SIMBRINZA - Brinzolamide / Brimonidine tartrate uses, dose and side effects

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

SABRINA is used to lower the pressure in the eyes in adult patients (18 years or older) who have eye diseases called glaucoma or ocular hypertension, and for whom it is not possible to effectively control the high pressure in the eyes with just one drug.

What you need to know before using 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 (for example medicines used to treat diabetes and infection and diuretics (diuretic tablets)
if you are taking monoamine oxidase inhibitors ( MAOIs ) (for example, medicines used to treat depression or Parkinson’s disease ) or certain antidepressants. You must tell your doctor if you are taking medicines for depression
if you have severe kidney problems
if you have too much acidity in your blood (a condition called hyperchloraemic acidosis )
to newborns and children under 2 years.

Warnings and cautions

Talk to your doctor, optician, or pharmacist before using SIMBRINZA if you have or have ever had:

liver problem
a type of high pressure in the eyes called narrow-angle glaucoma
dry eyes or corneal problems
coronary heart disease (symptoms may include chest pain, chest tightness, shortness of breath, or suffocation), heart failure, high or low blood pressure
Depression
disturbed or poor blood circulation (such as Raynaud’s disease or Raynaud’s syndrome or cerebral insufficiency )

If you wear soft contact lenses, do not use the drops with the contact lenses left in your eyes. See section “Using contact lenses – SIMBRINZA contains benzalkonium chloride” below).

Children and young people

SABRINA is not recommended for children and adolescents under 18 years of age as it has not been studied in this age group. The medicine mustn’t be used in children under 2 years of age as it cannot be considered safe (see section “Do not use SIMBRINZA” above).

Other medicines and SIMBRINZA

Tell your doctor, optician, or pharmacist if you are taking, have recently taken, or might take any other medicines.

SIMBRINZA can affect or be affected by other medicines you use, including other eye drops for glaucoma.

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

drugs that lower blood pressure et
cardiac drugs including digoxin (used to treat heart disease)
other anti- glaucoma medicines that also treat altitude sickness are called acetazolamide, methazolamide, and dorzolamide
drugs that may affect metabolisms, such as chlorpromazine, methylphenidate, and reserpine
antiviral, antiretroviral medicines (medicines used to treat HIV ), or antibiotics
drugs against yeasts and fungi
monoamine oxidase inhibitors ( MAOIs ), or antidepressants including amitriptyline, nortriptyline, clomipramine, mianserin, venlafaxine, and duloxetine
drugs for anesthesia
sedatives, opiates, or barbiturates.

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

SIMBRINZA with alcohol

If you drink alcohol regularly, consult your doctor, optician, or pharmacist before taking this medicine. SIMBRINZA can be affected by alcohol.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor, optician, or pharmacist for advice before taking this medicine. Women who may become pregnant should use effective contraception while being treated with SIMBRINZA. The use of SIMBRINZA is not recommended during pregnancy. Do not use SIMBRINZA unless your doctor prescribes it.

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

Driving and using machines

When you use SIMBRINZA, you may notice that your vision becomes blurred or abnormal for a while. SIMBRINZA may also cause dizziness, drowsiness, or fatigue in some patients.

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

Use of 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 discolor the contact lenses. Remove contact lenses before using the medicine and wait at least 15 minutes before re-inserting the contact lenses. Benzalkonium chloride can be irritating to the eyes, especially if you have dry eyes or problems with the cornea (the clear membrane at the front of the eye). If you experience irritation, tingling, or pain in the eye after using the medicine, consult a doctor.

How to use SIMBRINZA

Always use this medicine exactly as your doctor, optician or pharmacist has told you. If you are not sure, talk to your doctor, optician, or pharmacist.

SIMBRINZA should only be used in the eyes. It must not be swallowed or injected.

The recommended dose is one drop in the affected eye or eyes twice a day. Use the drops at the same time each day.

Instructions for use

Wash your hands before you start.

Shake well before use.

Turn off the bottle cap. If the safety collar is loose after removing the cover, remove the collar before using the medicine.

Avoid touching the drip tip with your fingers when opening or closing the bottle. It can contaminate the drops.

Hold the bottle upside down between your thumb and fingers.

Tilt your head back.

Pull down the lower eyelid with a clean finger until a “pocket” is formed between the eyelid and the eye. The drop should end up in the pocket (picture 1).

Move the tip of the bottle close to the eye. You can stand in front of a mirror if that helps.

Do not touch the eye or eyelid, surrounding areas, or other surfaces with the bottle tip. It can contaminate the drops.

Gently press the bottom of the bottle to release a drop of SIMBRINZA.

Do not squeeze the bottle; it is designed so that a light pressure at the bottom is sufficient (Fig. 2).

To reduce the amount of medicine that can get into the rest of your body after using the eye drop, close your eyes and press lightly with a finger in the corner of your eye at your nose for at least 2 minutes.

If you use the drops in both eyes, repeat the different steps for your other eye. You do not need to close and shake the bottle before administering the drop to the other eye. Tighten the bottle cap carefully immediately after use.

If you use other eye drops besides SIMBRINZA, wait at least five minutes between administering one off and the other drops.

If the drop misses the eye, try again.

If you use more SIMBRINZA than you should

Rinse the eye with lukewarm water. Do not take any more drops until it is time for your next regular dose.

Adults who inadvertently swallowed drugs containing brimonidine had a slower heart rate and decreased blood pressure which may be followed by high blood pressure, heart failure, difficulty breathing, and effects on the nervous system. If this happens, consult a doctor immediately.

Serious side effects have been reported in children who have swallowed brimonidine. Signs include drowsiness, lethargy, low body temperature, pallor, and difficulty breathing. If this happens, consult a doctor immediately.

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

If you forget to use SIMBRINZA

Continue with the next dose as planned. Do not take a double dose to make up for a forgotten dose. Do not use more than one drop in the affected eye (s) twice daily.

If you stop using SIMBRINZA

Do not stop using SIMBRINZA without talking to a doctor. If you stop using SIMBRINZA, the pressure in your eye will not be checked, which could lead to vision loss.

If you have any further questions on the use of this product, ask your doctor, optician, or pharmacist.

Possible side effects

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

If you get any of the following side effects, stop using the medicine and seek medical attention immediately, as it may be a sign of a reaction to the medicine. The frequency of allergic reactions to the drug is unknown (can not be calculated from the available data).

Severe skin reactions, including rash or redness or itching of the body or eyes.
Hard to breathe.
Chest pain, irregular heartbeat.

Contact a doctor immediately if you become extremely tired or dizzy.

The following side effects have been reported with SIMBRINZA and other medicines containing brinzolamide or brimonidine alone:

Common (may affect up to 1 in 10 people)

Effects on the eye: allergic conjunctivitis (eye allergy), superficial eye inflammation, eye pain, eye discomfort, blurred or abnormal vision, and red eyes.
General side effects: drowsiness, dizziness, bad taste in the mouth, dry mouth.

Uncommon (may affect up to 1 in 100 people)

Effects in the eye: superficial eye damage with loss of cells, inflammation of the eyelid, deposits on the surface of the eye, photosensitivity, swelling of the eye (in the cornea or eyelid), dry eye, discharge from the eye, watery eye, redness of the eyelid, abnormal or decreased sensation in the eye, fatigue in the eye, impaired vision, double vision, product particles in the eyes.
Common side effects: decreased blood pressure, chest pain, irregular heartbeat, slow or fast heartbeat, palpitations, difficulty sleeping (insomnia), nightmares, depression, general weakness, headache, dizziness, nervousness, irritability, general malaise, memory loss, shortness of breath, shortness of breath, shortness of breath, cold symptoms, dry nose or throat, sore throat, throat irritation, cough, runny nose, stuffy nose, sneezing, sinusitis, chest tightness, ringing in the ears, indigestion, gas in the intestines or stomach pain, nausea, diarrhea, vomiting, abnormal vomiting, mouth, increased allergic symptoms in the skin, rash, abnormal sensation in the skin, hair loss, general itching, elevated levels of chlorine in the blood, or decreased number of red blood cells during blood tests, pain, back pain, muscle pain or – spasm, kidney pain such as. low back pain, decreased sexual drive, sexual problems for men

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

Eye effects: reduced pupil size.
General side effects: fainting, high blood pressure.

No known frequency (can not be calculated from the available data)

Effects in the eye: decreased growth of the eyelashes.
Common side effects: shaking, decreased sensation, loss of taste, abnormal liver function values in blood tests, swelling of the face, joint pain, need to urinate frequently, chest pain and swelling in the extremities.

How to store 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 expiration date is the last day of the specified month.

No special storage instructions.

Discard the bottle 4 weeks after opening it, to prevent infection, and use a new bottle. Write down the date you opened it in the space provided on the box.

Medicines should not be disposed of via wastewater or household waste. Ask your optician or pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Contents of the packaging and other information

Content declaration

The active substances are brinzolamide and brimonidine tartrate. One ml of suspension contains 10 mg of brinzolamide and 2 mg of brimonidine tartrate corresponding to 1.3 mg of brimonidine.
The other ingredients 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 keep the acidity ( pH ) normal.

What the medicine looks like and the contents of the pack

SIMBRINZA eye drops, the suspension is a liquid (white to off-white suspension ) that is delivered in a package 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 Pharmacéutica, SA

Gran Via de Les Corts Catalanes, 764

08013 Barcelona

Spain

SA Alcon-Couvreur NV

Rijksweg 14

BE-2870 Puurs

Belgium

Novartis Pharma GmbH

Roonstraße 25

D-90429 Nuremberg

Germany

Siegfried El Masnou, SA

Camil Fabra 58

El Masnou

08320 Barcelona