Simbrinza 10mg/ml + 2mg/ml colirio en suspension

Label: information for the user

SIMBRINZA 10mg/ml+2mg/ml eye drop solution

brinzolamide/tartrate of brimonidine

Read this label carefully before starting to use this medication, as it contains important information for you.

• Keep this label, as you may need to refer to it again.
• If you have any questions, consult your doctor, ophthalmologist (eye specialist) or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who may have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, ophthalmologist (eye specialist) or pharmacist, even if they are not listed in this label. See section 4.

1.What is SIMBRINZA and for what it is used

2.What you need to know before starting to use SIMBRINZA

3.How to use SIMBRINZA

4.Possible adverse effects

5.Storage of SIMBRINZA

6.Contents of the package and additional information

SIMBRINZA contains two active ingredients, brinzolamida and brimonidine tartrate. Brinzolamida belongs to a group of medications called carbonic anhydrase inhibitors and brimonidine tartrate belongs to a group of medications called alpha-2 adrenergic receptor agonists. Both active ingredients work together to reduce eye pressure.

SIMBRINZA is used to reduce eye pressure in adult patients (18 years of age and older) with eye diseases known as glaucoma or ocular hypertension and in those whose elevated eye pressure cannot be effectively controlled with a single medication.

Do not use SIMBRINZA

• If you are allergic to brinzolamide or to brimonidine tartrate or to any of the other ingredients of this medication (listed in section6)
• If you are allergic to sulfonamides (including as examples medications used to treat diabetes and infections and also diuretics (tablets to urinate))
• If you are taking monoamine oxidase inhibitors (MAOIs) (including as examples medications to treat depression or Parkinson's disease) or certain antidepressants. Inform your doctor if you are taking any medication for depression
• If you have severe kidney problems
• If you have too much acid in your blood (a condition called hyperchloremic acidosis)
• In newborns and children under 2 years of age.

Warnings and precautions

Consult your doctor,ophthalmologist (eye specialist)or pharmacist before starting to use SIMBRINZA if you currently have or have had in the past:

• Liver problems.
• A type of high eye pressure called narrow-angle glaucoma.
• Dry eyes or corneal problems.
• Coronary heart disease (symptoms may include chest pressure or pain, shortness of breath or suffocation), 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, blisters and/or mouth sores after using SIMBRINZA or other related medications.

Be especially 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 medical attention immediately if you notice any 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 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 18years of age because it has not been studied in this age group. It is especially important that this medication not be used in children under 2years of age (see previous section “Do not use SIMBRINZA”) because it is unlikely to be safe.

Other medications and SIMBRINZA

Inform your doctor,ophthalmologist (eye specialist)or pharmacist if you are using, have used recently or may need to use any other medication.

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

Consult your doctor if you are using or think you may use any of the following medications:

• Medications to lower blood pressure
• Heart medications including digoxin (used to treat heart conditions)
• Other glaucoma medications that also treat altitude sickness, known as acetazolamide, metazolamide and dorzolamide
• Medications that may affect metabolism such as chlorpromazine, methylphenidate and reserpine
• Antiviral, antiretroviral (used to treat HIV) or antibiotic medications
• Antifungal or antilevadura medications (medications against infections caused by fungi or yeast)
• Monamine oxidase inhibitors (MAOIs) or antidepressants including amitriptyline, nortriptyline, clomipramine, mianserine, venlafaxine and duloxetine
• Anesthetics
• Sedatives, opioids or barbiturates

You must also inform your doctor if the dose of any of your current medications changes.

Use of SIMBRINZA with alcohol

If you regularly consume alcohol,consult your doctor,ophthalmologist (eye specialist)or pharmacist before using this medication. SIMBRINZA may be affected by alcohol.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant or intend to become pregnant, consult your doctor,ophthalmologist (eye specialist)or pharmacist before using this medication.It is recommended that women who may become pregnant use effective contraceptive methods during SIMBRINZA treatment. 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. SIMBRINZA is not recommended during breastfeeding.

Driving and operating machinery

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

Do not drive or operate machinery until the symptoms have disappeared.

If you wear contact lenses - SIMBRINZA contains benzalkonium chloride

This medication contains 0.15mgof benzalkonium chloride per 5ml, which is equivalent to 0.03mg/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 medication and wait 15minutes before putting them back in place. Benzalkonium chloride may cause eye irritation, especially if you have dry eyes or other corneal diseases (transparent layer at the front of the eye). Consult your doctor if you feel a strange sensation, burning or pain in the eye after using this medication.

Follow exactly the administration instructions of this medication indicated by your doctor, ophthalmologist (ophthalmologist) or pharmacist. In case of doubt, consult your doctor, ophthalmologist (ophthalmologist) or pharmacist again.

Only use SIMBRINZA in your eyes. Do not swallow or inject.

Recommended doseis onedrop in the affected eye or eyes twice a day.Use it at the same time every day.

How to use

Wash your hands before starting.

12

Shake well before using.

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

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

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

Incline your head back.

Gently separate your lower eyelid from your eye with a finger, until a pouch forms where the drop should fall (figure 1).

Bring the tip of the bottle close to your eye. You can help with a mirror.

Do not touch your eye, eyelid, nearby areas or other surfaces with the dropper,becausethe drops may become contaminated.

Gently press the base of the bottle to allow onedrop of SIMBRINZA to fall.

Do not squeeze the bottle: it is designed for a gentle pressure on the base to be sufficient (figure2).

After using this eye drop, close your eyes gently and press with your finger the edge of your eye, near the nose for at least 2minutes. This helps to prevent the medication from passing to the rest of the body.

If you apply drops in both eyes, repeat the previous steps for the other eye. No need to close and shake the bottle between administrations of both eyes. Tighten the cap on the bottle immediately after using the product.

If you are using other eye dropsin addition to SIMBRINZA, wait at least fiveminutes between the application of SIMBRINZA and the other drops.

If a drop falls outside the eye, try again.

If you use more SIMBRINZA than you should

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

Adults who accidentally ingested medications containing brimonidine experienced a decrease in heart rate, 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 adverse effects were reported in children who had accidentally ingested medications containing brimonidine. The signs included drowsiness, weakness, low body temperature, pallor and difficulty breathing. If this happens, contact your doctor immediately.

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

If you forgot to use SIMBRINZA

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

If you interrupt treatment with SIMBRINZA

Do not stop treatment with SIMBRINZA without consulting your doctor first, as your eye pressure will not be controlled, which may cause vision loss.

If you have any other questions about the use of this medication, ask your doctor, ophthalmologist (ophthalmologist) or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience 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 a drug reaction. The frequency of an allergic reaction to this medicine is unknown (it cannot be estimated from the available data).

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

Seek immediate contact with your doctor 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 separately.

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

Flat, non-elevated, circular or target-like red patches on the trunk, often with central blisters, skin peeling, mouth ulcers, throat, nose, genital, and eye ulcers. These severe skin reactions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).

Frequent(may affect up to 1 in 10 people)

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

Rare(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, light sensitivity, eyelid 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, particles of the product in the eyes.
• Other side effects: low blood pressure, chest pain, irregular heartbeat, slow or rapid heart rate, palpitations, insomnia, nightmares, depression, generalized weakness, headache, dizziness, nervousness, irritability, general feeling of not feeling well, memory loss, shortness of breath, asthma, nasal bleeding, cold symptoms, nasal dryness or throat dryness, sore throat, throat irritation, cough, nasal discharge (runny nose), stuffy nose, sneezing, sinusitis, chest congestion, ringing in the ears, indigestion, gas or abdominal pain, nausea, diarrhea, vomiting, abnormal sensation in the mouth, increased allergy symptoms in the skin, rash, abnormal sensation in the skin, hair loss, generalized itching, increased levels of chloride in the blood, or decreased red blood cell count in blood tests, pain, back pain, muscle pain or spasm, kidney pain that presents as lower back pain, decreased sex drive, male sexual problems.

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

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

Frequency unknown(cannot be estimated from the available data)

• Eye effects: eyelash growth reduction
• Other side effects: tremor, decreased sensation, taste loss, abnormal liver function test values observed in blood tests, facial swelling, joint pain, frequent urination, chest pain, limb swelling, flat, non-elevated, circular or target-like red patches on the trunk, often with central blisters, skin peeling, mouth ulcers, throat, nose, genital, and eye ulcers that may be preceded by fever and flu-like symptoms. These severe skin reactions may be potentially fatal (Stevens-Johnson syndrome, toxic epidermal necrolysis).

Reporting of side effects

If you experience any type of side effect, consult your doctor, ophthalmologist (eye specialist), or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the national notification system included in theAnexo V. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the bottle and on the box after “CAD”. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

To prevent infections, discard the bottle 4weeks after the first opening. Write the opening date in the space provided on the box.

Medications should not be thrown down the drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. In this way, you will help protect the environment.

Composition of SIMBRINZA

• The active principlesare brinzolamide and brimonidine tartrate.Aml of suspension contains 10mg of brinzolamide and 2mg of brimonidine tartrate, equivalent to 1.3mg of brimonidine.
• The other components arebenzalkonium 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.

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

Appearance of the product and contents of the pack

SIMBRINZA eye drops in suspension are a liquid (a uniform white to off-white suspension) presented in a box containing one or threeplastic bottles of 5ml 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

Responsible 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 obtain more information about this medicine by contacting the local representative of the marketing authorization holder:

Last update of this leaflet:

Other sources of information

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