Simbrinza 10 mg/2 mg Suspension

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 substances work together to reduce pressure within the eye. SIMBRINZA is used to lower pressure in the eyes in adult patients (aged 18 years and over) who have eye conditions known as glaucoma or ocular hypertension and whose high pressure in the eyes cannot be controlled effectively by one medicine alone.

Do not use SIMBRINZA:

• if you are hypersensitive (allergic) to brinzolamide or brimonidine tartrate or any of the other ingredients of SIMBRINZA
• if you are allergic to sulphonamides (examples include medicines used to treat diabetes and infections and also diuretics (water tablets))
• if you are taking a monoamine oxidase (MAO) inhibitors (examples include medicines to treat depression or Parkinson’s disease) or certain antidepressants. You must inform your doctor if you are taking any antidepressant medicines
• if you have severe kidney problems
• if you have too much acidity in your blood (a condition called hyperchloraemic acidosis)
• in babies and infants aged less than 2 years.

Do not share medicines prescribed for you with any other person.

Always use SIMBRINZA exactly as your doctor, optometrist (optician) or pharmacist has told you. Check with your doctor, optometrist (optician) or pharmacist if you are not sure.

Only use SIMBRINZA for your eyes. Do not swallow or inject. The recommended dose is:

• One drop in the affected eye or eyes two times a day. Use at the same time each day.

Your doctor will tell you how long your treatment with SIMBRINZA will last.

Do not stop treatment early because this may affect your condition.

If you have the impression that the effect of SIMBRINZA is too strong or too weak, tell your doctor, optometrist (optician) or pharmacist.

How to use:

1. Wash your hands before you start.
2. Shake bottle gently before use.
3. Twist off the bottle cap. After the cap is removed, if the tamper evident snap collar is loose, remove it before using SIMBRINZA.
4. Do not touch the dropper with your fingers when opening or closing the bottle as it could infect the drops.
5. Hold the bottle, pointing down, between your thumb and fingers.
6. Tilt your head back.
7. Pull down your lower eyelid with a clean finger, until there is a ‘pocket’ between the eyelid and your eye. The drop will go in here (picture 1).
8. Bring the bottle tip close to the eye. Do this in front of a mirror if it helps.
9. Do not touch your eye or eyelid, surrounding areas or other surfaces with the dropper. It could infect the drops.
10. Gently press on the base of the bottle to release one drop of SIMBRINZA.
11. Do not squeeze the bottle: it is designed so that a gentle press on the bottom is all that it needs (picture 2).
12. To reduce the amount of medicine that could come into the rest of the body after application of the eye drop, close your eye and apply gentle pressure to the corner of the eye next to the nose with a finger for at least 2 minutes.
13. If you use drops in both eyes, repeat the steps for your other eye. It is not necessary to close and shake the bottle before you apply the drop in your other eye. Close the bottle cap firmly immediately after use.
14. If you are using other eye drops as well as SIMBRINZA, wait at least five minutes between using SIMBRINZA and the other drops.
15. If a drop misses your eye, try again.

SIMBRINZA can have side effects. Not all side effects reported for SIMBRINZA are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking SIMBRINZA, please consult your healthcare professional for advice.

If any of the following happens, stop using SIMBRINZA and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing
• rash or itching
• red skin, skin peeling blistering of the lips, eyes or mouth, fever or any combination of these (Stevens-Johnson syndrome/ toxic epidermal necrolysis)
• extreme tiredness, dizziness, fainting
• trouble breathing
• chest pain, irregular heartbeat

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to SIMBRINZA. You may need urgent medical attention or hospitalisation.

Tell your doctor if you notice any of the following:

The following side effects have been reported frequently:

• Allergic conjunctivitis (eye allergy), eye surface inflammation, eye pain, eye discomfort, blurred or abnormal vision, eye redness
• drowsiness, bad taste in mouth, dry mouth

The following side effects have been reported less frequently:

• Eye surface damage with loss of cells, inflammation of the eyelid, deposits on the eye surface, sensitivity to light, swelling of the eye (affecting the cornea or eyelid), dry eye, eye discharge, watery eye, eyelid redness, abnormal or decreased sensation in eye, tired eye, reduced vision, double vision, product particles in eyes
• decreased blood pressure, slow or fast heart rate, palpitations
• difficulty sleeping (insomnia), nightmares, depression, generalised weakness, headache, dizziness, nervousness, irritability; general feeling of being unwell, memory loss
• asthma, nose bleeds, cold symptoms, dry nose or throat, sore throat, throat irritation, cough, runny nose, stuffy nose, sneezing, sinus infection, chest congestion, ringing in ear
• indigestion, intestinal gas or stomach-ache, nausea, diarrhoea, vomiting, abnormal sensation in mouth
• increased allergic symptoms on skin, abnormal skin sensation, hair loss, generalised itching
• increased blood chlorine levels, or decreased red blood cell count as seen in a blood test
• pain, back pain, muscle pain or spasm, kidney pain such as lower back pain
• decreased libido, male sexual difficulty
• decreased pupil size
• increased blood pressure

The following side effects have been reported but the frequency is unknown:

• Decreased growth of eyelashes
• tremor, decreased sensation, loss of taste, abnormal liver function values as seen in a blood test, swelling of the face, joint pain, frequent urination, chest pain, swelling of the extremities
• Skin rash, red skin, skin peeling, blistering of the lips, eyes or mouth, fever or any combination of these (Stevens-Johnson syndrome/ toxic epidermal necrolysis)

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Store all medicines out of out of reach of children.

Do not use SIMBRINZA after the expiry date which is stated on the bottle and the carton after “EXP”. The expiry date refers to the last day of that month.

Do not store above 30 ºC.

Throw away the bottle 30 days after first opening to prevent infections and use a new bottle. Write down the date of opening on the carton.

Do not throw away any medicines via wastewater or household waste. Ask your optometrist (optician) or pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

Store in the original package / container.

Do not store in a bathroom.

Do not dispose of unused medicine in drains or sewerage systems (e.g., toilets)