Brinzolamide/Timolol Aspire 10mg/ml + 5mg/ml eye drops, suspension

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them even if their signs of illnesses are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Brinzolamide/Timolol is and what it is used for
2. What you need to know before you use Brinzolamide/Timolol
3. How to use this medicine
4. Possible side effects
5. How to store this medicine
6. Contents of the pack and other information

• if you are allergic to brinzolamide, medicines called sulphonamides (examples include medicines used to treat diabetes, infections and also diuretics (water tablets)), timolol, beta-blockers (medicines used to lower blood pressure or to treat heart disease) or any of the other ingredients of this medicine (listed in section 6).
• if you have now or have had in the past respiratory problems such as asthma, severe long-lasting obstructive bronchitis (severe lung condition which may cause wheezing, difficulty in breathing and/or long-standing cough) or other types of breathing problems.
• if you have severe hay fever.
• if you have a slow heartbeat, heart failure or disorders of heart rhythm (irregular heartbeats).
• if you have too much acidity in your blood (a condition called hyperchloraemic acidosis).
• if you have severe kidney problems.

Only use this medicine for dropping in your eye(s).

If signs of serious reactions or hypersensitivity occur, discontinue the use of this product and talk to your doctor.

Talk to your doctor or pharmacist before using this medicine if you have or have had in the past:

• coronary heart disease (symptoms can include chest pain or tightness, breathlessness or choking), heart failure, low blood pressure.
• disturbances of heart rate such as slow heartbeat.
• breathing problems, asthma or chronic 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 an operation that you are using Brinzolamide/Timolol 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 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.
• if you have liver problems.
• if you have dry eyes or cornea problems.
• if you have problems with your kidneys.
• if you have ever developed a severe skin rash or skin peeling, blistering and/or mouth sores after using brinzolamide or other related medicines.

Serious skin reactions including Stevens- Johnson syndrome and toxic epidermal necrolysis have been reported in association with brinzolamide treatment. Stop using brinzolamide and seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.

This medicine is not recommended for children and adolescents under 18 years.

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

Brinzolamide/Timolol can affect, or be affected by, other medicines you are taking, including other eye drops for the treatment of glaucoma.

Tell your doctor if you are taking or intend to take medicines to lower blood pressure like parasympathomimetics and guanethidine, or other heart medicines including quinidine (used to treat heart conditions and some types of malaria), amiodarone or other medicines to treat heart rhythm disorders and glycosides to treat heart insufficiency. Also tell your doctor if you are taking or intend to take medicines to treat diabetes, or to treat gastric ulcers, antifungal, antiviral or antibiotic medicines, or antidepressants such as fluoxetine and paroxetine.

If you are taking another carbonic anhydrase inhibitor (acetazolamide or dorzolamide), talk to your doctor.

Increase in pupil size when taking Brinzolamide/Timolol and adrenaline (epinephrine) together has been reported occasionally.

You should not use this medicine if you are pregnant or might get pregnant, unless your doctor considers it necessary. Talk to your doctor before you use Brinzolamide/Timolol.

Do not use this medicine if you are breast-feeding, timolol may get into your milk.

Ask your doctor for advice before taking any medicine during breast-feeding.

Do not drive or use machines until your vision is clear. You may find that your vision is blurred for some time just after using this medicine.

One of the active ingredients may impair the ability to perform tasks requiring mental alertness and/or physical coordination.

If affected take care when driving or using machines.

This medicine contains 0.0033mg benzalkonium chloride in each drop which is equivalent to 0.01% or 0.1mg/ml.

Benzalkonium chloride is a preservative in Brinzolamide/Timolol that may be absorbed by soft contact lenses and may change the colour of the contact lenses. You should remove contact lenses before using this medicine and put them back 15 minutes afterwards.

Benzalkonium chloride may also cause eye irritation, especially if you have dry eyes or disorders of the cornea (the clear layer at the front of the eye). If you feel abnormal eye sensation, stinging or pain in the eye after using this medicine, talk to your doctor.

• Get the bottle and a mirror.
• Wash your hands.
• Shake well before use.
• Twist off the bottle cap. After the cap is removed, if the tamper evident snap collar is loose, remove before using product.
• Hold the bottle, pointing down, between your thumb and forefinger.
• Tilt your head back. Pull down your eyelid with a clean finger, until there is a ‘pocket’ between the eyelid and your eye. The drop will go in here (picture 1).

• Bring the bottle tip close to the eye. Use the mirror if it helps.
• Do not touch your eye or eyelid, surrounding areas or other surfaces with the dropper. It could infect the drops.
• Squeeze one drop into the formed pocket (picture 2).

• After using this medicine, press a finger to the corner of your eye, by the nose for at least 2 minutes. This helps to stop Brinzolamide/Timolol getting into the rest of the body (picture 3).

• If you use drops in both eyes, repeat the steps for your other eye.
• Close the bottle cap firmly immediately after use.
• Use up one bottle before opening the next bottle.

If a drop misses your eye, try again.

If you are using other eye drop or eye ointment medicines leave at least 5 minutes between each medicine. Eye ointments should be administered last.

Rinse your eye with warm water. Do not put in any more drops until it is time for your next regular dose.

You may experience a decreased heart rate, decreased blood pressure, heart failure; difficulty breathing and your nervous system may be affected.

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

If you stop using this medicine without speaking to your doctor, the pressure in your eye will not be controlled which could lead to loss of sight.

• if you develop a skin rash, severe skin reaction, or severe redness and itching of the eye.
  These could be the signs of an allergic reaction (frequency is not known).
• reddish non-elevated, target-like or circular patches on the trunk, often with central blisters, skin peeling, ulcers of mouth, throat, nose, genitals and eyes. These serious skin rashes can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).

You can usually carry on taking the drops, unless the effects are serious. If you are worried, talk to your doctor or pharmacist.

Do not stop using this medicine without speaking to your doctor first.

Common side effects (may affect up to 1 in 10 people):

• Effects in the eye: eye surface inflammation, blurred vision, signs and symptoms of eye irritation (e.g. burning, stinging, itching, tearing, redness), eye pain.
• General side effects: heart rate decreased, taste disturbances.

Uncommon side effects (may affect up to 1 in 100 people):

• Effects in the eye: corneal erosion (damage to the front layer of the eyeball), eye surface inflammation with surface damage, inflammation inside the eye, corneal staining, abnormal sensation in the eyes, eye discharge, dry eye, tired eyes, itchy eye, eye redness, eyelid redness.
• General side effects: decrease in white blood cell count, decreased blood pressure, cough, blood in urine, body weakness.

Rare side effects (may affect up to 1 in 1,000 people):

• Effects in the eye: corneal disorder, sensitivity to light, increased tear production, eyelid crusting.
• General side effects: difficulty sleeping (insomnia), throat pain, running nose.

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

• Effects in the eye: eye allergy, disturbance of vision, damage to the optic nerve, increased pressure in eye, deposits on the eye surface, decreased eye sensation, inflammation or infection of the conjunctiva (white of the eye), abnormal, double or reduced vision, increased pigmentation of the eye, growth on surface of eye, eye swelling, sensitivity to light, decreased growth or number of eyelashes, drooping of the upper eyelids (making the eye stay half closed), inflammation of the eyelid and eye lid glands, inflammation in the cornea and detachment of the layer below the retina that contains blood vessels following filtration surgery which may cause visual disturbances, decreased corneal sensitivity.
• Heart and circulation: changes in rhythm or rate of the heartbeat, slow heart rate, palpitations, a type of heart rhythm disorder, abnormal increase in heart rate, chest pain, reduced heart function, heart attack, increased blood pressure, reduced blood supply to the brain, stroke, oedema (fluid build-up), congestive heart failure (heart disease with shortness of breath and swelling of the feet and legs due to fluid build-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.
• Respiratory: constriction of the airways in the lungs (predominantly in patients with pre-existing disease) shortness of breath or difficulty breathing, cold symptoms, chest congestion, sinus infection, sneezing, stuffy nose, dry nose, nose bleeds, asthma, throat irritation.
• Nervous system and general disorders: depression, nightmares, memory loss, headache, nervousness, irritability, tiredness, shaking, feeling abnormal, fainting, dizziness, drowsiness, generalised or severe weakness, unusual sensations like pins and needles, hallucination.
• Gastric: nausea, vomiting, diarrhoea, intestinal gas or abdominal discomfort, inflammation of the throat, dry or abnormal sensation in mouth, indigestion, stomach ache.
• Blood: abnormal liver function values, increased blood chlorine levels, or decreased red blood cell count as seen in a blood test.
• Allergy: increased allergic symptoms, generalised allergic reactions including swelling beneath the skin that can occur in areas such as the face and limbs and can obstruct the airway which may cause difficulty swallowing or breathing, hives, localised and generalised rash, itchiness, severe sudden life-threatening allergic reaction.
• Ear: ringing in the ears, sensation of spinning or dizziness.
• Skin: rash, skin redness or inflammation, abnormal or decreased skin sensation, hair loss, rash with white silvery coloured appearance (psoriasiform rash) or worsening of psoriasis.
• Muscular: generalised back, joint, or muscle pain not caused by exercise, muscle spasms, pain in extremities, muscle weakness/tiredness, increases in the signs and symptoms of myasthenia gravis (muscle disorder).
• Kidney: kidney pain such as lower back pain, frequent urination.
• Reproduction: sexual dysfunction, decreased libido, male sexual difficulty.
• Metabolism: low blood sugar levels.
• General side effects: reddish non-elevated, target-like or circular patches on the trunk, often with central blisters, skin peeling, ulcers of mouth, throat, nose, genitals and eyes, which can be preceded by fever and flu-like symptoms. These serious skin rashes can be potentially life-threatening (Stevens-Johnson syndrome, toxic epidermal necrolysis).

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme (website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store). By reporting side effects you can help provide more information on the safety of this medicine.

• The active substances are brinzolamide and timolol. One ml of suspension contains 10mg of brinzolamide and timolol maleate corresponding to 5mg timolol.
• The other ingredients are benzalkonium chloride (see section 2 ‘Brinzolamide/Timolol contains benzalkonium chloride’), carbomer, disodium edetate, mannitol (E421), purified water, sodium chloride, hydrochloric acid and/or sodium hydroxide.

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

Brinzolamide/Timolol is a liquid (white to off-white uniform suspension) supplied in a carton containing a 10ml low density polyethylene (LDPE) bottle with a LDPE insert dropper and a high density polyethylene (HDPE) cap containing 5ml suspension.

Cartons contain 1, 3 or 6 bottles.

Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Manufacturer: