Brimonidine Omnovision

Package leaflet: Information for the patient

Brimonidina OmniVision 2 mg/ml eye drops, solution

Brimonidine tartrate
Generic Medicine
Please read this leaflet carefully before 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, consult 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.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Brimonidina OmniVision is and what it is used for

The active substance in Brimonidina OmniVision is brimonidine tartrate, which is used to reduce intraocular pressure.
It may be used alone or in combination with another eye drop that lowers intraocular pressure, in the treatment of glaucoma or ocular hypertension.

2. What you need to know before using Brimonidina OmniVision

Do not take Brimonidina OmniVision

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
• if you are taking monoamine oxidase inhibitors (MAO inhibitors) or certain antidepressants. If you are taking antidepressant medicines, inform your doctor;
• if you are breastfeeding;
• in newborns/children (from birth up to 2 years of age).

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

• you suffer or have previously suffered from depression, intellectual deficits, reduced blood flow to the brain, heart problems, circulatory disorders in the limbs, or blood pressure disorders;
• you have had or currently have kidney or liver problems;
• you are pregnant or breastfeeding;
• you wear soft (hydrophilic) contact lenses (see section “Brimonidina OmniVision contains benzalkonium chloride”);
• you regularly consume alcohol.

The use of Brimonidina OmniVision is not recommended in children aged between 2 and 12 years. If
Brimonidina OmniVision has been prescribed for a child under 12 years of age, consult your doctor before
use.
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Other medicines and Brimonidina OmniVision
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.
Inform your doctor if you are taking any of the following medicines:

• medicines acting on the central nervous system (opioids, painkillers, sedatives, and alcohol);
• chlorpromazine, methylphenidate, or reserpine;
• medicines for the treatment of high blood pressure or heart diseases;
• medicines for the treatment of metabolic disorders;
• isoprenaline or prazosin;
• monoamine oxidase inhibitors (MAO inhibitors) and other antidepressants.

Pregnancy and breastfeeding

• If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.
• Brimonidina OmniVision should not be used during pregnancy unless the benefit to the mother outweighs the potential risk to the fetus.
• Brimonidina OmniVision should not be used during breastfeeding.

Driving and using machines

• Brimonidina OmniVision may cause blurred vision and/or visual disturbances. This effect may be more pronounced at night or in low-light conditions.
• In some patients, Brimonidina OmniVision may also cause drowsiness or fatigue.

If you experience any of these symptoms, do not drive or operate machinery until they resolve.
Brimonidina OmniVision contains benzalkonium chloride
This medicine contains 1.8 micrograms of benzalkonium chloride per drop (equivalent to 0.05 mg/ml).
Benzalkonium chloride may be absorbed by soft contact lenses and may cause a change in their color. Remove your contact lenses before using this medicine and wait 15 minutes before reinserting them.
Benzalkonium chloride may also cause eye irritation, especially if you have dry eye or corneal disorders (the transparent outer layer of the eye). If you experience any unusual sensation, burning, or pain in the eye after using this medicine, speak with your doctor.

3. How to take Brimonidina OmniVision

Use this medicine exactly as directed by your doctor or pharmacist. If you have any doubts,
consult your doctor or pharmacist.
Adults
The usual dose is one drop twice daily, approximately 12 hours apart. If you are using this product together with
another eye drop, wait 5–15 minutes before applying the second eye drop.
For the medicine to be effective, it must be used every day.
Children under 12 years
Brimonidina OmniVision must not be administered to neonates and children under two years of age.
The use of Brimonidina OmniVision is not recommended in children (from 2 to 12 years of age).
Always wash your hands before using the eye drops. Follow the instructions given by your doctor.
Use the eye drops as follows:

1. Remove the protective cap.
2. Tilt your head backwards and look upwards at the ceiling.
3. Gently pull down the lower eyelid to form a small pocket.

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4. Turn the bottle upside down and press the dropper to release one drop into the eye.
5. Close the treated eye and press with your finger against the inner corner of the eye (the corner where the eye meets the nose) for 1 minute. Avoid touching the eye or other surfaces with the tip of the dropper. Immediately after use, replace and tighten the cap.
   If you use more Brimonidina OmniVision than you should

Adults
In adults who have instilled more drops than prescribed, the adverse effects reported have been those already
known.
Adults who have accidentally ingested brimonidine tartrate solutions have experienced a drop in blood
pressure, followed in some patients by an increase in blood pressure.
Children
Serious adverse effects have been reported in children who have accidentally ingested brimonidine tartrate
solutions. Symptoms included drowsiness, instability, low body temperature, pallor, and breathing difficulties.
If this occurs, contact your doctor immediately.
Adults and children
If Brimonidina OmniVision has been accidentally ingested or if you have used more than the prescribed amount,
contact your doctor immediately.
If you forget to use Brimonidina OmniVision
If you forget to apply a dose, apply it as soon as you remember. However, if it is almost time for your next
dose, skip the missed dose and continue your treatment as normal.
If you stop using Brimonidina OmniVision
Since you suffer from glaucoma or ocular hypertension, if you stop using this medicine, your intraocular pressure will rise back to the levels seen before treatment, and your vision may worsen over time. Inform your doctor if you need to discontinue treatment.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience a rare (affecting less than 1 in 1,000 people) but serious allergic reaction to brimonidine (such as difficulty breathing, feeling of suffocation, swelling of the lips, tongue or face, hives, allergic eye reactions), stop using the medicine immediately and contact your doctor straight away.
Tell your doctor if you notice any of the following side effects:

Very common: (may affect up to 1 in 10 people)

• allergic eye reactions, follicles or white spots on the conjunctiva, blurred vision, eye redness, burning, pain, sensation of a foreign body or itching in the eyes
• headache, fatigue, drowsiness and dry mouth.

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

• local irritation (inflammation and swelling of the eyelid, conjunctival swelling, sticky eyes, pain and tearing), light sensitivity, erosion and discoloration of the eye surface, dry eyes, whitening of the conjunctiva, abnormal vision, conjunctivitis

• dizziness, gastrointestinal symptoms, general weakness

• cold-like symptoms or altered taste.

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

• depression
• palpitations or changes in heart rate or dry nose
• generalized allergic reactions.

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

• shortness of breath.

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

• ocular inflammation or reduced pupil diameter. Some of these effects may be due to an allergy to the active substance or to any of the excipients
• fainting, increased or decreased blood pressure, or insomnia.

Side effects whose frequency is not known:
Skin reactions including redness, facial swelling, itching, rash and dilation of blood vessels.

Reporting of side effects
If you experience any side effect, 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 Brimonidine OmniVision

Keep this medicine out of the sight and reach of children.
No special storage conditions are required.
Do not use the bottle if the anti-tampering seal on the bottle is broken before first use.
Do not use this medicine after the expiry date stated on the bottle and carton after "Exp.". The expiry date refers to the last day of that month.
Discard the bottle 28 days after first opening, even if some of the solution remains.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Brimonidina OmniVision contains

• The active substance is brimonidine tartrate.
• 1 ml of solution contains 2.0 mg of brimonidine tartrate, equivalent to 1.3 mg of brimonidine. The other components are: benzalkonium chloride as preservative, polyvinyl alcohol, sodium chloride, disodium citrate dihydrate, citric acid monohydrate, purified water, and sodium hydroxide or hydrochloric acid to adjust pH.

Description of the appearance of Brimonidina OmniVision and contents of the pack
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Plastic bottle with dropper and screw cap containing 5 ml of a slightly greenish-yellow transparent solution.
Pack sizes: 1 x 5 ml
3 x 5 ml
6 x 5 ml
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
OmniVision Italia S.r.l.
Via Montefeltro, 6
20156 Milano
Italy

Manufacturer
TUBILUX PHARMA S.P.A.
Via Costarica 20/22
00071 Pomezia (RM)
ITALY

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Italy: Brimonidina OmniVision 2 mg/ml eye drops, solution
Germany: Brimo-Vision 2 mg/ml Augentropfen
Spain: Brimonidina cinfa 2 mg/ml colirio en solución
United Kingdom: Brimonidine Tartrate 2 mg/ml, eye drops solution
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