Brinzolamide/Timolol 10Mg/Ml + 5Mg/Ml Eye Drops, Suspension

Package leaflet: Information for the user Brinzolamide/Timolol 10mg/ml + 5mg/ml eye drops, suspension

Read all of this leaflet carefully Other medicines and before you start using this Brinzolamide/Timolol eye drops medicine because it contains Tell your doctor or pharmacist if you are using, have recently used or might important information for you. use any other medicines.

- Keep this leaflet. You may need Brinzolamide/Timolol eye drops can affect, or be affected by, other to read it again medicines you are taking, including - If you have any further questions, other eye drops for the treatment ask your doctor, pharmacist or of glaucoma. Tell your doctor if nurse you are taking or intend to take medicines to lower blood pressure - This medicine has been like parasympathomimetics and prescribed for you only. Do not guanetidine, or other heart medicines pass it on to others. It may harm including quinidine (used to treat heart them, even if their signs of illness conditions and some types of malaria), are the same as yours amiodarone or other medicines to treat heart rhythm disorders and glycosides - If you get any side effects, talk to to treat heart insufficiency. Also tell your doctor or pharmacist. This your doctor if you are taking or intend includes any possible side effects to take medicines to treat diabetes, not listed in this leaflet. See or to treat gastric ulcers, antifungal, antiviral or antibiotic medicines, or section 4 antidepressants such as fluoxetine and - The full name of this medicine is paroxetine. Brinzolamide/Timolol If you are taking another carbonic 10mg/mL + 5mg/mL eye drops, anhydrase inhibitor (acetazolamide or suspension but within this dorzolamide), talk to your doctor. leaflet it will be referred to as Increase in pupil size when taking Brinzolamide/Timolol eye drops. Brinzolamide/Timolol eye drops and adrenaline (epinephrine) together has What is in this leaflet been reported occasionally. 1 What Brinzolamide/Timolol Pregnancy and breast-feeding eye drops are and what they You should not use Brinzolamide/ are used for Timolol eye drops if you are pregnant 2 or might get pregnant, unless What you need to know your doctor considers it necessary. before you use Brinzolamide/ Talk to your doctor before you use Timolol eye drops Brinzolamide/Timolol eye drops. 3 How to use Brinzolamide/ Do not use Brinzolamide/Timolol eye Timolol eye drops drops if you are breast-feeding, timolol 4 Possible side effects may get into your milk. 5 How to store Brinzolamide/ Ask your doctor for advice before taking any medicine during breast- Timolol eye drops feeding. 6 Contents of the pack and other information Driving and using machines 1 Do not drive or use machines until What Brinzolamide/Timolol your vision is clear. You may find that eye drops are and what they your vision is blurred for some time just are used for after using Brinzolamide/Timolol eye drops. Brinzolamide/Timolol eye drops contain two active substances, One of the active ingredients may brinzolamide and timolol, which work impair the ability to perform tasks together to reduce pressure within the requiring mental alertness and/or eye. physical coordination. If affected take care when driving or using machines. Brinzolamide/Timolol eye drops are used to treat high pressure in the Brinzolamide/Timolol eye drops eyes, also called glaucoma or ocular contains benzalkonium chloride hypertension, in adult patients that are more than 18 years of age and This medicine contains 0.0033mg in whom high pressure in the eyes benzalkonium chloride in each drop cannot be controlled effectively by one which is equivalent to 0.01% or medicine alone. 0.1mg/ml. Benzalkonium chloride is a 2 What you need to know preservative in Brinzolamide/Timolol before you use Brinzolamide/ eye drops that may be absorbed by Timolol eye drops soft contact lenses and may change the colour of the contact lenses. You Do not use Brinzolamide/Timolol should remove contact lenses before eye drops if you: using this medicine and put them back - are allergic to brinzolamide, 15 minutes afterwards. medicines called sulphonamides Benzalkonium chloride may also cause (examples include medicines used eye irritation, especially if you have to treat diabetes, infections and also dry eyes or disorders of the cornea diuretics (water tablets)), timolol, (the clear layer at the front of the eye). beta-blockers (medicines used to If you feel abnormal eye sensation, lower blood pressure or to treat stinging or pain in the eye after using heart disease) or any of the other this medicine, talk to your doctor. ingredients of this medicine (listed in section 6) 3 How to use Brinzolamide/ - have now or have had in the past Timolol eye drops respiratory problems such as asthma, severe long lasting obstructive Always use this medicine exactly as bronchitis (a severe lung condition your doctor or pharmacist has told you. which may cause wheezing, difficulty Check with your doctor or pharmacist in breathing and/or long standing if you are not sure. cough) or other types of breathing If you are changing from another eye problems drop medicine used to treat glaucoma - have severe hay fever to Brinzolamide/Timolol eye drops, you - have a slow heartbeat, heart failure or should stop using the other medicine disorders of heart rhythm (irregular and start using Brinzolamide/Timolol heartbeats) eye drops the following day. Check - have too much acidity in your blood with your doctor or pharmacist if you (a condition called hyperchloraemic are not sure. acidosis) - have severe kidney problems. To prevent contamination of the dropper tip and the suspension, care Warnings and precautions must be taken not to touch the eyelids, surrounding areas, or other surfaces Only use Brinzolamide/Timolol eye with the dropper tip. Keep the bottle drops for dropping in your eye(s). tightly closed when not in use.

If signs of serious reactions or The following measure is useful to limit hypersensitivity occur, discontinue the the amount of medicine that will come use of this product and talk to your into the blood after application of eye doctor. drops: - Keep the eyelid closed, while Talk to your doctor, pharmacist or simultaneously applying gentle nurse before using Brinzolamide/ pressure to the corner of the eye next Timolol eye drops if you have or have to the nose with a finger for at least 2 had in the past: minutes. - coronary heart disease (symptoms can include chest pain or tightness, The recommended dose is one drop breathlessness or choking), heart in the affected eye or eyes, twice a day. failure, low blood pressure Only use Brinzolamide/Timolol eye - disturbances of heart rate such as drops in both eyes if your doctor slow heart beat told you to. Take it for as long as your - breathing problems, asthma or doctor told you to. chronic obstructive pulmonary disease How to use - 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 an operation that you are using Brinzolamide/Timolol eye drops 1 as timolol may change the effects of some medicines used during anaesthesia - 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 eye drops and adrenaline may not be as effective to treat an allergic reaction. When receiving any other treatment please tell the doctor or nurse that you are taking Brinzolamide/Timolol eye 2 drops - have liver problems - have dry eyes or cornea problems - have problems with your kidneys. Children and adolescents Brinzolamide/Timolol eye drops are not recommended for children and adolescents under 18 years.

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Brinzolamide/Timolol 10 mg/ml Eye drops, suspension 1 x 5ml PIL - UK

approved for print/date Item number: BBBA7130 Colours Non Printing Colours 1. Black 1. Originator: G. Worth Dimensions: 140x590 Origination Date: 13/12/2019 Min Body Text Size: 9pt 2. 2. Revision Date: 19/12/2019 Supplier: Lusomedicamenta 3. 3. Revised By: G. Worth (Recipharm Lisbon) 4. 5. Proof Round 13/12/2019 Technical Date sent: 6. 4 Approval Date received: 07/01/2020 [email protected]

Cartons and label leaflets only (labels only when specified) GTIN 13 (Belgium & Slovenia): German GTIN 14 (incorporating PZN): * Please note that only Artwork Studio is permitted to make changes to the above artwork. Version 6 No changes are permitted by any 3rd party other than added notes and mark ups for required changes. 12.12.2019 - Get the bottle and a mirror - Respiratory: Constriction of the - Wash your hands airways in the lungs (predominantly - Shake well before use in patients with pre-existing disease) - Twist off the bottle cap. After the cap shortness of breath or difficulty is removed, if the tamper evident breathing, cold symptoms, chest snap collar is loose, remove before congestion, sinus infection, sneezing, using product stuffy nose, dry nose, nose bleeds, - Hold the bottle, pointing down, asthma, throat irritation. between your thumb and forefinger - Nervous system and general - Tilt your head back. Pull down your disorders: depression, nightmares, eyelid with a clean finger, until there memory loss, headache, nervousness, is a ‘pocket’ between the eyelid and irritability, tiredness, shaking, your eye. The drop will go in here feeling abnormal, fainting, dizziness, (picture 1) drowsiness, generalised or severe - Bring the bottle tip close to the eye. weakness, unusual sensations like Use the mirror if it helps pins and needles, hallucinations. - Do not touch your eye or eyelid, - Gastric: nausea, vomiting, diarrhoea, surrounding areas, or other surfaces intestinal gas or abdominal with the dropper. It could infect the discomfort, inflammation of the drops throat, dry or abnormal sensation in - Squeeze one drop into the formed mouth, indigestion, stomach ache. pocket (picture 2) - Blood: abnormal liver function - After using Brinzolamide/Timolol values, increased blood chlorine eye drops, press a finger to the levels, or decreased red blood cell corner of your eye, by the nose for count as seen in a blood test. at least 1 minute. This helps to stop - Allergy: increased allergic symptoms, Brinzolamide/Timolol eye drops generalised allergic reactions getting into the rest of the body including swelling beneath the skin (picture 3) that can occur in areas such as the - If you use drops in both eyes, repeat face and limbs and can obstruct the the steps for your other eye airway which may cause difficulty - Close the bottle cap firmly swallowing or breathing, hives, immediately after use localised and generalised rash, - Use up one bottle before opening the itchiness, severe sudden life- next bottle. threatening allergic reaction. - Ear: ringing in the ears, sensation of If a drop misses your eye, try again. spinning or dizziness. - Skin: rash, skin redness or If you are using other eye drop or eye inflammation, abnormal or decreased ointment medicines leave at least skin sensation, hair loss, rash with 5 minutes between each medicine. Eye white silvery coloured appearance ointments should be administered last. (psoriasiform rash) or worsening of psoriasis. If you use more Brinzolamide/ - Muscular: generalised back, joint, or Timolol eye drops than you should, muscle pain not caused by exercise, rinse your eye with warm water. Do not muscle spasms, pain in extremities, put in any more drops until it is time muscle weakness/tiredness, increases for your next regular dose. in the signs and symptoms of myasthenia gravis (muscle disorder). You may experience a decreased heart - Kidney: kidney pain such as lower rate, decreased blood pressure, heart back pain, frequent urination. failure; difficulty breathing and your - Reproduction: sexual dysfunction, nervous system may be affected. decreased libido, male sexual difficulty. If you forget to use Brinzolamide/ - Metabolism: low blood sugar levels. Timolol eye drops, continue with the next dose as planned. Do not use Reporting of side effects a double dose to make up for the If you get any side effects, talk to forgotten dose. Do not use more than your doctor, pharmacist or nurse. This one drop in the affected eye(s) twice includes any possible side effects not daily. listed in this leaflet. You can also report side effects directly via the Yellow Card If you stop using Brinzolamide/ Scheme Website: Timolol eye drops without speaking www.mhra.gov.uk/yellowcard or to your doctor, the pressure in your eye search for MHRA Yellow Card in the will not be controlled which could lead Google Play or Apple App Store. to loss of sight. By reporting side effects you can help If you have any further questions on provide more information on the safety the use of this medicine, ask your of this medicine. doctor, pharmacist or nurse. 5 How to store Brinzolamide/ 4 Possible side effects Timolol eye drops

Like all medicines, this medicine Keep this medicine out of the sight and can cause side effects although not reach of children. everybody gets them. Do not use this medicine after the Stop using this medicine and contact expiry date which is stated on the your doctor immediately if you bottle and the carton after EXP. The develop skin rash, severe skin reaction, expiry date refers to the last day of that or severe redness and itching of the month. eye. These could be the signs of an allergic reaction (frequency is not This medicine does not require any known). special storage conditions.

You can usually carry on taking the Throw away the bottle 4 weeks after drops, unless the effects are serious. first opening to prevent infections and If you are worried, talk to your doctor use a new bottle. Write down the date or pharmacist. Do not stop using of opening on the bottle label and Brinzolamide/Timolol eye drops carton label in the space provided. without speaking to your doctor first. Do not throw away any medicines Common side effects (may affect via wastewater or household waste. up to 1 in 10 people): Ask your pharmacist how to throw away medicines you no longer use. - Effects in the eye: eye surface These measures will help protect the inflammation, blurred vision, signs environment. and symptoms of eye irritation (e.g. burning, stinging, itching, tearing, 6 Contents of the pack and redness), eye pain. - General side effects: heart rate other information decreased, taste disturbances. What Brinzolamide/Timolol eye Uncommon side effects (may drops contains affect up to 1 in 100 people): - The active substances are - Effects in the eye: corneal erosion brinzolamide and timolol. One ml (damage to the front layer of the of suspension contains 10mg of eyeball), Eye surface inflammation brinzolamide and timolol maleate with surface damage, inflammation corresponding to 5mg of timolol. inside the eye, corneal staining, abnormal sensation in the eyes, eye - The other ingredients are discharge, dry eye, tired eyes, itchy benzalkonium chloride (see section eye, eye redness, eyelid redness. 2 ‘Brinzolamide/Timolol eye drops - General side effects: decrease in contains benzalkonium chloride’), white blood cell count, decreased carbomer, disodium edetate, blood pressure, cough, blood in urine, mannitol (E421), purified water, body weakness. sodium chloride, hydrochloric acid and/or sodium hydroxide. Rare side effects (may affect up Tiny amounts of hydrochloric acid and/ to 1 in 1,000 people): or sodium hydroxide are added to keep acidity levels (pH levels) normal. - Effects in the eye: corneal disorder, sensitivity to light, increased tear production, eyelid crusting What Brinzolamide/Timolol eye - General side effects: difficulty drops looks like and contents of sleeping (insomnia), throat pain, the pack running nose Brinzolamide/Timolol eye drops is Not known (frequency cannot a liquid (white to off-white uniform be estimated from the available suspension) supplied in a carton data): containing a 5ml low density polyethylene (LDPE) bottle with a LDPE insert dropper and a high density - Effects in the eye: eye allergy, polyethylene (HDPE) cap containing disturbance of vision, damage 5ml suspension. to the optic nerve, increased pressure in eye, deposits on the eye Cartons contain 1 bottle. surface, decreased eye sensation, inflammation or infection of the conjunctiva (white of the eye), Marketing Authorisation Holder abnormal, double or reduced Accord Healthcare Limited, vision, increased pigmentation of Sage House, the eye, growth on surface of eye, 319 Pinner Road, eye swelling, sensitivity to light, North Harrow, decreased growth or number of Middlesex, eyelashes, drooping of the upper HA1 4HF, eyelids (making the eye stay half United Kingdom closed), inflammation of the eyelid and eye lid glands, inflammation in Manufacturer the cornea and detachment of the Lusomedicamenta Sociedade Técnica layer below the retina that contains Farmacêutica S.A., blood vessels following filtration Rua Norberto De Oliveira 1-5, surgery which may cause visual Povoa De Santo Adriao, disturbances, decreased corneal Lisbon, sensitivity. Portugal, - Heart and circulation: changes 2620-111 in rhythm or rate of the heartbeat, slow heart rate, palpitations, a type This leaflet was last revised in of heart rhythm disorder, abnormal December 2019. increase in heart rate, chest pain, reduced heart function, heart attack, increased blood pressure, reduced If you would like a blood supply to the brain, stroke, leaflet with larger oedema (fluid build-up), congestive heart failure (heart disease with text, please contact shortness of breath and swelling of the feet and legs due to fluid build- 01271 385257. up), swelling of the extremities, low blood pressure, discolouration of the fingers, toes and occasionally other areas of the body (Raynaud’s phenomenon), cold hands and feet.

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Brinzolamide/Timolol 10 mg/ml Eye drops, suspension 1 x 5ml PIL - UK