Visuplain

Package leaflet: Information for the user

Visuplain 0,1 mg/ml eye drops, solution

Bimatoprost
Equivalent medicine
Please 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful to them.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Visuplain is and what it is used for

Visuplain is an anti-glaucoma medicine. It belongs to a class of medicines called prostamides.
Visuplain eye drops are used to reduce elevated intraocular pressure. This medicine can be used
alone or in combination with other eye drops known as beta-blockers, which also help reduce eye
pressure.
The eye contains a clear, watery fluid that nourishes its internal structures. This fluid is constantly drained
from the eye, and new fluid is produced to replace the drained fluid. If the fluid is not drained quickly
enough, the pressure inside the eye increases. This medicine works by increasing the amount of fluid
drained from the eye, thereby reducing intraocular pressure. If elevated intraocular pressure is not
reduced, it may lead to a condition called glaucoma and may eventually cause damage to vision.

2. What you need to know before using 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).
• if in the past you had to discontinue use of eye drops due to an adverse reaction caused by the preservative benzalkonium chloride.

Warnings and precautions:
Talk to your doctor or pharmacist before using Visuplain if:

• you have respiratory problems
• you have liver or kidney problems
• you have previously undergone cataract surgery
• you suffer from dry eye
• you have or have had corneal problems (the transparent front part of the eye)
• you wear contact lenses (see "Visuplain contains benzalkonium chloride")
• you have or have had hypotension or bradycardia
• you have had a viral infection or inflammation of the eyes.

During treatment, Visuplain may cause loss of fat around the eye, which can lead to
deepening of the eyelid crease, sunken eye (enophthalmos), drooping of the upper eyelid (ptosis), tightness of the skin around the eye (dermatocalasis involution), and exposure of the lower white part of the eye (lower scleral show).
These changes are usually mild in degree, but if pronounced, they may impair the visual field.
If you stop using Visuplain, these changes may resolve. Visuplain may also cause darkening and lengthening of the eyelashes, as well as darkening of the eyelids. The color of the iris may also darken. These changes may be permanent and are more noticeable if only one eye is treated.

Children and adolescents
Visuplain has not been tested in patients under 18 years of age; therefore, it should not be used in patients under 18 years of age.

Other medicines and Visuplain
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Visuplain may pass into breast milk; therefore, breastfeeding is not recommended during treatment with Visuplain.

Driving and use of machinery
After administration of Visuplain, you may experience transient blurred vision. In this case, do not drive or operate machinery until your vision has cleared.

Visuplain contains benzalkonium chloride
This medicine contains 0.6 mg of benzalkonium chloride in 3 ml of solution, equivalent to 0.2 mg/ml.
Do not use the eye drops while wearing contact lenses. The preservative in Visuplain, benzalkonium chloride, may be absorbed by soft contact lenses and may cause discoloration. Remove your contact lenses before using this medicine and wait 15 minutes after administering the eye drops before reinserting your contact lenses.
Benzalkonium chloride may also cause ocular irritation, especially if you have dry eye or corneal disorders (the most superficial transparent layer of the eye). If you experience an abnormal sensation, burning, or pain in the eye after using this medicine, consult your doctor.

Visuplain contains phosphates
This medicine contains 0.028 mg of phosphates per drop, equivalent to 0.95 mg/ml.
If you have severe damage to the outermost transparent layer of the eye (the cornea), phosphates may, in very rare cases, cause cloudy spots on the cornea due to calcium accumulation during treatment.

3. How to use Visuplain

Use this medicine exactly as instructed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
Visuplain must be applied only in the eyes. The recommended dose is one drop of Visuplain once daily, in the evening, in each eye to be treated.
If you are using Visuplain with another eye medicine, wait at least five minutes between the administration
of Visuplain and the application of the second eye medicine.
Do not use it more than once a day, as the effectiveness of treatment may be reduced.
Instructions for use:
Do not use the bottle if the tamper-evident ring on the neck of the bottle is not intact before use.

1. Wash your hands and sit or stand in a comfortable position.
2. Unscrew the cap.
3. Remove the tamper-evident ring from the bottle.
4. Tilt your head backward and look upward.
5. Gently pull down the lower eyelid to form a small pocket (Figure 2).
6. Invert the bottle and apply gentle pressure to release one drop of eye drops into each eye to be treated (Figure 3).
7. Release the lower eyelid and close the eye for 30 seconds (Figure 4).

Wipe away any excess liquid running down the cheek.
If the drop did not enter the eye, repeat the procedure.
To avoid eye infections and injury, the tip of the bottle must not touch the eye or come into contact
with any other surfaces. After using the bottle, replace the cap and close the bottle securely.
If you use more Visuplain than you should
If you have instilled more Visuplain than you should, it is unlikely that serious
consequences will occur. Take the next dose at your usual time. If you are concerned, consult your
doctor or pharmacist.
If you forget to use Visuplain
If you forget to use Visuplain, as soon as you remember, apply one single drop and then return to your
regular dosing schedule. Do not use a double dose to make up for the missed dose.
If you stop using Visuplain
For Visuplain to work properly, it must be used every day. If you stop using Visuplain, your eye pressure may increase, so you should speak with your doctor before stopping this
treatment.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

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

• Mild redness (up to 29% of people)
• Loss of fat in the eye area which may lead to deepening of the eyelid crease, sunken eye (enophthalmos), drooping eyelid (ptosis), tightness of the skin around the eye (dermatocalasis), and exposure of the lower white part of the eye (lower scleral show).

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

• Small ulcers on the surface of the eye, with or without inflammation
• Irritation
• Itching of the eyes
• Eyelash growth
• Irritation when administering the eye drops
• Eye pain

Skin-related:

• Red, itchy eyelids
• Darkening of the skin around the eye
• Growth of hair around the eye

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

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

Skin-related:

• Dryness
• Crusting at the edge of the eyelid
• Swelling of the eyelid
• Itching

General:

• Headache
• Feeling unwell

Not known (frequency cannot be estimated from available data)
Eye-related:

• Macular edema (swelling of the retina at the back of the eye that may lead to worsening of vision)
• Darkening of the eyelids
• Dry eye
• Sticky eyes
• Foreign body sensation in the eye
• Eye swelling
• Increased tearing
• Eye discomfort
• Light sensitivity

General:

• Asthma
• Worsening of asthma
• Worsening of the lung disease known as chronic obstructive pulmonary disease (COPD)
• Shortness of breath
• Symptoms of allergic reaction (swelling, eye redness, skin rash)
• Dizziness
• Increase in blood pressure values
• Skin colour changes (around the eye)

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

• Eye burning
• An allergic reaction in the eye
• Inflamed eyelids
• Difficulty seeing clear images
• Worsening of vision
• Swelling of the transparent layer covering the eye surface
• Tearing
• Darker eyelashes
• Bleeding of the retina
• Inflammation inside the eye
• Cystoid macular edema (swelling of the retina inside the eye leading to worsening of vision)
• Eyelid spasms
• Narrowing of the eyelid, pulling away from the eye surface
• Redness of the skin around the eye
• Weakness
• Increased liver function test values in blood tests

Other side effects reported with eye drops containing phosphates
In very rare cases, some patients with severe damage to the transparent layer of the front part of the eye (the cornea) have developed opaque areas on the cornea due to calcium accumulation during treatment.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Visuplain

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle label and on the
pack after "Exp". The expiry date refers to the last day of the month.
Do not store above 25°C.
After first opening the bottle:
The bottle must be discarded 28 days after first opening, even if there are still
eye drops remaining. This will prevent infections. To help you remember, write the date of first opening in the space provided on the pack.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Visuplain contains

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

Description of the appearance of Visuplain and package contents
Visuplain is a clear, colourless eye drop solution. It is available in white plastic bottles of 5 ml with dropper, white screw cap and tamper-evident ring. Each bottle contains 3 ml of solution, sufficient for 4 weeks.
Visuplain is supplied in a pack containing 1 bottle or 3 bottles, each with a screw cap. 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

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Germany: Visuplain 0.1 mg/ml Augentropfen, Lösung
Spain: Visuplain 0.1 mg/ml colirio en solución