Oculobrim

Patient Information Leaflet

Oculobrim, 2 mg/ml, eye drops, solution
Brimonidine tartrate
Please read this leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm someone else, even if their symptoms are similar.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

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

1. What Oculobrim is and what it is used for

Oculobrim contains an active substance called brimonidine tartrate, which works by reducing intraocular pressure.
Oculobrim is used to lower pressure in the eye.
It may be used alone when eye drops containing beta-blockers are contraindicated, or in combination with other eye drops when monotherapy is insufficient to reduce elevated intraocular pressure, in the treatment of open-angle glaucoma or ocular hypertension.

2. Important information before using Oculobrim

When not to use Oculobrim

• if the patient is allergic to brimonidine or any of the other ingredients of this medicine (listed in section 6),
• in infants and young children (from birth to 2 years of age),
• if the patient is taking monoamine oxidase inhibitors (MAO inhibitors) or certain antidepressant medicines. It is essential to inform the doctor if the patient is taking any antidepressant medication,
• if the patient is breastfeeding.

Warnings and precautions
Before starting treatment with Oculobrim, discuss the following with your doctor or pharmacist:

• if the medicine is to be used in a child aged between 2 and 12 years, as Oculobrim is not recommended for use in this age group,
• if the patient has or has had depression, mental impairment, reduced blood flow to the brain, heart problems, circulation problems in the limbs, or blood pressure disorders,
• if the patient has or has previously had kidney or liver problems.

If any of the above conditions apply to the patient, consult a doctor before starting treatment with Oculobrim.
Children and adolescents
Do not use this medicine in children and adolescents under 12 years of age, as the safety and efficacy of Oculobrim have not been established in this age group. This is particularly important for children under 2 years of age.
Oculobrim and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Inform the doctor if the patient regularly consumes alcohol or is taking any of the following medicines:

• painkillers, sedatives, opioids, barbiturates,
• anaesthetics,
• heart medications or medicines that lower blood pressure,
• medicines that may affect metabolism, such as chlorpromazine, methylphenidate, or reserpine,
• medicines acting on the same receptor as Oculobrim, such as isoprenaline or prazosin,
• monoamine oxidase inhibitors (MAO inhibitors) and other antidepressants,
• medicines used for any condition, even if unrelated to eye disorders, from which the patient may be suffering,
• or if there are changes in the dosage of currently used medicines.

These medicines may affect treatment with Oculobrim.
Pregnancy and breastfeeding
If the patient is pregnant, suspects she may be pregnant, plans to become pregnant, or is breastfeeding, she should consult a doctor or pharmacist before using this medicine.
Do not use Oculobrim during breastfeeding.
Driving and operating machinery
Oculobrim may cause blurred vision or other visual disturbances. These effects may seem more pronounced at night or in dim lighting.
In some patients, Oculobrim may also cause drowsiness or a feeling of fatigue.
If the patient experiences any of these symptoms, driving or operating machinery should be avoided until these symptoms resolve.
Oculobrim contains a preservative called benzalkonium chloride
The preservative in Oculobrim, benzalkonium chloride, may cause eye irritation and may discolor soft contact lenses. Therefore, the use of soft contact lenses should be avoided. If the patient wears contact lenses, they should be removed before instilling the drops and not reinserted until 15 minutes after administration of Oculobrim.

3. How to use Oculobrim

This medicine should always be used exactly as your doctor has told you. If in doubt, consult your doctor or pharmacist.
Adults (including elderly patients):
The recommended dose is one drop into the affected eye(s) twice daily, approximately 12 hours apart.
Use in children under 12 years of age
Oculobrim must not be used in children below 2 years of age.
Oculobrim is not recommended for use in children (from 2 to 12 years of age).
Instructions for use
Oculobrim is an eye drop solution. Always wash your hands before instilling the drops. Your prescription will indicate the number of drops to be instilled into the eye at each dose. If you are using Oculobrim together with other eye drops, wait 15 minutes before instilling the second medicine.
Instill the eye drops as follows:

1. Tilt your head backwards and look upwards.
2. Gently pull down the lower eyelid to form a small pocket.
3. Turn the medicine bottle upside down and squeeze it to instill one drop into the eye.
4. With the treated eye closed, press with your finger on the inner corner of the eye (where the eye meets the nose) and hold for one minute. Avoid touching the eye or any other surface with the dropper tip. Immediately after use, replace and tighten the cap.

Use of more Oculobrim than recommended
Adults
Adverse effects observed in patients who instilled more drops than prescribed by the doctor are consistent with the known adverse effects of Oculobrim.
In adults who accidentally swallowed Oculobrim, a drop in blood pressure occurred, followed in some patients by an increase in blood pressure. In such cases, contact your doctor immediately.
Children
Serious adverse reactions have been reported in children who accidentally swallowed Oculobrim. Symptoms observed included drowsiness, weakness, decreased body temperature, paleness, and breathing difficulties. In such cases, contact your doctor immediately.
Adults, adolescents and children
If Oculobrim is accidentally swallowed or if more than the recommended dose has been used, contact your doctor immediately.
If you forget to use Oculobrim
If you miss a dose, instill it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and return to your regular dosing schedule.
Do not use a double dose to make up for a forgotten dose.
Stopping Oculobrim
To be effective, Oculobrim must be used every day. Do not stop using Oculobrim unless your doctor tells you to do so.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Some adverse reactions may be serious. These include, for example:

• fainting
• local irritation (inflammation and swelling of the eyelid, swelling of the transparent layer covering the surface of the eye, sticky eyes, pain and tearing)
• eye irritation (redness, burning, stinging, sensation of a foreign body in the eye, itching, eyelash follicles or white spots on the transparent layer covering the surface of the eye)
• eye inflammation
• allergic reaction in the eye
• palpitations or changes in heart rate
• shortness of breath
• general allergic reactions
• skin reactions, including redness, facial swelling, itching, rash, and dilation of blood vessels.

If any of the above-mentioned or other serious symptoms occur, you should
immediately contact your doctor or the nearest hospital emergency department for
appropriate treatment.

The following adverse reactions have been reported:
Eye-related reactions
Very common (may occur in more than 1 in 10 patients):

• eye irritation (redness, burning, stinging, sensation of a foreign body in the eye, itching, blisters or white spots on the cornea, i.e. the transparent layer on the surface of the eye);
• blurred vision;
• allergic reaction in the eye.

Common (may occur in up to 1 in 10 patients):

• local irritation (inflammatory condition and swelling of the eyelid, swelling of the cornea, i.e. the transparent layer on the surface of the eye, sticky eyes, pain and tearing);
• light sensitivity;
• erosion and discoloration of the surface of the eye;
• dry eye;
• whitening of the cornea, i.e. the transparent layer on the surface of the eye;
• visual disturbances;
• corneal inflammation, i.e. inflammation of the transparent layer on the surface of the eye.

Very rare (may occur in up to 1 in 10,000 patients):

• eye inflammation;
• pupillary constriction.

Frequency unknown (frequency cannot be determined from available data):

• eyelid itching.

Whole-body reactions
Very common (may occur in more than 1 in 10 patients):

• headache;
• dry mouth;
• fatigue/somnolence.

Common (may occur in up to 1 in 10 patients):

• dizziness;
• cold-like symptoms;
• stomach-related symptoms and indigestion;
• abnormal taste;
• general weakness.

Uncommon (may occur in up to 1 in 100 patients):

• depression;
• palpitations or change in heart rhythm;
• dry nose;
• general allergic reactions.

Rare (may occur in up to 1 in 1,000 patients):

• shortness of breath.

Very rare (may occur in up to 1 in 10,000 patients):

• insomnia;
• fainting;
• high blood pressure;
• low blood pressure.

Frequency unknown (frequency cannot be determined from available data):

• skin reactions including redness, facial swelling, itching, rash, and dilation of blood vessels.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported
directly to the Department for Monitoring Adverse Reactions to Medicinal Products
of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al.
Jerozolimskie 181C, 02-222 Warsaw, tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309, e-mail:
[email protected].
Adverse reactions can also be reported to the marketing authorization holder. By reporting
adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Oculobrim

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and bottle after "EXP".
The expiry date refers to the last day of the stated month.
The batch number marked "LOT" on the packaging identifies the production batch.
Discard the bottle 28 days after first opening, even if there is still some solution left.
This medicine does not require any special storage conditions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This helps protect the environment.

6. Contents of the pack and other information

What Oculobrim contains
The active substance is brimonidine tartrate.
1 ml of solution contains 2 mg of brimonidine tartrate, equivalent to 1.3 mg of brimonidine.
1 drop of solution contains 65.2 micrograms of brimonidine tartrate, equivalent to 43 micrograms
of brimonidine.
The other ingredients are: benzalkonium chloride, polyvinyl alcohol, sodium citrate, citric acid monohydrate, sodium chloride, purified water, hydrochloric acid, sodium hydroxide.

What Oculobrim looks like and contents of the pack
Oculobrim is a clear, greenish-yellow to pale greenish-yellow solution for ocular administration, supplied in an LDPE bottle with a dropper and a closure made of HDPE with a tamper-evident seal.
Each bottle contains 5 ml of eye drop solution.
Pack sizes: 1 x 5 ml or 3 x 5 ml
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Synoptis Pharma Sp. z o.o.
ul. Krakowiaków 65
02-255 Warszawa
Poland

Manufacturer
Jadran-Galenski Laboratorij d.d.
Svilno 20
51000 Rijeka
Croatia