Leaflet: information for the user

Visiotan50 micrograms/ml eye drops in a single-dose container

latanoprost

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

Visiotan belongs to a group of medications known as prostaglandin analogs. It works by increasing the natural drainage of fluid from the inside of the eye into the bloodstream.

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

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

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

Do not use Visiotan

Warnings and precautions

Consult your doctor, or the doctor treating your child, or pharmacist before using Visiotan or before giving it to your child if you consider that any of the following situations affect you or your child:

Use of Visiotan with other medications

Visiotan may interact with other medications. Inform your doctor, the doctor treating your child, or pharmacist if you or your child are using or have used recently or may need to use any other medication (or eye drops), including those obtained without a prescription. In particular, consult your doctor or pharmacist if you know you are using prostaglandins, prostaglandin analogs, 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 intend to become pregnant, consult your doctor before using this medication.

Driving and operating machinery

When using Visiotan, 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.

Visiotan contains phosphate buffer

This medication contains 6.4 mg of phosphates in each ml equivalent to 0.2 mg/drop.

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

Visiotan contains macrogolglycerol hydroxystearate

This medication may cause skin reactions because it contains macrogolglycerol hydroxystearate.

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

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

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

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

Users of contact lenses

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

Instructions for use

Wash your hands before using it. Make sure the single-use vial is intact before using this medication. The solution must be used immediately after opening the vial. To avoid contamination, do not let the tip of the single-use vial touch the eye or any other surface.

1. Take a single-use vial from the strip.
2. Hold the single-use vial in a vertical position (with the cap facing up) and turn the cap until it comes loose.
3. Gently pull the lower eyelid down to form a pouch, between the eyelid and the eye. Invert the single-use vial and press until a drop falls into the eye or affected eyes.
4. After using Visiotan, gently close your eyes, and with gentle pressure, press the edge of the eye, next to the nose for at least 1 minute. This helps to prevent Visiotan from passing into the rest of the body.
5. If a drop is applied to both eyes, repeat the above steps for the other eye.
6. Dispose of the single-use vial after use, even if there is solution left inside.

If a drop falls outside the eye, try again.

If you or your child is using other eye medications, such as eye drops or eye ointments, wait at least 5 minutes between the application of Visiotan and the other eye medications.

If you or your child receives more Visiotan than you should

If more drops than necessary have been applied to the eye, you may feel a slight irritation in the eye and 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.

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

If you or your child forgets to use Visiotan

Continue with the administration of the next dose in the usual manner. Do not apply an additional drop to the eye to compensate for the missed dose. If you have doubts, consult your doctor or the doctor treating your child or pharmacist.

If you or your child interrupts the treatment with Visiotan

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

If you have any other doubts about the use of this medication, ask your doctor or the doctor treating your child or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

The following are known side effects when using latanoprost:

Frequent side effects(may affect more than 1 in 10 patients):

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

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

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

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

The side effects observed in children at a frequency greater than in adults are runny nose, nasal itching, and fever.

There have been rare cases of corneal calcification associated with the use of eye drops containing phosphates in some patients with significantly damaged corneas.

Reporting of side effects:

If you experience any type of side effect, consult your doctor, 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 Medicines for Human Use: https://www.notificaram.es.

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Dispose of the single-use container immediately after use.

Do not use this medication after the expiration date that appears on the single-use container, the bag, and the box after “CAD”. The expiration date is the last day of the month indicated.

This medication does not require any special storage temperature.

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

Once the bag is opened, the single-use containers must be used within 30 days.

Medications should not be thrown down the drain or in the trash. Deposit the containers and unused medications at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and unused medications. By doing so, you will help protect the environment.

Composition of Visiotan

• The active principle is latanoprost 50 micrograms/ml.
• The other components are: sodium chloride, sodium dihydrogen phosphate monohydrate (E339), anhydrous sodium hydrogen phosphate (E339), macrogolglycerol 40 hydroxystearate, propylene glycol (E1520), sodium hydroxide and/or hydrochloric acid (for pH adjustment), and water for injection preparations.

Appearance of the product and contents of the package

Visiotan eye drops are a transparent and colorless solution supplied in single-dose plastic containers, each containing 0.2 ml of solution.

Each bag contains 10 single-dose containers.

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

Only some container sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

OmniVision GmbH

Lindberghstrasse 9

82178 Puchheim

Germany

Responsible for manufacturing

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 authorized in the Member States of the European Economic Area with the following names:

Austria: Latano-Vision sine 50 Mikrogramm/ml eye drops, solution in single-dose container

Germany: Latano-Vision sine 50 Mikrogramm/ml eye drops, solution in single-dose container

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

Italy:Droplatan SC50 micrograms/ml eye drops, solution, in single-dose container

France:Latanoprost OmniVision 50 micrograms/ml, eye drops in solution in single-dose container

Date of the last review of this leaflet:May 2023

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)