BRIMOFTAL 2 mg /Ml Eye Drops, Solution

Зміст інструкції

1. BRIMOFTAL 2 mg/ml Eye drops, solution
   1. WHAT IS BRIMOFTAL 2 MG/ML EYE DROPS, SOLUTION AND WHAT IT IS USED FOR
   2. BEFORE YOU USE BRIMOFTAL 2 MG/ML EYE DROPS, SOLUTION
   3. HOW TO USE BRIMOFTAL 2 MG/ML EYE DROPS, SOLUTION
   4. HOW TO STORE BRIMOFTAL 2 MG/ML EYE DROPS, SOLUTION
   5. OTHER INFORMATION

BRIMOFTAL 2 mg/ml Eye drops, solution

BRIMONIDINE TARTRATE

Read this leaflet carefully before using this medicine.

• 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 pass it on to others even if their symptoms are the same as yours because it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist.

Contents of this leaflet:

• 1. What BRIMOFTAL 2 mg/ml eye drops, solution is and what it is used for
• 2. Before using BRIMOFTAL 2 mg/ml eye drops, solution
• 3. How to use BRIMOFTAL 2 mg/ml eye drops, solution
• 4. Possible side effects
• 5. How to store BRIMOFTAL 2 mg/ml eye drops, solution
• 6. Further information

1. WHAT IS BRIMOFTAL 2 MG/ML EYE DROPS, SOLUTION AND WHAT IT IS USED FOR

• BRIMOFTAL 2 mg/ml eye drops, solution is a medicine for reducing intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension (high eye pressure)
• BRIMOFTAL 2 mg/ml eye drops, solution can be used alone or in combination with other medicines to reduce intraocular pressure.

2. BEFORE YOU USE BRIMOFTAL 2 MG/ML EYE DROPS, SOLUTION

Do not use BRIMOFTAL 2 mg/ml eye drops, solution:

• If you are allergic (or hypersensitive) to brimonidine tartrate or any of the ingredients of BRIMOFTAL 2 mg/ml eye drops, solution
• If you are, or have been, treated with medicines classified as monoamine oxidase inhibitors (MAO inhibitors)
• If you are treated with certain antidepressants (tricyclic antidepressants or mianserin) Inform your doctor if you are taking any antidepressant
• In newborns and very young children (from birth up to 2 years)

Take particular care with BRIMOFTAL 2 mg/ml eye drops, solution:

• In case of severe or unstable and uncontrolled cardiovascular diseases
• In case of depression
• In case of reduced blood supply to the brain (cerebral insufficiency) or to the heart (coronary insufficiency)
• If you suffer from low blood pressure that causes dizziness and fainting when you get up after lying down or sitting (orthostatic hypotension)
• In case of constriction of blood vessels, especially in the hands and arms (Raynaud's phenomenon), or chronic vascular inflammation with obstruction of blood vessels due to coagulation (thromboangiitis obliterans)
• In case of liver or kidney problems Consult your doctor if any of these circumstances occur. Brimonidine is not recommended in children (from 2 to 12 years)

Taking BRIMOFTAL 2 mg/ml eye drops, solution with other medicines
Tell your doctor or pharmacist if you are taking or have recently taken other medi-
cines, including products that do not require a prescription.

Substances active on the central nervous system (CNS):
the effect of substances that affect the central nervous system (CNS) (alcohol, barbiturates,
opioids, sedatives or anesthetics) may be potentiated by BRIMOFTAL 2 mg/ml eye drops,
solution.

Medicines that treat disorders of the central nervous system (chlorpromazine,

methylphenidate), antihypertensive medicines (reserpine):
caution is recommended in patients treated with medicines that may alter the
uptake and metabolism of adrenaline, noradrenaline and other so-called biogenic amines
in the blood.

Antihypertensive agents, cardioactive drugs:
a slight decrease in blood pressure has been observed in some patients do-
after the administration of BRIMOFTAL 2 mg/ml eye drops, solution. It is therefore recom-
mended caution if BRIMOFTAL 2 mg/ml eye drops, solution is used in concomitance with
antihypertensive agents and/or cardioactive drugs of the digitalis glycosides group.

Adrenergic agonists or antagonists:
caution is recommended when starting concomitant treatment with medicines with
systemic action, or if there is a change in dosage (regardless of the metho-
d of administration) that may interact with α-adrenergic agonists or interfere
with their activity, such as agonists or antagonists (isoprenaline or prazosin) of
adrenergic receptors.

Pregnancy and breastfeeding
Studies have not been conducted to determine whether it is safe to use BRIMOFTAL 2 mg/ml
eye drops, solution during pregnancy. BRIMOFTAL 2 mg/ml eye drops, solution should there-
fore be used with caution during pregnancy and only if the potential benefit for the mother
justifies the potential risk to the fetus.
It has not been established whether Brimonidine passes into breast milk. BRIMOFTAL 2 mg/ml
eye drops, solution should therefore not be used during breastfeeding.
Ask your doctor or pharmacist for advice before taking any medi-
cine.

Driving and using machines
BRIMOFTAL 2 mg/ml eye drops, solution may cause fatigue and/or drowsiness. This
may affect the ability to drive or operate machinery safely.
BRIMOFTAL 2 mg/ml eye drops, solution may also cause blurred and/or disturbed vision.
This may affect the ability to drive or operate machinery safely, especially at
night or in low light conditions.

If you experience any of these symptoms, it is recommended that you do not drive
vehicles or use machinery until the symptoms have completely disappeared.
Important information about some excipients of BRIMOFTAL 2 mg/ml eye drops,
solution
Brimoftal contains benzalkonium chloride
Brimoftal contains 0.05 mg of benzalkonium chloride per ml, equivalent to approximately 0.00165 mg
of benzalkonium chloride per drop.
Benzalkonium chloride can be absorbed by soft contact lenses and can lead
to a change in their color. Remove contact lenses before using this medi-
cine and wait 15 minutes before re-applying them.
Benzalkonium chloride can also cause irritation to the eyes, especially if you have dry eyes or corneal disorders (the transparent outermost layer of the eye). If
you experience an abnormal sensation in the eye, burning or pain after using ques-
this medicine, talk to your doctor.

3. HOW TO USE BRIMOFTAL 2 MG/ML EYE DROPS, SOLUTION

Always use BRIMOFTAL 2 mg/ml eye drops, solution exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
It is very important to use BRIMOFTAL 2 mg/ml eye drops, solution for the period prescribed
by your doctor.
If you feel that the effect of BRIMOFTAL 2 mg/ml eye drops, solution is too strong or too
weak, it is recommended to talk to your doctor.
Unless your doctor has recommended otherwise, the usual dosage is
one drop in the affected eye(s) twice a day, at intervals of approximately 12 hours.

Instructions for use
Brimonidine is for use as an eye drop only. Do not ingest.
Always wash your hands before applying the eye drops.
Instill the eye drops as follows:

• 1. Tilt your head back and look upwards
• 2. Gently lower the lower eyelid until a small pocket is formed
• 3. Press the inverted bottle to release one drop into the eye. Immediately after instilling each drop, close your eye and press the tip of your finger against the inner corner of the closed eye (near the nose) for one minute. This helps to reduce the systemic absorption of brimonidine. If you are using more than one eye medicine at the same time, apply the products at intervals of 5 – 15 minutes. Infants and children: BRIMOFTAL 2 mg/ml should not be used in infants and children (from birth to 2 years).

If you take more BRIMOFTAL 2 mg/ml eye drops than you should
Adults:
In adults who use more BRIMOFTAL 2 mg/ml eye drops, solution than
prescribed, the adverse effects that have been reported correspond to those already known
(see section 4).
:Adult patients who have inadvertently ingested brimonidine tartrate 2 mg/ml eye drops,
solution have experienced a decrease in blood pressure, in some cases
followed by an increase in blood pressure.
Contact your doctor immediately if you have inadvertently ingested
BRIMOFTAL 2 mg/ml eye drops, solution, as it may cause low blood pressure,
feeling of weakness, general malaise, lack of energy, feeling of
numbness, slowing of the heartbeat, irregular heartbeat,
constriction of the pupils, difficulty breathing including respiratory arrest, flaccid muscles,
lowering of body temperature and convulsions.
Children
Serious adverse effects have been reported in children who have inadvertently
ingested Brimonidine tartrate 2 mg/ml eye drops, solution. The signs observed include:
temporary coma, decreased levels of consciousness, lack of energy, drowsiness,
flaccid muscles, slowing of the heartbeat, lowering of body temperature,
pallor and difficulty breathing including respiratory arrest. If this should
happen, contact your doctor immediately.
Adults and children
If you suspect an overdose, contact your doctor or ophthalmologist immediately.
Bring the packaging of the medicine with you so that the doctor can be
aware of the active ingredient that has been taken.

If you forget to take BRIMOFTAL 2 mg/ml eye drops
If you forget to apply BRIMOFTAL 2 mg/ml eye drops, solution, apply the missed
dose as soon as possible. However, if it is almost time for the next dose, omit the missed dose and continue with the next dose according to
the usual schedule.
Do not use more drops to make up for the missed dose. If you have any doubts, ask
your doctor or pharmacist.
Do not change the prescribed dose on your own.

If you stop taking BRIMOFTAL 2 mg/ ml eye drops
Do not stop treatment with BRIMOFTAL 2 mg/ ml eye drops, solution, without
talking to your doctor.

SIDE EFFECTS
Like all medicines, BRIMOFTAL 2mg/ml eye drops, solution, can cause side
effects, although not everyone gets them. If any of the side
effects gets worse, or if you notice any side effect not listed
The most common side effects (in 22-25% of patients) are dry mouth, redness of the eyes, a burning and itchy sensation in the eyes. These side effects
are usually temporary and rarely serious enough to require stopping treatment with
BRIMOFTAL 2mg/ml eye drops, solution.
Allergic reactions in the eyes occurred in 12.7% of patients during clinical
trials. These occurred in most cases after 3-9 months. In case of
allergic reactions, treatment with BRIMOFTAL 2mg/ml eye drops, solution must be stopped.
An analysis of the side effects was based on the following incidence rate:
VERY COMMON: affects more than 1 in 10 patients
COMMON: affects 1 to 10 patients in 100
UNCOMMON: affects 1 to 10 patients in 1000
RARE: affects 1 to 10 patients in 10,000
VERY RARE: affects less than 1 in 10,000
UNKNOWN: the frequency cannot be estimated based on available data

The following side effects have been reported during treatment with BRIMOFTAL 2 mg/ml eye drops, solution:

Topical side effects
VERY COMMON:

• eye irritation, including allergic reactions (redness, pain and burning, itching, foreign body sensation in the eye, follicles or white spots on the layer covering the surface of the eye - conjunctival follicles), blurred vision COMMON:
• topical irritation (redness and swelling of the eyelids, inflamed eyelids, edema and conjunctival secretion, eye pain and tearing), photophobia, superficial damage or discoloration of the cornea, dry eyes, conjunctival blanching, altered vision, conjunctivitis VERY RARE:
• iritis, miosis UNKNOWN:
• itching of the eyebrows
• Inflammation inside the eye

Systemic side effects
VERY COMMON:

• headache, dry mouth, fatigue/drowsiness COMMON:
• symptoms affecting the respiratory tract, dizziness, gastrointestinal pain, weakness, altered taste UNCOMMON:
• palpitations/arrhythmia (including bradycardia and tachycardia), general allergic reactions, depression, nasal dryness RARE:
• dyspnea VERY RARE:
• syncope, hypertension, hypotension, insomnia UNKNOWN:
• Skin reactions, including: redness, facial swelling, itching, rash and dilation of blood vessels

5. HOW TO STORE BRIMOFTAL 2 MG/ML EYE DROPS, SOLUTION

KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Do not use BRIMOFTAL 2 mg/ml eye drops, solution after the expiry date which is reported on the
package and on the bottle. The expiry date refers to the last day of the month.
Once opened, BRIMOFTAL 2 mg/ml eye drops, solution can be stored for a maximum of 28 days.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines you no longer use. This will help to
protect the environment.

6. OTHER INFORMATION

What BRIMOFTAL 2mg/ml eye drops, solution contains:

• The active ingredient is brimonidine tartrate. 1 ml of solution contains 2 mg of brimonidine tartrate, equivalent to 1.3 mg of brimonidine.
• The excipients are: benzalkonium chloride, polyvinyl alcohol, sodium chloride, sodium citrate, citric acid monohydrate, purified water, sodium hydroxide and hydrochloric acid for pH correction.

What BRIMOFTAL 2 mg/ml eye drops, solution looks like and contents of the pack
BRIMOFTAL 2 mg/ml eye drops, solution is a clear solution with a yellowish-greenish coloration.
It is available in 5 ml bottles with droppers in packs of 1, 3 or 6 bottles and 10 ml bottles with droppers in packs of 1 or 3 bottles.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
BRUSCHETTINI s.r.l.
Via Isonzo, 6
16147 Genova

Manufacturers
Pharma Stulln GmbH
Werksstraße 3
92551 Stulln
Germany
or
UAB Santonika
Veiveriu Street 134B
46353 Kaunas
Lithuania
THIS MEDICINAL PRODUCT HAS BEEN AUTHORISED IN THE EEA MEMBER STATES UNDER THE FOLLOWING NAMES:
ITALY: BRIMOFTAL