmacist, even if the side effects are not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Visiotan is and what it is used for

Visiotan 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.

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

Visiotan 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 Visiotan

Visiotan can be used in adult men and women (including elderly people) and in children from birth up to 18 years of age. Visiotan has not been studied in premature children (less than 36 weeks of gestation).

Do not use Visiotan

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

Warnings and precautions

Talk to your doctor, your child's doctor, or pharmacist before using Visiotan or before giving it to your child if you think any of the following situations apply to you or your child:

• If you or your child have had or are about to have 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 Visiotan, but you must follow the instructions provided in section 3 for contact lens wearers.
• If you have had or currently have a viral eye infection caused by the herpes simplex virus (HSV).

Use of Visiotan with other medicines

Visiotan may interact with other medicines. Inform your doctor, your child's doctor, or pharmacist if you or your child are using, have recently used, or might need to use any other medicines (or eye drops), including those obtained without a prescription. In particular, consult your doctor or pharmacist if you know you are using prostaglandins, prostaglandin analogues, or prostaglandin derivatives.

Pregnancy and breastfeeding

You should not use Visiotan if you are pregnant or breastfeeding, unless your doctor considers it necessary. If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

Driving and use of machines

Blurred vision may occur for a short period of time after using Visiotan. If this happens to you, do not drive or operate tools or machinery until your vision returns to normal.

Visiotan contains phosphate buffer

This medicine contains 6.4 mg of phosphates per ml, equivalent to 0.2 mg/drop.

If you have severe damage to the transparent outer layer at the front of the eye (cornea), treatment with phosphates may, in very rare cases, cause cloudy patches in the cornea due to calcium deposition.

Visiotan contains macrogol glyceryl hydroxystearate

This medicine may cause skin reactions because it contains macrogol glyceryl hydroxystearate.

3. How to use Visiotan

Follow exactly the administration instructions for this medicine given by your doctor, or by the doctor treating your child. If in doubt, consult your doctor, the doctor treating your child, or pharmacist again.

The recommended dose for adults (including elderly people) and children is one drop into the affected eye or eyes once daily. It is preferable to administer it in the evening.

Do not use Visiotan more than once a day; treatment efficacy may decrease if administered more frequently.

Use Visiotan exactly as directed by your doctor or the doctor treating your child, until they tell you to stop.

Contact lens users

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

Instructions for use

Wash your hands before use. Ensure the single-dose container is intact before using this medicine. The solution should be used immediately after opening the container. To avoid contamination, do not let the tip of the single-dose container touch the eye or any other surface.

1. Take a single-dose container from the strip.
2. Hold the single-dose container vertically (with the cap facing upwards) and twist the cap until it comes off.
3. Gently pull down the lower eyelid to form a pouch between the eyelid and the eye. Invert the single-dose container and squeeze until one drop falls into the affected eye or eyes.
4. After using Visiotan, close your eyes gently and press softly with your finger at the inner corner of the eye, next to the nose, for at least 1 minute. This helps prevent Visiotan from passing into the rest of the body.
5. If drops are being applied to both eyes, repeat the previous steps for the other eye.
6. Discard the single-dose container after use, even if there is solution remaining inside.

If a drop misses the eye, try again.

If you or your child are using other eye medicines, such as eye drops or eye ointments, wait at least 5 minutes between applying Visiotan and the other eye medicines.

If you or your child has received more Visiotan than you should

If more drops than recommended 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 the doctor treating your child.

In case of accidental ingestion of Visiotan by you or your child, consult your doctor or pharmacist as soon as possible, or call the Toxicology Information Service at telephone: 91 562 04 20.

If you or your child forgot to use Visiotan

Continue with the next dose as usual. Do not apply an extra drop to make up for the missed dose. If you have any doubts, consult your doctor, the doctor treating your child, or pharmacist.

If you or your child stops treatment with Visiotan

If you wish to stop using Visiotan, consult your doctor or the doctor treating your child.

If you have any further questions about the use of this medicine, ask your doctor, the doctor treating your child, 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 effects when using latanoprost:

Very common adverse effects (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-color 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 over years, although it is usually noticeable after 8 months of treatment. The color change may be permanent and may be more noticeable if Visiotan is used in only one eye. The change in eye color does not appear to be associated with any eye problems. The color change does not progress once treatment with Visiotan is stopped.
• Redness of the eye.
• Eye irritation (burning sensation, gritty feeling in the eye, itching, pain, and 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). Your treatment may need to be 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, observed in most patients of Japanese origin. These changes include darkening (increased pigmentation), lengthening, thickening, and increased number of eyelashes.

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

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

Uncommon adverse effects (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.
• Nausea, vomiting.
• Chest pain (angina), awareness of heartbeat (palpitations).
• Asthma, breathing difficulty (dyspnea).
• Chest pain.
• Headache, dizziness.
• Muscle pain, joint pain.

Rare adverse effects (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 additional row of eyelashes, scarring of the eye surface, fluid accumulation in the colored 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 the herpes simplex virus (HSV).

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

• Worsening of angina in patients who also have heart problems, appearance of sunken eyes (increased depth of the eyelid crease).

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

Cases of corneal calcification have been reported very rarely with the use of eye drops containing phosphates in some patients with significantly damaged corneas.

Reporting of adverse effects:

If you experience any kind of adverse effect, consult your doctor, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through 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. Storage of Visiotan

Keep this medicine out of the sight and reach of children.

Immediately discard the single-dose container after use.

Do not use this medicine after the expiry date stated on the single-dose container, the bag, and the outer carton after "EXP". The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage temperature conditions.

Store the single-dose containers in their bag and outer packaging to protect them from light.

After opening the bag, the single-dose containers must be used within 30 days.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Visiotan

• The active substance is latanoprost 50 micrograms/ml.
• The other components are: sodium chloride, sodium dihydrogen phosphate monohydrate (E 339), anhydrous sodium hydrogen phosphate (E 339), macrogolglycerol hydroxystearate 40, propylene glycol (E 1520), sodium hydroxide and/or hydrochloric acid (for pH adjustment), water for injections.

Appearance of the medicine and contents of the pack

Visiotan eye drops is a clear, colourless solution supplied in single-dose plastic containers, each containing 0.2 ml of solution.

Each pouch contains 10 single-dose containers.

The carton contains 30, 60 or 90 single-dose containers.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

OmniVision GmbH

Lindberghstrasse 9

82178 Puchheim

Germany

Manufacturer

Actrevo GmbH

Grosser Burstah 25

20457 Hamburg

Germany

Local Representative

OmniVision Farma España S.L.

C/ Josep Irla i Bosch, 1-3

Pl: 6 Pt: 2

08034 Barcelona

Spain

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

Austria: Latano-Vision sine 50 Mikrogramm/ml Augentropfen, Lösung im Einzeldosisbehältnis
Germany: Latano-Vision sine 50 Mikrogramm/ml Augentropfen, Lösung im Einzeldosisbehältnis
Spain: Visiotan 50 microgramos/ml colirio en solución en envase unidosis
Italy: Monolan 50 microgrammi/ml collirio, soluzione, in contenitore monodose
France: XALATAN 50 microgrammes/ml, collyre en solution en récipient unidose

Date of the most recent review of this leaflet: March 2026

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