VISUPLAIN 0.1 mg/ml Eye Drops Solution
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How to use VISUPLAIN 0.1mg/ml EYE DROPS SOLUTION
Contents of the leaflet
- Introduction
- What is Visuplain and what is it used for
- What you need to know before you use Visuplain
- Children and adolescents
- Other medicines and Visuplain
- Pregnancy and breastfeeding
- Driving and using machines
- Visuplain contains benzalkonium chloride
- Visuplain contains phosphates
- How to use Visuplain
- If you use moreV
- If you forget to useV
- If you stop usingV
- Possible side effects
- Very common side effects
- Common side effects
- Eye disorder
- Skin disorder
- Uncommon side effects
- Eye disorder
- Skin disorder
- General disorders
- Side effects with unknown frequency (cannot be estimated from the available data)
- Eye disorder
- General disorders
- Reporting of side effects
- Storage of Visuplain
- Contents of the pack and other information
- Visuplain composition
- Appearance of the product and pack contents
Introduction
Package Leaflet: Information for the User
Visuplain 0.1mg/ml eye drops, solution
Bimatoprost
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 pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
Contents of the pack
- What is Visuplain and what is it used for
- What you need to know before you use Visuplain
- How to use Visuplain
- Possible side effects
- Storage of Visuplain
- Contents of the pack and other information
1. What is Visuplain and what is it used for
Visuplain is an anti-glaucoma preparation. It belongs to a group of medicines called prostamides.
Visuplain eye drops are used to reduce high pressure in the eye. This medicine can be used alone or with other eye drops, called beta-blockers, which also reduce pressure.
The eye contains a clear, watery liquid that keeps it moist. This liquid is constantly being drained and the body produces new liquid to replace it. If the liquid does not drain quickly enough, the pressure inside the eye increases. This medicine works by increasing the amount of liquid that drains. This reduces the pressure inside the eye. If high pressure is not reduced, it can lead to a disease called glaucoma and could damage your vision.
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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.
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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.
- Wash your hands and sit or stand in a comfortable position.
- Remove the cap.
- Remove the security ring from the bottle.
- Tilt your head back and look up at the ceiling.
- Gently pull down the lower eyelid to form a small pouch (figure 2).
- Invert the bottle and squeeze it to release one drop into each eye that needs treatment (figure 3).
- 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/
- Country of registration
- Dosage formEYEDROP, 0.1 mg/ml
- ATC codeS01EE03
- Active substance
- Prescription requiredYes
- Manufacturer
- CompositionBENZALCONIO, CLORURO DE (0,2 mg/ml mg), HIDROGENOFOSFATO DE SODIO HEPTAHIDRATO (2,68 mg/ml mg), CLORURO DE SODIO (8,1 mg/ml mg), HIDROXIDO DE SODIO (E 524) (Cantidad suficiente para pH 7.2-7.4 pH mg)
- This information is for reference only and does not constitute medical advice. Always consult a doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
- Alternatives to VISUPLAIN 0.1mg/ml EYE DROPS SOLUTIONDosage form: EYEDROP, 0.3 mg/mlActive substance: bimatoprostManufacturer: Tiedra Farmaceutica S.L.Prescription requiredDosage form: EYE DROP, 0.3 mg/mlActive substance: bimatoprostManufacturer: Sifi S.P.A.Prescription requiredDosage form: EYEDROP, 0.3 mg/mlActive substance: bimatoprostManufacturer: Laboratorio Stada S.L.Prescription required
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Frequently Asked Questions
VISUPLAIN 0.1mg/ml EYE DROPS SOLUTION requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
The active ingredient in VISUPLAIN 0.1mg/ml EYE DROPS SOLUTION is bimatoprost. This information helps identify medicines with the same composition but different brand names.
VISUPLAIN 0.1mg/ml EYE DROPS SOLUTION is manufactured by Visufarma S.P.A.. Pharmacy brands and packaging may differ depending on the distributor.
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether VISUPLAIN 0.1mg/ml EYE DROPS SOLUTION is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
Spain has a well-developed healthcare infrastructure across major cities such as Madrid, Barcelona, Valencia, and Seville. Pharmacies are widely available and operate under strict regulations, ensuring access to prescribed medications.
You can buy VISUPLAIN 0.1mg/ml EYE DROPS SOLUTION in Madrid, Barcelona, Seville, or Valencia at any local pharmacy with a valid prescription.
To obtain a prescription, you can use Oladoctor:
Other medicines with the same active substance (bimatoprost) include ABIPROST 0.3 mg/ml EYE DROPS SOLUTION IN SINGLE-DOSE CONTAINERS, AMIRIOX 0.3 mg/ml EYE DROPS SOLUTION, BIMATOPROST STADA 0.3 mg/ml EYE DROPS SOLUTION IN SINGLE-DOSE CONTAINERS. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
