Simbrinza 10 mg/ml + 2 mg/ml eye drops in suspension

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

SIMBRINZA 10mg/ml+2mg/ml eye drops, suspension

brinzolamide/brimonidine tartrate

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

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

Contents of the leaflet

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

1. What SIMBRINZA is and what it is used for

SIMBRINZA contains two active substances, brinzolamide and brimonidine tartrate. Brinzolamide belongs to a group of medicines called carbonic anhydrase inhibitors, and brimonidine tartrate belongs to a group of medicines called alpha-2 adrenergic receptor agonists. Both active substances work together to reduce the pressure inside the eye.

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

2. What you need to know before using SIMBRINZA

Do not use SIMBRINZA

• if you are allergic to brinzolamide or brimonidine tartrate, or to 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, as well as 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 must 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

Talk to your doctor, ophthalmologist (eye specialist), or pharmacist before starting to use SIMBRINZA if you currently have or have previously had:

• liver problems.
• a type of increased 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
• circulatory disorders or poor blood circulation (such as Raynaud's disease, Raynaud's syndrome, or cerebral insufficiency).
• if you have ever developed a severe skin rash, skin peeling, blisters, and/or mouth sores after using SIMBRINZA or other related medicines.

Take special care 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 serious skin reactions described in section 4.

If you wear soft contact lenses, do not use this eye drop while wearing them. 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, as it has not been studied in this age group. It is especially important not to use this medicine 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 taking, have recently taken, or might need to take any other medicines.

SIMBRINZA may affect, or be affected by, other medicines you are taking, including other eye drops used to treat glaucoma.

Consult your doctor if you are taking or plan to take any of the following medicines:

• medicines to lower blood pressure
• heart medications, 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 (medicines for fungal infections) or anti-yeast medicines (medicines for yeast infections)
• monoamine oxidase inhibitors (MAOIs) or antidepressants, including amitriptyline, nortriptyline, clomipramine, mianserine, venlafaxine, and duloxetine
• anesthetics
• sedatives, opioids, or barbiturates

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

Use of SIMBRINZA with alcohol

If you regularly consume alcohol, consult 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 are planning to become pregnant, consult your doctor, ophthalmologist (eye specialist), or pharmacist before using this medicine. Women who may become pregnant are advised to use effective contraception during treatment with SIMBRINZA. The use of SIMBRINZA during pregnancy is not recommended. Do not use SIMBRINZA unless clearly indicated by your doctor.

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

Driving and using machines

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

Do not drive or operate machinery until these symptoms have resolved.

If you wear contact lenses – SIMBRINZA contains benzalkonium chloride

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

Benzalkonium chloride can be absorbed by soft contact lenses and may alter the color of the lenses. Remove contact lenses before using this medicine and wait 15 minutes before reinserting them. Benzalkonium chloride may cause eye irritation, especially if you have dry eye or other corneal diseases (the transparent layer at the front of the eye). Consult your doctor if you experience a foreign body sensation, stinging, or eye pain after using this medicine.

3. How to use SIMBRINZA

Follow exactly the instructions for administering this medicine as given by your doctor, ophthalmologist (eye specialist), or pharmacist. If in doubt, consult your doctor, ophthalmologist (eye specialist), or pharmacist again.

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

Recommended dose
One drop in the affected eye or eyes twice daily. Use it at the same time each day.

How to use
Wash your hands before starting.

Shake well before use.

Unscrew the cap of the bottle. After removing the cap, remove the safety seal ring before using this medicine.

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

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

Tilt your head backward.

Gently pull down the lower eyelid of your eye with one finger, until a pouch is formed where the drop should fall (Figure 1).

Bring the tip of the bottle close to the eye. You may use a mirror to assist.

Do not touch the eye, eyelid, surrounding areas, or other surfaces with the dropper tip, as the drops could become contaminated.

Gently press the base of the bottle so that one drop of SIMBRINZA falls.

Do not squeeze the bottle: it is designed so that gentle pressure at the base is sufficient (Figure 2).

After using this eye drop, gently close your eyes and press with your finger at the inner corner of the eye, next to the nose, for at least 2 minutes. This helps prevent the medicine from draining into the rest of the body.

If you are applying drops to both eyes, repeat the steps above for the other eye. It is not necessary to close and shake the bottle between administrations to both eyes. Immediately after use, tightly screw the cap back onto the bottle.

If you are using other eye drops in addition to SIMBRINZA, wait at least five minutes between applying 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 rinsing your eyes with lukewarm water. Do not apply further drops until it is time for your next dose.

Adults who have accidentally ingested medicines containing brimonidine have experienced a decreased heart rate, decreased blood pressure which may be followed by increased blood pressure, heart failure, difficulty breathing, and effects on the nervous system. If this occurs, contact your doctor immediately.

Serious adverse effects have been reported in children who have accidentally ingested medicines containing brimonidine. Signs included drowsiness, weakness, low body temperature, paleness, and difficulty breathing. If this occurs, contact your doctor immediately.

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

If you forget to use SIMBRINZA

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

If you stop using SIMBRINZA

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

If you have any further questions about the use of this medicine, ask your doctor, ophthalmologist (eye specialist), or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

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

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

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

The following adverse effects have been observed with SIMBRINZA and with other medicines containing brinzolamide or brimonidine separately.

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

• Flat, reddish spots on the trunk, often target-shaped or circular, sometimes with central blisters, peeling skin, and 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 (eye allergy), inflammation of the surface of the eye, eye pain, eye discomfort, blurred or abnormal vision, eye redness
• Other adverse effects: drowsiness, dizziness, bitter taste in the mouth, dry mouth

Uncommon (may affect up to 1 in 100 people)

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

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

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

Frequency not known (cannot be estimated from available data)

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

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, ophthalmologist (eye specialist), or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system listed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of SIMBRINZA

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

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 the month indicated.

This medicine does not require any special storage conditions.

To prevent infection, discard the bottle 4 weeks after first opening. Write the date of opening in the space provided on the carton.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the container and other information

Composition of SIMBRINZA

• The active substances 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 components 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).

Appearance of the product and contents of the container

SIMBRINZA eye drops suspension is a liquid (a uniform white to almost white suspension) supplied in a carton containing one or three 5 ml plastic bottles with a screw cap.

Only certain 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

Sophie-Germain-Strasse 10

90443 Nürnberg

Germany

For more information about this medicine, you may contact the local representative of the Marketing Authorization Holder:

Date of the latest review of this leaflet:

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.eu游戏副本