SIMBRINZA 10mg/ml + 2mg/ml ophthalmic suspension

2. What you need to know before you use SIMBRINZA

Do not use SIMBRINZA

• if you are allergic to brinzolamide or brimonidine tartrate or any of the other ingredients of this medicine (listed in section 6)
• if you are allergic to sulfonamides (including, for example, medicines used to treat diabetes and infections, and also diuretics (water tablets))
• if you are taking monoamine oxidase inhibitors (MAOIs) (including, for example, medicines used to treat depression or Parkinson's disease) or certain antidepressants. You should tell your doctor if you are taking any medicine for depression
• if you have severe kidney problems
• if you have too much acid in the blood (a condition called hyperchloremic acidosis)
• in newborns and children under 2 years of age.

Warnings and precautions

Talk to your doctor, ophthalmologist (eye specialist) or pharmacist before you start using SIMBRINZA if you currently have or have had in the past:

• liver problems.
• a type of high pressure in the eyes called narrow-angle glaucoma.
• dry eyes or corneal problems.
• heart disease (symptoms may include chest pain or discomfort, shortness of breath or choking), heart failure, low or high blood pressure.
• depression
• blood circulation disorders (such as Raynaud's disease, Raynaud's syndrome, or cerebral insufficiency).
• if you have ever developed a severe skin rash or skin peeling or blisters and/or sores in the mouth after using SIMBRINZA or other related medicines.

Be careful with SIMBRINZA:

Severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported in association with brinzolamide treatment. Stop using SIMBRINZA and seek immediate medical attention if you notice any of the symptoms related to these severe skin reactions described in section 4.

If you wear soft contact lenses, do not use this eye drop with the contact lenses in place. See below under the section "If you wear contact lenses - SIMBRINZA contains benzalkonium chloride".

Children and adolescents

SIMBRINZA is not indicated for use in children and adolescents under 18 years of age because it has not been studied in this age group. It is especially important that this medicine is not used in children under 2 years of age (see previous section "Do not use SIMBRINZA") because it is unlikely to be safe.

Other medicines and SIMBRINZA

Tell your doctor, ophthalmologist (eye specialist) or pharmacist if you are using, have recently used, or might use any other medicines.

SIMBRINZA may affect or be affected by other medicines you are using, including other eye drops for the treatment of glaucoma.

Ask your doctor if you are using or plan to use any of the following medicines:

• medicines to lower blood pressure
• heart medicines, including digoxin (used to treat heart conditions)
• other glaucoma medicines that are also used to treat altitude sickness, known as acetazolamide, methazolamide, and dorzolamide
• medicines that may affect metabolism, such as chlorpromazine, methylphenidate, and reserpine
• antiviral, antiretroviral (used to treat Human Immunodeficiency Virus (HIV)) or antibiotic medicines
• antifungal (medicines used to treat fungal infections) or antilevurals (medicines used to treat yeast infections)
• monoamine oxidase inhibitors (MAOIs) or antidepressants, including amitriptyline, nortriptyline, clomipramine, mianserin, venlafaxine, and duloxetine
• anesthetics
• sedatives, opioids, or barbiturates

You should also tell your doctor if the dose of any of your current medicines changes.

Using SIMBRINZA with alcohol

If you regularly drink alcohol, talk to your doctor, ophthalmologist (eye specialist), or pharmacist before using this medicine. SIMBRINZA may be affected by alcohol.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or plan to become pregnant, talk to your doctor, ophthalmologist (eye specialist), or pharmacist before using this medicine. Women who may become pregnant are advised to use effective contraceptive methods during treatment with SIMBRINZA. The use of SIMBRINZA is not recommended during pregnancy. Do not use SIMBRINZA unless clearly indicated by your doctor.

If you are breastfeeding, SIMBRINZA may pass into breast milk. The use of SIMBRINZA is not recommended during breastfeeding.

Driving and using machines

Immediately after applying SIMBRINZA, you may notice that your vision becomes blurred or abnormal. SIMBRINZA may also cause dizziness, drowsiness, or fatigue in some patients.

Do not drive or use machines until the symptoms have resolved.

If you wear contact lenses - SIMBRINZA contains benzalkonium chloride

This medicine contains 0.15 mg of benzalkonium chloride per 5 ml, which is equivalent to 0.03 mg/ml.

Benzalkonium chloride can be absorbed by soft contact lenses and may alter the color of the contact lenses. Remove the contact lenses before using this medicine and wait 15 minutes before putting them back. Benzalkonium chloride may cause eye irritation, especially if you have dry eyes or other corneal diseases (the transparent layer on the front of the eye). Talk to your doctor if you feel any unusual sensation, itching, or pain in the eye after using this medicine.

3. How to use SIMBRINZA

Follow the instructions for administration of this medicine exactly as indicated by your doctor, ophthalmologist (eye specialist), or pharmacist. If you are unsure, talk to your doctor, ophthalmologist (eye specialist), or pharmacist again.

Use SIMBRINZA only in your eyes. Do not swallow or inject.

The recommended doseis one drop in the affected eye(s) twice a day. Use it at the same time each day.

How to use

Wash your hands before starting.

1 2

Shake well before use.

Remove the cap from the bottle. After removing the cap, the security seal ring must be removed before using this medicine.

Do not touch the dropper tip with your fingers when opening or closing the bottle, because the drops may become contaminated.

Hold the bottle upside down between your thumb and index finger.

Tilt your head back.

Gently pull down the lower eyelid to form a pocket for the drop (figure 1).

Bring the tip of the bottle close to the eye. You can use a mirror to help you.

Do not touch the eye, eyelid, or surrounding areas with the dropper tip, because the drops may become contaminated.

Gently press the base of the bottle to release one drop of SIMBRINZA.

Do not squeeze the bottle: it is designed to release one drop with a gentle pressure on the base (figure 2).

After using this eye drop, close your eyes and press the edge of the eye, next to the nose, for at least 2 minutes. This helps prevent the medicine from entering the rest of the body.

If you are putting drops in both eyes, repeat the above steps for the other eye. You do not need to close and shake the bottle between administrations for both eyes. Replace the cap on the bottle immediately after use.

If you are using other eye drops as well as SIMBRINZA, wait at least 5 minutes between applying SIMBRINZA and the other drops.

If a drop misses the eye, try again.

If you use more SIMBRINZA than you should

You can rinse your eyes with warm water. Do not apply more drops until it is time for the next dose.

Adults who accidentally ingested medicines containing brimonidine experienced a decrease in heart rate, a decrease in blood pressure that may be followed by an increase in blood pressure, heart failure, difficulty breathing, and effects on the nervous system. If this happens, contact your doctor immediately.

Severe side effects were reported in children who accidentally ingested medicines containing brimonidine. The signs included sleepiness, floppiness, low body temperature, paleness, and difficulty breathing. If this happens, contact your doctor immediately.

If you have accidentally ingested SIMBRINZA, contact your doctor immediately.

If you forget to use SIMBRINZA

Continue with the next scheduled dose. Do not apply a double dose to make up for the missed doses. Do not apply more than one drop twice a day in the affected eye(s).

If you stop using SIMBRINZA

Do not stop using SIMBRINZA without talking to your doctor first, because the pressure in your eye may not be controlled, which could lead to loss of vision.

If you have any other questions about using this medicine, ask your doctor, ophthalmologist (eye specialist), or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you experience any of the following side effects, stop using this medicine and seek immediate medical attention, as they may be signs of an allergic reaction to the medicine. The frequency of an allergic reaction to this medicine is not known (cannot be estimated from the available data).

• Severe skin reactions, including rash or redness or itching in the eyes or body
• Breathing problems
• Chest pain, irregular heartbeat

Contact your doctor immediately if you feel dizzy or extremely tired.

The following side effects have been observed with SIMBRINZA and with other medicines that contain brinzolamide or brimonidine alone.

Stop using SIMBRINZA and seek immediate medical attention if you notice any of the following symptoms:

red spots, target-shaped or circular, on the trunk, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).

Common(may affect up to 1 in 10 people)

• Eye effects: allergic conjunctivitis (allergy in the eye), inflammation of the eye surface, eye pain, eye discomfort, blurred or abnormal vision, eye redness
• Other side effects: drowsiness, dizziness, bad taste, dry mouth

Uncommon(may affect up to 1 in 100 people)

• Eye effects: damage to the eye surface with cell loss, eyelid inflammation, deposits on the eye surface, sensitivity to light, eye swelling (affecting the cornea or eyelid), dry eye, eye discharge, watery eyes, eyelid redness, abnormal or decreased sensation in the eyes, tired eyes, reduced vision, double vision, product particles in the eyes.
• Other side effects: low blood pressure, chest pain, irregular heartbeat, slow or fast heart rate, palpitations, difficulty sleeping (insomnia), nightmares, depression, weakness, headache, dizziness, nervousness, irritability, feeling unwell, memory loss, shortness of breath, asthma, nosebleeds, cold symptoms, dry or sore nose or throat, sore throat, throat irritation, cough, nasal discharge (runny nose), stuffy nose, sneezing, sinusitis, chest congestion, ringing in the ears, indigestion, intestinal gas or abdominal pain, nausea, diarrhea, vomiting, abnormal sensation in the mouth, increased allergy symptoms on the skin, rash, abnormal sensation on the skin, hair loss, generalized itching, increased blood chloride levels or decreased red blood cell count in blood tests, pain, back pain, muscle pain or spasms, kidney pain that feels like lower back pain, decreased sexual desire, sexual problems in men.

Rare(may affect up to 1 in 10,000 people)

• Eye effects: decreased pupil size
• Other side effects: fainting, increased blood pressure

Frequency not known(cannot be estimated from the available data)

• Eye effects: decreased eyelash growth
• Other side effects: tremors, decreased sensation, loss of taste, abnormal liver function test results, facial swelling, joint pain, frequent urination, chest pain, swelling of the limbs, red spots, target-shaped or circular, on the trunk, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes that may be preceded by fever and flu-like symptoms. These severe skin rashes can be life-threatening (Stevens-Johnson syndrome, toxic epidermal necrolysis).

Reporting side effects

If you experience any side effects, talk to your doctor, ophthalmologist (eye specialist), or pharmacist, even if they are not listed in this package leaflet. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing SIMBRINZA

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 bottle and carton after "EXP". The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions.

To avoid infections, discard the bottle 4 weeks after first opening. Write the opening date 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. This will help protect the environment.

6. Container contents and additional information

SIMBRINZA composition

• The active ingredients are brinzolamide and brimonidine tartrate. One ml of suspension contains 10 mg of brinzolamide and 2 mg of brimonidine tartrate, equivalent to 1.3 mg of brimonidine.
• The other ingredients are benzalkonium chloride (see section 2 "If you wear contact lenses - SIMBRINZA contains benzalkonium chloride"), propylene glycol, carbomer 974P, boric acid, mannitol, sodium chloride, tiloxapol, hydrochloric acid and/or sodium hydroxide, and purified water.

Very small amounts of sodium hydroxide and/or hydrochloric acid are added to maintain normal acidity levels (pH levels).

Product appearance and container contents

SIMBRINZA eye drops in suspension are a liquid (a uniform white to off-white suspension) that comes in a box containing one or three 5 ml plastic bottles with a screw cap.

Only some pack sizes may be marketed.

Marketing authorization holder

Novartis Europharm Limited

Vista Building

Elm Park, Merrion Road

Dublin 4

Ireland

Manufacturer

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona

Spain

Novartis Manufacturing NV

Rijksweg 14

2870 Puurs-Sint-Amands

Belgium

Novartis Pharma GmbH

Roonstraße 25

D-90429 Nuremberg

Germany

Siegfried El Masnou, S.A.

Camil Fabra 58

El Masnou

08320 Barcelona

Spain

Novartis Pharma GmbH

Sophie-Germain-Strasse 10

90443 Nürnberg

Germany

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Date of last revision of this leaflet:

Other sources of information

Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu