VISUPLAIN 0.1mg/ml EYE DROPS SOLUTION

2. What you need to know before you use Visuplain

Do not use Visuplain

if you are allergic to bimatoprost, benzalkonium chloride or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Visuplain.

Consult your doctor if:

• you have respiratory problems
• you have liver or kidney problems
• you have had cataract surgery in the past
• you have dry eye
• you have or have had problems with the cornea (the transparent layer on the front of the eye)
• you wear contact lenses (see "Visuplain contains benzalkonium chloride")
• you have or have had low blood pressure or low heart rate
• you have had an eye infection caused by a virus or eye inflammation.

During treatment, Visuplain may cause loss of fat around the eye, which can lead to deepening of the eyelid fold, sunken eyes (enophthalmos), drooping eyelids (ptosis), stretching of the skin around the eye (involution of the dermatocalasis), and increased visibility of the white part of the eye (inferior scleral exposure). The changes are usually mild, but if they worsen, they can affect your field of vision. The changes may disappear if you stop using Visuplain.

Visuplain may also cause darkening of the eyelashes and growth, as well as darkening of the skin around the eyelids. The color of the iris may also darken. These changes may be permanent. The change may be more noticeable if only one eye is being treated.

Children and adolescents

Visuplain has not been studied in children under 18 years of age and therefore should not be used in patients under 18 years of age.

Other medicines and Visuplain

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Visuplain may pass into breast milk, so you should not breastfeed while using Visuplain.

Driving and using machines

You may notice blurred vision shortly after using Visuplain. Do not drive or use machines until your vision is clear again.

Visuplain contains benzalkonium chloride

This medicine contains 0.006 mg of benzalkonium chloride in each drop, which is equivalent to 0.2 mg/ml.

Benzalkonium chloride may be absorbed by soft contact lenses and alter their color. Remove your contact lenses before using this medicine and wait 15 minutes before putting them back in.

Benzalkonium chloride may also cause eye irritation, especially if you have dry eye or other corneal diseases (the transparent layer on the front of the eye). If you notice any unusual sensation, itching, or pain in the eye after using this medicine, consult your doctor.

Visuplain contains phosphates

This medicine contains 0.028 mg of phosphates in each drop, which is equivalent to 0.95 mg/ml.

If you have a severe injury to the transparent layer on the front of the eye (the cornea), phosphates may cause, in very rare cases, cloudy spots or blurred vision due to calcium accumulation during treatment.

3. How to use Visuplain

Follow exactly the instructions of administration of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Visuplain should only be applied to the eye. The recommended dose is one drop of Visuplain once a day, at night, in each eye that needs treatment.

If you use Visuplain with another eye medicine, wait at least five minutes between the administration of Visuplain and the other medicine.

Do not use Visuplain more than once a day, as this may reduce the effectiveness of the treatment.

Follow exactly the instructions of administration of the medicine contained in this leaflet or as indicated by your doctor or pharmacist or nurse. In case of doubt, ask your doctor or pharmacist.

Instructions for use:

Do not use the bottle if the security ring on the neck is broken before using it for the first time.

1. Wash your hands and sit or stand in a comfortable position.
2. Remove the cap.
3. Remove the security ring from the bottle.
4. Tilt your head back and look up at the ceiling.
5. Gently pull down the lower eyelid to form a small pouch (figure 2).
6. Invert the bottle and squeeze it to release one drop into each eye that needs treatment (figure 3).
7. Release the lower eyelid and keep the eye closed for 30 seconds (figure 4).

Wipe away any excess that runs down your cheek.

If the drop does not enter the eye, try again.

To prevent infections and avoid eye injuries, make sure the tip of the bottle does not touch the eye or any other surface. Replace the cap and close the bottle immediately after use.

If you use moreV

If you use more Visuplain than you should, it is unlikely to cause serious harm. Take the next dose at the usual time. If you are concerned, talk to your doctor or pharmacist.

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

If you forget to useV

If you forget to use Visuplain, apply one drop as soon as you remember and then return to your usual routine. Do not take a double dose to make up for forgotten doses.

If you stop usingV

For Visuplain to work properly, it must be used every day. If you stop using Visuplain, it is possible that the pressure in the eye may increase, so you should consult your doctor before stopping this treatment.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

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

Very common side effects

May affect more than 1 in 10 people

Eye disorder

• Mild redness (up to 29% of people)
• Loss of fat in the eye area that can cause deepening of the eyelid fold, sunken eyes (enophthalmos), drooping eyelids (ptosis), stretching of the skin around the eye (involution of the dermatocalasis), and increased visibility of the white part of the eye (inferior scleral exposure).

Common side effects

May affect up to 1 in 10 people

Eye disorder

• Small erosions on the surface of the eye, with or without inflammation
• Irritation
• Itching of the eyes
• Longer eyelashes
• Eye irritation when instilling the drop
• Eye pain

Skin disorder

• Redness and itching of the eyelids
• Darker skin color around the eyes
• Hair growth around the eye

Uncommon side effects

May affect up to 1 in 100 people

Eye disorder

• Darkening of the iris color
• Tired eyes
• Swelling or inflammation of the eye surface
• Blurred vision
• Loss of eyelashes

Skin disorder

• Dry skin
• Crust formation on the eyelid margin
• Swelling of the eyelids
• Itching

General disorders

• Headache
• Discomfort

Side effects with unknown frequency (cannot be estimated from the available data)

Eye disorder

• Macular edema (inflammation of the retina, in the back of the eye, which can cause vision impairment)
• Darkening of the eyelid color
• Dryness
• Sticky eyes
• Feeling of a foreign body in the eye
• Eye swelling
• Tearing
• Eye discomfort
• Sensitivity to light

General disorders

• Asthma
• Worsening of asthma
• Worsening of a lung disease called chronic obstructive pulmonary disease (COPD)
• Breathing difficulties
• Symptoms of an allergic reaction (swelling, redness of the eye, and skin rash)
• Dizziness
• Increased blood pressure
• Change in skin color (around the eyes)

In addition to the side effects of Visuplain 0.1 mg/ml, the following side effects have been observed with another medicine that contains a higher concentration of bimatoprost (0.3 mg/ml):

• Eye irritation
• Ocular allergic reaction
• Eye inflammation
• Difficulty seeing clearly
• Worsening of vision
• Inflammation of the transparent layer that covers the eye
• Tearing
• Darkening of the eyelashes
• Retinal hemorrhage
• Intraocular inflammation
• Cystoid macular edema (swelling of the retina in the back of the eye that causes vision impairment)
• Eye spasms
• Retraction of the eyelid, moving away from the eye surface
• Redness of the skin around the eye
• Weakness
• Increased liver function test results

Other side effects reported with phosphate-containing eye drops

In very rare cases, some patients with severe injuries to the transparent layer on the front of the eye (the cornea) have developed corneal opacities due to calcium accumulation during treatment.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: http://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Visuplain

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

Do not use this medicine after the expiry date which is stated on the label of the bottle and on the carton after EXP. The expiry date is the last day of the month shown.

Do not use this medicine if you notice that the security ring on the neck is broken before using it for the first time.

Do not store above 25°C.

After first opening the bottle:

You must throw away the bottle 28 days after first opening, even if there is still some eye drops solution left. This will help prevent infections. To help you remember, write the date you opened the bottle on the space provided on the carton.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Visuplain composition

• The active substance is bimatoprost. One ml of solution contains 0.1 mg of bimatoprost.
• The other ingredients are benzalkonium chloride, disodium hydrogen phosphate heptahydrate, citric acid monohydrate, sodium chloride, hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment), and water for injections.

Appearance of the product and pack contents

Visuplain is a clear, colorless eye drops solution. It comes in a 5 ml plastic dropper bottle with a white screw cap and a security ring. Each bottle contains 3 ml of solution. This is enough for 4 weeks of use.

Visuplain is available in a pack containing 1 or 3 bottles with a screw cap each. Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Visufarma S.p.A.

Via Alberto Cadlolo 21

00136 Rome, Italy

e-mail: [email protected]

Manufacturer

RAFARM S.A.,

Thesi Pousi-Xatzi Agiou Louka,

Paiania Attiki 19002, P.O. Box 37,

Greece

Tel + 30 210 6643835

Date of last revision of this leaflet:02/2025.

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