VISIOTAN 50 micrograms/ml eye drops solution in single-dose containers

Introduction

Package Leaflet: Information for the User

Visiotan50 micrograms/ml eye drops, solution in single-dose container

latanoprost

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, or the doctor who is treating your child, or pharmacist.
• This medicine has been prescribed for you or your child only. Do not pass it on to others, as it may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor, or the doctor who is treating your child, or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet:

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

1. What is Visiotan and what is it used for

Visiotan belongs to a group of medicines known as prostaglandin analogues. It works by increasing the natural outflow of fluid from the eye into the bloodstream.

Visiotan is used to treat conditions known as open-angle glaucoma and ocular hypertension in adults. Both of these conditions are linked to an increase in pressure within the eye, which can lead to impaired vision.

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

2. What you need to know before you use Visiotan

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

Do not use Visiotan

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

Warnings and precautions

Consult your doctor, or the doctor who is treating your child, or pharmacist before using Visiotan or before giving it to your child if you think any of the following apply to you or your child:

• If you or your child have had or are going 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 uncontrolled asthma.
• If you or your child wear contact lenses. You can continue to use Visiotan, but you must follow the instructions in section 3 for contact lens wearers.
• If you have had or are having a viral infection of the eye caused by the herpes simplex virus (HSV).

Using Visiotan with other medicines

Visiotan may interact with other medicines. Tell your doctor, or the doctor who is treating your child, or pharmacist if you or your child are using or have recently used or might 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 are planning to have a baby, ask your doctor for advice before using this medicine.

Driving and using machines

When using Visiotan, blurred vision may occur for a short time. If this happens, do not drive or use tools or machines until your vision is clear again.

Visiotan contains phosphate buffer

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

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

Visiotan contains macrogolglycerol hydroxystearate

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

3. How to use Visiotan

Follow the instructions for administration of Visiotan exactly as told by your doctor, or by the doctor who is treating your child. If you are unsure, consult your doctor, or the doctor who is treating your child, or pharmacist again.

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

Do not use Visiotan more than once daily; the effectiveness of the treatment may decrease if it is administered more frequently.

Use Visiotan as your doctor or the doctor who is treating your child has told you until they tell you to stop.

Contact lens wearers

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

Instructions for use

Wash your hands before use. Make sure the single-dose container is intact before using this medicine. The solution must 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 in an upright position (with the cap up) and twist the cap until it comes off.
3. Gently pull the lower eyelid down to form a pocket between the eyelid and the eye. Invert the single-dose container and squeeze until one drop falls into the eye or eyes to be treated.
4. After using Visiotan, close your eyes gently, and gently press the edge of the eye, next to the nose, for at least 1 minute. This helps prevent Visiotan from getting into the rest of the body.
5. If drops are to be applied in both eyes, repeat the above steps for the other eye.
6. Discard the single-dose container after use, even if there is still solution left in it.

If a drop falls outside the eye, try again.

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

If you or your child use more Visiotan than you should

If you have applied more drops in the eye than you should, you may feel a mild irritation in the eye, and your eyes may become red and watery; this should pass, but if you are concerned, contact your doctor or the doctor who is 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, phone: 91 562 04 20.

If you or your child forget to use Visiotan

Continue with the next dose as usual. Do not apply an extra drop in the eye to make up for the missed dose. If you are unsure, consult your doctor or the doctor who is treating your child or pharmacist.

If you or your child stop using Visiotan

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

If you have any further questions on the use of this medicine, ask your doctor or the doctor who is treating your child or pharmacist.

4. Possible side effects

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

The following are known side effects of using latanoprost:

Very common side effects(may affect more than 1 in 10 people):

• 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, grey-brown, yellow-brown or green-brown), you are more likely to experience this change than if your eyes are a single color (blue, grey, 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 Visiotan is used in one eye only. The change in eye color does not seem to be associated with any problems. The change in eye color does not progress once treatment with Visiotan is stopped.
• Redness of the eye.
• Ocular irritation (feeling of burning, feeling of grit in the eye, itching, pain and feeling of a foreign body 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 right treatment for your condition.
• Gradual change in the eyelashes of the treated eye and the fine hair around the treated eye, seen in most patients of Japanese origin. These changes include an increase in color (darkening), length, thickness and number of eyelashes.

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

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

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

• Swelling of the eyelids, dry eye, inflammation or irritation of the surface of the eye (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), feeling your heartbeat (palpitations).
• Asthma, difficulty breathing (dyspnea).
• Chest pain.
• Headache, dizziness.
• Muscle pain, joint pain.

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

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

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

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

Side effects seen in children more frequently than in adults are runny nose and itchy nose and fever.

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

Reporting of side effects:

If you experience any side effects, talk to your doctor, even if you think they may be related to this medicine. You can also report side effects directly to the Spanish Medicines and Healthcare Products Agency (AEMPS) via the website: https://www.notificaram.es.

By reporting side 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.

Discard the opened single-dose container immediately after use.

Do not use this medicine after the expiry date which is stated on the single-dose container, the pouch and on the carton after “EXP”. The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

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

Once the pouch is opened, the single-dose containers must be used within 30 days.

Medicines should not be disposed of via wastewater or household waste. Dispose of the containers and any unused medicine in the pharmacy's SIGRE collection point. If you are unsure, ask your pharmacist how to dispose of the containers and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Visiotan

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

Appearance and packaging

Visiotan eye drops are a clear, colorless solution supplied in plastic single-dose 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.

Not all 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 micrograms/ml eye drops, solution in single-dose container

Italy: Droplatan SC50 microgrammi/ml collirio, soluzione, in contenitore monodose

France: Latanoprost OmniVision 50 microgrammes/ml, collyre en solution en récipient unidose

Date of last revision of this leaflet:May 2023

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