Package leaflet: Information for for the treatment of . Tell your the user doctor if you are taking or intend to take medicines to lower blood pressure like / parasympathomimetics and guanetidine, or other heart medicines including Mylan quinidine (used to treat heart conditions and some types of malaria), amiodarone 10 mg/ml + 5 mg/ml or other medicines to treat heart rhythm disorders and glycosides to treat heart eye drops, insufficiency. Also tell your doctor if you are taking or intend to take medicines suspension to treat diabetes, or to treat gastric brinzolamide/timolol ulcers, antifungal, antiviral or antibiotic medicines, or antidepressants such as Read all of this leaflet carefully fluoxetine and paroxetine. before you start using this medicine because it contains important If you are taking another carbonic information for you. anhydrase inhibitor ( or ), talk to your doctor. • Keep this leaflet. You may need to Increase in pupil size when taking read it again. Brinzolamide/Timolol Mylan and • If you have any further questions, ask your doctor or pharmacist. (epinephrine) together has • This medicine has been prescribed been reported occasionally. for you only. Do not pass it on to Pregnancy and breast-feeding others. It may harm them even if You should not use Brinzolamide/Timolol their signs of illnesses are the same Mylan if you are pregnant or might get as yours. pregnant, unless your doctor considers it • If you get any side effects, talk to necessary. Talk to your doctor before you your doctor or pharmacist. This includes any possible side effects not use Brinzolamide/Timolol Mylan. listed in this leaflet. See section 4. Do not use Brinzolamide/Timolol Mylan if you are breast feeding, timolol may get What is in this leaflet into your milk. 1. What Brinzolamide/Timolol Mylan is Ask your doctor for advice before taking and what it is used for any medicine during breastfeeding. 2. What you need to know before you use Brinzolamide/Timolol Mylan Driving and using machines 3. How to use Brinzolamide/Timolol Do not drive or use machines until Mylan your vision is clear. You may find that 4. Possible side effects your vision is blurred for some time just 5. How to store Brinzolamide/Timolol after using Brinzolamide/Timolol Mylan. Mylan 6. Contents of the pack and other One of the active ingredients may impair information the ability to perform tasks requiring mental alertness and/or physical 1. What Brinzolamide/Timolol coordination. If affected take care when Mylan is and what it is used for driving or using machines. Brinzolamide/Timolol Mylan contains two active substances, brinzolamide and Brinzolamide/Timolol Mylan contains timolol, which work together to reduce benzalkonium chloride pressure within the eye. This medicine contains 0.0033 mg benzalkonium chloride in each drop Brinzolamide/Timolol Mylan is used which is equivalent to 0.01% or 0.1 mg/ml. to treat high pressure in the eyes, also called glaucoma or ocular hypertension, Benzalkonium chloride is a preservative in adult patients that are more than in Brinzolamide/Timolol Mylan that may 18 years of age and in whom high be absorbed by soft contact lenses and pressure in the eyes cannot be controlled may change the colour of the contact effectively by one medicine alone. lenses. You should remove contact lenses 2. What you need to know before before using this medicine and put them you use Brinzolamide/Timolol back 15 minutes afterwards. TBC Mylan Benzalkonium chloride may also cause Do not use Brinzolamide/Timolol eye irritation, especially if you have dry Mylan: eyes or disorders of the cornea (the clear • If you are allergic to brinzolamide, layer at the front of the eye). If you feel medicines called sulphonamides abnormal eye sensation, stinging or pain (examples include medicines used in the eye after using this medicine, talk to treat diabetes, infections and also to your doctor. diuretics (water tablets)), timolol, beta-blockers (medicines used to 3. How to use Brinzolamide/ lower blood pressure or to treat heart Timolol Mylan disease) or any of the other ingredients

TBC Always use this medicine exactly as your of this medicine (listed in section 6). • If you have now or have had in the doctor or pharmacist has told you. Check past respiratory problems such as with your doctor or pharmacist if you are asthma, severe long lasting obstructive not sure. bronchitis (severe lung condition If you are changing from another eye which may cause wheezing, difficulty drop medicine used to treat glaucoma to in breathing and/or long standing Brinzolamide/Timolol Mylan, you should cough) or other types of breathing stop using the other medicine and start problems. using Brinzolamide/Timolol Mylan the • If you have severe hay fever following day. Check with your doctor or • If you have a slow heart beat, heart pharmacist if you are not sure failure or disorders of heart rhythm (irregular heartbeats). To prevent contamination of the • If you have too much acidity in dropper tip and the suspension, care your blood (a condition called must be taken not to touch the eyelids, hyperchloraemic acidosis). surrounding areas or other surfaces with • If you have severe kidney problems. the dropper tip. Keep the bottle tightly Warnings and precautions closed when not in use. Only use Brinzolamide/Timolol Mylan for The following measure is useful to limit dropping in your eye(s). the amount of medicine that will come If signs of serious reactions or into the blood after application of eye TBC hypersensitivity occur, discontinue the drops: use of this product and talk to your • Keep the eyelid closed, while doctor. simultaneously applying gentle Talk to your doctor or pharmacist before pressure to the corner of the eye using Brinzolamide/Timolol Mylan if you next to the nose with a finger for at have or have had in the past: least 2 minutes. • coronary heart disease (symptoms can include chest pain or tightness, The recommended dose is one drop in breathlessness or choking), heart the affected eye or eyes, twice a day. failure, low blood pressure Only use Brinzolamide/Timolol Mylan in • disturbances of heart rate such as slow both eyes if your doctor told you to. Take heart beat it for as long as your doctor told you to. • breathing problems, asthma or chronic How to use: obstructive pulmonary disease • poor blood circulation disease (such as Raynaud’s disease or Raynaud’s syndrome) • diabetes as timolol may mask signs and symptoms of low blood sugar • overactivity of the thyroid gland as timolol may mask signs and symptoms of thyroid disease • muscular weakness (myasthenia gravis) • tell your doctor before you have Picture 1 an operation that you are using Brinzolamide/Timolol Mylan as timolol may change effects of some medicines used during anaesthesia. • if you have a history of atopy (a tendency to develop an allergic reaction) and severe allergic reactions you may be more sensitive to developing an allergic reaction whilst using Brinzolamide/Timolol Mylan and adrenaline may not be as effective to treat an allergic reaction. When Picture 2 receiving any other treatment please tell the doctor or nurse that you are taking Brinzolamide/Timolol Mylan. • if you have liver problems. • if you have dry eyes or cornea problems. • if you have problems with your kidneys. Children and adolescents Picture 3 Brinzolamide/Timolol Mylan is not recommended for children and adolescents under 18 years. • Get the bottle and a mirror. • Wash your hands. Other medicines and Brinzolamide/ • Shake well before use. Timolol Mylan • Twist off the bottle cap. After the cap Tell your doctor or pharmacist if you are using, have recently used or might use is removed, if the tamper evident snap any other medicines. collar is loose, remove before using product. Brinzolamide/Timolol Mylan can affect, • Hold the bottle, pointing down, or be affected by, other medicines you between your thumb and forefinger. are taking, including other eye drops

Description Brinzolamide_Timolol_10mg_ml+5mg_ml_1 Date: 03 Jan 20 Time: 16:35

Component Type Leaflet Pharma Code TBC No. of colours 1 Page Count 1 / 2 Affiliate Item Code 2033429 SAP No. 400546982 Colours Black Superceded Affiliate Item Code N/A Vendor Job No. 103223180/0120 Non-Print TrackWise PR No. 2033429 Trackwise Proof No. 5 Colours MA No. PL 04569/1807 Client Market United Kingdom Equate CMYK Packing Site/Printer Lusomedicamenta Keyline/Drawing No with (Barcarena - PT) 140x590 mm V2 Supplier Code TBC Barcode Info. N/A Main Font Myriad Pro Body Text Size 9 pt 3D Render ID N/A Dimensions 140 x 590 mm Min Text Size used 9 pt Sign-offs

v3/Jul 2017 • Tilt your head back. Pull down your low blood pressure, discoloration of eyelid with a clean finger, until there the fingers, toes, and occasionally is a ‘pocket’ between the eyelid and other areas of the body (Raynaud’s your eye. The drop will go in here phenomenon), cold hands and feet. (picture 1). • Respiratory: Constriction of the • Bring the bottle tip close to the eye. airways in the lungs (predominantly Use the mirror if it helps. in patients with pre-existing disease) • Do not touch your eye or eyelid, shortness of breath or difficulty surrounding areas or other surfaces breathing, cold symptoms, chest with the dropper. It could infect the congestion, sinus infection, sneezing, drops. stuffy nose, dry nose, nose bleeds, • Squeeze one drop into the formed asthma, throat irritation. pocket (picture 2). • Nervous system and general • After using Brinzolamide/Timolol disorders: depression, nightmares, Mylan, press a finger to the corner memory loss, headache, nervousness, of your eye, by the nose for at irritability, tiredness, shaking, least 1 minute. This helps to stop feeling abnormal, fainting, dizziness, Brinzolamide/Timolol Mylan getting drowsiness, generalised or severe into the rest of the body (picture 3). weakness, unusual sensations like pins • If you use drops in both eyes, repeat and needles, hallucination. the steps for your other eye. • Gastric: nausea, vomiting, diarrhoea, • Close the bottle cap firmly immediately intestinal gas or abdominal discomfort, after use. inflammation of the throat, dry • Use up one bottle before opening the or abnormal sensation in mouth, next bottle. indigestion, stomach ache. • Blood: abnormal liver function values, If a drop misses your eye, try again. increased blood chlorine levels, or If you are using other eye drop or eye decreased red blood cell count as seen ointment medicines leave at least in a blood test. 5 minutes between each medicine. Eye • Allergy: increased allergic symptoms, ointments should be administered last. generalised allergic reactions including swelling beneath the skin that can If you use more Brinzolamide/Timolol occur in areas such as the face and Mylan than you should, rinse your eye limbs and can obstruct the airway with warm water. Do not put in any more which may cause difficulty swallowing drops until it is time for your next regular or breathing, hives, localised and dose. generalised rash, itchiness, severe You may experience a decreased heart sudden life-threatening allergic rate, decreased blood pressure, heart reaction. failure; difficulty breathing and your • Ear: ringing in the ears, sensation of nervous system may be affected. spinning or dizziness. • Skin: rash, skin redness or If you forget to use Brinzolamide/ inflammation, abnormal or decreased Timolol Mylan, continue with the next skin sensation, hair loss, rash with dose as planned. Do not use a double white silvery coloured appearance dose to make up for the forgotten dose. (psoriasiform rash) or worsening of Do not use more than one drop in the psoriasis. affected eye(s) twice daily. • Muscular: generalised back, joint, or If you stop using Brinzolamide/ muscle pain not caused by exercise, Timolol Mylan without speaking to your muscle spasms, pain in extremities, doctor, the pressure in your eye will not muscle weakness/tiredness, increases be controlled which could lead to loss of in the signs and symptoms of sight. myasthenia gravis (muscle disorder). • Kidney: kidney pain such as lower If you have any further questions on the back pain, frequent urination. use of this medicine, ask your doctor or • Reproduction: sexual dysfunction, pharmacist. decreased libido, male sexual 4. Possible side effects difficulty. • Metabolism: low blood sugar levels. Like all medicines, this medicine can cause side effects although not Reporting of side effects everybody gets them. If you get any side effects, talk to your doctor or pharmacist. This includes any Stop using this medicine and contact possible side effects not listed in this your doctor immediately if you develop leaflet. You can also report side effects skin rash, severe skin reaction, or severe directly via the Yellow Card Scheme redness and itching of the eye. These at www.mhra.gov.uk/yellowcard or could be the signs of an allergic reaction search for MHRA Yellow Card in the (frequency is not known). Google Play or Apple App Store By reporting side effects you can help You can usually carry on taking the provide more information on the safety drops, unless the effects are serious. of this medicine. If you are worried, talk to your doctor or pharmacist. Do not stop using 5. How to store Brinzolamide/ Brinzolamide/Timolol Mylan without Timolol Mylan speaking to your doctor first. Keep this medicine out of the sight and Common side effects (may affect up reach of children. to 1 in 10 people): Do not use this medicine after the expiry • Effects in the eye: eye surface date which is stated on the bottle and inflammation, blurred vision, signs the carton after EXP. The expiry date and symptoms of eye irritation (e.g. refers to the last day of that month. burning, stinging, itching, tearing, This medicine does not require any redness), eye pain. special storage conditions. • General side effects: heart rate decreased, taste disturbances. Throw away the bottle 4 weeks after first opening to prevent infections, and use Uncommon side effects (may affect up a new bottle. Write down the date of to 1 in 100 people): opening on the bottle label and carton • Effects in the eye: corneal erosion label in the space provided. (damage to the front layer of the eyeball), Eye surface inflammation with Do not throw away any medicines surface damage, inflammation inside via wastewater or household waste. the eye, corneal staining, abnormal Ask your pharmacist how to throw sensation in the eyes, eye discharge, away medicines you no longer use. dry eye, tired eyes, itchy eye, eye These measures will help protect the redness, eyelid redness. environment. • General side effects: decrease in 6. Contents of the pack and other white blood cell count, decreased information blood pressure, cough, blood in urine, body weakness. What Brinzolamide/Timolol Mylan contains: Rare side effects (may affect up • The active substances are brinzolamide to 1 in 1000 people): and timolol. One ml of suspension • Effects in the eye: corneal disorder, contains 10 mg of brinzolamide and sensitivity to light, increased tear timolol maleate corresponding to 5 mg production, eyelid crusting timolol. • General side effects: difficulty sleeping (insomnia), throat pain, • The other ingredients are running nose benzalkonium chloride (see section 2 ‘Brinzolamide/Timolol Mylan Not known (frequency cannot be contains benzalkonium chloride’), estimated from the available data): carbomer, disodium edetate, mannitol • Effects in the eye: eye allergy, (E421), purified water, sodium chloride, disturbance of vision, damage to the hydrochloric acid and/or sodium optic nerve, increased pressure in eye, hydroxide. deposits on the eye surface, decreased Tiny amounts of hydrochloric acid and/ eye sensation, inflammation or or sodium hydroxide are added to keep infection of the conjunctiva (white of acidity levels (pH levels) normal. the eye), abnormal, double or reduced vision, increased pigmentation of the What Brinzolamide/Timolol Mylan eye, growth on surface of eye, eye looks like and contents of the pack swelling, sensitivity to light, decreased Brinzolamide/Timolol Mylan is a liquid growth or number of eyelashes, (white to off-white uniform suspension) drooping of the upper eyelids supplied in a carton containing a 5 ml (making the eye stay half closed), low density polyethylene (LDPE) bottle inflammation of the eyelid and eye lid with a LDPE insert dropper and a high glands, inflammation in the cornea density polyethylene (HDPE) cap and detachment of the layer below containing 5 ml suspension. the retina that contains blood vessels Cartons contain 1, 3 or 6 bottles. following filtration surgery which may cause visual disturbances, decreased Not all pack sizes may be marketed. corneal sensitivity. Marketing Authorisation Holder • Heart and circulation: changes in Mylan, rhythm or rate of the heartbeat, slow Potters Bar, heart rate, palpitations, a type of heart EN6 1TL, rhythm disorder, abnormal increase in United Kingdom. heart rate, chest pain, reduced heart function, heart attack, increased blood Manufacturer pressure, reduced blood supply to the Lusomedicamenta Sociedade Tecnica Farmaceutica SA, brain, stroke, oedema (fluid build-up), Povoa de Santo Adriao, congestive heart failure (heart disease Portugal with shortness of breath and swelling of the feet and legs due to fluid This leaflet was last revised in build-up), swelling of the extremities, December 2019

2033429

Description Brinzolamide_Timolol_10mg_ml+5mg_ml_1 Date: 03 Jan 20 Time: 16:35

Component Type Leaflet Pharma Code TBC No. of colours 1 Page Count 2 / 2 Affiliate Item Code 2033429 SAP No. 400546982 Colours Black Superceded Affiliate Item Code N/A Vendor Job No. 103223180/0120 Non-Print TrackWise PR No. 2033429 Trackwise Proof No. 5 Colours MA No. PL 04569/1807 Client Market United Kingdom Equate CMYK Packing Site/Printer Lusomedicamenta Keyline/Drawing No with (Barcarena - PT) 140x590 mm V2 Supplier Code TBC Barcode Info. N/A Main Font Myriad Pro Body Text Size 9 pt 3D Render ID N/A Dimensions 140 x 590 mm Min Text Size used 9 pt Sign-offs

v3/Jul 2017