Simbrinza

Package leaflet: Information for the user

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

brinzolamide/brimonidine tartrate
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, ophthalmologist, or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, ophthalmologist, or pharmacist. See section 4.

Contents of this 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 class of medicines called carbonic anhydrase inhibitors, and brimonidine tartrate
belongs to a class of medicines known as alpha-2 adrenergic receptor agonists. Both
substances reduce pressure in the eye.
SIMBRINZA is used to lower the pressure inside the eyes in adult patients (aged 18 years and older) who suffer from an eye disease known as glaucoma or ocular hypertension, in which high pressure inside the eye 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 (examples include medicines used to treat diabetes and infections, as well as diuretics (tablets))
• if you are taking monoamine oxidase inhibitors (MAO inhibitors) (e.g. medicines for the treatment of depression or Parkinson’s disease) or certain antidepressants. Inform your doctor if you are taking any antidepressant medication
• 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, or pharmacist before using SIMBRINZA if you have or have previously had:

• liver problems
• a type of high eye pressure called narrow-angle glaucoma
• dry eye problems or corneal disorders
• coronary heart disease (symptoms may include chest pain or tightness, difficulty breathing or suffocation), heart failure, high or low blood pressure
• depression
• disturbed or reduced blood circulation (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 ulcers after using SIMBRINZA or related medicines.

Use particular caution with SIMBRINZA:
Severe skin reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported in association with treatment with brinzolamide. If you notice any symptoms related to these severe skin reactions described in section 4, stop treatment with SIMBRINZA and contact your doctor immediately.
If you wear soft contact lenses, do not use the eye drops while wearing your lenses. (See the section below “Use of contact lenses – SIMBRINZA contains benzalkonium chloride”).
Children and adolescents
SIMBRINZA is not intended for use in children and adolescents under 18 years of age, as it has not been studied in this age group. It is particularly important that this medicine is not used in children under 2 years of age (see section above ‘Do not use SIMBRINZA’) as it may not be safe.
Other medicines and SIMBRINZA
Inform your doctor, ophthalmologist, or pharmacist if you are taking, have recently taken, or might take any other medicines.
SIMBRINZA may affect other medicines or be affected by other medicines you are using, including other eye drops for the treatment of glaucoma.
Inform your doctor if you are taking or intend to take any of the following medicines:

• medicines that lower blood pressure
• medicines for the heart, including digoxin (used to treat heart conditions)
• other medicines for the treatment of glaucoma that are also used for altitude sickness, such as acetazolamide, methazolamide, and dorzolamide
• medicines that affect metabolism such as chlorpromazine, methylphenidate, and reserpine
• antivirals, antiretrovirals (used for the treatment of Human Immunodeficiency Virus (HIV)) or antibiotics
• antifungal or anti-yeast medicines
• monoamine oxidase inhibitors (MAO inhibitors), or antidepressants including amitriptyline, nortriptyline, clomipramine, mianserin, venlafaxine, and duloxetine
• anaesthetics
• sedatives, opioids, or barbiturates.

Also inform your doctor if the dose of any medicine you are taking has been changed.
SIMBRINZA and alcohol
If you regularly consume alcohol, consult your doctor, ophthalmologist, or pharmacist before taking this medicine. Alcohol may affect SIMBRINZA.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor, ophthalmologist, or pharmacist before taking this medicine. Women of childbearing potential 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 prescribed by your doctor.
If you are breastfeeding, you should know that SIMBRINZA may be excreted in breast milk; therefore, the use of SIMBRINZA is not recommended during breastfeeding.
Driving and using machines
You may experience blurred or abnormal vision for a period of time after using SIMBRINZA.
SIMBRINZA may also cause dizziness, fatigue, or tiredness in some patients.
Do not drive or operate machinery until these symptoms have resolved.
Use of 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 may be absorbed by soft contact lenses and may cause a change in their colour. Remove your contact lenses before using this medicine and wait 15 minutes before reinserting them. Benzalkonium chloride may also cause eye irritation, especially if you have dry eyes or corneal disorders (the transparent outer layer of the eye). If you experience an unusual sensation in the eye, burning, or pain after using this medicine, speak with your doctor.

3. How to use SIMBRINZA

Always use this medicine exactly as instructed by your doctor, ophthalmologist, or pharmacist. If you have any doubts, consult your doctor, ophthalmologist, or pharmacist.
Use SIMBRINZA only in the eyes. Do not swallow or inject.
The recommended dose is one drop in the affected eye(s) twice daily. Use at the same time each day.
Instructions for use
Wash your hands before starting

1	2

Shake well before use.
Unscrew the cap. After removing the cap, if the loose protective ring is loose, remove it before using the medicine.
Do not touch the dropper tip with your fingers when opening or closing the bottle. This could contaminate the eye drops.
Take the bottle, turn it upside down, and hold it between your thumb and index finger.
Tilt your head backward.
Pull down the lower eyelid with a clean finger to create a "pocket" between the eyelid and the eye.
The drop should be instilled here (Figure 1).
Hold the tip of the bottle close to the eye. Use a mirror if it helps.
Do not touch the eye, eyelid, surrounding areas, or other surfaces with the tip of the bottle. This could contaminate the eye drops.
Gently press the base of the bottle to release one drop of SIMBRINZA.
Do not squeeze the bottle forcefully: it is designed to work with light pressure on the bottom (Figure 2).
To reduce the amount of medicine that may be absorbed into the rest of the body after eye drop application, close the eye and gently press with a finger on the corner of the eye near the nose for at least 2 minutes.

If you need to instill the eye drops in both eyes, repeat the steps for the other eye. It is not necessary to close and shake the bottle before using the drops in the other eye. Screw the cap back on tightly immediately after use.

If you are using other eye drops in addition to SIMBRINZA, wait at least five minutes between instilling SIMBRINZA and the other eye drop.

If a drop does not enter the eye, try again.

If you use more SIMBRINZA than you should
Immediately rinse the eye with lukewarm water. Do not use the eye drops until the next scheduled dose.
Adults who have accidentally ingested medicines containing brimonidine have experienced reduced heart rate, decreased blood pressure (which may be followed by increased blood pressure), heart failure, breathing difficulties, and effects on the nervous system. If any of these occur, contact your doctor immediately.
Serious adverse effects have been reported in children who have accidentally ingested medicines containing brimonidine. Some signs include drowsiness, weakness, low body temperature, paleness, and breathing difficulties. If any of these occur, contact your doctor immediately.
In case of accidental ingestion of SIMBRINZA, contact your doctor immediately.

If you forget to use SIMBRINZA
Continue treatment with the next dose as scheduled. Do not use a double dose to make up for the missed dose. Do not use more than one drop in the affected eye(s) twice daily.

If you stop using SIMBRINZA
Do not stop treatment with SIMBRINZA without first talking to your doctor. If you stop treatment with SIMBRINZA, intraocular pressure will not be controlled, which may lead to possible vision loss.

If you have any questions about the use of this medicine, consult your doctor, ophthalmologist, 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 help, as these may be signs of a reaction to the medicine. The frequency of an allergic reaction to the medicine is unknown (frequency cannot be estimated from the available data).

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

Contact your doctor immediately if you experience extreme tiredness or dizziness.
The following side effects have been observed with SIMBRINZA and with other medicines containing brinzolamide or brimonidine used separately:
Stop treatment with SIMBRINZA and contact your doctor immediately if you notice any of the following symptoms:

• Flat, reddish spots on the trunk, target-like or circular in appearance, often with central blisters, skin peeling, mouth, throat, nose, genital or eye ulcers. 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 users)

• Eye effects: allergic conjunctivitis (eye allergy), inflammation of the eye surface, eye pain, eye discomfort, blurred or abnormal vision, red eyes
• General side effects: drowsiness, dizziness, unpleasant taste, dry mouth

Uncommon (may affect up to 1 in 100 users)

• Eye effects: damage to the eye surface with loss of cells, eyelid inflammation, formation of deposits on the eye surface, light sensitivity, eye swelling (affecting the cornea or eyelid), dry eye, eye discharge, watery eyes, eyelid redness, abnormal or decreased eye sensitivity, tired eyes, reduced vision, double vision, drug residue in the eyes
• General side effects: decreased blood pressure, chest pain, irregular heartbeat, slow or fast heart rate, palpitations, difficulty sleeping (insomnia), nightmares, depression, generalized weakness, headache, dizziness, nervousness, irritability, general malaise, memory loss, shortness of breath, asthma, nosebleeds, cold symptoms, dry nose or throat, sore throat, irritated throat, cough, runny nose, nasal congestion, sneezing, sinus infection, chest congestion, ringing in the ears, indigestion, intestinal gas or stomach ache, nausea, diarrhoea, vomiting, abnormal taste sensation, increased allergic skin symptoms, rash, abnormal skin sensation, generalised itching, hair loss, increased blood chloride levels, blood tests showing a reduced red blood cell count, pain, back pain, muscle pain or spasms, kidney pain such as lower back pain, decreased libido, male sexual dysfunction

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

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

Not known (frequency cannot be estimated from the available data)

• Eye effects: reduced eyelash growth
• General side effects: tremor, reduced sensation, loss of taste, blood tests showing abnormal liver function values, facial swelling, joint pain, frequent urination, chest pain, swelling of the extremities, flat reddish spots on the trunk, target-like or circular in appearance, often with central blisters, skin peeling, mouth, throat, nose, genital or eye ulcers, 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 side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, ophthalmologist, or pharmacist. You can also report side effects directly via the national reporting system referred to in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store 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 that month.
This medicine does not require any special storage conditions.
To prevent infection, discard the bottle 4 weeks after first opening and use a new bottle.
Write the date of opening in the space provided on the carton.
Do not dispose of any medicine via wastewater or household waste. Ask your ophthalmologist or
pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What SIMBRINZA contains

• 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 "Use of contact lenses – SIMBRINZA contains benzalkonium chloride"), propylene glycol, carbomer 974P, boric acid, mannitol, sodium chloride, tyloxapol, hydrochloric acid and/or sodium hydroxide, and purified water.

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

Description of the appearance of SIMBRINZA and contents of the pack

SIMBRINZA ophthalmic suspension is a liquid (white to almost white suspension) supplied in a pack containing one or three 5 ml plastic bottles with screw caps. Not all pack sizes may be marketed.

Marketing Authorisation 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 Nuremberg
Germany

For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Novartis Pharma N.V. SIA Novartis Baltics Lietuvos filialas
Tél/Tel: +32 2 246 16 11 Tel: +370 5 269 16 50

България Luxembourg/Luxemburg
Novartis Bulgaria EOOD Novartis Pharma N.V.
Тел.: +359 2 489 98 28 Tél/Tel: +32 2 246 16 11

Česká republika Magyarország
Novartis s.r.o. Novartis Hungária Kft.
Tel: +420 225 775 111 Tel.: +36 1 457 65 00

Danmark Malta
Novartis Healthcare A/S Novartis Pharma Services Inc.
Tlf: +45 39 16 84 00 Tel: +356 2122 2872

Deutschland Nederland
Cranach Pharma GmbH
Novartis Pharma B.V.
Tel: +49 40 3803837-10 Tel: +31 88 04 52 111

Eesti Norge
SIA Novartis Baltics Eesti filiaal Novartis Norge AS
Tel: +372 66 30 810 Tlf: +47 23 05 20 00

Ελλάδα Österreich
Novartis (Hellas) A.E.B.E. Novartis Pharma GmbH
Τηλ: +30 210 281 17 12 Tel: +43 1 86 6570

España Polska
Novartis Farmacéutica, S.A. Novartis Poland Sp. z o.o.
Tel: +34 93 306 42 00 Tel.: +48 22 375 4888

France Portugal
Novartis Pharma S.A.S. Novartis Farma - Produtos Farmacêuticos, S.A.
Tél: +33 1 55 47 66 00 Tel: +351 21 000 8600

Hrvatska România
Novartis Hrvatska d.o.o. Novartis Pharma Services Romania SRL
Tel. +385 1 6274 220 Tel: +40 21 31299 01

Ireland Slovenija
Novartis Ireland Limited Novartis Pharma Services Inc.
Tel: +353 1 260 12 55 Tel: +386 1 300 75 50

Ísland Slovenská republika
Vistor hf. Novartis Slovakia s.r.o.
Sími: +354 535 7000 Tel: +421 2 5542 5439

Italia Suomi/Finland
Novartis Farma S.p.A. Novartis Finland Oy
Tel: +39 02 96 54 1 Puh/Tel: +358 (0)10 6133 200

Κύπρος Sverige
Novartis Pharma Services Inc. Novartis Sverige AB
Τηλ: +357 22 690 690 Tel: +46 8 732 32 00

Latvija
SIA Novartis Baltics
Tel: +371 67 887 070

Other sources of information

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